Working With HIV Clinics to Adopt Addiction Treatments Using Implementation Facilitation

Substance-related Disorders Clinical Trial

— WHAT-IF?  

Official title:

Working With HIV Clinics to Adopt Addiction Treatments Using Implementation Facilitation (WHAT-IF?)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02907944
• Other study ID #: HIC1509016500
• Secondary ID: R01DA041067
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: September 30, 2021

Study information

• Verified date: April 2023
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3838
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Substance-related Disorders

Intervention

Behavioral:
• Implementation Facilitation
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

Locations

Country	Name	City	State
United States	SUNY Downstate Medical Center	Brooklyn	New York
United States	Hartford Hospital's HIV Clinic	Hartford	Connecticut
United States	Haelen Center at Yale New Haven Hospital	New Haven	Connecticut
United States	Immunology Center at Miriam Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (4)

Edelman EJ, Dziura J, Esserman D, Porter E, Becker WC, Chan PA, Cornman DH, Rebick G, Yager J, Morford K, Muvvala SB, Fiellin DA. Working with HIV clinics to adopt addiction treatment using implementation facilitation (WHAT-IF?): Rationale and design for a hybrid type 3 effectiveness-implementation study. Contemp Clin Trials. 2020 Nov;98:106156. doi: 10.1016/j.cct.2020.106156. Epub 2020 Sep 23. — View Citation

Edelman EJ, Gan G, Dziura J, Esserman D, Morford KL, Porter E, Chan PA, Cornman DH, Oldfield BJ, Yager JE, Muvvala SB, Fiellin DA. Readiness to Provide Medications for Addiction Treatment in HIV Clinics: A Multisite Mixed-Methods Formative Evaluation. J A — View Citation

Edelman EJ, Gan G, Dziura J, Esserman D, Porter E, Becker WC, Chan PA, Cornman DH, Helfrich CD, Reynolds J, Yager JE, Morford KL, Muvvala SB, Fiellin DA. Effect of Implementation Facilitation to Promote Adoption of Medications for Addiction Treatment in U — View Citation

Morford KL, Muvvala SB, Chan PA, Cornman DH, Doernberg M, Porter E, Virata M, Yager JE, Fiellin DA, Edelman EJ. Patients' perspectives of medications for addiction treatment in HIV clinics: A qualitative study. J Subst Abuse Treat. 2022 Aug;139:108767. do — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 6 months
Primary	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.	Baseline, 12 months
Secondary	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.	6 months
Secondary	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.	12 months
Secondary	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.	6 months
Secondary	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.	12 months
Secondary	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.	6 months
Secondary	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.	12 months
Secondary	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.	6 months
Secondary	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.	12 months
Secondary	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.	6 months
Secondary	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.	12 months
Secondary	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.	6 months
Secondary	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.	12 months