Integrated Services for Pain: Interventions to Reduce Pain Effectively

Study Overview
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Brief Summary
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What is the research about? Chronic pain, or pain that lasts for months or years, is one of the most common health problems. Doctors often treat chronic pain with a type of medicine called opioids. Opioids can help ease pain in the short term. But long-term opioid use can lead to addiction or overdose. This study compares two ways to help people living with chronic pain to improve their function while managing their pain. The study is looking at how each approach affects opioid use, pain levels, physical and emotional well-being, and satisfaction with pain care. Who can this research help? Doctors and patients can use findings from the study when considering ways to treat chronic pain. What is the research team doing? The research team enrolled 526 adults ages 18 to 85 who have used opioid medicines for at least 90 days to treat chronic pain. The patients are receiving care at three health systems in North Carolina and Tennessee. The team assigned patients by chance to one of two treatment groups. Patients in both groups get recommended opioid therapy. In the first group, doctors get training to talk with patients about the benefits, harms, and risks of different treatments and what matters most to the patient. Patients and doctors in this group make decisions about treatment together, based on each patient's values and preferences. Patients in the second group get eight weekly group sessions and one individual visit with a therapist. These sessions focus on enhancing and supporting patients' knowledge, beliefs, and skills in managing their pain. The research team is looking at patients' electronic health records at the study's start and again at 6, 12, and 18 months. The team is comparing whether patients in the two groups reduce or stop using opioids. Patients also complete surveys at the study's start, at 6 months, and at 12 months to answer questions about Ability to do daily activities, such as running errands How pain interferes with their ability to do daily activities Pain level Anxiety and emotional distress Depression symptoms Ability to cope with pain Satisfaction with pain care The research team is also comparing results among people with different backgrounds or health needs. The team is asking a small number of patients about their experiences with the study through interviews and focus groups. An advisory committee is working with the team to design and conduct the study. The committee includes patients with chronic non-cancer pain; experts in pain management; and people from patient advocacy organizations, a state government agency, and a health insurer.

Detailed Description
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Rationale: Up to one-third of Americans suffer from chronic non-cancer pain (CNCP) (Institute of Medicine, 2011). Opioids are often used to treat CNCP. Once on chronic opioid therapy (COT) individuals often continue with this class of medication for years (Martin et al., 2011; Vanderlip et al., 2014). Evidence for the effectiveness of COT to treat CNCP is limited, exposing individuals to known risks (Chou et al., 2014). 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, randomized pragmatic trial implementing pharmacotherapy guidelines and behavioral interventions in real-world settings. In this trial, the researchers will examine the comparative effectiveness of two approaches to reducing opioid dose for chronic non-cancer patients (CNCP) who are on chronic opioid therapy (COT): shared decision making (SDM) and guideline-concordant pharmacotherapy (Arm 1) versus motivational interviewing plus cognitive behavioral therapy for chronic pain (MI+CBT-CP) and guideline-concordant pharmacotherapy (Arm 2). 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: Shared Decision-Making as compared with Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain. 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 will occur 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 Arm 1 or Arm 2 of the intervention. Interventions: In Arm 1, patients and clinicians will engage in SDM. In Arm 2, patients will participate in MI+CBT-CP. Patients in both study arms will receive guideline-concordant pharmacotherapy treatment, based on clinical guidelines for opioid therapy for CNCP. Data Collection: The researchers will employ a comprehensive, multi-mode data collection method that includes 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, opioid dose reduction, using EHR data at four timepoints: baseline, 6 months, 12 months, and 18 months. Reduction of opioid use will be measured as prescribed milligrams of daily 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.

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

Conditions
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Chronic Pain

Intervention / Treatment
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* Behavioral: Shared Decision Making
* Behavioral: Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 to 85 years History of chronic non-cancer pain (CNCP) Receiving high-dose chronic opioid therapy for CNCP as evidenced by current or most recent prescription of an average daily morphine-equivalent dose of 20 mg or greater Receiving care at a participating clinic from a participating provider, as evidenced by at least 1 in-person visit within the past 12 months. Exclusion Criteria: Not meeting the above inclusion criteria Opioid use is for pain directly related to an active cancer diagnosis Opioid use is for maintenance treatment of an opioid use disorder Suicide attempt within the past 3 years Active suicidal ideation Currently receiving Cognitive-Behavioral Therapy (CBT) Non-English speaking Other reason at the discretion of the investigator

