Substance-related Disorders
Conditions
Brief summary
Tobacco, alcohol and opioid use disorders threaten the health of HIV-infected patients. What if evidence-based counseling and medication treatments for tobacco, alcohol and opioid use disorders (herein refered to as addiction treatments) were routinely provided in HIV clinics? Implementation Facilitation is an established strategy to increase the uptake of evidence-based treatments. Our goal is to evaluate the impact of Implementation Facilitation on the use of addiction treatments in four large HIV clinics. The purpose of the WHAT-IF study is: Aim 1. Among key stakeholders, to use quantitative and qualitative (mixed) methods to identify the site-specific evidence, context and facilitation-related barriers and facilitators to the integration of addiction treatments to help tailor an Implementation Facilitation for each clinic. Aim 2. To evaluate the impact of Implementation Facilitation on: 2a: Organizational readiness to deliver addiction treatments 2b: Provider readiness to deliver addiction treatments 2c: Provision of addiction treatments 2d: Changes in organizational models of care used to deliver addiction treatments Aim 3. To evaluate the impact of Implementation Facilitation on antiretroviral therapy receipt, HIV viral suppression, VACS Index, and retention in HIV care among patients eligible for addiction treatment.
Detailed description
The Working with HIV clinics to adopt Addiction Treatments using Implementation Facilitation (WHAT IF?) study will evaluate the impact of Implementation Facilitation on the adoption of addiction treatment services in four HIV clinics. We will use a stepped wedge design . The primary comparison is of the change that occurs from the pre-implementation period to two post-implementation periods, the initial six months (evaluation) and the following six months (maintenance). This proposal will consist of three main components in each of four clinics: 1) formative evaluation with key stakeholders at each site to guide and refine the Implementation Facilitation, 2) conduct of the Implementation Facilitation and 3) an evaluation of the impact of the Implementation Facilitation on organization and provider-level readiness, provision of addiction treatments, and HIV outcomes.
Interventions
Implementation Facilitation is an evidence-based strategy tailored to the specific needs of the clinic, designed to increase uptake of evidence based treatments for tobacco, alcohol and opioid use disorders. Will include provider education and academic detailing. * External Facilitator: Outside content expert who assists site * Local Champion: Site stakeholder who promotes change * Provider Education and Academic Detailing: Provision of unbiased peer education * Stakeholder Engagement: Aligning goals of implementation and those impacted * Tailor Program to Site: Addressing site specific needs based on Aim 1 * Performance Monitoring and Feedback: Assess implementation of screening and treatment efforts and inform site of results * Formative Evaluation: Quant. and qual. determination of impact * Establish a Learning Collaborative: Shared learning opportunities tailored to stakeholders * Program Marketing: Increase attention to availability of on-site addiction treatment services
Sponsors
Study design
Eligibility
Inclusion criteria
Patient inclusion criteria: * HIV-infected * Receiving HIV care in the index clinic * Age \>18 years old * Meets criteria for lifetime or current tobacco, alcohol and/or opioid use disorder regardless of addiction treatment status * Able to provide verbal informed consent Staff inclusion criteria: * Employed at participating HIV clinic for at least 6 months * Able to provide verbal informed consent. Payer/health insurance provider inclusion criteria: * Employed at an organization or agency that provides funding for medical services for HIV-infected individuals for at least 6 months. * Able to provide verbal informed consent.
Exclusion criteria
* Unable to provide verbal informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Provision of Addiction Treatments | Baseline, 6 months | Study team will use the electronic health record (EHR) to identify prescriptions for each of the target medications in the surveillance period. Study team will use CPT codes to determine whether specific counseling therapies were provided. Patients diagnosed with Opioid Use Disorder and/or Alcohol Use Disorder and/or Tobacco Use Disorder were identified and then assessed in the EHR to determine if medication assisted therapy was provided by a provider during the 6 month Intervention period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antiretroviral Therapy (ART) Receipt | 6 months | ART receipt will be defined as at least 180 days of three concurrent antiretroviral agents in the 6-month interval based on prescriptions in the electronic medical record. |
| Viral Suppression | 6 months | Viral suppression, will be defined as HIV RNA \<200 copies/mL at last test closest to the time of data extraction, consistent with Department of Health and Human Services (DHHS) guidelines. Although current limits of detection are lower, this cutoff allows for low-level blips that have no clinical significance. |
| VACS Index | 6 months | The Veterans Aging Cohort Study Index (VACS Index) creates a score by summing pre-assigned points for age, routinely monitored indicators of HIV disease (CD4 count and HIV-1 RNA), and general indicators of organ system injury including hemoglobin, platelets, aspartate and alanine transaminase (AST and ALT), creatinine, and viral hepatitis C infection (HCV). This score is weighted to indicate increasing risk of all-cause mortality with increasing score. The score can be used to estimate risk of all-cause mortality using a conversion factor. The VACS Index will be evaluated based on most recent values at the time of data extraction. VACS Index score will be treated as a continuous variable. VACS Index: minimum value: 0; maximum value: 164- a higher score means a worse outcome. |
| Retention in HIV Care | 6 months | Retention in HIV care, per DHHS guidelines uses a 24-month measurement period. It is defined as at least one HIV medical care visit in each 6-month period, with a minimum of 60 days between the first medical visit in the prior 6-month period and the last medical visit in the subsequent 6-month period. This measure has good agreement with the Institute of Medicine indicator for retention in care and is an independent predictor of mortality. We will evaluate whether patients have had at least 1 visit in the 6-month period prior to time of data extraction. |
| Organizational Readiness | 6 months | Investigators will use the ORCA to measure factors impacting the provision of addiction treatments. This 15-minute survey is based on the PARiHS framework and asks the respondent to rate local factors related to evidence, context and facilitation on a 5-point Likert scale from strongly disagree to strongly agree. Facilitation questions will be omitted from the pre-implementation assessment since this part of the intervention and will not have taken place. The score has a range from 1 to 5 where a higher score indicates higher readiness. |
| Provider Readiness | 6 months | Investigators will use change rulers, among appropriate providers, for each of the medications and counseling to assess readiness to provide each medication and counseling intervention. The change rulers will independently assess, on a 0-10 scale each provider's: 1) confidence to prescribe/provide the intervention, 2) readiness to prescribe/provide the intervention and 3) commitment to prescribe/provide the intervention. Presented is the score that indicates readiness to prescribe medication. The score has a range from 1 to 10 where a higher score indicates increased readiness. |
| Provider Readiness: | 12 months | Investigators will use change rulers, among appropriate providers, for each of the medications and counseling to assess readiness to provide each medication and counseling intervention.185 The change rulers will independently assess, on a 0-10 scale each provider's: 1) confidence to prescribe/provide the intervention, 2) readiness to prescribe/provide the intervention and 3) commitment to prescribe/provide the intervention. Presented is the score that indicates readiness to prescribe medication. The score has a range from 1 to 10 where a higher score indicates increased readiness. |
Countries
United States
Participant flow
Recruitment details
At each of the 6 month assessment stages, the numbers fluctuate based on the number of patients identified in the electronic health record (EHR) and the number of clinicians and staff that completed each survey. The numbers at each stage are part of a sliding cohort where direct follow up with patients and clinicians longitudinally is not part of the design. Assessment of patients using EHR began 6 months prior to the assessment of clinicians and staff using surveys.
