Working With HIV Clinics to Adopt Addiction Treatments Using Implementation Facilitation

NCT02907944 | Completed Results

• 2 other identifiers: HIC1509016500R01DA041067
• Study Type: interventional
• Target: 3,838
• Locations: 1 country
• Sites: 4

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.

Conditions

Substance-related Disorders

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (12)

• Antiretroviral Therapy (ART) Receipt

  6 months

• Antiretroviral Therapy (ART) Receipt

  12 months

• Viral Suppression

  6 months

• Viral Suppression

  12 months

• VACS Index

  6 months

Study Arms (2)

Usual Care- Control

NO INTERVENTION

We will use a stepped wedge design to evaluate the effect of the Implementation Facilitation on the outcomes. The first phase for all clinics is a control phase where clinic staff and patients engage in usual care. The time to implementation is randomly assigned. Each clinic is then followed prospectively to determine their outcome status.

Implementation Facilitation

EXPERIMENTAL

We will use a stepped wedge design to evaluate the effect of the Implementation Facilitation on the outcomes. The time to implementation in a stepped wedge design is randomly assigned. Clinics are then followed prospectively to determine their outcome status..

Behavioral: Implementation Facilitation

Interventions

Implementation Facilitation BEHAVIORAL

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

Implementation Facilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Employed at participating HIV clinic for at least 6 months
• Able to provide verbal informed consent.
• 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.

You may not qualify if:

• Unable to provide verbal informed consent

Sponsors & Collaborators

• Yale University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (4)

Hartford Hospital's HIV Clinic

Hartford, Connecticut, 06115, United States

Location

Haelen Center at Yale New Haven Hospital

New Haven, Connecticut, 06511, United States

Location

SUNY Downstate Medical Center

Brooklyn, New York, 11203, United States

Location

Immunology Center at Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Related 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.

  PMID: 32976995 BACKGROUND

• 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 Acquir Immune Defic Syndr. 2021 Jul 1;87(3):959-970. doi: 10.1097/QAI.0000000000002666.

  PMID: 33675619 RESULT

• 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. doi: 10.1016/j.jsat.2022.108767. Epub 2022 Mar 18.

  PMID: 35341613 RESULT

• 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 US HIV Clinics: A Randomized Clinical Trial. JAMA Netw Open. 2022 Oct 3;5(10):e2236904. doi: 10.1001/jamanetworkopen.2022.36904.

  PMID: 36251291 RESULT

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: David Fiellin, MD
• Organization: Yale School of Medicine

david.fiellin@yale.edu

(203) 688-5555

Study Officials

• David Fiellin, MD

  Yale University

  PRINCIPAL INVESTIGATOR

• Jennifer Edelmen, MD

  Yale University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2016
• First Posted: September 20, 2016
• Study Start: September 1, 2016
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: May 8, 2023
• Results First Posted: May 8, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)