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

HIV Clinical Trial

— CHOACOT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02272829
• Other study ID #: DA038203
• Status: Completed
• Phase: N/A
• First received: October 21, 2014
• Last updated: September 15, 2017
• Start date: May 2015
• Est. completion date: August 2017

Study information

• Verified date: September 2017
• Source: Butler Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• HIV
• Older Adults
• Opioid Misuse

Intervention

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.

Other:
• Health Education

Locations

Country	Name	City	State
United States	Butler Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Butler Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	pain	pain will be assessed, through self-report measures, monthly over the course of the 4-month study participation period	4 months
Secondary	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
Secondary	antiretroviral adherence	antiretroviral adherences will be assessed, through self-report measures, monthly over the course of the 4-month study participation period	4 months
Secondary	psychosocial functioning	psychosocial functioning will be assessed, through self-report measures, monthly over the course of the 4-month study participation period	4 months