Depression, Problematic Alcohol Use
Conditions
Keywords
Latin America, Depression, mHealth, Problematic Alcohol Use
Brief summary
Conduct systematic, multi-site mental health implementation research in both rural and urban primary care settings with a broad group of stakeholders in the US and Latin America.
Detailed description
The investigators plan to launch and evaluate a new mental health service delivery model in Latin America. Specifically, in this new multi-component, mental health service delivery intervention, the investigators propose to: (1) harness mobile behavioral health technology for mental health (with a primary focus on depression and a secondary focus on problematic alcohol and other substance abuse), (2) launch new workforce training and service delivery models (including the integration of technology into service delivery), (3) launch and evolve an integrated data management system for systematic data tracking and outcomes assessment, and (4) launch and grow a learning collaborative of organizations integrating mental health into primary care. The investigators will launch this project at multiple primary care sites in various parts of Colombia, with a plan to inform subsequent adoption in several other Latin American countries, including Chile and Peru.
Interventions
Laddr is a mobile behavioral health technology that offers science-based self-regulation monitoring and health behavior change tools via an integrated platform to a wide array of populations. Specifically, the core functionality of Laddr (e.g., problem-solving therapy) will be structured to focus on an end user's management of depression and its impact on their functioning and quality of life. The program will secondarily focus on problematic alcohol use and its relationship to depression management.
Sponsors
Study design
Intervention model description
The investigators will initially pilot test this mental health service delivery model at a single primary care site and then refine the model based on pilot data. The investigators will then expand implementation across 6 Colombia-based healthcare sites in urban and rural communities (including approximately 2000 participants). Consistent with a modified stepped wedge design (multiple baseline design), the investigators will implement the model across sites on a staggered basis and expand the number of sites in which the investigators implement over time. By conducting this multi-site implementation research project, the investigators can assess the extent to which the implementation model and associated outcomes are replicable across sites and/or the extent to which the model needs to be modified for differing contexts.
Eligibility
Inclusion criteria
* Provider and administrative staff Inclusion Criteria: * Aged \> 18 years * Have worked for the study site for at least 3 months. * Participant Inclusion Criteria: * Aged \> 18 years * Patients at one of our collaborating primary care sites * Screen positive for minor (score of 5-9), moderate (score of 10-14), moderately severe (score of 15-19) or severe (score of 20-27) depression on Patient Health Questionnaire (PHQ-9)62 and/or screen positive for problematic alcohol use on Alcohol Use Disorder Identification Test (AUDIT) developed by the World Health Organization (a score of 8 or more on 10-item AUDIT)63 and have a confirmed diagnosis of depression and/or alcohol use disorder based on clinical consultation at the primary care site * Willing to provide informed consent to use mobile intervention and complete study assessments
Exclusion criteria
-Participant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Program Sustainability Assessment Tool (PSAT) Administrative Staff | At the time of the staff training, 6 months, 12 months, 18 months, and 24 months. | This instrument was developed from the Program Sustainability Assessment and consists of 7 scales: Environmental Support, Funding Stability, Partnerships, Organizational Capacity, Program Evaluation, Program Adaptation, Communication with Public, Communications within the organization, and Communication with Government. All seven scales have a range of 1 to 4 (1- Not at all, 2- A little bit, 3- A moderate amount, 4- A lot). The seven sub-scales are combined to an overall score by averaging the sub-scale scores. The computed overall scales have a range of 1 to 4. |
| The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Consumer Instrument | At 6- and 12-month follow-up visits with a sub-sample of participants | This measure consists of 5 scales: Adoption, Appropriateness, Acceptability, Feasibility, and Reach/Access. All four scales have a range of 1 to 4 (1- Not at all, 2- A little bit, 3- A moderate amount, 4- A lot). |
| The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument | At the time of the provider training, 6 months, 12 months, 18 months, and 24 months. | This measure consists of 8 scales: Adoption, Appropriateness, Feasibility, Reach/Access, Organizational climate, Leadership in Implementing, and General Leadership Skills. All eight scales have a range of 1 to 4 (1- Not at all, 2- A little bit, 3- A moderate amount, 4- A lot). |
| The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument | At the time of the staff training, 6 months, 12 months, 18 months, and 24 months. | This measure consists of 9 scales: 1) Adoption, Appropriateness, Acceptability, Feasibility, Reach/Access, Organizational climate, Leadership in Implementing, General Leadership Skills, and Knowledge. All nine scales have a range of 1 to 4 (1- Not at all, 2- A little bit, 3- A moderate amount, 4- A lot). |
| The Program Sustainability Assessment Tool (PSAT) Providers | At the time of the provider training, 6 months, 12 months, 18 months, and 24 months. | This instrument was developed from the Program Sustainability Assessment and consists of 7 scales: Environmental Support, Partnerships, Organizational Capacity, Program Evaluation, Program Adaptation, Communication with Public, and Communications within the organization. All scales have a range of 1 to 4 (1- Not at all, 2- A little bit, 3- A moderate amount, 4- A lot). The seven sub-scales are combined to an overall score by averaging the sub-scale scores. The computed overall scales have a range of 1 to 4. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 12-item World Health Organization Disability Assessment Schedule 2.0 (WHODAS) | This patient measure were assessed at baseline and every 3 months for a period of 12 months (for a total of 5 assessment timepoints-level assessments per patient). | The WHODAS 2.0 assesses health-related difficulties across six different domains of functioning (cognition, mobility, self-care, socializing, life activities, and participation) that are linked conceptually and operationally to the International Classification of Functioning, Disability and Health (ICF). The scores assigned to 12 items are - none (1), mild (2) moderate (3), severe (4) and extreme (5). The scores for the 12 items are summed into a total score ranging from 12 (least severe) to 50 (most severe). The last 3 items of the assessment collect the number of days the reported health-related difficulties impact the participants in the past 90 days. |
| General Anxiety Disorder Screener (GAD-7) | This patient measure were assessed at baseline and every 3 months for a period of 12 months (for a total of 5 assessment timepoints per patient). | The GAD-7 is a 7-item self-reported screening questionnaire that has been validated to assess for generalized anxiety disorder (GAD) in outpatient and primary care settings. The measure is scored from 0 to 21, with 0 meaning minimal anxiety and 21 meaning most severe anxiety. |
| The Quick Drinking Screen (QDS) (for Full Implementation Study Only) | At baseline and every 3 months for a period of 12 months (for a total of 5 assessment timepoints per patient with implementation study participants). | The Quick Drinking Screen (QDS) is a 3-item questionnaire which asks about average drinking habits over the last ninety days. The responses are used to calculate the number of standard drinks consumed per week. In this measure, a standard drink is defined as 1-12 oz. regular can or glass of beer, or 1-5 oz. glass of regular wine, or 1 ½ oz. of regular proof hard liquor or spirits. Patients with alcohol use disorder will be asked to complete this measure as part of the baseline assessment and at every 3 months follow-up (a total of 5 assessment timepoints). |
