Comprehensive Post-Acute Stroke Services (COMPASS) Study, North Carolina, 2016-2018 (ICPSR 38185)
The Comprehensive Post-Acute Stroke Services (COMPASS) Study is a pragmatic cluster-randomized clinical trial that evaluated the real-world effectiveness of the COMPASS transitional care (COMPASS-TC) model compared to usual care among adult stroke and transient ischemic attack (TIA) patients discharged home between 2016 and 2018. In Phase 1, 40 North Carolina hospital units were randomized 1:1 to the COMPASS-TC intervention or usual care, stratified by stroke patient volume and stroke center certification. In Phase 2, hospitals randomized to usual care crossed over to implement COMPASS-TC, and hospitals randomized to the intervention sustained COMPASS-TC. The intervention was patient-centered and assessed social and functional determinates of health to inform individualized care plans for secondary prevention, recovery, and referrals to services and community-based resources. COMPASS-TC was consistent with Centers for Medicare and Medicaid Services (CMS) TC management reimbursement requirements.
The primary outcome was functional status (Stroke Impact Scale-16; SIS-16) at 90 days; secondary outcomes were mortality, disability, medication adherence, depression, cognition, self-rated health, fatigue, care satisfaction, home blood pressure monitoring, falls, and caregiver strain. Telephone interviewers, blinded to treatment assignment, assessed these outcomes at 90 days.
Development and Evaluation of a Patient-Centered Approach to Assess Quality of Care: Patient-Reported Outcomes-Based Performance Measures (PRO-PMs) [Methods Study], 6 U.S. States, 2016-2020 (ICPSR 39628)
Patient-reported outcome measures, or PROMs, ask patients how they feel and what activities they can do in daily life. Patients receiving cancer treatment, such as chemotherapy, often have side effects. PROMs can help cancer centers know if patients are getting high-quality care that helps manage their side effects.
In this study, the research team wanted to
- Learn from patients and clinicians, like doctors and nurses, what side effects are important to track during chemotherapy
- Create PROMs that can measure important side effects of chemotherapy
The research team also wanted to test the PROMs to see
- If patients find them easy to complete
- If the PROMs can detect differences in how well cancer centers control patients' treatment side effects
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
Measuring and Talking to Patients About the Accuracy of Data Used in Patient-Centered Outcomes Research [Methods Study], North Carolina and Arkansas, 2013-2018 (ICPSR 39515)
For research studies, researchers can use data about patients' health and treatments from electronic health records, or EHRs. They may also collect self-reported data directly from patients. But a patient's EHR and self-reported data may not always agree. For example, differences may exist between the medicines that patients report taking and the medicines listed in their EHRs. Researchers don't know which of these two data sources is the most accurate.
In this project, the research team looked at EHR and self-reported data to learn which data source was more accurate.
Measuring Patient-Centered Communication for Colorectal Cancer Care and Research [Methods Study], North Carolina, 2013-2018 (ICPSR 39491)
Patients are often more satisfied with care when it matches their goals. To provide care that matches what matters to patients, doctors and other clinical staff need to communicate well with patients so they can learn about their needs and concerns. Healthcare organizations can use patient surveys to measure how well clinicians communicate with patients. To be useful, a survey needs to be
- Valid, or correctly capturing how well doctors communicate
- Reliable, or getting the same results over time
In this study, the research team created and tested a survey for patients getting care for colorectal cancer that asked about communication between the patient and their care team.
Technology-Assisted Qualitative Research: How Does Modality Affect Outcome? [Methods Study], North Carolina, 2014-2018 (ICPSR 39565)
To learn about people's experiences, researchers often use one-on-one interviews and group interviews, called focus groups. Researchers can do interviews and focus groups in person or online.
In this study, the research team wanted to learn if people shared more or different information in person versus online. The team did interviews and focus groups with women about safety during pregnancy and compared the information collected in person or online. To collect information online, the team used either online video, chat, a message board, or email. The team then compared differences in the average number of words and what women discussed across the methods.