Toward Safer Opioid Prescribing in HIV care (TOWER): a mixed-methods, cluster-randomized trial.

Analgesics, Opioid / adverse effects Chronic Pain / drug therapy Guideline Adherence HIV Infections / complications Humans Pain Management Practice Patterns, Physicians'
Chronic pain HIV Opioid prescribing guidelines Opioids

Journal

Addiction science & clinical practice
ISSN: 1940-0640
Titre abrégé: Addict Sci Clin Pract
Pays: England
ID NLM: 101316917

Informations de publication

Date de publication:
16 05 2022
Historique:
received: 23 11 2021
accepted: 02 05 2022
entrez: 16 5 2022
pubmed: 17 5 2022
medline: 20 5 2022
Statut: epublish

Résumé

The 2016 U.S. Centers for Disease Control Opioid Prescribing Guideline (CDC Guideline) is currently being revised amid concern that it may be harmful to people with chronic pain on long-term opioid therapy (CP-LTOT). However, a methodology to faithfully implement the CDC guideline, measure prescriber adherence, and systematically test its effect on patient and public health outcomes is lacking. We developed and tested a CDC Guideline implementation strategy (termed TOWER), focusing on an outpatient HIV-focused primary care setting. TOWER was developed in a stakeholder-engaged, multi-step iterative process within an Information, Motivation and Behavioral Skills (IMB) framework of behavior change. TOWER consists of: 1) a patient-facing opioid management app (OM-App); 2) a progress note template (OM-Note) to guide the office visit; and 3) a primary care provider (PCP) training. TOWER was evaluated in a 9-month, randomized-controlled trial of HIV-PCPs (N = 11) and their patients with HIV and CP-LTOT (N = 40). The primary outcome was CDC Guideline adherence based on electronic health record (EHR) documentation and measured by the validated Safer Opioid Prescribing Evaluation Tool (SOPET). Qualitative data including one-on-one PCP interviews were collected. We also piloted patient-reported outcome measures (PROMs) reflective of domains identified as important by stakeholders (pain intensity and function; mood; substance use; medication use and adherence; relationship with provider; stigma and discrimination). PCPs randomized to TOWER were 48% more CDC Guideline adherent (p < 0.0001) with significant improvements in use of: non-pharmacologic treatments, functional treatment goals, opioid agreements, prescription drug monitoring programs (PDMPs), opioid benefit/harm assessment, and naloxone prescribing. Qualitative data demonstrated high levels of confidence in conducting these care processes among intervention providers, and that OM-Note supported these efforts while experience with OM-App was mixed. There were no intervention-associated safety concerns (defined as worsening of any of the PROMs). CDC-guideline adherence can be promoted and measured, and is not associated with worsening of outcomes for people with HIV receiving LTOT for CP. Future work would be needed to document scalability of these results and to determine whether CDC-guideline adherence results in a positive effect on public health. Trial registration https://clinicaltrials.gov/ct2/show/NCT03669939 . Registration date: 9/13/2018.

Sections du résumé

BACKGROUND
The 2016 U.S. Centers for Disease Control Opioid Prescribing Guideline (CDC Guideline) is currently being revised amid concern that it may be harmful to people with chronic pain on long-term opioid therapy (CP-LTOT). However, a methodology to faithfully implement the CDC guideline, measure prescriber adherence, and systematically test its effect on patient and public health outcomes is lacking. We developed and tested a CDC Guideline implementation strategy (termed TOWER), focusing on an outpatient HIV-focused primary care setting.
METHODS
TOWER was developed in a stakeholder-engaged, multi-step iterative process within an Information, Motivation and Behavioral Skills (IMB) framework of behavior change. TOWER consists of: 1) a patient-facing opioid management app (OM-App); 2) a progress note template (OM-Note) to guide the office visit; and 3) a primary care provider (PCP) training. TOWER was evaluated in a 9-month, randomized-controlled trial of HIV-PCPs (N = 11) and their patients with HIV and CP-LTOT (N = 40). The primary outcome was CDC Guideline adherence based on electronic health record (EHR) documentation and measured by the validated Safer Opioid Prescribing Evaluation Tool (SOPET). Qualitative data including one-on-one PCP interviews were collected. We also piloted patient-reported outcome measures (PROMs) reflective of domains identified as important by stakeholders (pain intensity and function; mood; substance use; medication use and adherence; relationship with provider; stigma and discrimination).
RESULTS
PCPs randomized to TOWER were 48% more CDC Guideline adherent (p < 0.0001) with significant improvements in use of: non-pharmacologic treatments, functional treatment goals, opioid agreements, prescription drug monitoring programs (PDMPs), opioid benefit/harm assessment, and naloxone prescribing. Qualitative data demonstrated high levels of confidence in conducting these care processes among intervention providers, and that OM-Note supported these efforts while experience with OM-App was mixed. There were no intervention-associated safety concerns (defined as worsening of any of the PROMs).
CONCLUSIONS
CDC-guideline adherence can be promoted and measured, and is not associated with worsening of outcomes for people with HIV receiving LTOT for CP. Future work would be needed to document scalability of these results and to determine whether CDC-guideline adherence results in a positive effect on public health. Trial registration https://clinicaltrials.gov/ct2/show/NCT03669939 . Registration date: 9/13/2018.

