Veterans' Pain Care Organizational Improvement Comparative Effectiveness Study

Comparative Effectiveness of Patient-Centered Strategies to Improve Pain Management and Opioid Safety for Veterans

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03026790

Acronym

VOICE

Enrollment

820

Registered

2017-01-20

Start date

2017-10-19

Completion date

2022-10-30

Last updated

2023-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain

Keywords

Opioid analgesics, Opioid partial agonists, Health care delivery, Back pain, Osteoarthritis, Veterans health

Brief summary

Background and significance: Treatment with opioid pain medications (like hydrocodone and morphine) is common for severe pain, but studies show these medications may not always help and can cause serious problems. High daily doses of opioids can be especially unsafe. To help patients with chronic pain have better quality of life and avoid medication toxicity, health care teams need to manage pain while helping patients reduce opioid medication doses to safer levels.

Detailed description

Study aims: This study will test which of two pain treatment strategies is better for managing pain and helping patients improve safety of opioid medication. For patients on high opioid doses who want to reduce, this study will also test whether offering an extra option for tapering (buprenorphine-naloxone) helps them succeed. Finally, the study will examine patients' and clinicians' experiences with the interventions. Study description: The study will compare two treatment strategies among patients with pain who are taking long-term opioid pain medications prescribed by VA healthcare facilities across the country. Patients who wish to enter the study will be assigned by chance to telecare collaborative management (TCM) or integrated pain team (IPT). TCM involves a pharmacist and supervising physician working together to find the best medication options for each individual patient. In IPT, a team of clinicians focuses on non-medication pain management options, in addition to pain medication. All participants will be asked to stay in the study for 12 months. Patients for whom it would be unsafe to participate will not be invited to join. With either treatment strategy, TCM or IPT, participants will have individualized pain care tailored to their needs and preferences. Participants on high opioid medication doses who want to reduce their opioid medication dose will be assigned by chance to get either a regular step-wise taper or a choice between a regular taper or switching to a different medication (buprenorphine-naloxone). At the end of the study, the two treatment strategies will be compared to see which worked better to (1) decrease pain severity and (2) reduce opioid medication dose. Other outcomes important to patients will also be tracked. These include quality of life, sleep, fatigue, depression, anxiety, and side effects.

Interventions

OTHERMedication management

Individualized management of medications for pain

OTHERNon-pharmacological pain management

Individualized management of non-medication pain treatment approaches

DRUGBuprenorphine-Naloxone

Option of using buprenorphine-naloxone to assist with opioid dose reduction or discontinuation

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

Inclusion criteria

* Moderate or high-dose long-term opioid therapy (≥ 20 ME mg daily for at least 3 months) for chronic pain * Chronic pain of at least moderate severity (defined as pain that is present every or nearly every day for ≥ 6 months and with a score on the PEG 3-item pain measure of ≥ 5)

Exclusion criteria

* Dementia diagnosis * Unstable or severe untreated psychiatric disorder, including severe untreated substance use disorder or active suicidal ideation * Unstable or end-stage medical disease that would interfere with participation, including cancer requiring active treatment and life expectancy \< 12 months * Documentation of suspected controlled substance diversion * Inability to communicate by telephone

Design outcomes

Primary

Measure	Time frame	Description
Pain Response	12 months	Binary response variable defined by reduction of at least 30% in Brief Pain Inventory (BPI) total score from baseline

Secondary

Measure	Time frame	Description
50% Reduction in Opioid Daily Dose	12 months	Binary response variable defined by reduction of at least 50% in opioid daily dose (morphine-equivalent mg) from baseline
Composite Response	12 months	Binary composite response variable defined by achieving at least a 30% reduction in BPI total score and at least 50% reduction in opioid daily dose from baseline.
Brief Pain Inventory (BPI) Total Score	12 months	Brief Pain Inventory (BPI) total score calculated as average of 11 items (range 0-10; higher is worse)