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomly assigned to one of two intervention arms for the duration of the study. The study will use real-time 1:1 ratio randomization to limit participant loss prior to treatment. Eligible patients will be randomized using a stratified, permuted-block design, as this constrained randomization approach ensures balance between treatment groups within each of the 3 clinical institutions (our only stratification factor) at the completion of each block. Consequently, throughout the trial, the intervention arms are expected to have approximately equal sample sizes both within an institution and across the study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br>Arm 1 participants will receive guideline-concordant pharmacotherapy based on clinical guidelines for opioid therapy for chronic noncancer pain plus the Shared Decision Making (SDM) intervention during their opioid management visits. | Behavioral: Shared Decision Making<br>* The Shared Decision Making (SDM) intervention is a patient-provider communication intervention to explore and compare treatment options, assess a patient's values and preferences, and reach a shared decision about chronic pain treatment. The intervention will have both clinician and patient educational components. The content of the clinician component will be based on the Agency for Healthcare Research and Quality (AHRQ) SHARE Approach, which is a 5-step process for shared decision making that includes exploring and comparing the benefits, harms, and risks of each option through meaningful dialogue about what matters most to the patient (Agency for Healthcare Research and Quality, 2017). Participants randomized to Arm 1 will have their study visits and opioid use managed by an SDM-trained clinician at their practice.<br>|
| Active Comparator: Arm 2<br>Arm 2 participants will receive the guideline-concordant pharmacotherapy based on clinical guidelines for opioid therapy for chronic noncancer pain plus the Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP) Intervention. | Behavioral: Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain<br>* The Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP) intervention is an empirically based behavioral pain management behavioral therapy intervention (Monticone et al., 2015), including MI to enhance motivation for active participation in the CBT-CP, and the use of CBT-CP to enhance pain coping skills. One individual MI session will focus on patient engagement and enhancing a patient's own intrinsic motivation for CBT-CP participation. MI will also be woven into the group CBT-CP sessions. We will deliver 8 sessions of CBT-CP, as is standard in a group setting, in-person or virtually.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of opioid use | Average daily opioid dose in milligrams of morphine equivalent. Briefly, total morphine equivalents for each prescription will be calculated by multiplying the quantity of each prescription by the strength of the prescription (milligrams of opioid per unit dispensed). The quantity-strength product is then multiplied by conversion factors derived from published sources to estimate the milligrams of morphine equivalent to the opioids dispensed in the prescription. The total average dose in morphine equivalents per day supplied is calculated by summing the morphine equivalents for each prescription filled during a given period, and dividing by the number of days supplied. Prescribing data are derived from electronic health records (EHRs). | Baseline | 
| Reduction of opioid use | Average daily opioid dose in milligrams of morphine equivalent. Briefly, total morphine equivalents for each prescription will be calculated by multiplying the quantity of each prescription by the strength of the prescription (milligrams of opioid per unit dispensed). The quantity-strength product is then multiplied by conversion factors derived from published sources to estimate the milligrams of morphine equivalent to the opioids dispensed in the prescription. The total average dose in morphine equivalents per day supplied is calculated by summing the morphine equivalents for each prescription filled during a given period, and dividing by the number of days supplied. Prescribing data are derived from electronic health records (EHRs). | 6 months | 
| Reduction of opioid use | Average daily opioid dose in milligrams of morphine equivalent. Briefly, total morphine equivalents for each prescription will be calculated by multiplying the quantity of each prescription by the strength of the prescription (milligrams of opioid per unit dispensed). The quantity-strength product is then multiplied by conversion factors derived from published sources to estimate the milligrams of morphine equivalent to the opioids dispensed in the prescription. The total average dose in morphine equivalents per day supplied is calculated by summing the morphine equivalents for each prescription filled during a given period, and dividing by the number of days supplied. Prescribing data are derived from electronic health records (EHRs). | 12 months | 
| Reduction of opioid use | Average daily opioid dose in milligrams of morphine equivalent. Briefly, total morphine equivalents for each prescription will be calculated by multiplying the quantity of each prescription by the strength of the prescription (milligrams of opioid per unit dispensed). The quantity-strength product is then multiplied by conversion factors derived from published sources to estimate the milligrams of morphine equivalent to the opioids dispensed in the prescription. The total average dose in morphine equivalents per day supplied is calculated by summing the morphine equivalents for each prescription filled during a given period, and dividing by the number of days supplied. Prescribing data are derived from electronic health records (EHRs). | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical functioning | Patient-Reported Outcomes Measurement Information System - Physical Functioning (PROMIS-PF). Assesses self-reported capability rather than actual performance of physical activities. Patient-reported outcome. | Baseline | 
| Physical functioning | Patient-Reported Outcomes Measurement Information System - Physical Functioning (PROMIS-PF). Assesses self-reported capability rather than actual performance of physical activities. Patient-reported outcome. | 6 months | 
| Physical functioning | Patient-Reported Outcomes Measurement Information System - Physical Functioning (PROMIS-PF). Assesses self-reported capability rather than actual performance of physical activities. Patient-reported outcome. | 12 months | 
| Pain interference on functioning | Patient-Reported Outcomes Measurement Information System - Pain Interference (PROMIS-PI), 8-item Short Form. Assesses extent to which pain interferes with daily functioning. Items measured on 5-point Likert scale. Patient-reported outcome. | Baseline | 
| Pain interference on functioning | Patient-Reported Outcomes Measurement Information System - Pain Interference (PROMIS-PI), 8-item Short Form. Assesses extent to which pain interferes with daily functioning. Items measured on 5-point Likert scale. Patient-reported outcome. | 6 months | 
| Pain interference on functioning | Patient-Reported Outcomes Measurement Information System - Pain Interference (PROMIS-PI), 8-item Short Form. Assesses extent to which pain interferes with daily functioning. Items measured on 5-point Likert scale. Patient-reported outcome. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pragmatic Clinical Trial, Comparative Effectiveness Research, Analgesics, Opioid, Decision Making, Shared, Motivational Interviewing, Cognitive Therapy, Patient Reported Outcome Measures, Chronic Pain, Pain, Neurologic Manifestations