| Patient Health Questionnaire (PHQ-8) | This patient measure were assessed at baseline and every 3 months thereafter for a period of 12 months (for a total of 5 assessment timepoints per patient). | A measure with 8 items used to assess depression. The total score of the scale ranges from 0 to 24, with 0 representing no significant depressive symptoms and 24 representing the most severe depressive symptoms. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient Utilization Interviews/Observations | At 3- and 6-months post-implementation (+/- a 2 week window around the targeted data collection date) | The investigators will recruit and follow a sample of patients (approx. 5 at each site) during the implementation project to explore feasibility issues regarding use, barriers and facilitating strategies for using the program, optimal dissemination strategies for promoting use of the program, and overall experiences using the program over time. These patient participants will be encouraged to document their experiences with the mental health service delivery model in an ongoing manner (e.g., note jotting, pictures, audio recording). |
| EuroQOL Five Dimensions Questionnaire (EQ-5D) (Only for Pilot Participants) | This patient measure will be assessed at baseline and every 3 months for a period of 12 months (for a total of 5 assessment timepoints per patient with pilot participants). | The EQ-5D. The EQ-5D is a standardized instrument that has been widely used and validated within Spanish speaking populations from several countries in Latin America, and assesses 5 key dimensions of health. |
| COVID-19 Impact Survey | Patients will be assessed once at a follow-up visit every 3 months or at a separately scheduled visit. Providers and administrators will be assessed once at a follow-up visit every 6 months or at a separate visit. | The COVID-19 Impact Survey is a self-reported questionnaire developed by the NIMH U19 Scale-Up Hubs and will assess the impact of COVID-19 among patients, providers, and administrators enrolled in this study. Given the unknown and widespread implications of the COVID-19 pandemic in Colombia, it is critical to understand the context of COVID-19 for interpreting the study's findings. |
| Provider Interviews | At 3- and 6-months post-implementation (+/- a 2 week window around the targeted data collection date) | Provider interviews will assess implementation experiences, challenges to implementation and strategies used to facilitate implementation with different patient populations, changes made to workflow with use of the intervention, and salience of monitoring and feedback processes to inform providers and other stakeholders about the implementation success (approx. 5 at each site). The investigators will also assess the extent to which patients initiated use of the program via inquiry of their providers after learning of the program through patient channels. |
| EuroQol Visual Analogue Scale (EQ-VAS) (Only for Pilot Participants) | This patient measure will be assessed at baseline and every 3 months for a period of 12 months (for a total of 5 assessment timepoints per patient with pilot participants). | The EQ-VAS assess health-related quality of life. The EQ-VAS asks how good or bad your health is today? The scale ranges from 0 (worst health imaginable) to 100 (best health imaginable). The participants marks their number with an X on the scale and writes it in a box. |
| Alcohol Timeline Follow-back (Alcohol TLFB) (Only for Pilot Participants) | This patient measure will be assessed at baseline and every 3 months for a period of 12 months (for a total of 5 assessment timepoints per patient with pilot participants). | A measure used to assess problematic alcohol use. The Alcohol TLFB asks patients about their alcohol use in the past 30 days. |
| Behavioral Health Integration in Medical Care Index (BHIMC) | Approximately every year prior to the time of implementation launch at a given site (starting with baseline in late 2017); at the time of implementation launch; and approximately every year thereafter at each site until study completion (April 2021). | The BHIMC is an organizational measure of the level of behavioral health integration in medical practice settings. It evaluates policy, clinical practice and workforce dimensions of integration using mixed methods, i.e. combination of document review and observation. |
| The Time-driven Activity-based Costing (TDABC) Approach | Approximately every year prior to the time of implementation launch at a given site (starting with baseline in late 2017); at the time of implementation launch; and approximately every year thereafter at each site until study completion (April 2021). | The TDABC method measures costs of implementing the proposed model of care for depression and alcohol use disorders.The TDABC method will be used to determine the costs of the specific human, equipment, and facility resources used for delivering mental health care to patients as part of the model of care. |
| Non-Study Medical and Other Services (NSMOS) | At baseline and every 3 months for a period of 12 months (for a total of 5 assessment timepoints per patient). | The NSOMS assesses patients' medical resource use that is not part of the intervention, including non-treatment therapy visits, physician visits, residential and/or hospital detoxification, hospital and emergency department visits, and medication use through patient self-report. |
| Non-Medical Expenses for Depression (NMED) | At baseline and every 3 months for a period of 12 months (for a total of 5 assessment timepoints per patient). | The NMED assesses the non-medical costs of depression. This measure is in Spanish and has been used in Latin America and used by our team at Javeriana. |
| Health and Work Performance Questionnaire (HPQ) | At baseline, 6-month follow-ups, and 12-month follow-ups (for a total of 3 assessment timepoints per patient). | The HPQ was developed by the World Health Organization, and assess the impact of depression on work performance (including sickness absence, presenteeism, and critical incidents). |
| Administrative Interviews | At 3- and 6-months post-implementation (+/- a 2 week window around the targeted data collection date) | Administrative interviews will assess implementation experiences, challenges to implementation and strategies used to facilitate implementation with different patient populations, changes made to workflow with use of the intervention, and salience of monitoring and feedback processes to inform providers and other stakeholders about the implementation success (approx. 5 at each site). The investigators will also assess the extent to which patients initiated use of the program via inquiry of their providers after learning of the program through patient channels. |
Countries
Colombia
Participant flow
Recruitment details
At the primary care site patients upon arrival were asked to complete screeners (for depression and problematic alcohol use). In the event of positive screen for depression and/or alcohol use problems, clinicians at site completed an in-depth diagnostic interview. Participants who met all inclusionary criteria were informed about this project and provided an informed consent form. Providers and administrators who worked for the site for at least 3 months were asked to participate.
Participants by arm
| Arm | Count |
|---|---|
| Patients in Digital Health Assisted Mental Healthcare Intervention Patients were offered a multi-component model of science-based mental health care. All participants who consented to participate were given access to the mobile therapeutic tool based on the novel mobile-based platform (Laddr® from Square2 Systems). A trained staff member at the primary care site showed them how to use the tool.
Laddr is a mobile behavioral health technology that offers science-based self-regulation monitoring and health behavior change tools via an integrated platform to a wide array of populations. The program secondarily focused on problematic alcohol use and its relationship to depression management. | 1,264 |
| Providers in Digital Health Assisted Mental Healthcare Intervention Providers at partnering primary care sites were all offered the opportunity to complete the implementation context and outcome measure in this research project at the time of implementation launch and at designated timepoints thereafter. | 45 |
| Administrative Staff in Digital Health Assisted Mental Healthcare Intervention Administrative staff at partnering primary care sites were all offered the opportunity to complete the implementation context and outcome measure in this research project at the time of implementation launch and at designated timepoints thereafter. | 39 |
| Total | 1,348 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 0 |
| Overall Study | Death | 4 | 0 | 0 |
| Overall Study | Lack of Efficacy | 29 | 0 | 0 |
| Overall Study | Lost to Follow-up | 122 | 13 | 9 |
| Overall Study | Withdrawal by Subject | 180 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Administrative Staff in Digital Health Assisted Mental Healthcare Intervention | Providers in Digital Health Assisted Mental Healthcare Intervention | Patients in Digital Health Assisted Mental Healthcare Intervention |
|---|---|---|---|---|
| Age, Continuous | 48.88 years STANDARD_DEVIATION 17.34 | 36.39 years STANDARD_DEVIATION 12.51 | 32.87 years STANDARD_DEVIATION 10.12 | 49.60 years STANDARD_DEVIATION 17.28 |
| Alcoholics Anonymous No | 1252 Participants | 0 Participants | 0 Participants | 1252 Participants |
| Alcoholics Anonymous Prefers not to respond | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Alcoholics Anonymous Yes | 12 Participants | 0 Participants | 0 Participants | 12 Participants |
| Antidepressants Use No | 1075 Participants | 0 Participants | 0 Participants | 1075 Participants |
| Antidepressants Use Prefers not to respond | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Antidepressants Use Yes | 187 Participants | 0 Participants | 0 Participants | 187 Participants |
| Education Level At least one year in two-year university program | 21 Participants | 0 Participants | 0 Participants | 21 Participants |
| Education Level At least three years in four-year university program | 36 Participants | 1 Participants | 0 Participants | 35 Participants |
| Education Level Diploma | 4 Participants | 0 Participants | 0 Participants | 4 Participants |
| Education Level Doctorate | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Education Level Grade 1 | 64 Participants | 0 Participants | 0 Participants | 64 Participants |
| Education Level Grade 10 | 17 Participants | 0 Participants | 0 Participants | 17 Participants |
| Education Level Grade 11 | 21 Participants | 0 Participants | 0 Participants | 21 Participants |
| Education Level Grade 2 | 71 Participants | 0 Participants | 0 Participants | 71 Participants |
| Education Level Grade 3 | 72 Participants | 0 Participants | 0 Participants | 72 Participants |
| Education Level Grade 4 | 47 Participants | 0 Participants | 0 Participants | 47 Participants |
| Education Level Grade 5 | 178 Participants | 0 Participants | 0 Participants | 178 Participants |
| Education Level Grade 6 | 36 Participants | 0 Participants | 0 Participants | 36 Participants |
| Education Level Grade 7 | 43 Participants | 0 Participants | 0 Participants | 43 Participants |
| Education Level Grade 8 | 31 Participants | 0 Participants | 0 Participants | 31 Participants |
| Education Level Grade 9 | 40 Participants | 0 Participants | 0 Participants | 40 Participants |
| Education Level Kindergarten | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Education Level Less than one year of university | 19 Participants | 1 Participants | 0 Participants | 18 Participants |
| Education Level Master's Degree | 43 Participants | 12 Participants | 13 Participants | 18 Participants |
| Education Level None | 34 Participants | 0 Participants | 0 Participants | 34 Participants |
| Education Level One year in four-year university program | 13 Participants | 0 Participants | 0 Participants | 13 Participants |
| Education Level Preschool | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Education Level Professional Degree | 177 Participants | 14 Participants | 28 Participants | 135 Participants |
| Education Level Secondary Education Diploma | 199 Participants | 1 Participants | 0 Participants | 198 Participants |
| Education Level Technical Studies | 160 Participants | 9 Participants | 2 Participants | 149 Participants |
| Education Level Two years in four-year university program | 9 Participants | 0 Participants | 0 Participants | 9 Participants |
| Education Level University Degree | 11 Participants | 1 Participants | 2 Participants | 8 Participants |
| Education Level Unknown or prefers not to respond | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Employment Status Full-time Employed | 171 Participants | 0 Participants | 0 Participants | 171 Participants |
| Employment Status Housekeeper | 428 Participants | 0 Participants | 0 Participants | 428 Participants |
| Employment Status Part-time Employed | 49 Participants | 0 Participants | 0 Participants | 49 Participants |
| Employment Status Pensioner | 75 Participants | 0 Participants | 0 Participants | 75 Participants |
| Employment Status Prefers not to respond | 9 Participants | 0 Participants | 0 Participants | 9 Participants |
| Employment Status Self-employed | 286 Participants | 0 Participants | 0 Participants | 286 Participants |
| Employment Status Student | 70 Participants | 0 Participants | 0 Participants | 70 Participants |
| Employment Status Unable to work | 25 Participants | 0 Participants | 0 Participants | 25 Participants |
| Employment Status Unemployed, not seeking jobs | 39 Participants | 0 Participants | 0 Participants | 39 Participants |
| Employment Status Unemployed, seeking jobs | 112 Participants | 0 Participants | 0 Participants | 112 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1067 Participants | 34 Participants | 42 Participants | 991 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants | 1 Participants | 0 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 260 Participants | 4 Participants | 3 Participants | 253 Participants |
| Family History of Depression First degree relatives with depression | 132 Participants | 0 Participants | 0 Participants | 132 Participants |
| Family History of Depression No family history of depression | 764 Participants | 0 Participants | 0 Participants | 764 Participants |
| Family History of Depression Parents with depression | 163 Participants | 0 Participants | 0 Participants | 163 Participants |
| Family History of Depression Prefers not to respond | 156 Participants | 0 Participants | 0 Participants | 156 Participants |
| Family History of Depression Siblings with depression | 133 Participants | 0 Participants | 0 Participants | 133 Participants |
| Family History of Harmful Alcohol Use First degree relatives with harmful alcohol use | 367 Participants | 0 Participants | 0 Participants | 367 Participants |
| Family History of Harmful Alcohol Use No family history of harmful alcohol use | 605 Participants | 0 Participants | 0 Participants | 605 Participants |
| Family History of Harmful Alcohol Use Parents with harmful alcohol use | 473 Participants | 0 Participants | 0 Participants | 473 Participants |
| Family History of Harmful Alcohol Use Prefers not to respond | 18 Participants | 0 Participants | 0 Participants | 18 Participants |
| Family History of Harmful Alcohol Use Siblings with harmful alcohol use | 356 Participants | 0 Participants | 0 Participants | 356 Participants |
| Health Insurance Status Contributory plan (EPS) | 413 Participants | 0 Participants | 0 Participants | 413 Participants |
| Health Insurance Status Indigenous Health plan | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Health Insurance Status No insurance | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Health Insurance Status Prefers not to respond | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Health Insurance Status Special plan (Armed Forces, Ecopetrol) | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Health Insurance Status Subsidized plan (ARS, SISBEN, EPS-S) | 845 Participants | 0 Participants | 0 Participants | 845 Participants |
| Health Insurance Status Supplemental plan or prepaid medical plan | 4 Participants | 0 Participants | 0 Participants | 4 Participants |
| History of previous depressive episodes 0 episodes | 890 Participants | 0 Participants | 0 Participants | 890 Participants |
| History of previous depressive episodes 1 episode | 225 Participants | 0 Participants | 0 Participants | 225 Participants |
| History of previous depressive episodes 2 episodes | 70 Participants | 0 Participants | 0 Participants | 70 Participants |
| History of previous depressive episodes 3 episodes | 71 Participants | 0 Participants | 0 Participants | 71 Participants |
