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



Status:Recruiting
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:50 - Any
Updated:3/10/2017
Start Date:May 2015
End Date:August 2017
Contact:Michael Stein, MD
Email:mstein@butler.org
Phone:401-455-6646

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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.

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.

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.
We found this trial at
1
site
345 Blackstone Blvd
Providence, Rhode Island 02906
(401) 455-6200
Principal Investigator: Michael Stein, MD
Phone: 401-455-6646
Butler Hospital Founded in 1844, Butler Hospital is the state's only non-profit, free-standing psychiatric hospital...
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mi
from
Providence, RI
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