Integrated Services for Pain: Interventions to Reduce Pain Effectively (INSPIRE)

Integrated Health Services to Reduce Opioid Use While Managing Chronic Pain

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Behavioral: Shared Decision Making; Behavioral: Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain

Detailed Description

Objective:

To compare the effectiveness of individual motivational interviewing plus group-based cognitive behavioral therapy (MI+CBT) versus patient-clinician shared decision making (SDM) on change in daily dosage of prescribed opioids, physical functioning, and pain interference for individuals with chronic non-cancer pain (CNCP).

Rationale:

About 24% of Americans suffer from CNCP and clinicians often prescribe opioids to treat it. 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 was a large-scale, pragmatic randomized controlled trial implementing pharmacotherapy guidelines and behavioral interventions in real-world settings. A key eligibility criterion was individuals who were prescribed ≥ 20 milligrams of morphine equivalents for more than three months.

Interventions:

Researchers examined the comparative effectiveness of MI+CBT versus SDM for who are on COT. Neither approach is directive, and both support patient choice. Although MI+CBT and SDM are both behavioral intervention strategies, they differ in content covered and training of those delivering the intervention (behavioral vs. medical). Participants in both study arms received guideline-concordant pharmacotherapy treatment, based on clinical guidelines for opioid therapy for CNCP.

Outcomes:

• Primary: The change from baseline in average daily prescribed opioid dosage, measured in milligrams of morphine equivalents, at 12 months, with secondary time points at 6 months and 18 months
• Secondary: The change from baseline to 6 and 12 months (primary timepoint) in the PROMIS Short Form v1.0 Pain Interference and PROMIS Short Form v1.0 Physical Function scales.

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 randomized 525 participants from primary care and pain clinics at three medical centers in North Carolina and Tennessee. The researchers identified individuals who were potentially eligible through electronic health records and invited them to participate. A Research Coordinator contacted individuals to complete screening, enrollment, and randomization.

Data Collection:

The researchers collected validated patient-reported outcomes through Web-based and phone-based surveys and leveraged existing harmonized electronic health record (EHR) data for clinical outcomes.

Data Analysis:

Outcomes were analyzed for all randomized participants in an intent-to-treat fashion, irrespective of the amount of intervention received. Because some individuals did not attend an intervention session, sensitivity analyses were based on a modified intent-to-treat population limited to participants receiving at least 1 intervention session and a per-protocol population limited to participants receiving at least four CBT or SDM sessions.

Changes from baseline were analyzed with a repeated measures linear model accounting for correlation of measurements over time, with effects for intervention arm, time interval as a categorical predictor, intervention-by-time interaction, and adjustment for baseline value and study site. Differential treatment effects for two preplanned subgroups based on sex and prior mental health diagnosis, as defined by IDC-10 codes recorded in the EHR, were assessed at 12 months via a subgroup-by-intervention interaction within the repeated measures model.

Qualitative research methods were used to obtain participant input on their experiences.

