Integrated Services for Pain: Interventions to Reduce Pain Effectively

NCT03454555 | Completed Results DMC

• 1 other identifier: PCORI-OPD-1610-37006
• Study Type: interventional
• Target: 543
• Locations: 1 country
• Sites: 3

Brief Summary

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 prescribe opioids which can help ease pain in the short term, but evidence does not support their effectiveness over the long term. For some people, long-term opioid use can lead to addiction and overdose. People need effective options and support to help maintain or improve their function and quality of life. This study compared two programs for helping people living with long-term pain who have been prescribed opioids for 3 or more months. This study was done at primary care and pain care clinics at 3 health systems in the Southeastern United States. The study team assigned people by chance to one of two study programs: (1) individual motivational interviewing plus group-based cognitive behavioral therapy (MI+CBT) or (2) patient-clinician shared decision making. In the MI+CBT program, the patient learned strategies to better cope with chronic pain. In the SDM program, the patient and clinician worked together through enhanced communication to make decisions that aligned with values and preferences of the patient. The study team compared the two programs by looking at changes in opioid dosage, physical functioning, and pain interference over time. They collected information about prescribed opioid dosage from electronic health records and patients completed surveys at the start of the study and 6 and 12 months later. 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.

Conditions

Chronic Pain

Keywords

Pragmatic Clinical Trial; Comparative Effectiveness Research; Analgesics, Opioid; Decision Making, Shared; Motivational Interviewing; Cognitive Therapy; Patient Reported Outcome Measures; Chronic Pain; Pain; Neurologic Manifestations

Outcome Measures

Primary Outcomes (12)

• Change From Baseline in Average Daily Opioid Dose in Morphine Milligram Equivalents (MME) at Month 12

  The primary outcome was derived from electronic health records. Total morphine equivalents for each prescription was calculated by multiplying the quantity of each prescription by the strength of the prescription (milligrams of opioid per unit dispensed). The quantity-strength product was 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 was calculated by summing the morphine equivalents for each prescription filled during a given period and dividing by the number of days supplied. Opioid dose was calculated as the prescribed milligrams of daily morphine equivalent dose 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 was computed as the difference between the dose calculated during that period and the dose from the baseline period.

  Month 12 (PRIMARY TIMEPOINT)

• Change From Baseline in Average Daily Opioid Dose in Morphine Milligram Equivalents (MME) at Month 3

  The primary outcome was derived from electronic health records. Total morphine equivalents for each prescription was calculated by multiplying the quantity of each prescription by the strength of the prescription (milligrams of opioid per unit dispensed). The quantity-strength product was 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 was calculated by summing the morphine equivalents for each prescription filled during a given period and dividing by the number of days supplied. Opioid dose was calculated as the prescribed milligrams of daily morphine equivalent dose 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 was computed as the difference between the dose calculated during that period and the dose from the baseline period.

  Month 3

• Change From Baseline in Average Daily Opioid Dose in in Morphine Milligram Equivalents (MME) at Month 6

  The primary outcome was derived from electronic health records. Total morphine equivalents for each prescription was calculated by multiplying the quantity of each prescription by the strength of the prescription (milligrams of opioid per unit dispensed). The quantity-strength product was 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 was calculated by summing the morphine equivalents for each prescription filled during a given period and dividing by the number of days supplied. Opioid dose was calculated as the prescribed milligrams of daily morphine equivalent dose 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 was computed as the difference between the dose calculated during that period and the dose from the baseline period.

  Month 6

• Change From Baseline in Average Daily Opioid Dose in Morphine Milligram Equivalents (MME) at Month 9

  The primary outcome was derived from electronic health records. Total morphine equivalents for each prescription was calculated by multiplying the quantity of each prescription by the strength of the prescription (milligrams of opioid per unit dispensed). The quantity-strength product was 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 was calculated by summing the morphine equivalents for each prescription filled during a given period and dividing by the number of days supplied. Opioid dose was calculated as the prescribed milligrams of daily morphine equivalent dose 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 was computed as the difference between the dose calculated during that period and the dose from the baseline period.

  Month 9

• Change From Baseline in Average Daily Opioid Dose in Morphine Milligram Equivalents (MME) at Month 15

  The primary outcome was derived from electronic health records. Total morphine equivalents for each prescription was calculated by multiplying the quantity of each prescription by the strength of the prescription (milligrams of opioid per unit dispensed). The quantity-strength product was 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 was calculated by summing the morphine equivalents for each prescription filled during a given period and dividing by the number of days supplied. Opioid dose was calculated as the prescribed milligrams of daily morphine equivalent dose 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 was computed as the difference between the dose calculated during that period and the dose from the baseline period.

  Month 15

• Change From Baseline in Average Daily Opioid Dose in Morphine Milligram Equivalents (MME) at Month 18

  The primary outcome was derived from electronic health records. Total morphine equivalents for each prescription was calculated by multiplying the quantity of each prescription by the strength of the prescription (milligrams of opioid per unit dispensed). The quantity-strength product was 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 was calculated by summing the morphine equivalents for each prescription filled during a given period and dividing by the number of days supplied. Opioid dose was calculated as the prescribed milligrams of daily morphine equivalent dose 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 was computed as the difference between the dose calculated during that period and the dose from the baseline period.

  Month 18

• Change From Baseline of at Least 10 Morphine Milligram Equivalents (MME) at Month 12

  Dichotomous variable indicating a decrease of 10 MME or more from baseline to 12 months (1=yes and 0 =no). Modeled the probability of having a 10 or more MME decrease from baseline.

  Month 12

• Change From Baseline of at Least 10 Morphine Milligram Equivalents (MME) at Month 3

  Dichotomous variable indicating a decrease of 10 MME or more from baseline to 12 months (1=yes and 0 =no). Modeled the probability of having a 10 or more MME decrease from baseline.

  Month 3

• Change From Baseline of at Least 10 Morphine Milligram Equivalents (MME) at Month 6

  Dichotomous variable indicating a decrease of 10 MME or more from baseline to 12 months (1=yes and 0 =no). Modeled the probability of having a 10 or more MME decrease from baseline.

  Month 6

• Change From Baseline of at Least 10 Morphine Milligram Equivalents (MME) at Month 9

  Dichotomous variable indicating a decrease of 10 MME or more from baseline to 12 months (1=yes and 0 =no). Modeled the probability of having a 10 or more MME decrease from baseline.

  Month 9

• Change From Baseline of at Least 10 Morphine Milligram Equivalents (MME) at Month 15

  Dichotomous variable indicating a decrease of 10 MME or more from baseline to 12 months (1=yes and 0 =no). Modeled the probability of having a 10 or more MME decrease from baseline.

  Month 15

• Change From Baseline of at Least 10 Morphine Milligram Equivalents (MME) at Month 18

  Dichotomous variable indicating a decrease of 10 MME or more from baseline to 12 months (1=yes and 0 =no). Modeled the probability of having a 10 or more MME decrease from baseline.

  Month 18

Secondary Outcomes (4)

• Change From Baseline in Pain Interference on the 8-item Patient-Reported Outcomes Measurement Information System - Pain Interference (PROMIS-PI) at Month 6

  Month 6

• Change From Baseline in Pain Interference on the 8-item Patient-Reported Outcomes Measurement Information System - Pain Interference (PROMIS-PI) at Month 12

  Month 12

• Change From Baseline in Physical Functioning on the 8-item Patient-Reported Outcomes Measurement Information System - Physical Functioning (PROMIS-PF) at Month 6

  Month 6

• Change From Baseline in Physical Functioning on the 8-item Patient-Reported Outcomes Measurement Information System - Physical Functioning (PROMIS-PF) at Month 12

  Month 12

Other Outcomes (15)

• Change From Baseline in Pain Intensity on the 3-item Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity at Month 6

  Month 6

• Change From Baseline in Pain Intensity on the 3-item Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity at Month 12

  Month 12

• Change From Baseline in Anxiety on the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Anxiety at Month 6

  Month 6

Study Arms (2)

Shared Decision Making (SDM)

ACTIVE COMPARATOR

Shared Decision Making (SDM) participants received guideline-concordant pharmacotherapy based on clinical guidelines for opioid therapy for chronic noncancer pain plus the SDM intervention during their opioid management visits.

Behavioral: Shared Decision Making

Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP)

ACTIVE COMPARATOR

Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP) participants received the guideline-concordant pharmacotherapy based on clinical guidelines for opioid therapy for chronic noncancer pain plus the MI+CBT-CP intervention.

Behavioral: Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain

Interventions

Shared Decision Making BEHAVIORAL

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. Participants in the SDM arm received their regular pain care visits with a designated SDM-trained clinician over a 12-month period. SDM intervention participants scheduled pain visits as often as needed for pain management (typically quarterly). SDM participants also received an electronic and physical packet of educational materials after randomization.

Shared Decision Making (SDM)

Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain BEHAVIORAL

The Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP) intervention is an empirically based behavioral pain management behavioral therapy intervention, including MI to enhance motivation for active participation in the CBT-CP, and the use of CBT-CP to enhance pain coping skills. MI + CBT-CP participants received one MI session plus up to eight weekly CBT-CP group sessions.

Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain (MI+CBT-CP)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 to 85 years
• History of chronic non-cancer pain (CNCP)
• Receiving chronic opioid therapy for CNCP as evidenced by current or most recent prescription of an average daily prescribed dosage of 20 milligrams of morphine equivalents
• Receiving care at a participating clinic from a participating provider, as evidenced by at least 1 in-person visit within the past 12 months.

You may not qualify if:

• 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

Sponsors & Collaborators

• RTI International: lead
• Patient-Centered Outcomes Research Institute: collaborator
• University of North Carolina Health Care System: collaborator
• Duke Health: collaborator
• Vanderbilt University Medical Center: collaborator

Study Sites (3)

University of North Carolina Health Care System

Chapel Hill, North Carolina, 27599, United States

Location

Duke University Health System

Durham, North Carolina, 27701, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 27232, United States

Location

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• Edlund MJ, Thomas SM, Wagner LK, Thompson JE, Wu LT, Dolor RJ, Chelminski PR, Ives TJ, Archer KR, Dewey CM, Sullivan MD, McCormack LA; INSPIRE Study Team. Design of a Multicenter Randomized Controlled Trial comparing the effectiveness of shared decision making versus motivational interviewing plus cognitive behavioral therapy for voluntary opioid tapering: The INSPIRE study protocol. Contemp Clin Trials. 2024 Feb;137:107410. doi: 10.1016/j.cct.2023.107410. Epub 2023 Dec 12.

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  PMID: 40338272 RESULT

• Chang SH, Hirsch SC, Thomas SM, Edlund MJ, Dolor RJ, Ives TJ, Dewey CM, Gulur P, Chelminski PR, Archer KR, Wu LT, Curtis J, Goldstein AO, McCormack LA; INSPIRE Study Team. Complexities and approaches for deriving longitudinal daily morphine milligram equivalents using electronic health record prescription data. JAMIA Open. 2025 Jun 16;8(3):ooaf053. doi: 10.1093/jamiaopen/ooaf053. eCollection 2025 Jun.

  PMID: 40524838 RESULT

Related Links

• Study description on research team's organizational website
• Institute of Medicine (US) Committee on Advancing Pain Research, Care, and Education. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Washington (DC): National Academies Press (US); 2011.
• Study description on funder's website

MeSH Terms

Conditions

Chronic Pain; Pain; Neurologic Manifestations

Interventions

Motivational Interviewing; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services; Behavior Therapy; Psychotherapy

Limitations and Caveats

Academic medical centers as study sites may limit applicability to other settings. Patients mostly on low or medium opioid doses. INSPIRE was conducted during the peak of coronavirus disease 2019 (COVID-19). Technological barriers could have hindered participation. Clinicians and patients may have been reluctant to taper opioids during telehealth visits. Pandemic-related hardships may have affected self-reported quality of life measures.

Results Point of Contact

• Title: Dr. Lauren McCormack
• Organization: RTI International

lmac@rti.org

919-541-6277

Study Officials

• Lauren McCormack, PhD, MSPH

  RTI International

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Vice President

Model Details: Participants were randomly assigned to one of two intervention arms for the duration of the study. The study used real-time 1:1 ratio randomization to limit participant loss prior to treatment. Eligible patients were randomized using a stratified, permuted-block design, as this constrained randomization approach ensured balance between treatment groups within each of the 3 clinical institutions (the only stratification factor) at the completion of each block. Consequently, throughout the trial, the intervention arms were expected to have approximately equal sample sizes both within an institution and across the study.

Study Record Dates

• First Submitted: February 27, 2018
• First Posted: March 6, 2018
• Study Start: June 26, 2019
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: August 12, 2025
• Results First Posted: August 12, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Study data will be available for third-party requests when one of two conditions is met (whichever is met first): * The study funder, Patient-Centered Outcomes Research Institute (PCORI), makes the Final Research Report available on the PCORI website. * At the time of publication of the research project's primary results in a peer-reviewed journal. It is expected that data will be available until 7 years after RTI's contract with PCORI ends (2032).
• Access Criteria: Third-party investigators seeking to access data will be required to complete and submit a data request form to PCODR. All requests for data will undergo review by an independent committee directed by PCODR staff. If the data request is approved, the data requestor's institution must enter into a Data Use Agreement (DUA). Approved data requestors will only have access to study data through a secure Virtual Data Enclave (VDE).

Locations

US (3)