Substance Use Disorders
Conditions
Brief summary
This research will test a technology adoption framework to increase use of the A-CHESS smartphone app. The project, based in Iowa, will compare a control condition (using a typical product training approach to software implementation that includes user tutorials and instruction on administrative and clinical protocols, followed by access to on-line support) to the typical product training combined with NIATx-TI. Terms - A-CHESS: Addiction Comprehensive Health Enhancement Support System NIATx-TI: Network for the Improvement of Addiction Treatment-Technology Implementation
Detailed description
Patient-centered e-health has failed to achieve its promise despite considerable consumer interest in technology and research supporting its potential. E-health adoption rates in healthcare are poor, with specialty substance use disorder (SUD) treatment having the lowest technology adoption rate of any sector. Implementation science can address this emerging gap in the e-health field by augmenting existing models, that explain organizational and individual e-health behaviors retrospectively, with prospective models that can guide implementation. The organizational planning discipline, with its decades of research, could provide a cross-disciplinary jump start to developing an e-health implementation model for health organizations. Henry Mintzberg, a respected pioneer in this field, describes 2 beneficial approaches to planning: the deliberate approach, which is grounded in pre-implementation planning, and the emergent approach that is grounded in adapting to the environment as the plan is implemented. The proposed e-health implementation model, called the Network for the Improvement of Addiction Treatment-Technology Implementation (NIATx-TI) Framework, incorporates both approaches. NIATx-TI was piloted in the Iowa Rural Health Information Technology Initiative (IRHIT) with 14 of Iowa's 105 SUD treatment sites and resulted in a 2-fold increase in patients receiving distance treatment. The framework's deliberate component includes using an organizational technology assessment and patient simulation. These tools identify and address assets and barriers to incorporate into the technology's implementation protocol. The framework's emergent component includes using a project team to uncover and prioritize implementation barriers as they arise, develop changes to address identified barriers, and monitor selected adoption measures, while receiving monthly coaching. This project, based in Iowa, will compare a control condition (using a typical product training approach to software implementation that includes user tutorials and instruction on administrative and clinical protocols, followed by access to on-line support) to the typical product training combined with NIATx-TI. While e-health spans many modalities and health disciplines, this project will focus on the implementing Addiction Comprehensive Health Enhancement Support System (A-CHESS), an evidence-based SUD treatment recovery app developed by our Center for a disease that affects 21.5 million and kills 136,000 Americans annually: substance use disorder. A mobile app was selected, as opposed to another e-health technology, because of the near ubiquitous daily use of mobile technology and because mobile e-health adoption requires supportive participation of both health centers and patients. In response to the COVID-19 pandemic, the study team added a study component focused on describing how patients are responding to receiving remote treatment (e.g., telehealth). The study team will also seek to understand how using A-CHESS mitigates COVID-19 associated anxiety and loneliness among those with substance use disorders.
Interventions
NIATx-TI framework includes the product training as well as a preimplementation phase and a post-implementation phase. A NIATx-TI coach will provide the training for this arm. The coach will also assist the organizations with applying the NIATx-TI framework.
Sponsors
Study design
Eligibility
Inclusion criteria
* Must be 18+ years old * Understand English * Have a SUD diagnosis * Have access to a smartphone
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reach: As Assessed by the Mean Number of Clinics With Participants Who Download the A-CHESS App | 45 months | The mean number of clinics with patients who download the A-CHESS app will be obtained monthly during the study via the A-CHESS server and Iowa Department of Public Health (IDPH) data. |
| Reach: As Assessed by the Number of Days That Participants Use the A-CHESS | 45 months | The frequency of use of A-CHESS by each participant will be obtained monthly during the study via the A-CHESS server and Iowa Department of Public Health (IDPH) data. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adoption: Number of Days Each Counselor Used the A-CHESS | 45 months | Number of days each counselor used the A-CHESS will be assessed by A-CHESS logs |