| History of previous depressive episodes Prefers not to respond | 8 Participants | 0 Participants | 0 Participants | 8 Participants |
| History of Traumatic Events 1 | 372 Participants | 0 Participants | 0 Participants | 372 Participants |
| History of Traumatic Events 10 | 6 Participants | 0 Participants | 0 Participants | 6 Participants |
| History of Traumatic Events 2 | 199 Participants | 0 Participants | 0 Participants | 199 Participants |
| History of Traumatic Events 3 | 83 Participants | 0 Participants | 0 Participants | 83 Participants |
| History of Traumatic Events 4 | 37 Participants | 0 Participants | 0 Participants | 37 Participants |
| History of Traumatic Events 5 | 24 Participants | 0 Participants | 0 Participants | 24 Participants |
| History of Traumatic Events 6 | 10 Participants | 0 Participants | 0 Participants | 10 Participants |
| History of Traumatic Events 7 | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| History of Traumatic Events 9 | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| History of Traumatic Events No traumatic events | 500 Participants | 0 Participants | 0 Participants | 500 Participants |
| History of Traumatic Events Prefers not to respond | 31 Participants | 0 Participants | 0 Participants | 31 Participants |
| Internet Use No, does not use the Internet | 421 Participants | 0 Participants | 0 Participants | 421 Participants |
| Internet Use Yes, uses the Internet | 843 Participants | 0 Participants | 0 Participants | 843 Participants |
| Length of time to reach healthcare center 0-29 minutes | 631 Participants | 0 Participants | 0 Participants | 631 Participants |
| Length of time to reach healthcare center 30-59 minutes | 464 Participants | 0 Participants | 0 Participants | 464 Participants |
| Length of time to reach healthcare center 60-120 minutes | 134 Participants | 0 Participants | 0 Participants | 134 Participants |
| Length of time to reach healthcare center More than 120 minutes | 34 Participants | 0 Participants | 0 Participants | 34 Participants |
| Length of time to reach healthcare center Prefers not to respond | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Marital Status Divorced | 36 Participants | 0 Participants | 0 Participants | 36 Participants |
| Marital Status Married or Free Union | 544 Participants | 0 Participants | 0 Participants | 544 Participants |
| Marital Status Prefers not to respond | 6 Participants | 0 Participants | 0 Participants | 6 Participants |
| Marital Status Separated | 172 Participants | 0 Participants | 0 Participants | 172 Participants |
| Marital Status Single | 399 Participants | 0 Participants | 0 Participants | 399 Participants |
| Marital Status Widowed | 107 Participants | 0 Participants | 0 Participants | 107 Participants |
| Medication for controlling problematic alcohol use No | 1262 Participants | 0 Participants | 0 Participants | 1262 Participants |
| Medication for controlling problematic alcohol use Prefers not to respond | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Medication for controlling problematic alcohol use Yes | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Name of Primary Care Center Site Hospital Armero Guayabal | 14 Participants | 3 Participants | 2 Participants | 9 Participants |
| Name of Primary Care Center Site Hospital de Chaparral | 84 Participants | 3 Participants | 3 Participants | 78 Participants |
| Name of Primary Care Center Site Hospital Granja de Lerida | 41 Participants | 9 Participants | 5 Participants | 27 Participants |
| Name of Primary Care Center Site Hospital Regional de Duitama | 491 Participants | 6 Participants | 14 Participants | 471 Participants |
| Name of Primary Care Center Site Hospital Santa Rosa de Viterbo | 210 Participants | 6 Participants | 8 Participants | 196 Participants |
| Name of Primary Care Center Site Javesalud - Bogota | 508 Participants | 12 Participants | 13 Participants | 483 Participants |
| Name of Primary Care Center Site Prefer not to respond | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Number of persons in household 0 | 130 Participants | 0 Participants | 0 Participants | 130 Participants |
| Number of persons in household 1 | 312 Participants | 0 Participants | 0 Participants | 312 Participants |
| Number of persons in household 10 | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Number of persons in household 11 | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Number of persons in household 12 | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Number of persons in household 14 | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Number of persons in household 2 | 277 Participants | 0 Participants | 0 Participants | 277 Participants |
| Number of persons in household 3 | 253 Participants | 0 Participants | 0 Participants | 253 Participants |
| Number of persons in household 4 | 148 Participants | 0 Participants | 0 Participants | 148 Participants |
| Number of persons in household 5 | 77 Participants | 0 Participants | 0 Participants | 77 Participants |
| Number of persons in household 6 | 33 Participants | 0 Participants | 0 Participants | 33 Participants |
| Number of persons in household 7 | 16 Participants | 0 Participants | 0 Participants | 16 Participants |
| Number of persons in household 8 | 8 Participants | 0 Participants | 0 Participants | 8 Participants |
| Number of persons in household 9 | 4 Participants | 0 Participants | 0 Participants | 4 Participants |
| Psychotherapy Treatment Use No | 1048 Participants | 0 Participants | 0 Participants | 1048 Participants |
| Psychotherapy Treatment Use Prefers not to respond | 3 Participants | 0 Participants | 0 Participants | 3 Participants |
| Psychotherapy Treatment Use Yes | 213 Participants | 0 Participants | 0 Participants | 213 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 24 Participants | 1 Participants | 0 Participants | 23 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 0 Participants | 0 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 726 Participants | 23 Participants | 22 Participants | 681 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 340 Participants | 8 Participants | 14 Participants | 318 Participants |
| Race (NIH/OMB) White | 248 Participants | 7 Participants | 9 Participants | 232 Participants |
| Region of Enrollment Colombia | 1348 participants | 39 participants | 45 participants | 1264 participants |
| Sex: Female, Male Female | 1026 Participants | 27 Participants | 30 Participants | 969 Participants |
| Sex: Female, Male Male | 322 Participants | 12 Participants | 15 Participants | 295 Participants |
| Smartphone Use No - does not have a smartphone | 382 Participants | 0 Participants | 0 Participants | 382 Participants |
| Smartphone Use Yes - has a smartphone. | 882 Participants | 0 Participants | 0 Participants | 882 Participants |
| Socioeconomic Status Prefers not to respond | 14 Participants | 0 Participants | 0 Participants | 14 Participants |
| Socioeconomic Status Rural Area | 168 Participants | 0 Participants | 0 Participants | 168 Participants |
| Socioeconomic Status Stratum 1 | 300 Participants | 0 Participants | 0 Participants | 300 Participants |
| Socioeconomic Status Stratum 2 | 316 Participants | 0 Participants | 0 Participants | 316 Participants |
| Socioeconomic Status Stratum 3 | 272 Participants | 0 Participants | 0 Participants | 272 Participants |
| Socioeconomic Status Stratum 4 | 152 Participants | 0 Participants | 0 Participants | 152 Participants |
| Socioeconomic Status Stratum 5 | 33 Participants | 0 Participants | 0 Participants | 33 Participants |
| Socioeconomic Status Stratum 6 | 9 Participants | 0 Participants | 0 Participants | 9 Participants |
| Substance Use Cannabis | 53 Participants | 0 Participants | 0 Participants | 53 Participants |
| Substance Use Cocaine | 7 Participants | 0 Participants | 0 Participants | 7 Participants |
| Substance Use Hallucinogens | 5 Participants | 0 Participants | 0 Participants | 5 Participants |
| Substance Use Methamphetamine | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Substance Use Prescription Opioids | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Substance Use Prescription Stimulants | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Substance Use Sedatives | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Substance Use Street Opioids | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Substance Use Tobacco | 163 Participants | 0 Participants | 0 Participants | 163 Participants |
| Tobacco Use Current smoker | 163 Participants | 0 Participants | 0 Participants | 163 Participants |
| Tobacco Use Former smoker | 414 Participants | 0 Participants | 0 Participants | 414 Participants |
| Tobacco Use Never smoked | 686 Participants | 0 Participants | 0 Participants | 686 Participants |
| Tobacco Use Prefers not to respond | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 7 / 1,264 |
| other Total, other adverse events | 615 / 1,264 |
| serious Total, serious adverse events | 107 / 1,264 |
Outcome results
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Consumer Instrument
This measure consists of 5 scales: Adoption, Appropriateness, Acceptability, Feasibility, and Reach/Access. All four scales have a range of 1 to 4 (1- Not at all, 2- A little bit, 3- A moderate amount, 4- A lot).