Identifiants

DOI: 10.1186/s13722-022-00311-8 PMID: 35578356 PMC: PMC9108346
pubmed: 35578356
doi: 10.1186/s13722-022-00311-8
pii: 10.1186/s13722-022-00311-8
pmc: PMC9108346
doi:

Substances chimiques

Analgesics, Opioid 0

Banques de données

ClinicalTrials.gov
['NCT03669939']

Types de publication

Journal Article Randomized Controlled Trial

Langues

eng

Sous-ensembles de citation

IM

Pagination

28

Subventions

Organisme : AHRQ HHS
ID : R18 HS025641
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR004419
Pays : United States

Informations de copyright

© 2022. The Author(s).

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Auteurs

Gabriela Cedillo (G)

Department of Neurology, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, Box 1052, New York, NY, 10029, USA.

Mary Catherine George (MC)

Department of Neurology, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, Box 1052, New York, NY, 10029, USA.

Richa Deshpande (R)

Department of Neurology, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, Box 1052, New York, NY, 10029, USA.
Department of Medicine, Division of Infectious Diseases, Icahn School of Medicine at Mount Sinai, New York, USA.
Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, USA.
Department of Psychology and Neuroscience, University of Colorado Boulder, Boulder, USA.
Caring Accent (Consultancy), San Jose, CA, USA.
Department of Economics and the Center On Alcoholism, Substance Use and Addictions, University of New Mexico, Albuquerque, USA.
Center for Evaluation and Applied Research, New York Academy of Medicine, New York, USA.
School of Nursing, University of Connecticut, Storrs, CT, USA.
Institute for Collaboration On Health, Intervention, and Policy (InCHIP), University of Connecticut, Storrs, CT, USA.

Emma K T Benn (EKT)

Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, USA.

Allison Navis (A)

Department of Neurology, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, Box 1052, New York, NY, 10029, USA.

Alexandra Nmashie (A)

Department of Neurology, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, Box 1052, New York, NY, 10029, USA.

Alina Siddiqui (A)

Department of Neurology, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, Box 1052, New York, NY, 10029, USA.

Bridget R Mueller (BR)

Department of Neurology, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, Box 1052, New York, NY, 10029, USA.

Yosuke Chikamoto (Y)

Caring Accent (Consultancy), San Jose, CA, USA.

Linda Weiss (L)

Center for Evaluation and Applied Research, New York Academy of Medicine, New York, USA.

Maya Scherer (M)

Center for Evaluation and Applied Research, New York Academy of Medicine, New York, USA.

Alexandra Kamler (A)

Center for Evaluation and Applied Research, New York Academy of Medicine, New York, USA.

Judith A Aberg (JA)

Department of Medicine, Division of Infectious Diseases, Icahn School of Medicine at Mount Sinai, New York, USA.

Barbara G Vickrey (BG)

Department of Neurology, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, Box 1052, New York, NY, 10029, USA.

Angela Bryan (A)

Department of Psychology and Neuroscience, University of Colorado Boulder, Boulder, USA.

Brady Horn (B)

Department of Economics and the Center On Alcoholism, Substance Use and Addictions, University of New Mexico, Albuquerque, USA.

Angela Starkweather (A)

School of Nursing, University of Connecticut, Storrs, CT, USA.

Jeffrey Fisher (J)

Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, USA.
Institute for Collaboration On Health, Intervention, and Policy (InCHIP), University of Connecticut, Storrs, CT, USA.

Jessica Robinson-Papp (J)

Department of Neurology, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, Box 1052, New York, NY, 10029, USA. jessica.robinson-papp@mssm.edu.
ORCID: 0000-0001-9397-8873

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Classifications MeSH

questionsmedicales.fr › Actions chimiques et utilisations › Actions pharmacologiques › Utilisations thérapeutiques › Agents du système nerveux central › Dépresseurs du système nerveux central › Stupéfiants › Analgésiques morphiniques › Toward Safer Opioid Prescribing in HIV care...
questionsmedicales.fr › États, signes et symptômes pathologiques › Signes et symptômes › Manifestations neurologiques › Douleur chronique › Toward Safer Opioid Prescribing in HIV care...
questionsmedicales.fr › Qualité, accès, évaluation des soins de santé › Qualité des soins de santé › Mécanismes d'évaluation des soins de santé › Adhésion aux directives › Toward Safer Opioid Prescribing in HIV care...
questionsmedicales.fr › Maladies du système immunitaire › Déficits immunitaires › Infections à VIH › Toward Safer Opioid Prescribing in HIV care...
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questionsmedicales.fr › Administration des services de santé › Gestion des soins aux patients › Prise en charge de la maladie › Gestion de la douleur › Toward Safer Opioid Prescribing in HIV care...
questionsmedicales.fr › Qualité, accès, évaluation des soins de santé › Prestations des soins de santé › Types de pratiques des médecins › Toward Safer Opioid Prescribing in HIV care...