| Adoption - The Percentage of Counselors Using A-CHESS Will be Assessed Via the Organizational Survey and A-CHESS Logs | Collected twice during study; starting M22 - 31 and M35-44 | Organizational survey will be completed by a member of the management team two times during the project (organizational baseline, end of the intervention) |
| Organizational Readiness of Participating Organizations as Assessed by Organizational Change Manager (Survey) | Collected twice during study; approx. M14 - 25 and M32 - 43 | Survey data on the organizational readiness of participating organizations. Organizational Readiness (as measured by Organizational Change Manager) - 5 categories from Not True (0) to True (3) and Don't Know (No score). Scores range from 0-66. Higher scores indicate greater readiness for change. |
| Financial Resource Availability (Survey) | Collected twice during study; starting M22 - 31 and M35-44 | Survey data on how the organization's financial resource availability affects A-CHESS implementation. Scored the availability of financial resources on a 5-point scale from 0= Not Ture to 4= True. Scores range from 0-28. Higher score indicates greater availability of resources. |
| Difference in Number of Admissions in Rural vs. Urban Location | Collected during months 7, 18, 30, and 42, month 42 reported | Statistical analysis of organizational traits will be done by calculating the difference in number of admissions in rural vs. urban location. The number of clinics located in a rural area was counted. The number of clinics in an urban location were counted. |
| A-CHESS/NIATx Implementation Fidelity (Survey) | Collected twice during study; approx. M14 - 25 and M32 - 43 | Survey data on participating organizations' fidelity to the NIATx Technology Implementation (NIATx-TI) process. The Implementation Fidelity survey is a 13 item questionnaire using a 4-point scale where 0 = Not True and 4 = True. Scores range from 0-52. Higher scores indicate greater implementation fidelity. |
| Effectiveness of A-CHESS as Assessed by the Retention Rate of Eligible Participants. | Collected monthly during months 13 - 45 | Retention rates of eligible participants |
Other
| Measure | Time frame | Description |
|---|---|---|
| Supplement 1 - Understand Impact of ACHESS on pt Anxiety and Loneliness During COVID-19 Pandemic | M34-37 | Online survey |
| Supplement 2 - Understand How Treatment Organizations and Staff Used ACHESS During COVID Pandemic | M34-37 | Online survey |
Countries
United States
Participant flow
Recruitment details
Participants (SUD clinic sites) funded by the Iowa Department of Health and Human Services (formerly Iowa Department of Public Health) were recruited between May 2019 and April 2020.
Participants by arm
| Arm | Count |
|---|---|
| TAU/Control Sites in the Treatment as Usual (TAU)/Control Arm will receive product training/online support. Sites in the TAU/Control Arm will participate in a one-day product implementation or training session. | 10,586 |
| TAU/Control Sites in the Treatment as Usual (TAU)/Control Arm will receive product training/online support. Sites in the TAU/Control Arm will participate in a one-day product implementation or training session. | 19 |
| NIATx-TI Framework Sites in the NIATx-TI Arm will receive product training/online support, and training in the NIATx-TI framework. The NIATx-TI framework will include a pre-implementation (planning) phase, and post-implementation (problem-solving) phase, with training delivered by a NIATx-TI coach.
NIATx-TI with Product Training/On-line Support: NIATx-TI framework includes the product training as well as a preimplementation phase and a post-implementation phase. A NIATx-TI coach will provide the training for this arm. The coach will also assist the organizations with applying the NIATx-TI framework. | 12,573 |
| NIATx-TI Framework Sites in the NIATx-TI Arm will receive product training/online support, and training in the NIATx-TI framework. The NIATx-TI framework will include a pre-implementation (planning) phase, and post-implementation (problem-solving) phase, with training delivered by a NIATx-TI coach.
NIATx-TI with Product Training/On-line Support: NIATx-TI framework includes the product training as well as a preimplementation phase and a post-implementation phase. A NIATx-TI coach will provide the training for this arm. The coach will also assist the organizations with applying the NIATx-TI framework. | 21 |
| Total | 23,199 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 500 | 0 |
Baseline characteristics
| Characteristic | TAU/Control | NIATx-TI Framework | Total |
