DOI: 10.3886/icpsr38893.v1
title: Veterans' Pain Care Organizational Improvement Comparative Effectiveness (VOICE) Study, United States, 2017-2022
title: Version 1

description: The Veterans' Pain Care Organizational Improvement Comparative Effectiveness (VOICE) Study was a 12-month pragmatic randomized comparative effectiveness trial. The target population was primary care patients (n=820) at ten sites within the United States Department of Veterans Affairs (VA) Health Care System with moderate to severe pain despite treatment with moderate or high-dose long-term opioid treatment (LTOT). The study's primary aim was to compare integrated pain team (IPT) versus pharmacist telecare collaborative management (TCM) for improving pain and reducing opioid use among patients with chronic pain prescribed LTOT. In TCM, a lower-intensity intervention, a clinical pharmacist provides care management, structured symptom monitoring, and pain medication optimization. In IPT, a higher-intensity intervention, an interdisciplinary clinician team delivers care using a multi-modal approach to target biopsychosocial contributors to pain and disability with emphasis on non-drug therapies and behavioral activation sessions.
All participants were randomized to receive either IPT or TCM interventions for 12 months. Common elements of both interventions included individualized pain care and opioid taper recommendations tailored to patient preferences and treatment goals. Outcomes were assessed every three months and the primary time point for comparisons was 12 months. The primary outcome was pain, assessed with the Brief Pain Inventory (BPI) total score, with secondary outcomes as opioid daily dose and quality of life measures.
description: The overall purpose of this study was to improve effectiveness and safety of pain management among patients with chronic pain. Specifically, the research aims were:

To compare telecare collaborative pain management (TCM) versus integrated pain team management (IPT) for improving pain and reducing opioid use among Department of Veterans Affairs (VA) patients receiving long-term opioid treatment for chronic pain
To compare standard versus expanded opioid taper options for chronic pain patients on long-term, high-dose opioids
description: Recruitment occurred between October 2017 and March 2021. Centralized and site-based recruitment methods were used. For centralized recruitment, site investigators requested permission from local primary care physicians and advanced practice providers (PCPs) for study personnel to contact their patients. A list of potentially eligible patients of permitting PCPs was updated each month for each active site. Each month, a subset of potentially eligible patients was selected for recruitment outreach, with preferential selection of women and patients prescribed high-dose opioids. Site-based recruitment was based on local clinician referrals. To encourage referrals, study personnel used
broad-based and targeted outreach (e.g., providing clinicians with names of their potentially eligible patients). Potential participants contacted by study personnel were assessed for eligibility and interest in participation.
Enrollment visits were conducted in person or by video. Following the start of the COVID-19 pandemic, enrollment visits were also conducted by phone. A site coordinator conducted baseline interviews after obtaining informed consent from patients and prior to randomization. Participants were assigned by randomization to either telecare collaborative pain management (TCM) or integrated pain team management (IPT). Patient reported outcomes were collected at five timepoints (baseline, 3, 6, 9, and 12 months) via structured interviews by coordinating center staff. Post-baseline outcome data was collected via telephone or an abbreviated mailed questionnaire by blinded assessors located at the study's coordinating center in Minneapolis. Participants received payment after completing each assessment ($50 at baseline, $25 at 3 months, $50 at 6 months, $25 at 9 months, $50 at 12 months).
If patients were interested in reducing or discontinuing opioids during the course of the study, they received individualized information about opioid tapering options. Those in the moderate-dose subgroup received standard options, while the high-dose subgroup were randomized to either standard options or the expanded options arm that included switching to sublingual buprenorphine-naloxone.
Administrative data, including opioid dose outcomes, was collected via the Department of Veterans Affairs (VA) electronic medical record (Corporate Data Warehouse) by the study's coordinating center data management team.
description: Survey data: Items on pain level and severity, health-related quality of life, functioning, adverse effects, and COVID-19 were asked at all timepoints. Items on fatigue/sleep, mental health, substance use, and use of health care services/self-care practices (including non-drug therapies) were asked at baseline, 6 months, and 12 months. Scales were calculated as totals for this collection. For more information on the scales used, refer to the Scales field and the P.I. documentation.
Administrative data: Items include number of study intervention visits, number of pain-related and mental health services received outside of intervention visits (pre- and post-randomization), and number of hospitalizations. Pharmacy dispensing data included opioid dose and other prescriptions per three month interval. Demographic items include age, gender, race, ethnicity, marital status, education level, and employment status.
description: Response Rates: Among the 820 randomized participants, response rates to the follow-up surveys were 89.3% at 3 months, 88.5% at six months, 83.3% at 9 months, and 87.9% at 12 months. These response rates omit a small number of participants responding to the surveys but with no patient reported outcomes available for analysis.
description: Presence of Common Scales: 
Brief Pain Inventory (BPI)
Pain, Enjoyment of Life and General Activity (PEG)
Veterans RAND 12 Item Health
Survey (VR-12)
Prescribed Opioids Difficulty Scale (PODS) Problems scale
PROMIS Sleep Disturbances - short form
PROMIS Fatigue - short form
PROMIS Pain Interference
PROMIS Physical Function
PROMIS Satisfaction with Roles
Patient Health Questionnaire (PHQ-8)
General Anxiety Disorders (GAD-7)
Post-Traumatic Stress Disorder Checklist (PCL-5)
Fibromyalgia Severity Score, derived from Widespread Pain Index and Symptom Severity score
Headache Impact Test (HIT)
Alcohol Use Disorders Identification Test (AUDIT-C)
Tobacco, Alcohol, Prescription Medication, and Other Substance Use (TAPS-2)
Health Behaviors Inventory
Pain Manageable/Tolerable Items
Participatory Decision Making
Primary Care Continuity
Ambulatory Care Experience Survey - Whole Person Orientation
Fear Avoidance Beliefs Questionnaire - Physical Activity Scale
Pain Medication Attitudes Questionnaire Needs and Side Effects
Pain Catastrophizing Scale
Pain Self Efficacy
description: Department of Veterans Affairs (VA) health care sites were selected for geographic and patient demographic diversity. Inclusion criteria were VA patients receiving long-term opioid treatment (LTOT) at a moderate or high opioid daily dose (receiving qualifying prescribed opioid analgesics greater than or equal to three consecutive months and a daily dose of 20 morphine equivalent mg), chronic pain present every or nearly every day for six months, and availability for twelve months. Patients were ineligible if they had dementia or moderate-severe cognitive impairment, active suicidal ideation, severe untreated psychiatric or substance use disorder, opioid use disorder, unstable or end-stage medical disease, suspected controlled substance diversion, or an inability to communicate by telephone for follow-up assessments. Due to underrepresentation in U.S. veteran populations, women were oversampled.
A total of 6,966 patients were identified as potentially eligible through clinical referral and administrative record search. Of those, 4,731 were screened for eligibility and 821 enrolled (359 were not eligible, 3398 declined to enroll, and 153 agreed but did not complete enrollment). One patient was determined to be ineligible after enrollment and withdrawn prior to randomization. The final randomized sample was 820, with 409 assigned to telecare collaborative pain management (TCM) and 411 assigned to integrated pain team management (IPT).
description: Datasets: 
DS0: Study-Level Files
DS1: Participant Survey Data
DS2: Process and Demographic Information Data
DS3: Administrative Diagnostic Data
DS4: Administrative Utilization Data
DS5: Pharmaceutical Administrative Data
description: Veterans aged 18 or older receiving care at 10 selected Department of Veterans Affairs (VA) health care sites in all regions of the United States.
description: record abstracts; face-to-face interview; mail questionnaire; telephone interview