Clinical trial NCT02272829: Behavioral Consultation for HIV+ Older Adults Prescribed Opioids for Chronic Pain
Official title: Behavioral Consultation for HIV+ Older Adults Prescribed Opioids for Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Misuse
Older Adults
HIV
Lead sponsor: Butler Hospital
Sponsor class: OTHER
First posted: 2014-10-23
Enrollment: 8
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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.

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.

Primary outcomes:
measure: opioid use
timeFrame: 4 months
Secondary outcomes:
measure: quality of the patient-provider relationship
timeFrame: 4 months
measure: pain
timeFrame: 4 months
measure: problematic use of other substances
timeFrame: 4 months
measure: antiretroviral adherence
timeFrame: 4 months
measure: psychosocial functioning
timeFrame: 4 months
Other outcomes:
Locations:
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
Study officials:
affiliation: Butler Hospital
name: Michael Stein, MD
role: PRINCIPAL_INVESTIGATOR
References: