Veterans' Pain Care Organizational Improvement Comparative Effectiveness Study

Chronic Pain Clinical Trial

— VOICE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03026790
• Other study ID #: OPD-1511-33052
• Status: Completed
• Phase: Phase 2
• Start date: October 19, 2017
• Est. completion date: October 30, 2022

Study information

• Verified date: May 2023
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 820
• Est. completion date: October 30, 2022
• Est. primary completion date: March 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Other:
• Medication management
Individualized management of medications for pain
• Non-pharmacological pain management
Individualized management of non-medication pain treatment approaches

Drug:
• Buprenorphine-Naloxone
Option of using buprenorphine-naloxone to assist with opioid dose reduction or discontinuation

Locations

Country	Name	City	State
United States	Minneapolis VA Health Care System	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	VR-12 Physical Component Score	Veterans RAND 12-item health survey (VR-12) Physical Component Score (range 0-100; higher is better)	12 months
Other	Symptom Checklist	Medication-related adverse symptoms count (0-19; higher is worse)	12 months
Other	PODS Problems	Prescribed Opioids Difficulty Scale (PODS) Problems score (range 0-32; higher is worse)	12 months
Other	PHQ-8	Patient Health Questionnaire 8-item (PHQ-8) depression scale score (range 0-24; higher is worse)	12 months
Other	GAD-7	General Anxiety Disorders 7-item questionnaire (GAD-7) score (range 0-21; higher is worse)	12 months
Other	PROMIS Sleep Disturbance	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.	12 months
Other	PROMIS Fatigue	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.	12 months
Other	Headache Impact Test	Headache Impact Test score (range 36-78; higher is worse)	12 months
Other	VR-12 Mental Component Score	Veterans RAND 12-item health survey (VR-12) Mental Component Score (range 0-100; higher is better)	12 months
Other	PODS Concerns	Prescribed Opioids Difficulty Scale (PODS) Concerns score (range 0-28; higher is worse)	12 months
Primary	Pain Response	Binary response variable defined by reduction of at least 30% in Brief Pain Inventory (BPI) total score from baseline	12 months
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	12 months
Secondary	Composite Response	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.	12 months
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)	12 months