Participants by arm
| Arm | Count |
|---|---|
| Patient Characteristics Presented are the characteristics of patients across 4 clinics in the control (baseline) phase in the implementation facilitation design. | 3,647 |
| Patient Characteristics Presented are the characteristics of patients across 4 clinics in the control (baseline) phase in the implementation facilitation design. | 4 |
| Clinician/Staff Characteristics Presented are the characteristics of clinician/staff participants across 4 clinics in the control (baseline) phase in the implementation facilitation design. | 70 |
| Clinician/Staff Characteristics Presented are the characteristics of clinician/staff participants across 4 clinics in the control (baseline) phase in the implementation facilitation design. | 4 |
| Total | 3,725 |
Baseline characteristics
| Characteristic | Patient Characteristics | Clinician/Staff Characteristics | Total |
|---|---|---|---|
| Age, Continuous | 49 years STANDARD_DEVIATION 12 | 58 years STANDARD_DEVIATION 41 | NA years |
| CD4 cell count categorized (cells/μL) 100-199 | 154 Participants | — | 154 Participants |
| CD4 cell count categorized (cells/μL) 200-349 | 336 Participants | — | 336 Participants |
| CD4 cell count categorized (cells/μL) 350-499 | 480 Participants | — | 480 Participants |
| CD4 cell count categorized (cells/μL) <50 | 31 Participants | — | 31 Participants |
| CD4 cell count categorized (cells/μL) >500 | 1697 Participants | — | 1697 Participants |
| CD4 cell count categorized (cells/μL) 50-99 | 42 Participants | — | 42 Participants |
| CD4 cell count categorized (cells/μL) Missing | 907 Participants | — | 907 Participants |
| Clinician (physicians, physician assistant, nurse practitioner) No | — | 36 Participants | 36 Participants |
| Clinician (physicians, physician assistant, nurse practitioner) Yes | — | 34 Participants | 34 Participants |
| Completed Visits at Baseline | 2 Clinic Visits | — | 2 Clinic Visits |
| Detectable HIV viral load (>200 copies/mL) Missing | 548 Participants | — | 548 Participants |
| Detectable HIV viral load (>200 copies/mL) No | 2774 Participants | — | 2774 Participants |
| Detectable HIV viral load (>200 copies/mL) Yes | 325 Participants | — | 325 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 781 Participants | 12 Participants | 793 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2859 Participants | 52 Participants | 2911 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 7 Participants | 6 Participants | 13 Participants |
| Ever prescribed medications to treat tobacco use disorder | — | 32 Participants | 32 Participants |
| Ever prescribed medications to treat unhealthy alcohol use | — | 14 Participants | 14 Participants |
| Ever prescribed oral or injectable (eg, Vivitrol) naltrexone to treat opioid use disorder | — | 5 Participants | 5 Participants |
| Ever provided counseling to treat opioid use disorder | — | 32 Participants | 32 Participants |
| Ever provided counseling to treat tobacco use disorder | — | 34 Participants | 34 Participants |
| Ever provided counseling to treat unhealthy alcohol use | — | 34 Participants | 34 Participants |
| Hepatitis C virus infection Missing | 53 Participants | — | 53 Participants |
| Hepatitis C virus infection No | 3072 Participants | — | 3072 Participants |
| Hepatitis C virus infection Yes | 522 Participants | — | 522 Participants |
| Hold a waiver that allows buprenorphine (eg, Suboxone) prescribing | — | 11 Participants | 11 Participants |
| Prescribed Antiretroviral Therapy No | 217 Participants | — | 217 Participants |
| Prescribed Antiretroviral Therapy Yes | 3430 Participants | — | 3430 Participants |
| Private or commercial insurance Missing | 1182 Participants | — | 1182 Participants |
| Private or commercial insurance No | 1480 Participants | — | 1480 Participants |
| Private or commercial insurance Yes | 985 Participants | — | 985 Participants |
| Public insurance Missing | 1182 Participants | — | 1182 Participants |
| Public insurance No | 740 Participants | — | 740 Participants |
| Public insurance Yes | 1725 Participants | — | 1725 Participants |
| Race/Ethnicity, Customized Race Asian | 19 Participants | 6 Participants | 25 Participants |
| Race/Ethnicity, Customized Race Black | 1814 Participants | 10 Participants | 1824 Participants |
| Race/Ethnicity, Customized Race Missing | 7 Participants | 1 Participants | 8 Participants |
