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

Primary Purpose

Opioid Misuse, Older Adults, HIV

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Choacot: Behavioral Intervention for Chronic Opioid Use
Health Education
Sponsored by
Butler Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Misuse

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Butler Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active

Health Education

Arm Description

Participants in this arm will receive the study intervention (sessions with the BHC and the PCP).

Participants in this arm will receive study sessions about various health topics.

Outcomes

Primary Outcome Measures

opioid use
opioid use will be assessed, through self-report measures, monthly over the course of the 4-month study participation period

Secondary Outcome Measures

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
pain
pain will be assessed, through self-report measures, monthly over the course of the 4-month study participation period
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
antiretroviral adherence
antiretroviral adherences will be assessed, through self-report measures, monthly over the course of the 4-month study participation period
psychosocial functioning
psychosocial functioning will be assessed, through self-report measures, monthly over the course of the 4-month study participation period

Full Information

First Posted
October 21, 2014
Last Updated
September 15, 2017
Sponsor
Butler Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02272829
Brief Title
Behavioral Consultation for HIV+ Older Adults Prescribed Opioids for Chronic Pain
Acronym
CHOACOT
Official Title
Behavioral Consultation for HIV+ Older Adults Prescribed Opioids for Chronic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
May 2015 (Actual)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Butler Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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: three meetings between the Behavioral Health Specialist (BHS) and the patient two brief consultations between the BHC and the HIV-PCP 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Misuse, Older Adults, HIV

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Active Comparator
Arm Description
Participants in this arm will receive the study intervention (sessions with the BHC and the PCP).
Arm Title
Health Education
Arm Type
Placebo Comparator
Arm Description
Participants in this arm will receive study sessions about various health topics.
Intervention Type
Behavioral
Intervention Name(s)
Choacot: Behavioral Intervention for Chronic Opioid Use
Intervention Description
This is an intervention for individuals who use opioid medication for chronic pain, and targets the collaboration between the participant and his/her PCP.
Intervention Type
Other
Intervention Name(s)
Health Education
Primary Outcome Measure Information:
Title
opioid use
Description
opioid use will be assessed, through self-report measures, monthly over the course of the 4-month study participation period
Time Frame
4 months
Secondary Outcome Measure Information:
Title
quality of the patient-provider relationship
Description
quality of the patient-provider relationship will be assessed, through self-report measures, monthly over the course of the 4-month study participation period
Time Frame
4 months
Title
pain
Description
pain will be assessed, through self-report measures, monthly over the course of the 4-month study participation period
Time Frame
4 months
Title
problematic use of other substances
Description
problematic use of other substances will be assessed, through self-report measures, monthly over the course of the 4-month study participation period
Time Frame
4 months
Title
antiretroviral adherence
Description
antiretroviral adherences will be assessed, through self-report measures, monthly over the course of the 4-month study participation period
Time Frame
4 months
Title
psychosocial functioning
Description
psychosocial functioning will be assessed, through self-report measures, monthly over the course of the 4-month study participation period
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Stein, MD
Organizational Affiliation
Butler Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Butler Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States

12. IPD Sharing Statement

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Behavioral Consultation for HIV+ Older Adults Prescribed Opioids for Chronic Pain

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