Evidence map›Paper›PMID 35578356›Full record

Trial reportAddiction science & clinical practice2022

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

Gabriela Cedillo, Mary Catherine George, Richa Deshpande, Emma K T Benn, Allison Navis, Alexandra Nmashie, Alina Siddiqui, Bridget R Mueller, Yosuke Chikamoto, Linda Weiss and 9 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Addiction science & clinical practice, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03669939 (Toward Safer Opioid Prescribing for Chronic Pain in High Risk Populations), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03669939 completednot on this map

Toward Safer Opioid Prescribing for Chronic Pain in High Risk Populations: Implementing the Centers for Disease Control Guideline (CDC) Guideline in the Primary Care HIV Clinic.

TypeobservationalSponsorIcahn School of Medicine at Mount SinaiRan2018 to 2020Enrolled42ConditionsHIV Disease, Chronic PainArmsCommunication Strategy, Standard of Care
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Consumer Involvement in the Design and Development of Medication Safety Interventions or Services in Primary Care: A Scoping Review.Health expectations : an international journal of public participation in health care and health policy · 2024
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors.

Gabriela CedilloDepartment of Neurology, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, Box 1052, New York, NY, 10029, USA.
Mary Catherine GeorgeDepartment of Neurology, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, Box 1052, New York, NY, 10029, USA.
Richa DeshpandeDepartment of Neurology, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, Box 1052, New York, NY, 10029, USA.
Emma K T BennDepartment of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, USA.
Allison NavisDepartment of Neurology, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, Box 1052, New York, NY, 10029, USA.
Alexandra NmashieDepartment of Neurology, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, Box 1052, New York, NY, 10029, USA.
Alina SiddiquiDepartment of Neurology, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, Box 1052, New York, NY, 10029, USA.
Bridget R MuellerDepartment of Neurology, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, Box 1052, New York, NY, 10029, USA.
Yosuke ChikamotoCaring Accent (Consultancy), San Jose, CA, USA.
Linda WeissCenter for Evaluation and Applied Research, New York Academy of Medicine, New York, USA.
Maya SchererCenter for Evaluation and Applied Research, New York Academy of Medicine, New York, USA.
Alexandra KamlerCenter for Evaluation and Applied Research, New York Academy of Medicine, New York, USA.
Judith A AbergDepartment of Medicine, Division of Infectious Diseases, Icahn School of Medicine at Mount Sinai, New York, USA.
Barbara G VickreyDepartment of Neurology, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, Box 1052, New York, NY, 10029, USA.
Angela BryanDepartment of Psychology and Neuroscience, University of Colorado Boulder, Boulder, USA.
Brady HornDepartment of Economics and the Center On Alcoholism, Substance Use and Addictions, University of New Mexico, Albuquerque, USA.
Angela StarkweatherSchool of Nursing, University of Connecticut, Storrs, CT, USA.
Jeffrey FisherDepartment of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, USA.
Jessica Robinson-PappDepartment 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

Funding

Conduits: Mount Sinai Health System Translational Science HubUL1TR004419 · NCATS · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · PI Rosalind J Wright · 2022 to 2026
$46.4M
Toward safer opioid prescribing for chronic pain in high risk populations: implementing the Centers for Disease Control Guideline (CDC) guideline in the primary care HIV clinicR18HS025641 · AHRQ · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · PI ROBINSON-PAPP, JESSICA · 2017 to 2019
$1.5M
AHRQ HHS R18 HS025641NCATS NIH HHS UL1 TR004419
6 · The paper itself

Abstract

backgroundThe 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.

methodsTOWER 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).

resultsPCPs 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).

conclusionsCDC-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.

Indexed as

Chronic PainHIV InfectionsAnalgesics, OpioidGuideline AdherenceHumansPain ManagementPractice Patterns, Physicians'Analgesics, OpioidChronic painHIVOpioid prescribing guidelinesOpioids

Identifiers

PMID35578356
PMCPMC9108346

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.