Time frame: At 6- and 12-month follow-up visits with a sub-sample of participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Consumer Instrument | 6-month follow-up Adoption | 2.76 score on a scale | Standard Deviation 0.58 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Consumer Instrument | 6-month follow-up Acceptability | 3.22 score on a scale | Standard Deviation 0.64 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Consumer Instrument | 6-month follow-up Appropriateness | 3.21 score on a scale | Standard Deviation 0.64 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Consumer Instrument | 6-month follow-up Feasibility | 2.91 score on a scale | Standard Deviation 0.62 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Consumer Instrument | 6-month follow-up Reach/Access | 2.59 score on a scale | Standard Deviation 0.69 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Consumer Instrument | 12-month follow-up Adoption | 3.05 score on a scale | Standard Deviation 0.62 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Consumer Instrument | 12-month follow-up Acceptability | 3.27 score on a scale | Standard Deviation 0.61 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Consumer Instrument | 12-month follow-up Appropriateness | 3.28 score on a scale | Standard Deviation 0.5 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Consumer Instrument | 12-month follow-up Feasibility | 2.93 score on a scale | Standard Deviation 0.54 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Consumer Instrument | 12-month follow-up Reach/Access | 2.67 score on a scale | Standard Deviation 0.66 |
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument
This measure consists of 9 scales: 1) Adoption, Appropriateness, Acceptability, Feasibility, Reach/Access, Organizational climate, Leadership in Implementing, General Leadership Skills, and Knowledge. All nine scales have a range of 1 to 4 (1- Not at all, 2- A little bit, 3- A moderate amount, 4- A lot).
Time frame: At the time of the staff training, 6 months, 12 months, 18 months, and 24 months.
Population: The study implementation timeline was designed to have staggered launch dates for the six sites. Specifically, Javesalud (Site 1) and Santa Rosa (Site 2) launched first and were able to complete all follow-ups. Tundama (Site 3) was only able to complete through 18-month follow-ups. Guasca (Site 4) and Armero (Site 5) were only able to complete through 12-month follow-ups. Soacha (Site 6) was only able to complete through the 6-month follow-ups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument | Feasibility at Baseline | 2.88 score on a scale | Standard Deviation 0.6 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument | Feasibility at 6 months | 3.17 score on a scale | Standard Deviation 0.52 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument | Feasibility at 12 months | 2.96 score on a scale | Standard Deviation 0.55 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument | Feasibility at 18 months | 3.20 score on a scale | Standard Deviation 0.49 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument | Feasibility at 24 months | 3.17 score on a scale | Standard Deviation 0.59 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument | Reach/Access at Baseline | 2.93 score on a scale | Standard Deviation 0.58 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument | Reach/Access at 6 months | 3.41 score on a scale | Standard Deviation 0.62 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument | Reach/Access at 12 months | 3.47 score on a scale | Standard Deviation 0.54 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument | Reach/Access at 18 months | 3.70 score on a scale | Standard Deviation 0.35 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument | Reach/Access at 24 months | 3.58 score on a scale | Standard Deviation 0.27 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument | Organizational Climate at Baseline | 3.39 score on a scale | Standard Deviation 0.43 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument | Organizational Climate at 6 months | 3.20 score on a scale | Standard Deviation 0.77 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument | Organizational Climate at 12 months | 3.22 score on a scale | Standard Deviation 0.63 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument | Organizational Climate at 18 months | 3.52 score on a scale | Standard Deviation 0.64 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument | Organizational Climate at 24 months | 3.47 score on a scale | Standard Deviation 0.48 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument | Leadership in Implementing at Baseline | 3.29 score on a scale | Standard Deviation 0.69 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument | Leadership in Implementing at 6 months | 3.17 score on a scale | Standard Deviation 0.78 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument | Leadership in Implementing at 12 months | 3.25 score on a scale | Standard Deviation 0.8 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument | Leadership in Implementing at 18 months | 3.65 score on a scale | Standard Deviation 0.37 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument | Leadership in Implementing at 24 months | 3.47 score on a scale | Standard Deviation 0.45 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument | General Leadership Skills at Baseline | 3.34 score on a scale | Standard Deviation 0.56 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument | General Leadership Skills at 6 months | 2.42 score on a scale | Standard Deviation 1.02 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument | General Leadership Skills at 12 months | 2.92 score on a scale | Standard Deviation 0.81 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument | General Leadership Skills at 18 months | 2.44 score on a scale | Standard Deviation 0.63 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument | General Leadership Skills at 24 months | 2.80 score on a scale | Standard Deviation 1.05 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument | Knowledge at Baseline | 1.95 score on a scale | Standard Deviation 0.48 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument | Knowledge at 6 months | 1.95 score on a scale | Standard Deviation 0.28 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument | Knowledge at 12 months | 1.92 score on a scale | Standard Deviation 0.27 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument | Knowledge at 18 months | 1.91 score on a scale | Standard Deviation 0.26 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument | Knowledge at 24 months | 1.92 score on a scale | Standard Deviation 0.26 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument | Adoption at Baseline | 3.38 score on a scale | Standard Deviation 0.47 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument | Adoption at 6 months | 3.37 score on a scale | Standard Deviation 0.46 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument | Adoption at 12 months | 3.69 score on a scale | Standard Deviation 0.4 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument | Adoption at 18 months | 3.87 score on a scale | Standard Deviation 0.22 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument | Adoption at 24 months | 3.50 score on a scale | Standard Deviation 0.67 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument | Accessibility at Baseline | 3.77 score on a scale | Standard Deviation 0.37 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument | Accessibility at 6 months | 3.50 score on a scale | Standard Deviation 0.39 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument | Accessibility at 12 months | 3.50 score on a scale | Standard Deviation 0.42 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument | Accessibility at 18 months | 3.60 score on a scale | Standard Deviation 0.42 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument | Accessibility at 24 months | 3.39 score on a scale | Standard Deviation 0.55 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument | Appropriateness at Baseline | 3.54 score on a scale | Standard Deviation 0.37 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument | Appropriateness at 6 months | 2.77 score on a scale | Standard Deviation 0.89 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument | Appropriateness at 12 months | 2.99 score on a scale | Standard Deviation 0.55 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument | Appropriateness at 18 months | 3.19 score on a scale | Standard Deviation 0.53 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Organizational Staff Instrument | Appropriateness at 24 months | 3.07 score on a scale | Standard Deviation 0.55 |
The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument
This measure consists of 8 scales: Adoption, Appropriateness, Feasibility, Reach/Access, Organizational climate, Leadership in Implementing, and General Leadership Skills. All eight scales have a range of 1 to 4 (1- Not at all, 2- A little bit, 3- A moderate amount, 4- A lot).
Time frame: At the time of the provider training, 6 months, 12 months, 18 months, and 24 months.
Population: The study implementation timeline was designed to have staggered launch dates for the six sites. Specifically, Javesalud (Site 1) and Santa Rosa (Site 2) launched first and were able to complete all follow-ups. Tundama (Site 3) was only able to complete through 18-month follow-ups. Guasca (Site 4) and Armero (Site 5) were only able to complete through 12-month follow-ups. Soacha (Site 6) was only able to complete through the 6-month follow-ups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument | Adoption at Baseline | 2.95 score on a scale | Standard Deviation 0.55 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument | Adoption at 6 months | 2.65 score on a scale | Standard Deviation 0.61 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument | Adoption at 12 months | 2.93 score on a scale | Standard Deviation 0.43 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument | Adoption at 18 months | 2.92 score on a scale | Standard Deviation 0.51 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument | Adoption at 24 months | 2.85 score on a scale | Standard Deviation 0.68 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument | Accessibility at Baseline | 3.41 score on a scale | Standard Deviation 0.51 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument | Accessibility at 6 months | 3.35 score on a scale | Standard Deviation 0.45 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument | Accessibility at 12 months | 3.50 score on a scale | Standard Deviation 0.47 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument | Accessibility at 18 months | 3.55 score on a scale | Standard Deviation 0.32 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument | Accessibility at 24 months | 3.38 score on a scale | Standard Deviation 0.44 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument | Appropriateness at Baseline | 3.40 score on a scale | Standard Deviation 0.34 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument | Appropriateness at 6 months | 3.32 score on a scale | Standard Deviation 0.47 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument | Appropriateness at 12 months | 3.52 score on a scale | Standard Deviation 0.31 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument | Appropriateness at 18 months | 3.41 score on a scale | Standard Deviation 0.42 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument | Appropriateness at 24 months | 3.16 score on a scale | Standard Deviation 0.48 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument | Feasibility at Baseline | 2.94 score on a scale | Standard Deviation 0.55 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument | Feasibility at 6 months | 2.88 score on a scale | Standard Deviation 0.38 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument | Feasibility at 12 months | 2.72 score on a scale | Standard Deviation 0.4 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument | Feasibility at 18 months | 3.01 score on a scale | Standard Deviation 0.31 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument | Feasibility at 24 months | 2.84 score on a scale | Standard Deviation 0.63 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument | Resources at Baseline | 3.14 score on a scale | Standard Deviation 0.65 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument | Resources at 6 months | 3.08 score on a scale | Standard Deviation 0.42 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument | Resources at 12 months | 2.98 score on a scale | Standard Deviation 0.47 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument | Resources at 18 months | 3.17 score on a scale | Standard Deviation 0.44 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument | Resources at 24 months | 3.14 score on a scale | Standard Deviation 0.64 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument | Reach/Access at Baseline | 2.78 score on a scale | Standard Deviation 0.65 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument | Reach/Access at 6 months | 2.85 score on a scale | Standard Deviation 0.48 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument | Reach/Access at 12 months | 2.96 score on a scale | Standard Deviation 0.44 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument | Reach/Access at 18 months | 3.00 score on a scale | Standard Deviation 0.52 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument | Reach/Access at 24 months | 2.91 score on a scale | Standard Deviation 0.22 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument | Organizational Climate at Baseline | 3.42 score on a scale | Standard Deviation 0.44 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument | Organizational Climate at 6 months | 3.43 score on a scale | Standard Deviation 0.43 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument | Organizational Climate at 12 months | 3.56 score on a scale | Standard Deviation 0.3 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument | Organizational Climate at 18 months | 3.60 score on a scale | Standard Deviation 0.35 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument | Organizational Climate at 24 months | 3.43 score on a scale | Standard Deviation 0.61 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument | Leadership in Implementing at Baseline | 3.38 score on a scale | Standard Deviation 0.65 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument | Leadership in Implementing at 6 months | 3.24 score on a scale | Standard Deviation 0.64 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument | Leadership in Implementing at 12 months | 3.46 score on a scale | Standard Deviation 0.41 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument | Leadership in Implementing at 18 months | 3.57 score on a scale | Standard Deviation 0.44 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument | Leadership in Implementing at 24 months | 3.06 score on a scale | Standard Deviation 0.86 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument | General Leadership Skills at Baseline | 3.32 score on a scale | Standard Deviation 0.67 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument | General Leadership Skills at 6 months | 3.36 score on a scale | Standard Deviation 0.55 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument | General Leadership Skills at 12 months | 3.48 score on a scale | Standard Deviation 0.45 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument | General Leadership Skills at 18 months | 3.48 score on a scale | Standard Deviation 0.5 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Integrated Measure of Implementation Context and Outcomes as a Change Over Time in Low and Middle Income Countries Provider Instrument | General Leadership Skills at 24 months | 3.20 score on a scale | Standard Deviation 0.94 |
The Program Sustainability Assessment Tool (PSAT) Administrative Staff
This instrument was developed from the Program Sustainability Assessment and consists of 7 scales: Environmental Support, Funding Stability, Partnerships, Organizational Capacity, Program Evaluation, Program Adaptation, Communication with Public, Communications within the organization, and Communication with Government. All seven scales have a range of 1 to 4 (1- Not at all, 2- A little bit, 3- A moderate amount, 4- A lot). The seven sub-scales are combined to an overall score by averaging the sub-scale scores. The computed overall scales have a range of 1 to 4.
Time frame: At the time of the staff training, 6 months, 12 months, 18 months, and 24 months.