|---|---|---|---|
| Age, Continuous Counselors | 42.4 years STANDARD_DEVIATION 11.5 | 45.1 years STANDARD_DEVIATION 12.4 | 44.3 years STANDARD_DEVIATION 12.2 |
| Age, Continuous Participants | 34.8 years STANDARD_DEVIATION 12.2 | 36.0 years STANDARD_DEVIATION 12.4 | 35.5 years STANDARD_DEVIATION 12.3 |
| Average # of admissions | 68.2 Number of admissions STANDARD_DEVIATION 82.6 | 78.3 Number of admissions STANDARD_DEVIATION 111.6 | 73.5 Number of admissions STANDARD_DEVIATION 97.8 |
| Ethnicity (NIH/OMB) Counselors Hispanic or Latino | 2 Participants | 6 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Counselors Not Hispanic or Latino | 98 Participants | 118 Participants | 216 Participants |
| Ethnicity (NIH/OMB) Counselors Unknown or Not Reported | 14 Participants | 70 Participants | 84 Participants |
| Ethnicity (NIH/OMB) Patients Hispanic or Latino | 926 Participants | 674 Participants | 1600 Participants |
| Ethnicity (NIH/OMB) Patients Not Hispanic or Latino | 8920 Participants | 11212 Participants | 20132 Participants |
| Ethnicity (NIH/OMB) Patients Unknown or Not Reported | 626 Participants | 493 Participants | 1119 Participants |
| Region of Enrollment United States | 10586 participants | 12573 participants | 23159 participants |
| Sex/Gender, Customized Counselors: Genderqueer/Other | 0 Participants | 0 Participants | 0 Participants |
| Sex/Gender, Customized Counselors: Man | 10 Participants | 48 Participants | 58 Participants |
| Sex/Gender, Customized Counselors: Refused/Unknown | 3 Participants | 30 Participants | 33 Participants |
| Sex/Gender, Customized Counselors: Transgender Man | 0 Participants | 0 Participants | 0 Participants |
| Sex/Gender, Customized Counselors: Transgender Woman | 0 Participants | 0 Participants | 0 Participants |
| Sex/Gender, Customized Counselors: Woman | 101 Participants | 116 Participants | 217 Participants |
| Sex/Gender, Customized Patients: Genderqueer/Other | 5 Participants | 73 Participants | 78 Participants |
| Sex/Gender, Customized Patients: Man | 5192 Participants | 7623 Participants | 12815 Participants |
| Sex/Gender, Customized Patients: Refused/Unknown | 2564 Participants | 445 Participants | 3009 Participants |
| Sex/Gender, Customized Patients: Transgender Man | 5 Participants | 3 Participants | 8 Participants |
| Sex/Gender, Customized Patients: Transgender Woman | 3 Participants | 6 Participants | 9 Participants |
| Sex/Gender, Customized Patients: Woman | 2703 Participants | 4229 Participants | 6932 Participants |
| Site location (rural v urban) Half Rural/ Half Urban | 1 Number of sites | 1 Number of sites | 2 Number of sites |
| Site location (rural v urban) Rural | 1 Number of sites | 3 Number of sites | 4 Number of sites |
| Site location (rural v urban) Urban | 17 Number of sites | 17 Number of sites | 34 Number of sites |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10,586 | 0 / 12,573 |
| other Total, other adverse events | 0 / 10,586 | 0 / 12,573 |
| serious Total, serious adverse events | 0 / 10,586 | 0 / 12,573 |
Outcome results
Reach: As Assessed by the Mean Number of Clinics With Participants Who Download the A-CHESS App
The mean number of clinics with patients who download the A-CHESS app will be obtained monthly during the study via the A-CHESS server and Iowa Department of Public Health (IDPH) data.
Time frame: 45 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TAU/Control | Reach: As Assessed by the Mean Number of Clinics With Participants Who Download the A-CHESS App | 0.039 Mean number of clinics | Standard Error 0.029 |
| NIATx-TI Framework | Reach: As Assessed by the Mean Number of Clinics With Participants Who Download the A-CHESS App | 0.171 Mean number of clinics | Standard Error 0.041 |
Reach: As Assessed by the Number of Days That Participants Use the A-CHESS
The frequency of use of A-CHESS by each participant will be obtained monthly during the study via the A-CHESS server and Iowa Department of Public Health (IDPH) data.
Time frame: 45 months
Population: 6 sites are excluded from the analysis because they are comprised entirely of patients without activated accounts.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TAU/Control | Reach: As Assessed by the Number of Days That Participants Use the A-CHESS | 0.161 Days | Standard Deviation 0.466 |
| NIATx-TI Framework | Reach: As Assessed by the Number of Days That Participants Use the A-CHESS | 1.845 Days | Standard Deviation 1.487 |
A-CHESS/NIATx Implementation Fidelity (Survey)
Survey data on participating organizations' fidelity to the NIATx Technology Implementation (NIATx-TI) process. The Implementation Fidelity survey is a 13 item questionnaire using a 4-point scale where 0 = Not True and 4 = True. Scores range from 0-52. Higher scores indicate greater implementation fidelity.
