Integrated Services for Pain: Interventions to Reduce Pain Effectively — INSPIRE  

Chronic Pain Clinical Trial

Official title: Integrated Health Services to Reduce Opioid Use While Managing Chronic Pain

Status Completed

Clinical Trial Summary

What is the research about? Long-term pain -or pain that lasts for months or years-is one of the most common health problems in the United States. Clinicians often treat long-term pain with opioids. Opioids can help ease pain in the short term, but evidence does not support their effectiveness in the long term. For some people, long-term opioid use can lead to addiction and overdose. People need effective options and support to help improve their function and enjoy life as much as possible. What is the research team doing? This study that compared two programs for helping people living with long-term pain to improve their function while managing their pain. People with long-term pain who had been taking opioid medicines for 3 or more months could be in the study. This study was done at primary care and pain care clinics at 3 health systems in North Carolina and Tennessee. The study team assigned people by chance to one of two study programs: (1) Shared Decision Making (SDM) or (2) Cognitive Behavioral Therapy and Motivational Interviewing (CBT+MI). Both programs went by clinical guidelines for opioid prescribing. In the SDM program, the patient and clinician worked together to make decisions that were best for the patient. In the CBT+MI program, the patient learned strategies to better cope with chronic pain. The study team compared the two programs by looking at changes in opioid dose, physical functioning, and pain interference over time. They collected information on prescribed opioid dose from electronic health records. People did surveys at the start of the study and at 6 and 12 months. Study data collection is over, and the study team is analyzing data. Results are forthcoming. The study team worked with an advisory group that included patients, advocates, clinicians, and pain experts. The advisory group met with the study team two to three times per year to provide input on the study.

Clinical Trial Description

Rationale: Up to one-third of Americans suffer from chronic non-cancer pain (CNCP). Opioids are often used to treat CNCP. Once on chronic opioid therapy (COT) individuals often continue with this class of medication for years. Evidence for the effectiveness of COT to treat CNCP is limited, exposing individuals to known risks. Modified or novel pharmacological and nonpharmacological strategies are needed to improve pain management and promote informed decision making regarding possible opioid dose reduction. Study Design and Approach: This is a large-scale, pragmatic randomized controlled trial implementing pharmacotherapy guidelines and behavioral interventions in real-world settings. A pragmatic trial is a study designed to evaluate the effectiveness of interventions in broad patient groups in routine clinical practice. This differs from an explanatory trial, which is designed to evaluate efficacy under ideal conditions. In this trial, the researchers will examine the comparative effectiveness of two approaches to reducing opioid dose for CNCP who are on COT: shared decision making (SDM) and guideline-concordant pharmacotherapy (SDM Arm) versus motivational interviewing plus cognitive behavioral therapy for chronic pain (MI+CBT-CP) and guideline-concordant pharmacotherapy (MI+CBT-CP Arm). This project will evaluate two nonpharmacologic approaches to pain management and opioid reduction in primary care and specialty pain clinics. The approaches are designed to educate medical care providers, educate patients currently being treated for CNCP, help patients address pain and pain coping skills, and enhance patient motivation to reduce or discontinue opioid use. This study will determine the feasibility, effectiveness and potential scalability of these interventions in reducing opioid use in patients who are using ≥ 20 morphine equivalent doses (MED). The study will also assess patient acceptability of the interventions including involvement in their implementation and willingness to incur out-of-pocket costs associated with the visits. Objectives: To conduct a multisite pragmatic trial of two active interventions: SDM as compared with MI+CBT-CP. Primary Objective: * To assess if the interventions result in opioid dose reduction and to compare their effectiveness. Secondary Objectives: - To examine the impact of the interventions on physical function. - To examine the impact of the interventions on pain interference. Timeline: The project commenced in February 2018. Participant recruitment occurred from June 2019 to March 2022. Delivery of the intervention occurred on a rolling basis through March 2023. Recruitment, Screening, Enrollment, and Randomization: The study enrolled 526 participants from primary care and pain clinics at three medical centers in North Carolina and Tennessee. The researchers identified patients who are potentially eligible through electronic health records and contacted these patients with an invitation to participate. A Research Coordinator contacted patients to complete screening, enrollment, and randomization. The researchers randomized enrolled participants to either the SDM Arm or MI+CBT-CP Arm of the intervention. Interventions: In the SDM arm, patients and clinicians engaged in SDM. In the MI+CBT-CP Arm, patients participated in MI+CBT-CP. Patients in both study arms received guideline-concordant pharmacotherapy treatment, based on clinical guidelines for opioid therapy for CNCP. Data Collection: The researchers employed a comprehensive, multi-mode data collection method that included collecting patient-reported outcomes through Web-based and phone-based surveys and leveraging existing harmonized electronic health record (EHR) data. The researchers will use validated measures to measure the impact of the interventions. The researchers will assess the primary outcome, change in opioid dose from baseline, using EHR data at 6 timepoints: 3 months, 6 months, 9 months, 12 months, 15 months, and 18 months. Change from baseline in average daily opioid dose will be measured as prescribed morphine equivalent dose (MED). The researchers will measure the secondary outcomes, physical functioning and pain interference, via participant survey at three timepoints: baseline, 6 months, and 12 months. Data Analysis and Reporting: In a large pragmatic trial such as the one planned, the probability is small that the groups will have imbalance by age, sex, health behaviors, or other measured or unmeasured possible confounding factors. Nevertheless, the researchers will assess whether randomization has successfully created comparable groups by descriptively comparing their baseline demographic characteristics and potential confounders, including baseline pain score, comorbidities, opioid dosage, and number and type of CNCP conditions. The researchers will evaluate clinical outcomes and patient-reported outcomes using cross-sectional and longitudinal intent-to-treat analyses. These analyses will use mixed effects models to compare opioid dose between the two study arms over an 18-month period. The researchers also will explore differences in the intervention effect according to participant characteristics, such as age, sex, baseline pain level, baseline opioid dose, and the presence of physical comorbidities, mental health comorbidities, or history of substance abuse. Qualitative research methods have been used to obtain participant input on their experiences. ;

Related Conditions & MeSH terms

• Chronic Pain

• NCT number: NCT03454555
• Study type: Interventional
• Source: RTI International
• Status: Completed
• Phase: N/A
• Start date: June 21, 2019
• Completion date: September 30, 2023