Population: The study implementation timeline was designed to have staggered launch dates for the six sites. For providers/staff, not all sites completed 18 and 24-month follow-up assessments. Also, baseline data was collected prior to site implementation launch. Some providers/administrators consented and provided data (at various follow-up times) after baseline implementation data collection took place at the sites.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Program Sustainability Assessment Tool (PSAT) Administrative Staff | Baseline overall | 2.72 score on a scale | Standard Deviation 0.58 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Program Sustainability Assessment Tool (PSAT) Administrative Staff | 6 months follow-up overall | 3.14 score on a scale | Standard Deviation 0.37 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Program Sustainability Assessment Tool (PSAT) Administrative Staff | 12 months follow-up overall | 3.23 score on a scale | Standard Deviation 0.27 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Program Sustainability Assessment Tool (PSAT) Administrative Staff | 18 months follow-up overall | 3.41 score on a scale | Standard Deviation 0.29 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Program Sustainability Assessment Tool (PSAT) Administrative Staff | 24 months follow-up overall | 3.32 score on a scale | Standard Deviation 0.32 |
The Program Sustainability Assessment Tool (PSAT) Providers
This instrument was developed from the Program Sustainability Assessment and consists of 7 scales: Environmental Support, Partnerships, Organizational Capacity, Program Evaluation, Program Adaptation, Communication with Public, and Communications within the organization. All scales have a range of 1 to 4 (1- Not at all, 2- A little bit, 3- A moderate amount, 4- A lot). The seven sub-scales are combined to an overall score by averaging the sub-scale scores. The computed overall scales have a range of 1 to 4.
Time frame: At the time of the provider training, 6 months, 12 months, 18 months, and 24 months.
Population: The study implementation timeline was designed to have staggered launch dates for the six sites. For providers/staff, not all sites completed 18 and 24-month follow-up assessments. Also, baseline data is collected prior to site implementation launch. Some providers/administrators consented and provided data (at various follow-up times) after baseline implementation data collection took place at the sites.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Program Sustainability Assessment Tool (PSAT) Providers | Baseline overall | 3.01 score on a scale | Standard Deviation 0.61 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Program Sustainability Assessment Tool (PSAT) Providers | 6 months follow-up overall | 2.91 score on a scale | Standard Deviation 0.63 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Program Sustainability Assessment Tool (PSAT) Providers | 12 months follow-up overall | 2.99 score on a scale | Standard Deviation 0.41 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Program Sustainability Assessment Tool (PSAT) Providers | 18 months follow-up overall | 3.01 score on a scale | Standard Deviation 0.51 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Program Sustainability Assessment Tool (PSAT) Providers | 24 months follow-up overall | 2.82 score on a scale | Standard Deviation 0.63 |
12-item World Health Organization Disability Assessment Schedule 2.0 (WHODAS)
The WHODAS 2.0 assesses health-related difficulties across six different domains of functioning (cognition, mobility, self-care, socializing, life activities, and participation) that are linked conceptually and operationally to the International Classification of Functioning, Disability and Health (ICF). The scores assigned to 12 items are - none (1), mild (2) moderate (3), severe (4) and extreme (5). The scores for the 12 items are summed into a total score ranging from 12 (least severe) to 50 (most severe). The last 3 items of the assessment collect the number of days the reported health-related difficulties impact the participants in the past 90 days.
Time frame: This patient measure were assessed at baseline and every 3 months for a period of 12 months (for a total of 5 assessment timepoints-level assessments per patient).
Population: The number of participants analyzed differs at each assessment timepoint due to a number of participants who were unable to reach during the designated window of assessment and participants who actively withdrew from the study for various non-safety related reasons.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients in Digital Health Assisted Mental Healthcare Intervention | 12-item World Health Organization Disability Assessment Schedule 2.0 (WHODAS) | Baseline Total Sum Score | 23.07 score on a scale | Standard Deviation 7.72 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | 12-item World Health Organization Disability Assessment Schedule 2.0 (WHODAS) | 3-Month Total Sum Score | 19.55 score on a scale | Standard Deviation 7.3 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | 12-item World Health Organization Disability Assessment Schedule 2.0 (WHODAS) | 6-Month Total Sum Score | 19.32 score on a scale | Standard Deviation 7.5 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | 12-item World Health Organization Disability Assessment Schedule 2.0 (WHODAS) | 9-Month Total Sum Score | 18.87 score on a scale | Standard Deviation 6.98 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | 12-item World Health Organization Disability Assessment Schedule 2.0 (WHODAS) | 12-Month Total Sum Score | 18.59 score on a scale | Standard Deviation 6.73 |
General Anxiety Disorder Screener (GAD-7)
The GAD-7 is a 7-item self-reported screening questionnaire that has been validated to assess for generalized anxiety disorder (GAD) in outpatient and primary care settings. The measure is scored from 0 to 21, with 0 meaning minimal anxiety and 21 meaning most severe anxiety.
Time frame: This patient measure were assessed at baseline and every 3 months for a period of 12 months (for a total of 5 assessment timepoints per patient).
Population: Number of participants analyzed differ at each assessment timepoint because some participants were unable to be reached during the designated window of follow-up and some participants withdrew from the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients in Digital Health Assisted Mental Healthcare Intervention | General Anxiety Disorder Screener (GAD-7) | 12-Month | 3.34 score on a scale | Standard Deviation 3.69 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | General Anxiety Disorder Screener (GAD-7) | Baseline | 9.11 score on a scale | Standard Deviation 5.43 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | General Anxiety Disorder Screener (GAD-7) | 3-Month | 5.21 score on a scale | Standard Deviation 4.65 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | General Anxiety Disorder Screener (GAD-7) | 6-Month | 4.63 score on a scale | Standard Deviation 4.35 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | General Anxiety Disorder Screener (GAD-7) | 9-Month | 4.05 score on a scale | Standard Deviation 3.97 |
Patient Health Questionnaire (PHQ-8)
A measure with 8 items used to assess depression. The total score of the scale ranges from 0 to 24, with 0 representing no significant depressive symptoms and 24 representing the most severe depressive symptoms.
Time frame: This patient measure were assessed at baseline and every 3 months thereafter for a period of 12 months (for a total of 5 assessment timepoints per patient).
Population: Only patient participants with a depression diagnosis completed the PHQ assessment at all timepoints. The number of participants analyzed varies at each assessment timepoint due to participants unable to reach during the window of follow-up and participants who withdrew from the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients in Digital Health Assisted Mental Healthcare Intervention | Patient Health Questionnaire (PHQ-8) | Baseline | 11.32 score on a scale | Standard Deviation 5.07 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | Patient Health Questionnaire (PHQ-8) | 3-Month | 5.82 score on a scale | Standard Deviation 5.09 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | Patient Health Questionnaire (PHQ-8) | 6-Month | 5.51 score on a scale | Standard Deviation 4.94 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | Patient Health Questionnaire (PHQ-8) | 9-Month | 5.37 score on a scale | Standard Deviation 4.67 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | Patient Health Questionnaire (PHQ-8) | 12-Month | 4.67 score on a scale | Standard Deviation 4.38 |
The Quick Drinking Screen (QDS) (for Full Implementation Study Only)
The Quick Drinking Screen (QDS) is a 3-item questionnaire which asks about average drinking habits over the last ninety days. The responses are used to calculate the number of standard drinks consumed per week. In this measure, a standard drink is defined as 1-12 oz. regular can or glass of beer, or 1-5 oz. glass of regular wine, or 1 ½ oz. of regular proof hard liquor or spirits. Patients with alcohol use disorder will be asked to complete this measure as part of the baseline assessment and at every 3 months follow-up (a total of 5 assessment timepoints).
