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Randomized Controlled Trial
. 2025 Feb 1;185(2):208-220.
doi: 10.1001/jamainternmed.2024.6683.

Care Models to Improve Pain and Reduce Opioids Among Patients Prescribed Long-Term Opioid Therapy: The VOICE Randomized Clinical Trial

Erin E Krebs  1   2 , William C Becker  3   4 , David B Nelson  1   5 , Beth M DeRonne  1 , Agnes C Jensen  1 , Allyson M Kats  6 , Benjamin J Morasco  7   8 , Joseph W Frank  9   10 , Una E Makris  11   12 , Kelli D Allen  13   14 , Jennifer C Naylor  13   15 , Amanda S Mixon  16   17 , Amy Bohnert  18   19 , Thomas E Reznik  20 , Jacob T Painter  21   22 , Teresa J Hudson  23 , Hildi J Hagedorn  1   24 , Jennifer K Manuel  25   26 , Brian Borsari  25   26 , Natalie Purcell  25   27 , Patrick Hammett  1   5 , Erin C Amundson  1 , Robert D Kerns  3   28 , Monica R Barbosa  11   29   30 , Caitlin Garvey  25 , Elzie J Jones  31 , Maureen Y Noh  13   32 , Jennifer B Okere  11   30 , Sujata Bhushan  11   33 , John Pinsonnault  11 , Beth E Williams  34 , Ellen Herbst  25   26 , Pooja Lagisetty  18   35 , Sara Librodo  25   36 , Payal S Mapara  25   37 , Elizabeth Son  38 , Christina Tat  39 , Rebecca A Marraffa  1 , Randy L Seys  13   40 , Catherine Baxley  25   26 , Karen H Seal  25   37   41 ; VOICE Study Group
Collaborators, Affiliations
Randomized Controlled Trial

Care Models to Improve Pain and Reduce Opioids Among Patients Prescribed Long-Term Opioid Therapy: The VOICE Randomized Clinical Trial

Erin E Krebs et al. JAMA Intern Med. .

Abstract

Importance: Patients prescribed long-term opioid therapy for chronic pain often experience unrelieved pain, poor quality of life, and serious adverse events.

Objective: To compare the effects of integrated pain team (IPT) vs pharmacist collaborative management (PCM) on pain and opioid dosage.

Design, setting, and participants: This study was a pragmatic multisite 12-month randomized comparative effectiveness trial with masked outcome assessment. Patients were recruited from October 2017 to March 2021; follow-up was completed June 2022. The study sites were Veterans Affairs primary care clinics. Eligible patients had moderate to severe chronic pain despite long-term opioid therapy (≥20 mg/d for at least 3 months).

Interventions: IPT involved interdisciplinary pain care planning, visits throughout 12 months with medical and mental health clinicians, and emphasis on nondrug therapies and motivational interviewing. PCM was a collaborative care intervention involving visits throughout 12 months with a clinical pharmacist care manager who conducted structured monitoring and medication optimization. Both interventions provided individualized pain care and opioid tapering recommendations to patients.

Main outcomes and measures: The primary outcome was pain response (≥30% decrease in Brief Pain Inventory total score) at 12 months. The main secondary outcome was 50% or greater reduction in opioid daily dosage at 12 months.

Results: A total of 820 patients were randomized to IPT (n = 411) or PCM (n = 409). Participants' mean (SD) age was 62.2 (10.6) years, and 709 (86.5%) were male. A pain response was achieved in 58/350 patients in the IPT group (16.4%) vs 54/362 patients in the PCM group (14.9%) (odds ratio, 1.11 [95% CI, 0.74-1.67]; P = .61). A 50% opioid dose reduction was achieved in 102/403 patients in the IPT group (25.3%) vs 98/399 patients in the PCM group (24.6%) (odds ratio, 1.03 [95% CI, 0.75-1.42]; P = .85). Over 12 months, the mean (SD) Brief Pain Inventory total score improved from 6.7 (1.5) points to 6.1 (1.8) points (P < .001) in IPT and from 6.6 (1.6) points to 6.0 (1.9) points (P < .001) in PCM (between-group P = .82). Over 12 months, mean (SD) opioid daily dosage decreased from 80.8 (74.2) mg/d to 54.2 (65.0) mg/d in IPT (P < .001) and from 74.5 (56.9) mg/d to 52.8 (51.9) mg/d (P < .001) in PCM (between-group P = .22).

Conclusions and relevance: Outcomes in this randomized clinical trial did not differ between groups; both had small improvements in pain and substantial reductions in opioid dosage.

Trial registration: ClinicalTrials.gov Identifier: NCT03026790.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Krebs reported grants from the National Institutes of Health (NIH) and the VA paid to her institution outside the submitted work, funding from Origin Editorial for serving as Associate Editor for Patient-Centered Outcomes Research Institute (PCORI) research reports, and travel support from the American College of Physicians, the Foundation for Opioid Response Efforts (FORE), and the US Association for the Study of Pain; Dr Krebs is also a member of the Scientific Advisory Council for FORE. Dr Morasco reported grants from Oregon Health & Science University. Dr Frank reported grants from the VA Office of Rural Health and NIH outside the study. Dr Makris is partly supported by a VA Health Systems Research grant (IIR 20-256) outside the study. Dr Manuel reported personal fees from the American Psychological Association outside the study. Dr Kerns reported personal fees from NIH, the Canadian Chronic Pain Centre of Excellence, and the American Academy of Pain Medicine outside the study. Dr Barbosa reported grants from the US Department of Defense. Dr Lagisetty reported Veterans Health Administration funding (SDR21-107) and NIH funding (K23DA047475). Dr Baxley reported grants from the US Department of VA paid to their institution. No other disclosures were reported.

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