Time frame: Collected twice during study; approx. M14 - 25 and M32 - 43
Population: Not all sites completed surveys at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAU/Control | A-CHESS/NIATx Implementation Fidelity (Survey) | Survey 2 | 2.26 score on a scale | Standard Deviation 0.55 |
| TAU/Control | A-CHESS/NIATx Implementation Fidelity (Survey) | Survey 3 | 2.20 score on a scale | Standard Deviation 0.63 |
| NIATx-TI Framework | A-CHESS/NIATx Implementation Fidelity (Survey) | Survey 2 | 2.91 score on a scale | Standard Deviation 0.51 |
| NIATx-TI Framework | A-CHESS/NIATx Implementation Fidelity (Survey) | Survey 3 | 2.91 score on a scale | Standard Deviation 0.55 |
Adoption: Number of Days Each Counselor Used the A-CHESS
Number of days each counselor used the A-CHESS will be assessed by A-CHESS logs
Time frame: 45 months
Population: Those counselors that did not use RISE at least once were not included in this calculation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TAU/Control | Adoption: Number of Days Each Counselor Used the A-CHESS | 1.81 days | Standard Deviation 2.52 |
| NIATx-TI Framework | Adoption: Number of Days Each Counselor Used the A-CHESS | 19.11 days | Standard Deviation 62.68 |
Adoption - The Percentage of Counselors Using A-CHESS Will be Assessed Via the Organizational Survey and A-CHESS Logs
Organizational survey will be completed by a member of the management team two times during the project (organizational baseline, end of the intervention)
Time frame: Collected twice during study; starting M22 - 31 and M35-44
Population: Any counselor who had the opportunity to have patients connected to them in the app is counted in the overall number
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TAU/Control | Adoption - The Percentage of Counselors Using A-CHESS Will be Assessed Via the Organizational Survey and A-CHESS Logs | 24 Participants |
| NIATx-TI Framework | Adoption - The Percentage of Counselors Using A-CHESS Will be Assessed Via the Organizational Survey and A-CHESS Logs | 84 Participants |
Difference in Number of Admissions in Rural vs. Urban Location
Statistical analysis of organizational traits will be done by calculating the difference in number of admissions in rural vs. urban location. The number of clinics located in a rural area was counted. The number of clinics in an urban location were counted.
Time frame: Collected during months 7, 18, 30, and 42, month 42 reported
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| TAU/Control | Difference in Number of Admissions in Rural vs. Urban Location | Rural | 1 Clinics |
| TAU/Control | Difference in Number of Admissions in Rural vs. Urban Location | Urban | 17 Clinics |
| TAU/Control | Difference in Number of Admissions in Rural vs. Urban Location | Half Rural/ Half Urban | 1 Clinics |
| NIATx-TI Framework | Difference in Number of Admissions in Rural vs. Urban Location | Rural | 3 Clinics |
| NIATx-TI Framework | Difference in Number of Admissions in Rural vs. Urban Location | Urban | 17 Clinics |
| NIATx-TI Framework | Difference in Number of Admissions in Rural vs. Urban Location | Half Rural/ Half Urban | 1 Clinics |
Effectiveness of A-CHESS as Assessed by the Retention Rate of Eligible Participants.
Retention rates of eligible participants
Time frame: Collected monthly during months 13 - 45
Population: This data was not collected
Financial Resource Availability (Survey)
Survey data on how the organization's financial resource availability affects A-CHESS implementation. Scored the availability of financial resources on a 5-point scale from 0= Not Ture to 4= True. Scores range from 0-28. Higher score indicates greater availability of resources.
Time frame: Collected twice during study; starting M22 - 31 and M35-44
Population: Not all sites completed all surveys
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAU/Control | Financial Resource Availability (Survey) | Survey 1 | 2.68 units on a scale | Standard Deviation 0.73 |
| TAU/Control | Financial Resource Availability (Survey) | Survey 2 | 2.77 units on a scale | Standard Deviation 0.83 |
| NIATx-TI Framework | Financial Resource Availability (Survey) | Survey 1 | 3.41 units on a scale | Standard Deviation 0.57 |
| NIATx-TI Framework | Financial Resource Availability (Survey) | Survey 2 | 3.13 units on a scale | Standard Deviation 0.87 |
Organizational Readiness of Participating Organizations as Assessed by Organizational Change Manager (Survey)
Survey data on the organizational readiness of participating organizations. Organizational Readiness (as measured by Organizational Change Manager) - 5 categories from Not True (0) to True (3) and Don't Know (No score). Scores range from 0-66. Higher scores indicate greater readiness for change.
Time frame: Collected twice during study; approx. M14 - 25 and M32 - 43
Population: Not all sites completed all surveys
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TAU/Control | Organizational Readiness of Participating Organizations as Assessed by Organizational Change Manager (Survey) | Survey 2 | 2.99 score on a scale | Standard Deviation 0.58 |
| TAU/Control | Organizational Readiness of Participating Organizations as Assessed by Organizational Change Manager (Survey) | Survey 3 | 2.73 score on a scale | Standard Deviation 0.75 |
| NIATx-TI Framework | Organizational Readiness of Participating Organizations as Assessed by Organizational Change Manager (Survey) | Survey 2 | 3.17 score on a scale | Standard Deviation 0.5 |
| NIATx-TI Framework | Organizational Readiness of Participating Organizations as Assessed by Organizational Change Manager (Survey) | Survey 3 | 3.28 score on a scale | Standard Deviation 0.4 |
Supplement 1 - Understand Impact of ACHESS on pt Anxiety and Loneliness During COVID-19 Pandemic
Online survey
Time frame: M34-37
Supplement 2 - Understand How Treatment Organizations and Staff Used ACHESS During COVID Pandemic
Online survey
Time frame: M34-37