Behavioral Consultation for HIV+ Older Adults Prescribed Opioids for Chronic Pain (CHOACOT)

This project will develop a novel collaborative treatment, based on the primary care behavioral consultation model and behavior therapy techniques including motivational interviewing and functional assessment, in which a patient, a Behavioral Health Consultant (BHC) and a HIV primary care provider share a unified plan targeting misuse of prescribed opioid analgesics in older HIV+ adults. The intervention will involve meetings between the BHC and the PCP, the BHC and the participant, and the BHC, PCP and the participant. Opioid misuse will be the primary outcome variable. Quality of the patient-provider relationship, pain, problematic use of other substances, antiretroviral adherence, and psychosocial functioning will be secondary outcomes.

Study Overview

• Status: Completed
• Conditions: HIV; Older Adults; Opioid Misuse
• Intervention / Treatment: Other: Health Education; Behavioral: Choacot: Behavioral Intervention for Chronic Opioid Use

Detailed Description

Up to 20% of HIV patients receive prescriptions for chronic opioid therapy (COT) to treat chronic pain. This project will develop a novel collaborative treatment, based on the primary care behavioral consultation model and behavior therapy techniques including motivational interviewing and functional assessment, in which a patient, a Behavioral Health Consultant and a HIV primary care provider share a unified plan targeting misuse of prescribed opioid analgesics in older HIV+ adults. This would be the first theoretically-driven, empirically-tested intervention that specifically attends to the difficult issues around chronic pain and opioid prescription in HIV clinical practice.

This project will develop a collaborative, brief, behavioral consultation intervention targeting misuse of prescribed opioids in older HIV+ adults. The intervention, CHOACOT (Consultation for HIV+ Older Adults on Chronic Opioid Therapy), will consist of:

1. three meetings between the Behavioral Health Specialist (BHS) and the patient
2. two brief consultations between the BHC and the HIV-PCP
3. a joint meeting of the patient, BHC, and HIV-PCP.

To achieve our aims, we will develop CHOACOT beginning with an iterative open trial (n=10). Next, we will conduct a pilot randomized clinical trial (n=30) of CHOACOT versus enhanced Treatment-As-Usual. Opioid misuse will be the primary outcome variable. Quality of the patient-provider relationship, pain, problematic use of other substances, antiretroviral adherence, and psychosocial functioning will be secondary outcomes. The specific aims are:

Aim 1. Develop and refine CHOACOT so that it meets standards of feasibility and acceptability for HIV PCPs, BHCs, and participants;

1a. To develop and field test a CHOACOT BHC manual;

1b. To develop a reliable measure of BHC manual adherence;

1c. To develop and field-test BHC training and supervision procedures. Aim 2. Refine research procedures (e.g., consent and randomization processes, assessment procedures), and establish their feasibility and acceptability to participants while confirming recruitment goal targets.

Misuse of prescribed opioids is the primary outcome. Secondary outcomes are problematic use of substances with a high potential for lethality when used with COT (benzodiazepines, cocaine, alcohol, heroin), ARV adherence, viral load, pain, psychosocial functioning, patient-provider alliance, and treatment satisfaction and acceptability.

This line of work could lead to the incorporation into HIV care of a theoretically-driven and empirically-tested brief intervention for older HIV patients who are prescribed opioids for chronic pain and for whom there is concern about opioid misuse.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • Butler Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• HIV patients with a physician at the enrollment site;
• Age 50 or older;
• Chronic pain (pain duration for at least six months);
• Daily use of an opioid analgesic, prescribed by an HIV-PCP at the study site, for at least the past 90 days;
• Patients endorse "feeling at risk of losing their pain medication prescription," or that they are "unhappy with how they and their doctors are working together to manage their pain";
• Patient-rated Addictions Behavior Checklist score > 3, as a recommended cut-point indicating opioid misuse.

Exclusion Criteria:

• Current, severe psychiatric symptoms requiring immediate clinical attention;
• Inability to understand English;
• Cognitive impairment severe enough to interfere with ability to actively participate in CHOACOT.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active; Participants in this arm will receive the study intervention (sessions with the BHC and the PCP).	Behavioral: Choacot: Behavioral Intervention for Chronic Opioid Use; This is an intervention for individuals who use opioid medication for chronic pain, and targets the collaboration between the participant and his/her PCP.
Placebo Comparator: Health Education; Participants in this arm will receive study sessions about various health topics.	Other: Health Education

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
opioid use	opioid use will be assessed, through self-report measures, monthly over the course of the 4-month study participation period	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
quality of the patient-provider relationship	quality of the patient-provider relationship will be assessed, through self-report measures, monthly over the course of the 4-month study participation period	4 months
pain	pain will be assessed, through self-report measures, monthly over the course of the 4-month study participation period	4 months
problematic use of other substances	problematic use of other substances will be assessed, through self-report measures, monthly over the course of the 4-month study participation period	4 months
antiretroviral adherence	antiretroviral adherences will be assessed, through self-report measures, monthly over the course of the 4-month study participation period	4 months
psychosocial functioning	psychosocial functioning will be assessed, through self-report measures, monthly over the course of the 4-month study participation period	4 months

Collaborators and Investigators

• Sponsor: Butler Hospital
• Investigators: Principal Investigator: Michael Stein, MD, Butler Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2015
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: October 21, 2014
• First Submitted That Met QC Criteria: October 21, 2014
• First Posted (Estimate): October 23, 2014

Study Record Updates

• Last Update Posted (Actual): September 18, 2017
• Last Update Submitted That Met QC Criteria: September 15, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Pain; Neurologic Manifestations; Narcotic-Related Disorders; Chronic Pain; Opioid-Related Disorders; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Narcotics; Analgesics, Opioid
• Other Study ID Numbers: DA038203