• Study Type: Interventional
• Enrollment (Actual): 543
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina Health Care System
    • Durham, North Carolina, United States, 27701
      • Duke University Health System
  • Tennessee
    • Nashville, Tennessee, United States, 27232
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Shared Decision Making (SDM); 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; 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.
Active Comparator: 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 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Pain Interference on the 8-item Patient-Reported Outcomes Measurement Information System - Pain Interference (PROMIS-PI) at Month 6	The Patient-Reported Outcomes Measurement Information System - Pain Interference (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 T-scores indicate higher pain interference and worse health. Change = Month 6 Score - Baseline Score.	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	The Patient-Reported Outcomes Measurement Information System - Pain Interference (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 T-scores indicate higher pain interference and worse health. Change = Month 12 Score - Baseline Score.	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	The Patient-Reported Outcomes Measurement Information System - Physical Functioning (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 T-scores indicate higher physical functioning and better health. Change = Month 6 Score - Baseline Score.	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	The Patient-Reported Outcomes Measurement Information System - Physical Functioning (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 T-scores indicate higher physical functioning and better health. Change = Month 12 Score - Baseline Score.	Month 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Pain Intensity on the 3-item Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity at Month 6	The Patient-Reported Outcomes Measurement Information System (PROMIS)-Pain Intensity is a validated, self-reported instrument assessing pain intensity over the past 7 days. Possible scores on each item range in value from 1 (no pain) to 5 (very severe). Higher T-scores indicate higher pain intensity and worse health. Change = Month 6 Score - Baseline Score.	Month 6
Change From Baseline in Pain Intensity on the 3-item Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity at Month 12	The Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity is a validated, self-reported instrument assessing pain intensity over the past 7 days. Possible scores on each item range in value from 1 (no pain) to 5 (very severe). Higher T-scores indicate higher pain intensity and worse health. Change = Month 12 Score - Baseline Score.	Month 12
Change From Baseline in Anxiety on the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Anxiety at Month 6	The Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Anxiety is a validated, self-reported instrument assessing anxiety over the past 7 days. Anxiety measures self-reported fear, anxiety, hyperarousal, and somatic symptoms related to arousal. Anxiety is best differentiated by symptoms that reflect autonomic arousal and experience of threat. Possible scores on each item range in value from 1 (never) to 5 (always). Higher T-scores indicate higher anxiety and worse health. Change = Month 6 Score - Baseline Score.	Month 6
Change From Baseline in Anxiety on the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Anxiety at Month 12	The Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Anxiety is a validated, self-reported instrument assessing anxiety over the past 7 days. Anxiety measures self-reported fear, anxiety, hyperarousal, and somatic symptoms related to arousal. Anxiety is best differentiated by symptoms that reflect autonomic arousal and experience of threat. Possible scores on each item range in value from 1 (never) to 5 (always). Higher T-scores indicate higher anxiety and worse health. Change = Month 12 Score - Baseline Score.	Month 12
Change From Baseline in Depression on the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Depression at Month 6	The Patient-Reported Outcomes Measurement Information System (PROMIS)-Emotional Distress-Depression is a validated, self-reported instrument assessing depression over the past 7 days. Depression measures self-reported negative mood, views of self, social cognition, and decreased positive affect and engagement. Possible scores on each item range in value from 1 (never) to 5 (always). Higher T-scores indicate higher depression and worse health. Change = Month 6 Score - Baseline Score.	Month 6
Change From Baseline in Depression on the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Depression at Month 12	The Patient-Reported Outcomes Measurement Information System (PROMIS)-Emotional Distress-Depression is a validated, self-reported instrument assessing depression over the past 7 days. Depression measures self-reported negative mood, views of self, social cognition, and decreased positive affect and engagement. Possible scores on each item range in value from 1 (never) to 5 (always). Higher T-scores indicate higher depression and worse health. Change = Month 12 Score - Baseline Score.	Month 12