| Race/Ethnicity, Customized Race Other | 689 Participants | 8 Participants | 697 Participants |
| Race/Ethnicity, Customized Race White | 1118 Participants | 45 Participants | 1163 Participants |
| Region of Enrollment United States | 3647 participants | 70 participants | 3717 participants |
| Self-Pay Missing | 1182 Participants | — | 1182 Participants |
| Self-Pay No | 2444 Participants | — | 2444 Participants |
| Self-Pay Yes | 21 Participants | — | 21 Participants |
| Sex: Female, Male Female | 1407 Participants | 51 Participants | 1458 Participants |
| Sex: Female, Male Male | 2240 Participants | 19 Participants | 2259 Participants |
| Time per week spent working at HIV clinic | — | 31 hours | 31 hours |
| Time working at clinic | — | 7 years STANDARD_DEVIATION 8 | 7 years STANDARD_DEVIATION 8 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Change in Provision of Addiction Treatments
Study team will use the electronic medical record to identify prescriptions for each of the target medications in the surveillance period. Study team will use CPT codes to determine whether specific counseling therapies were provided. Patients diagnosed with Opioid Use Disorder and/or Alcohol Use Disorder and/or Tobacco Use Disorder were identified and then assessed in the EHR to determine if medication assisted therapy was provided by a provider during the 12 month Evaluation period.
Time frame: Baseline, 12 months
Population: Unique patients assessed across the two time points by disorder type.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Opioid Use Disorder Patients | Change in Provision of Addiction Treatments | Control (Baseline) | 66 Participants |
| Opioid Use Disorder Patients | Change in Provision of Addiction Treatments | Evaluation (12 months) | 38 Participants |
| Alcohol Use Disorder Patients | Change in Provision of Addiction Treatments | Evaluation (12 months) | 15 Participants |
| Alcohol Use Disorder Patients | Change in Provision of Addiction Treatments | Control (Baseline) | 20 Participants |
| Tobacco Use Disorder | Change in Provision of Addiction Treatments | Control (Baseline) | 268 Participants |
| Tobacco Use Disorder | Change in Provision of Addiction Treatments | Evaluation (12 months) | 190 Participants |
Change in Provision of Addiction Treatments
Study team will use the electronic health record (EHR) to identify prescriptions for each of the target medications in the surveillance period. Study team will use CPT codes to determine whether specific counseling therapies were provided. Patients diagnosed with Opioid Use Disorder and/or Alcohol Use Disorder and/or Tobacco Use Disorder were identified and then assessed in the EHR to determine if medication assisted therapy was provided by a provider during the 6 month Intervention period.
Time frame: Baseline, 6 months
Population: Unduplicate count of participants from control stage to intervention stage.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Opioid Use Disorder Patients | Change in Provision of Addiction Treatments | Control (Baseline) | 66 Participants |
| Opioid Use Disorder Patients | Change in Provision of Addiction Treatments | Intervention (6 months) | 33 Participants |
| Alcohol Use Disorder Patients | Change in Provision of Addiction Treatments | Control (Baseline) | 20 Participants |
| Alcohol Use Disorder Patients | Change in Provision of Addiction Treatments | Intervention (6 months) | 15 Participants |
| Tobacco Use Disorder | Change in Provision of Addiction Treatments | Control (Baseline) | 268 Participants |
| Tobacco Use Disorder | Change in Provision of Addiction Treatments | Intervention (6 months) | 183 Participants |
Antiretroviral Therapy (ART) Receipt
ART receipt will be defined as at least 180 days of three concurrent antiretroviral agents in the 6-month interval based on prescriptions in the electronic medical record.
Time frame: 12 months
Population: All patients monitored across all (multiple) control and evaluation periods.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Opioid Use Disorder Patients | Antiretroviral Therapy (ART) Receipt | 4106 Participants |
| Alcohol Use Disorder Patients | Antiretroviral Therapy (ART) Receipt | 3508 Participants |
Antiretroviral Therapy (ART) Receipt
ART receipt will be defined as at least 180 days of three concurrent antiretroviral agents in the 6-month interval based on prescriptions in the electronic medical record.
