Integrated Services for Pain: Interventions to Reduce Pain Effectively
- Conditions
- Chronic Pain
- Interventions
- Behavioral: Motivational Interviewing and Cognitive Behavioral Therapy for Chronic PainBehavioral: Shared Decision Making
- Registration Number
- NCT03454555
- Lead Sponsor
- RTI International
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 526
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP) Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain MI+CBT-CP participants will receive the guideline-concordant pharmacotherapy based on clinical guidelines for opioid therapy for chronic noncancer pain plus the MI+CBT-CP intervention. Shared Decision Making (SDM) Shared Decision Making SDM participants will receive guideline-concordant pharmacotherapy based on clinical guidelines for opioid therapy for chronic noncancer pain plus the SDM intervention during their opioid management visits.
- Primary Outcome Measures
Name Time Method Change From Baseline in Average Daily Opioid Dose in Morphine Equivalent Dose (MED) at Month 9 Baseline and Month 9 The primary outcome will be derived from electronic health records. 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 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. Opioid dose will be calculated as the prescribed milligrams of daily MED averaged over the 90 days prior to randomization and averaged over 90 days for the time period of 9 months post-randomization. Change in daily opioid dose will be computed as the difference between the dose calculated during that period and the dose from the baseline period.
Change From Baseline in Average Daily Opioid Dose in Morphine Equivalent Dose (MED) at Month 12 Baseline and Month 12 The primary outcome will be derived from electronic health records. 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 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. Opioid dose will be calculated as the prescribed milligrams of daily MED averaged over the 90 days prior to randomization and averaged over 90 days for the time period of 12 months post-randomization. Change in daily opioid dose will be computed as the difference between the dose calculated during that period and the dose from the baseline period.
Change From Baseline in Average Daily Opioid Dose in Morphine Equivalent Dose (MED) at Month 3 Baseline and Month 3 The primary outcome will be derived from electronic health records. 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 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. Opioid dose will be calculated as the prescribed milligrams of daily MED averaged over the 90 days prior to randomization and averaged over 90 days for the time period of 3 months post-randomization. Change in daily opioid dose will be computed as the difference between the dose calculated during that period and the dose from the baseline period.
Change From Baseline in Average Daily Opioid Dose in Morphine Equivalent Dose (MED) at Month 6 Baseline and Month 6 The primary outcome will be derived from electronic health records. 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 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. Opioid dose will be calculated as the prescribed milligrams of daily MED averaged over the 90 days prior to randomization and averaged over 90 days for the time period of 6 months post-randomization. Change in daily opioid dose will be computed as the difference between the dose calculated during that period and the dose from the baseline period.
Change From Baseline in Average Daily Opioid Dose in Morphine Equivalent Dose (MED) at Month 15 Baseline and Month 15 The primary outcome will be derived from electronic health records. 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 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. Opioid dose will be calculated as the prescribed milligrams of daily MED averaged over the 90 days prior to randomization and averaged over 90 days for the time period of 15 months post-randomization. Change in daily opioid dose will be computed as the difference between the dose calculated during that period and the dose from the baseline period.
Change From Baseline in Average Daily Opioid Dose in Morphine Equivalent Dose (MED) at Month 18 Baseline and Month 18 The primary outcome will be derived from electronic health records. 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 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. Opioid dose will be calculated as the prescribed milligrams of daily MED averaged over the 90 days prior to randomization and averaged over 90 days for the time period of 18 months post-randomization. Change in daily opioid dose will be computed as the difference between the dose calculated during that period and the dose from the baseline period.
Percent Change from Baseline in Average Daily Opioid Dose in Morphine Equivalent Dose (MED) at Month 3 Baseline and Month 3 Percent change is difference from baseline value divided by the baseline value and multiplied by 100. Positive values indicate an increase in opioid use from baseline, while negative values indicates a decrease from baseline.
Percent Change from Baseline in Average Daily Opioid Dose in Morphine Equivalent Dose (MED) at Month 6 Baseline and Month 6 Percent change is difference from baseline value divided by the baseline value and multiplied by 100. Positive values indicate an increase in opioid use from baseline, while negative values indicates a decrease from baseline.
Change from Baseline of at least 10 Morphine Equivalent Dose (MED) at Month 3 Baseline and Month 3 Dichotomous variable indicating a decrease of 10 MED or more from baseline.
Percent Change from Baseline in Average Daily Opioid Dose in Morphine Equivalent Dose (MED) at Month 9 Baseline and Month 9 Percent change is difference from baseline value divided by the baseline value and multiplied by 100. Positive values indicate an increase in opioid use from baseline, while negative values indicates a decrease from baseline.
Percent Change from Baseline in Average Daily Opioid Dose in Morphine Equivalent Dose (MED) at Month 15 Baseline and Month 15 Percent change is difference from baseline value divided by the baseline value and multiplied by 100. Positive values indicate an increase in opioid use from baseline, while negative values indicates a decrease from baseline.
Percent Change from Baseline in Average Daily Opioid Dose in Morphine Equivalent Dose (MED) at Month 18 Baseline and Month 18 Percent change is difference from baseline value divided by the baseline value and multiplied by 100. Positive values indicate an increase in opioid use from baseline, while negative values indicates a decrease from baseline.
Percent Change from Baseline in Average Daily Opioid Dose in Morphine Equivalent Dose (MED) at Month 12 Baseline and Month 12 Percent change is difference from baseline value divided by the baseline value and multiplied by 100. Positive values indicate an increase in opioid use from baseline, while negative values indicates a decrease from baseline.
Change from Baseline of at least 10 Morphine Equivalent Dose (MED) at Month 6 Baseline and Month 6 Dichotomous variable indicating a decrease of 10 MED or more from baseline.
Change from Baseline of at least 10 Morphine Equivalent Dose (MED) at Month 9 Baseline and Month 9 Dichotomous variable indicating a decrease of 10 MED or more from baseline.
Change from Baseline of at least 10 Morphine Equivalent Dose (MED) at Month 12 Baseline and Month 12 Dichotomous variable indicating a decrease of 10 MED or more from baseline.
Change from Baseline of at least 10 Morphine Equivalent Dose (MED) at Month 15 Baseline and Month 15 Dichotomous variable indicating a decrease of 10 MED or more from baseline.
Change from Baseline of at least 10 Morphine Equivalent Dose (MED) at Month 18 Baseline and Month 18 Dichotomous variable indicating a decrease of 10 MED or more from baseline.
- Secondary Outcome Measures
Name Time Method Change from Baseline in Pain Interference on the 8-item Patient-Reported Outcomes Measurement Information System - Pain Interference (PROMIS-PI) at Month 6 Baseline and Month 6 The PROMIS-PI is a validated, self-reported instrument assessing pain interference over the past 7 days. Pain interference is a measure of the extent to which pain interferes with patient physical, mental, and social activities. Possible scores on each item range in value from 1 (not at all) to 5 (very much). Higher scores indicate higher pain interference and worse health. Change = Month 6 Score - Baseline Score.
Change from Baseline in Pain Interference on the 8-item Patient-Reported Outcomes Measurement Information System - Pain Interference (PROMIS-PI) at Month 12 Baseline and Month 12 The PROMIS-PI is a validated, self-reported instrument assessing pain interference over the past 7 days. Pain interference is a measure of the extent to which pain interferes with patient physical, mental, and social activities. Possible scores on each item range in value from 1 (not at all) to 5 (very much). Higher scores indicate higher pain interference and worse health. Change = Month 12 Score - Baseline Score.
Change from Baseline in Physical Functioning on the 8-item Patient-Reported Outcomes Measurement Information System - Physical Functioning (PROMIS-PF) at Month 6 Baseline and Month 6 The PROMIS-PF is a validated, self-reported instrument assessing physical functioning over the past 7 days. Physical functioning measures one's upper extremities (dexterity), lower extremities (walking and mobility), central regions (back and neck), and instrumental activities of daily living.
Possible scores on each item range in value from 1 (without any difficulty) to 5 (unable to do). Higher scores indicate higher physical functioning and better health. Change = Month 6 Score - Baseline Score.Change from Baseline in Physical Functioning on the 8-item Patient-Reported Outcomes Measurement Information System - Physical Functioning (PROMIS-PF) at Month 12 Baseline and Month 12 The PROMIS-PF is a validated, self-reported instrument assessing physical functioning over the past 7 days. Physical functioning measures one's upper extremities (dexterity), lower extremities (walking and mobility), central regions (back and neck), and instrumental activities of daily living.
Possible scores on each item range in value from 1 (without any difficulty) to 5 (unable to do). Higher scores indicate higher physical functioning and better health. Change = Month 12 Score - Baseline Score.
Trial Locations
- Locations (3)
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Duke University Health System
🇺🇸Durham, North Carolina, United States
University of North Carolina Health Care System
🇺🇸Chapel Hill, North Carolina, United States