Change From Baseline in Pain Severity on the 4-item Brief Pain Inventory (BPI) Pain Severity at Month 6	The Brief Pain Inventory (BPI) Pain Severity is a validated, self-reported instrument assessing pain severity at its worst and least in the past 7 days, on average, and right now. Possible scores on each item range from 0 (no pain) to 10 (pain as bad as you can imagine). Higher scores indicate higher pain severity and worse health. Change = Month 6 Score - Baseline Score.	Month 6
Change From Baseline in Pain Severity on the 4-item Brief Pain Inventory (BPI) Pain Severity at Month 12	The Brief Pain Inventory (BPI) Pain Severity is a validated, self-reported instrument assessing pain severity at its worst and least in the past 7 days, on average, and right now. Possible scores on each item range from 0 (no pain) to 10 (pain as bad as you can imagine). Higher scores indicate higher pain severity and worse health. Change = Month 12 Score - Baseline Score.	Month 12
Change From Baseline in Pain Interference on the 7-item Brief Pain Inventory (BPI) Pain Interference at Month 6	The Brief Pain Inventory (BPI) Pain Interference is a validated, self-reported instrument assessing pain interference over the past 7 days in 7 categories: general activity, walking, work, mood, enjoyment of life, relation with others, and sleep. Possible scores on each item range from 0 (does not interfere) to 10 (completely interferes). Higher scores indicate higher pain interference and worse health. Change = Month 6 Score - Baseline Score.	Month 6
Change From Baseline in Pain Interference on the 7-item Brief Pain Inventory (BPI) Pain Interference at Month 12	The Brief Pain Inventory (BPI) Pain Interference is a validated, self-reported instrument assessing pain interference over the past 7 days in 7 categories: general activity, walking, work, mood, enjoyment of life, relation with others, and sleep. Possible scores on each item range from 0 (does not interfere) to 10 (completely interferes). Higher scores indicate higher pain interference and worse health. Change = Month 12 Score - Baseline Score.	Month 12
Discontinuation of Opioid Medications at Month 12	Discontinuation of opioid medications at Month 12 was assessed with a self-reported item newly developed for this study and electronic health record (EHR) data. Discontinuation was defined as a response of "No" to a question on the Month 12 participant survey that asked: "Are you currently taking an opioid medicine now? Commonly prescribed opioids include hydrocodone, oxycodone, codeine, morphine, and fentanyl" AND no opioid prescriptions in the EHR within 15 days prior to Month 12 through Month 18.	Month 12
Intent to Taper at Month 6	Intent to Taper was assessed with a self-reported item, newly developed for this study, that assessed intent to reduce the amount of opioids taken: "Please say how much you agree with this statement: 'Reducing the amount of opioid medicines I take is a goal of mine.'" Possible response options included Strongly Agree, Agree, Uncertain, Disagree, and Strongly Disagree. Responses of Strongly Agree or Agree were categorized as an intent to taper, and responses of Uncertain, Disagree, Strongly Disagree, or Don't Know were categorized as no intent to taper.	Month 6
Intent to Taper at Month 12	Intent to Taper was assessed with a self-reported item, newly developed for this study, that assessed intent to reduce the amount of opioids taken: "Please say how much you agree with this statement: 'Reducing the amount of opioid medicines I take is a goal of mine.'" Possible response options included Strongly Agree, Agree, Uncertain, Disagree, and Strongly Disagree. Responses of Strongly Agree or Agree were categorized as an intent to taper, and responses of Uncertain, Disagree, Strongly Disagree, or Don't Know were categorized as no intent to taper.	Month 12
Relative Opioid Use Self-report at Month 6	Opioid use relative to baseline was assessed with a self-reported item, newly developed for this study: "Since you started taking part in this study, would you say that your overall use of opioids has increased, stayed about the same, or decreased? In thinking about your "overall use" we ask you consider how often you take the opioid medicine, the different types of opioid medicines, and their amounts." Possible response options included: My overall use of opioids has increased; My overall use of opioids has stayed about the same; and My overall use of opioids has decreased.	Month 6
Relative Opioid Use Self-report at Month 12	Opioid use relative to baseline was assessed with a self-reported item, newly developed for this study: "Since you started taking part in this study, would you say that your overall use of opioids has increased, stayed about the same, or decreased? In thinking about your "overall use" we ask you consider how often you take the opioid medicine, the different types of opioid medicines, and their amounts." Possible response options included: My overall use of opioids has increased; My overall use of opioids has stayed about the same; and My overall use of opioids has decreased.	Month 12