Other

Measure	Time frame	Description
GAD-7	12 months	General Anxiety Disorders 7-item questionnaire (GAD-7) score (range 0-21; higher is worse)
PROMIS Sleep Disturbance	12 months	Patient Reported Outcomes Measurement Information System (PROMIS) sleep disturbance short-form 4a T-score (higher is worse). Raw scores were rescaled into standardized T-scores with a mean of 50 representing the average for the US population and a standard deviation (SD) of 10. A person with a T-score of 40 is one SD below the mean.
PROMIS Fatigue	12 months	Patient Reported Outcomes Measurement Information System (PROMIS) fatigue short-form 4a T-score (higher is worse). Raw scores were rescaled into standardized T-scores with a mean of 50 representing the average for the US population and a standard deviation (SD) of 10. A person with a T-score of 40 is one SD below the mean.
VR-12 Physical Component Score	12 months	Veterans RAND 12-item health survey (VR-12) Physical Component Score (range 0-100; higher is better)
VR-12 Mental Component Score	12 months	Veterans RAND 12-item health survey (VR-12) Mental Component Score (range 0-100; higher is better)
PODS Concerns	12 months	Prescribed Opioids Difficulty Scale (PODS) Concerns score (range 0-28; higher is worse)
Headache Impact Test	12 months	Headache Impact Test score (range 36-78; higher is worse)
Symptom Checklist	12 months	Medication-related adverse symptoms count (0-19; higher is worse)
PODS Problems	12 months	Prescribed Opioids Difficulty Scale (PODS) Problems score (range 0-32; higher is worse)
PHQ-8	12 months	Patient Health Questionnaire 8-item (PHQ-8) depression scale score (range 0-24; higher is worse)

Countries

United States

Participant flow

Participants by arm

Arm	Count
Active Comparator: Telecare Collaborative Management (TCM) Uses medication management approach delivered by a clinical pharmacist care manager with a collaborating physician to address common barriers to effective pain medication management in primary care.	411
Active Comparator: Integrated Pain Team (IPT) Uses a biopsychosocial management approach delivered by a multidisciplinary team that emphasizes non-pharmacological pain management options.	409
Total	820

Baseline characteristics

Characteristic	Active Comparator: Integrated Pain Team (IPT)	Total	Active Comparator: Telecare Collaborative Management (TCM)
Age, Continuous	62.2 years STANDARD_DEVIATION 10.4	62.2 years STANDARD_DEVIATION 10.6	62.1 years STANDARD_DEVIATION 10.8
Race (NIH/OMB) American Indian or Alaska Native	10 Participants	16 Participants	6 Participants
Race (NIH/OMB) Asian	1 Participants	2 Participants	1 Participants
Race (NIH/OMB) Black or African American	67 Participants	130 Participants	63 Participants
Race (NIH/OMB) More than one race	22 Participants	44 Participants	22 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	3 Participants	3 Participants
Race (NIH/OMB) Unknown or Not Reported	12 Participants	16 Participants	4 Participants
Race (NIH/OMB) White	297 Participants	609 Participants	312 Participants
Sex: Female, Male Female	51 Participants	111 Participants	60 Participants
Sex: Female, Male Male	358 Participants	709 Participants	351 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	7 / 358	9 / 363
other Total, other adverse events	207 / 358	178 / 363
serious Total, serious adverse events	109 / 358	109 / 363

Outcome results

Primary

Pain Response

Binary response variable defined by reduction of at least 30% in Brief Pain Inventory (BPI) total score from baseline

Time frame: 12 months

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Active Comparator: Telecare Collaborative Management (TCM)	Pain Response	58 Participants
Active Comparator: Integrated Pain Team (IPT)	Pain Response	54 Participants

Secondary

50% Reduction in Opioid Daily Dose

Binary response variable defined by reduction of at least 50% in opioid daily dose (morphine-equivalent mg) from baseline

Time frame: 12 months

Population: All participants who were alive at 12 months

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Active Comparator: Telecare Collaborative Management (TCM)	50% Reduction in Opioid Daily Dose	102 Participants
Active Comparator: Integrated Pain Team (IPT)	50% Reduction in Opioid Daily Dose	98 Participants

Secondary

Brief Pain Inventory (BPI) Total Score

Brief Pain Inventory (BPI) total score calculated as average of 11 items (range 0-10; higher is worse)

Time frame: 12 months