Time frame: At baseline and every 3 months for a period of 12 months (for a total of 5 assessment timepoints per patient with implementation study participants).
Population: The overall number of participants is different from the overall number of the patients arm, because this assessment was only administered to patients diagnosed with alcohol use disorder. There are different numbers of participants analyzed at each timepoint due to a number of participants who were unable to be reached in the designated window of follow-up and who withdrew from the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Quick Drinking Screen (QDS) (for Full Implementation Study Only) | Baseline Standard Drinks per Week | 22.74 standard drinks per week | Standard Deviation 28.28 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Quick Drinking Screen (QDS) (for Full Implementation Study Only) | 3-Month Standard Drinks per Week | 35.20 standard drinks per week | Standard Deviation 96.14 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Quick Drinking Screen (QDS) (for Full Implementation Study Only) | 6-Month Standard Drinks per Week | 46.37 standard drinks per week | Standard Deviation 102 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Quick Drinking Screen (QDS) (for Full Implementation Study Only) | 9-Month Standard Drinks per Week | 38.11 standard drinks per week | Standard Deviation 80.02 |
| Patients in Digital Health Assisted Mental Healthcare Intervention | The Quick Drinking Screen (QDS) (for Full Implementation Study Only) | 12-Month Standard Drinks per Week | 25.33 standard drinks per week | Standard Deviation 72.61 |
Administrative Interviews
Administrative interviews will assess implementation experiences, challenges to implementation and strategies used to facilitate implementation with different patient populations, changes made to workflow with use of the intervention, and salience of monitoring and feedback processes to inform providers and other stakeholders about the implementation success (approx. 5 at each site). The investigators will also assess the extent to which patients initiated use of the program via inquiry of their providers after learning of the program through patient channels.
Time frame: At 3- and 6-months post-implementation (+/- a 2 week window around the targeted data collection date)
Alcohol Timeline Follow-back (Alcohol TLFB) (Only for Pilot Participants)
A measure used to assess problematic alcohol use. The Alcohol TLFB asks patients about their alcohol use in the past 30 days.
Time frame: This patient measure will be assessed at baseline and every 3 months for a period of 12 months (for a total of 5 assessment timepoints per patient with pilot participants).
Behavioral Health Integration in Medical Care Index (BHIMC)
The BHIMC is an organizational measure of the level of behavioral health integration in medical practice settings. It evaluates policy, clinical practice and workforce dimensions of integration using mixed methods, i.e. combination of document review and observation.
Time frame: Approximately every year prior to the time of implementation launch at a given site (starting with baseline in late 2017); at the time of implementation launch; and approximately every year thereafter at each site until study completion (April 2021).
COVID-19 Impact Survey
The COVID-19 Impact Survey is a self-reported questionnaire developed by the NIMH U19 Scale-Up Hubs and will assess the impact of COVID-19 among patients, providers, and administrators enrolled in this study. Given the unknown and widespread implications of the COVID-19 pandemic in Colombia, it is critical to understand the context of COVID-19 for interpreting the study's findings.
Time frame: Patients will be assessed once at a follow-up visit every 3 months or at a separately scheduled visit. Providers and administrators will be assessed once at a follow-up visit every 6 months or at a separate visit.
EuroQOL Five Dimensions Questionnaire (EQ-5D) (Only for Pilot Participants)
The EQ-5D. The EQ-5D is a standardized instrument that has been widely used and validated within Spanish speaking populations from several countries in Latin America, and assesses 5 key dimensions of health.
Time frame: This patient measure will be assessed at baseline and every 3 months for a period of 12 months (for a total of 5 assessment timepoints per patient with pilot participants).
EuroQol Visual Analogue Scale (EQ-VAS) (Only for Pilot Participants)
The EQ-VAS assess health-related quality of life. The EQ-VAS asks how good or bad your health is today? The scale ranges from 0 (worst health imaginable) to 100 (best health imaginable). The participants marks their number with an X on the scale and writes it in a box.
Time frame: This patient measure will be assessed at baseline and every 3 months for a period of 12 months (for a total of 5 assessment timepoints per patient with pilot participants).
Health and Work Performance Questionnaire (HPQ)
The HPQ was developed by the World Health Organization, and assess the impact of depression on work performance (including sickness absence, presenteeism, and critical incidents).
Time frame: At baseline, 6-month follow-ups, and 12-month follow-ups (for a total of 3 assessment timepoints per patient).
Non-Medical Expenses for Depression (NMED)
The NMED assesses the non-medical costs of depression. This measure is in Spanish and has been used in Latin America and used by our team at Javeriana.
Time frame: At baseline and every 3 months for a period of 12 months (for a total of 5 assessment timepoints per patient).
Non-Study Medical and Other Services (NSMOS)
The NSOMS assesses patients' medical resource use that is not part of the intervention, including non-treatment therapy visits, physician visits, residential and/or hospital detoxification, hospital and emergency department visits, and medication use through patient self-report.
Time frame: At baseline and every 3 months for a period of 12 months (for a total of 5 assessment timepoints per patient).
Patient Utilization Interviews/Observations
The investigators will recruit and follow a sample of patients (approx. 5 at each site) during the implementation project to explore feasibility issues regarding use, barriers and facilitating strategies for using the program, optimal dissemination strategies for promoting use of the program, and overall experiences using the program over time. These patient participants will be encouraged to document their experiences with the mental health service delivery model in an ongoing manner (e.g., note jotting, pictures, audio recording).
Time frame: At 3- and 6-months post-implementation (+/- a 2 week window around the targeted data collection date)
Provider Interviews
Provider interviews will assess implementation experiences, challenges to implementation and strategies used to facilitate implementation with different patient populations, changes made to workflow with use of the intervention, and salience of monitoring and feedback processes to inform providers and other stakeholders about the implementation success (approx. 5 at each site). The investigators will also assess the extent to which patients initiated use of the program via inquiry of their providers after learning of the program through patient channels.
Time frame: At 3- and 6-months post-implementation (+/- a 2 week window around the targeted data collection date)
The Time-driven Activity-based Costing (TDABC) Approach
The TDABC method measures costs of implementing the proposed model of care for depression and alcohol use disorders.The TDABC method will be used to determine the costs of the specific human, equipment, and facility resources used for delivering mental health care to patients as part of the model of care.
Time frame: Approximately every year prior to the time of implementation launch at a given site (starting with baseline in late 2017); at the time of implementation launch; and approximately every year thereafter at each site until study completion (April 2021).