Comparing Two Ways to Manage Symptoms for Patients Who Have Chronic Migraine and Frequent Medication Use (The MOTS Trial), United States, 2017-2020 (ICPSR 38546)
Integrated Health Services to Reduce Opioid Use While Managing Chronic Pain (INSPIRE Trial), North Carolina and Tennessee, 2019-2023 (ICPSR 39271)
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
Targeted Interventions to Prevent Chronic Low Back Pain in High Risk Patients: A Multi-Site Pragmatic Randomized Controlled Trial (TARGET Trial), 4 U.S. cities, 2016-2019 (ICPSR 38145)
The TARGET (Targeted Interventions to Prevent Chronic Low Back Pain in High-Risk Patients) Trial was a primary care-based, multisite, cluster randomized, pragmatic trial comparing guideline-based care (GBC) to GBC + referral to Psychologically Informed Physical Therapy (PIPT) for patients presenting with acute lower back pain (LBP) and identified as high risk for persistent disabling symptoms. Chronic lower back pain (LBP) is defined as a response of "more than three months" to question 1, and a response of "half the days or more than half the days" in the past 6 months to question 2. See Appendix 1 for the LBP Questionnaire in the Protocol report.
Study sites included primary care clinics within each of four geographical regions in the United States, with clinics randomized to either GBC or GBC+PIPT. Acute LBP patients at all clinics were risk stratified (high, medium, low) using the STarT Back Tool. The primary outcomes were the presence of chronic LBP and LBP-related functional disability determined by the Oswestry Disability Index at 6 months. Secondary outcomes were LBP-related processes of health care and utilization of services over 12 months, determined through electronic medical records.
Study enrollment began in May 2016 and concluded in June 2018. The trial was powered to include at least 1,860 high-risk patients in the cluster-randomized controlled trial cohort. A prospective observational cohort of approximately 6,900 low and medium-risk acute LBP patients was enrolled concurrently.
This data collection contains a single data file with 223 variables and 9,730 cases. The number of respondents at each of the study locations were:
- Boston Medical Center: 997 respondents
- Intermountain Health (Salt Lake City): 2,094 respondents
- Johns Hopkins University (Baltimore): 1,615 respondents
- University of Pittsburg Medical Center: 5,024 respondents