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

15. september 2017 opdateret af: Michael Stein, MD, Butler Hospital
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.

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

8

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Rhode Island
      • Providence, Rhode Island, Forenede Stater, 02906
        • Butler Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

50 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Active
Participants in this arm will receive the study intervention (sessions with the BHC and the PCP).
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 komparator: Health Education
Participants in this arm will receive study sessions about various health topics.

Hvad måler undersøgelsen?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
quality of the patient-provider relationship
Tidsramme: 4 months
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
Tidsramme: 4 months
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
Tidsramme: 4 months
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
Tidsramme: 4 months
antiretroviral adherences will be assessed, through self-report measures, monthly over the course of the 4-month study participation period
4 months
psychosocial functioning
Tidsramme: 4 months
psychosocial functioning will be assessed, through self-report measures, monthly over the course of the 4-month study participation period
4 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Efterforskere

  • Ledende efterforsker: Michael Stein, MD, Butler Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. maj 2015

Primær færdiggørelse (Faktiske)

1. august 2017

Studieafslutning (Faktiske)

1. august 2017

Datoer for studieregistrering

Først indsendt

21. oktober 2014

Først indsendt, der opfyldte QC-kriterier

21. oktober 2014

Først opslået (Skøn)

23. oktober 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. september 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. september 2017

Sidst verificeret

1. september 2017

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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