Collaborators and Investigators

• Sponsor: RTI International
• Collaborators: Patient-Centered Outcomes Research Institute; Vanderbilt University Medical Center; Duke Health; University of North Carolina Health Care System
• Investigators: Principal Investigator: Lauren McCormack, PhD, MSPH, RTI International

Publications and helpful links

General Publications

• Tan G, Jensen MP, Thornby JI, Shanti BF. Validation of the Brief Pain Inventory for chronic nonmalignant pain. J Pain. 2004 Mar;5(2):133-7. doi: 10.1016/j.jpain.2003.12.005.
• Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.
• Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.
• Rose M, Bjorner JB, Gandek B, Bruce B, Fries JF, Ware JE Jr. The PROMIS Physical Function item bank was calibrated to a standardized metric and shown to improve measurement efficiency. J Clin Epidemiol. 2014 May;67(5):516-26. doi: 10.1016/j.jclinepi.2013.10.024.
• Amtmann D, Cook KF, Jensen MP, Chen WH, Choi S, Revicki D, Cella D, Rothrock N, Keefe F, Callahan L, Lai JS. Development of a PROMIS item bank to measure pain interference. Pain. 2010 Jul;150(1):173-182. doi: 10.1016/j.pain.2010.04.025.
• Chou R, Deyo R, Devine B, Hansen R, Sullivan S, Jarvik JG, Blazina I, Dana T, Bougatsos C, Turner J. The Effectiveness and Risks of Long-Term Opioid Treatment of Chronic Pain. Evid Rep Technol Assess (Full Rep). 2014 Sep;(218):1-219. doi: 10.23970/AHRQEPCERTA218.
• Martin BC, Fan MY, Edlund MJ, Devries A, Braden JB, Sullivan MD. Long-term chronic opioid therapy discontinuation rates from the TROUP study. J Gen Intern Med. 2011 Dec;26(12):1450-7. doi: 10.1007/s11606-011-1771-0. Epub 2011 Jul 13.
• Monticone M, Ambrosini E, Cedraschi C, Rocca B, Fiorentini R, Restelli M, Gianola S, Ferrante S, Zanoli G, Moja L. Cognitive-behavioral Treatment for Subacute and Chronic Neck Pain: A Cochrane Review. Spine (Phila Pa 1976). 2015 Oct 1;40(19):1495-504. doi: 10.1097/BRS.0000000000001052.
• Vanderlip ER, Sullivan MD, Edlund MJ, Martin BC, Fortney J, Austen M, Williams JS, Hudson T. National study of discontinuation of long-term opioid therapy among veterans. Pain. 2014 Dec;155(12):2673-2679. doi: 10.1016/j.pain.2014.09.034. Epub 2014 Sep 30.
• Boonstra AM, Schiphorst Preuper HR, Balk GA, Stewart RE. Cut-off points for mild, moderate, and severe pain on the visual analogue scale for pain in patients with chronic musculoskeletal pain. Pain. 2014 Dec;155(12):2545-2550. doi: 10.1016/j.pain.2014.09.014. Epub 2014 Sep 17.
• Rose M, Bjorner JB, Becker J, Fries JF, Ware JE. Evaluation of a preliminary physical function item bank supported the expected advantages of the Patient-Reported Outcomes Measurement Information System (PROMIS). J Clin Epidemiol. 2008 Jan;61(1):17-33. doi: 10.1016/j.jclinepi.2006.06.025.
• 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.
• Bann CM, McCormack LA, Berkman ND, Squiers LB. The Health Literacy Skills Instrument: a 10-item short form. J Health Commun. 2012;17 Suppl 3(Suppl 3):191-202. doi: 10.1080/10810730.2012.718042.
• McCormack LA, Edlund MJ, Thomas SM, Wu LT, Chelminski PR, Archer KR, Wagner LK, Hirsch S, Thompson JE, Dolor RJ, Ives TJ, Dewey CM, Chang S; INSPIRE Study Team. Effectiveness of motivational interviewing plus cognitive behavioral therapy vs shared decision making for voluntary opioid tapering in patients with chronic pain: the INSPIRE randomized pragmatic trial. Pain Med. 2025 Aug 1;26(8):477-489. doi: 10.1093/pm/pnaf049.
• 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.

Helpful 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

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2019
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: February 27, 2018
• First Submitted That Met QC Criteria: March 2, 2018
• First Posted (Actual): March 6, 2018

Study Record Updates

• Last Update Posted (Actual): August 12, 2025
• Last Update Submitted That Met QC Criteria: July 24, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Motivational Interviewing; Pain; Chronic Pain; Decision Making, Shared; Neurologic Manifestations; Cognitive Therapy; Patient Reported Outcome Measures; Comparative Effectiveness Research; Analgesics, Opioid; Pragmatic Clinical Trial
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: PCORI-OPD-1610-37006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

RTI International plans to make available data from this study through the Patient-Centered Outcomes Data Repository (PCODR).

The data package will include a de-identified copy of datasets containing all derived data used for all analysis and reporting.

IPD Sharing 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).

• IPD Sharing 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).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No