Time frame: 6 months
Population: All those included in the multiple control and intervention phases across sites.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Opioid Use Disorder Patients | Antiretroviral Therapy (ART) Receipt | 4106 Participants |
| Alcohol Use Disorder Patients | Antiretroviral Therapy (ART) Receipt | 3547 Participants |
Organizational Readiness
Investigators will use the ORCA to measure factors impacting the provision of addiction treatments. This 15-minute survey is based on the PARiHS framework and asks the respondent to rate local factors related to evidence, context and facilitation on a 5-point Likert scale from strongly disagree to strongly agree. Facilitation questions will be omitted from the pre-implementation assessment since this part of the intervention and will not have taken place. The score has a range from 1 to 5 where a higher score indicates higher readiness.
Time frame: 6 months
Population: Unduplicated count of survey respondents for the intervention period.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Opioid Use Disorder Patients | Organizational Readiness | 4.46 units on a scale |
| Alcohol Use Disorder Patients | Organizational Readiness | 4.14 units on a scale |
| Tobacco Use Disorder | Organizational Readiness | 4.31 units on a scale |
Organizational Readiness
Investigators will use the ORCA to measure factors impacting the provision of addiction treatments. This 15-minute survey is based on the PARiHS framework and asks the respondent to rate local factors related to evidence, context and facilitation on a 5-point Likert scale from strongly disagree to strongly agree. Facilitation questions will be omitted from the pre-implementation assessment since this part of the intervention and will not have taken place. The score has a range from 1 to 5 where a higher score indicates higher readiness.
Time frame: 12 months
Population: Unduplicated count of survey respondents for the maintenance period.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Opioid Use Disorder Patients | Organizational Readiness | 4.37 units on a scale |
| Alcohol Use Disorder Patients | Organizational Readiness | 4.05 units on a scale |
| Tobacco Use Disorder | Organizational Readiness | 4.13 units on a scale |
Provider Readiness
Investigators will use change rulers, among appropriate providers, for each of the medications and counseling to assess readiness to provide each medication and counseling intervention. The change rulers will independently assess, on a 0-10 scale each provider's: 1) confidence to prescribe/provide the intervention, 2) readiness to prescribe/provide the intervention and 3) commitment to prescribe/provide the intervention. Presented is the score that indicates readiness to prescribe medication. The score has a range from 1 to 10 where a higher score indicates increased readiness.
Time frame: 6 months
Population: Unduplicated count of survey respondents for the intervention period.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Opioid Use Disorder Patients | Provider Readiness | 6.75 units on a scale |
| Alcohol Use Disorder Patients | Provider Readiness | 6.22 units on a scale |
| Tobacco Use Disorder | Provider Readiness | 7.24 units on a scale |
Provider Readiness:
Investigators will use change rulers, among appropriate providers, for each of the medications and counseling to assess readiness to provide each medication and counseling intervention.185 The change rulers will independently assess, on a 0-10 scale each provider's: 1) confidence to prescribe/provide the intervention, 2) readiness to prescribe/provide the intervention and 3) commitment to prescribe/provide the intervention. Presented is the score that indicates readiness to prescribe medication. The score has a range from 1 to 10 where a higher score indicates increased readiness.
Time frame: 12 months
Population: Unduplicated count of survey respondents for the maintenance period.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Opioid Use Disorder Patients | Provider Readiness: | 7.28 units on a scale |
| Alcohol Use Disorder Patients | Provider Readiness: | 7.16 units on a scale |
| Tobacco Use Disorder | Provider Readiness: | 7.50 units on a scale |
Retention in HIV Care
Retention in HIV care, per DHHS guidelines uses a 24-month measurement period. It is defined as at least one HIV medical care visit in each 6-month period, with a minimum of 60 days between the first medical visit in the prior 6-month period and the last medical visit in the subsequent 6-month period. This measure has good agreement with the Institute of Medicine indicator for retention in care and is an independent predictor of mortality. We will evaluate whether patients have had at least 1 visit in the 6-month period prior to time of data extraction.
Time frame: 6 months
Population: Patients identified at the control period to follow up with at the end of the intervention period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Opioid Use Disorder Patients | Retention in HIV Care | 3567 Participants |
Retention in HIV Care
Retention in HIV care, per DHHS guidelines uses a 24-month measurement period. It is defined as at least one HIV medical care visit in each 6-month period, with a minimum of 60 days between the first medical visit in the prior 6-month period and the last medical visit in the subsequent 6-month period. This measure has good agreement with the Institute of Medicine indicator for retention in care and is an independent predictor of mortality. We will evaluate whether patients have had at least 1 visit in the 6-month period prior to time of data extraction.
Time frame: 12 months
Population: Patients identified at the control period to follow up with at the end of the evaluation period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Opioid Use Disorder Patients | Retention in HIV Care | 3450 Participants |
VACS Index
The Veterans Aging Cohort Study Index (VACS Index) creates a score by summing pre-assigned points for age, routinely monitored indicators of HIV disease (CD4 count and HIV-1 RNA), and general indicators of organ system injury including hemoglobin, platelets, aspartate and alanine transaminase (AST and ALT), creatinine, and viral hepatitis C infection (HCV). This score is weighted to indicate increasing risk of all-cause mortality with increasing score. The score can be used to estimate risk of all-cause mortality using a conversion factor. The VACS Index will be evaluated based on most recent values at the time of data extraction. VACS Index score will be treated as a continuous variable. VACS Index: minimum value: 0; maximum value: 164- a higher score means a worse outcome.
Time frame: 12 months
Population: Unduplicated count of survey respondents at each administration.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Opioid Use Disorder Patients | VACS Index | 23.53 units on a scale |
| Alcohol Use Disorder Patients | VACS Index | 25.12 units on a scale |
VACS Index
The Veterans Aging Cohort Study Index (VACS Index) creates a score by summing pre-assigned points for age, routinely monitored indicators of HIV disease (CD4 count and HIV-1 RNA), and general indicators of organ system injury including hemoglobin, platelets, aspartate and alanine transaminase (AST and ALT), creatinine, and viral hepatitis C infection (HCV). This score is weighted to indicate increasing risk of all-cause mortality with increasing score. The score can be used to estimate risk of all-cause mortality using a conversion factor. The VACS Index will be evaluated based on most recent values at the time of data extraction. VACS Index score will be treated as a continuous variable. VACS Index: minimum value: 0; maximum value: 164- a higher score means a worse outcome.
Time frame: 6 months
Population: Unduplicated count of survey respondents at each administration.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Opioid Use Disorder Patients | VACS Index | 23.53 units on a scale |
| Alcohol Use Disorder Patients | VACS Index | 24.54 units on a scale |
Viral Suppression
Viral suppression, will be defined as HIV RNA \<200 copies/mL at last test closest to the time of data extraction, consistent with Department of Health and Human Services (DHHS) guidelines. Although current limits of detection are lower, this cutoff allows for low-level blips that have no clinical significance.
Time frame: 12 months
Population: All patients monitored across all control (multiple) and evaluation periods.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Opioid Use Disorder Patients | Viral Suppression | 3849 Participants |
| Alcohol Use Disorder Patients | Viral Suppression | 2830 Participants |
Viral Suppression
Viral suppression, will be defined as HIV RNA \<200 copies/mL at last test closest to the time of data extraction, consistent with Department of Health and Human Services (DHHS) guidelines. Although current limits of detection are lower, this cutoff allows for low-level blips that have no clinical significance.
Time frame: 6 months
Population: All patients monitored across all control (multiple) and intervention periods.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Opioid Use Disorder Patients | Viral Suppression | 3849 Participants |
| Alcohol Use Disorder Patients | Viral Suppression | 2880 Participants |