DOI: 10.3886/icpsr39271.v1
title: Integrated Health Services to Reduce Opioid Use While Managing Chronic Pain (INSPIRE Trial), North Carolina and Tennessee, 2019-2023
title: Version 1

description: INtegrated Services for Pain: Interventions to Reduce Pain Effectively (INSPIRE) was a pragmatic randomized trial conducted from 2019 to 2023 with adults receiving chronic opioid therapy (COT) of at least 20 morphine milligram equivalents (MME) daily for chronic noncancer pain (CNCP). Participants were recruited from primary care and specialty pain clinics at three academic health centers in North Carolina and Tennessee. The study compared the effectiveness of the two behavioral interventions, 1) shared decision making (SDM) versus 2) motivational interviewing plus cognitive behavioral therapy for chronic pain (MI+CBT), on change in opioid dose, physical function, and pain interference. INSPIRE combined data from electronic health records (EHR) on opioid dose from baseline to 18 months and comorbidities with participant survey data at baseline, 6, and 12 months on the following topics:
physical function,
pain interference,
pain intensity,
anxiety,
depression,
pain severity,
discontinuation of opioids,
intent to reduce opioids,
opioid use relative to baseline,
adverse events,
demographics,
health insurance coverage,
health literacy,
patient-centered communication, and
types of pain treatment used.
The collection includes three analysis datasets:
Adverse Events Dataset - one record per subject per adverse event
Opioid Prescriptions Dataset (post-processed opioid prescriptions used to derive the study's primary outcome) - one record per subject per opioid prescription
Outcomes Dataset (contains all of the study's demographics, primary, secondary, exploratory, and subgroup analysis variables) - one record per subject per timepoint
description: The primary objective of the INtegrated Services for Pain: Interventions to Reduce Pain Effectively (INSPIRE) trial was to test whether chronic noncancer pain (CNCP) patients who receive guideline-concordant pharmacotherapy with a motivational interviewing plus cognitive behavioral therapy for chronic pain (MI+CBT) intervention have a greater opioid dose reduction relative to their counterparts who receive guideline-concordant pharmacotherapy integrated with shared decision making (SDM). Secondary objectives were to test whether CNCP patients who receive guideline-concordant pharmacotherapy with an MI+CBT intervention have improved physical functioning and lower pain interference relative to their counterparts who receive guideline-concordant pharmacotherapy integrated with SDM.
description: A baseline survey was administered after participant screening and consent. Participants received $30 to complete the baseline survey, which collected the following information: demographics, health insurance coverage, health literacy, patient-centered communication, types of pain treatment used, intention to reduce opioids, current opioid use, and baseline levels of physical functioning, pain interference, pain intensity, anxiety, depression, and pain severity. After the baseline survey was complete, participants were randomized to one of two intervention arms: shared decision making (SDM) or cognitive behavioral therapy for chronic pain (MI+CBT). Study staff assigned participants to a treatment arm using the randomization tool in REDCap.
Surveys at 6 and 12 months from randomization were administered. Participants were compensated $25 for each follow-up survey completed. The follow-up surveys collected the following information: potential adverse events (including hospitalization or emergency department visit for self-harm, opioid overdose, or opioid withdraw), experience with healthcare professionals, satisfaction with pain management care, opioid use since participation in the study, and levels of physical functioning, pain interference, pain intensity, anxiety, depression, and pain severity.
Electronic health record (EHR) data were abstracted from all randomized participants to measure the primary outcome of opioid dosage. Clinical data were extracted from each site's PCORnet Common Data Model (CDM) data warehouse. EHR data were collected for all enrolled participants through 18 months, and included: all opioid prescriptions from 180-days prior to enrollment through 18-months post-randomization, baseline International Classification of Diseases, 10th Revision (ICD-10) codes (prior to randomization) to categorize comorbidities, death dates, and ICD-10 codes to identify potential adverse events including self-harm, opioid overdose, or opioid withdrawal.
description: Response Rates: A total of 2,417 potentially eligible participants were approached, 679 were screened, 543 consented, and 525 were randomized: 263 to motivational interviewing plus cognitive behavioral therapy (MI+CBT) and 262 to shared decision making (SDM). The analytic sample includes all 525 randomized participants (intent-to-treat population). Of participants randomized, 193 (73 percent) in MI+CBT and 224 (85 percent) in SDM received at least 1 intervention session over the 12-month period (modified intent-to-treat population), and 132 (50 percent) and 148 (56 percent), respectively, received at least 4 intervention sessions (per-protocol population). Seventy-four participants (28 percent) in MI+CBT and 34 (13 percent) for SDM were lost to follow-up, died, or withdrew from the study. The survey completion rate at 12 months was 49 percent in MI+CBT and 58 percent in SDM. Opioid prescription data were available for 84 percent of MI+CBT participants and 85 percent of SDM participants through 12 months and 75 percent in each group through 18 months.
description: Presence of Common Scales: 8-item Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Pain Interference 8a
8-item PROMIS Short Form v1.0 - Physical Function 8a
3-item PROMIS Scale v1.0 - Pain Intensity 3a
4-item PROMIS Short Form v1.0 - Anxiety 4a
4-item PROMIS Short Form v1.0 - Depression 4a
11-item Brief Pain Inventory
5-item Health Literacy Skills Instrument
6-item Patient-Centered Communication in Cancer Care
description: People with chronic non-cancer pain (CNCP) on long-term opioid therapy were recruited from 17 clinics in three health systems. Eligible participants were aged 18-85 years, taking at least 20 morphine milligram equivalents (MME) for CNCP from the most recent prescription, and receiving care at a participating clinic. Exclusion criteria included receiving opioids for cancer pain or for maintenance or treatment of an opioid use disorder, currently receiving cognitive behavioral therapy (CBT), being non-English speaking, having active suicidal ideation, having a suicide attempt within the past 3 years, or other reasons at the discretion of the investigator. The research team included the discretionary exclusion criteria to allow sites to handle rare cases in which patients would clearly be inappropriate for the study, such as behavioral disturbances or cognitive impairment.
Study staff at each site queried electronic health records to identify potentially eligible patients and manually derived average daily MME for the most recent prescription using standard conversion ratios to confirm eligibility criteria. Recruitment began June 26, 2019, and ended March 31, 2022. Participants were recruited by mail, email, phone, and in participating clinics by study staff and clinicians who explained the study and assessed interest. Staff conducted screening in-person and remotely. Staff informed patients that they would not have to decrease or discontinue their opioids to participate in the study. The decision to reduce or discontinue opioid use was voluntary (unless a clinician had concerns regarding misuse or an excessively high MME independent of any risk of misuse).
description: Datasets: 
DS0: Study-Level Files
DS1: Adverse Events Dataset
DS2: Opioid Prescriptions Dataset
DS3: Outcomes Dataset
description: Adults aged 18 to 85 years with chronic noncancer pain receiving high-dose chronic opioid therapy of at least 20 morphine milligram equivalents daily, and receiving care at a participating clinic from a participating provider, as evidenced by at least one in-person visit within the past 12 months.
description: computer-assisted telephone interview (CATI); coded on-site observation; web-based surveyFor additional information on INtegrated Services for Pain: Interventions to Reduce Pain Effectively (INSPIRE), please visit the INSPIRE study page.