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

This study is currently recruiting participants.
Verified July 2017 by David Fiellin, Yale University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02907944
First Posted: September 20, 2016
Last Update Posted: July 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
David Fiellin, Yale University
  Purpose

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.


Condition Intervention
Substance-related Disorders Behavioral: Implementation Facilitation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Working With HIV Clinics to Adopt Addiction Treatments Using Implementation Facilitation (WHAT IF?)

Resource links provided by NLM:


Further study details as provided by David Fiellin, Yale University:

Primary Outcome Measures:
  • Provision of addiction treatments [ Time Frame: 6 months ]
    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.

  • Provision of addiction treatments [ Time Frame: 12 months ]
    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.


Secondary Outcome Measures:
  • Antiretroviral Therapy (ART) receipt [ Time Frame: 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.

  • Antiretroviral Therapy (ART) receipt [ Time Frame: 12 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 [ Time Frame: 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.

  • Viral suppression [ Time Frame: 12 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 [ Time Frame: 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 [ Time Frame: 12 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.

  • Retention in HIV care [ Time Frame: 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.

  • Retention in HIV care [ Time Frame: 12 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 [ Time Frame: 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.

  • Organizational Readiness [ Time Frame: 12 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.

  • Provider Readiness: [ Time Frame: 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.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. Stage of change assessments have been validated and have been used in the field of addiction and mental health to assess readiness to adopt evidence-based treatments.

  • Provider Readiness: [ Time Frame: 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. Stage of change assessments have been validated and have been used in the field of addiction and mental health to assess readiness to adopt evidence-based treatments.


Estimated Enrollment: 375
Actual Study Start Date: September 2016
Estimated Study Completion Date: September 2021
Estimated Primary Completion Date: September 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual Care- Control
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.
Experimental: Implementation Facilitation
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

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

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02907944


Contacts
Contact: David Fiellin, MD +1 (203) 737-3347 david.fiellin@yale.edu

Locations
United States, Connecticut
Hartford Hospital's HIV Clinic Recruiting
Hartford, Connecticut, United States, 06115
Contact: Deborah Cornman, PhD    860-486-4645      
Haelen Center at Yale New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06511
Contact: Evangelia Louizos    203-737-3347      
United States, New York
SUNY Downstate Medical Center Recruiting
Brooklyn, New York, United States, 11203
Contact: Gabriel Rebick, MD    718-270-3745      
United States, Rhode Island
Immunology Center at Miriam Hospital Recruiting
Providence, Rhode Island, United States, 02906
Contact: Philip Chan, MD    401-793-2928      
Sponsors and Collaborators
Yale University
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: David Fiellin, MD Yale University
Study Director: Jennifer Edelmen, MD Yale University
  More Information

Responsible Party: David Fiellin, Professor of Medicine, Yale University
ClinicalTrials.gov Identifier: NCT02907944     History of Changes
Other Study ID Numbers: HIC1509016500
R01DA041067 ( U.S. NIH Grant/Contract )
First Submitted: September 14, 2016
First Posted: September 20, 2016
Last Update Posted: July 21, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders