Pain Management in Primary Care: A Randomized Controlled Trial of a Computerized Decision Support Tool
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 528
- Primary Endpoint
- Worst Pain Intensity
Study Overview
Brief Summary
Chronic pain is highly prevalent, compromises quality of life, and increases care utilization. Primary care providers are challenged to provide effective treatments, use opioid therapy appropriately, and address the adverse consequences of pain. Technology-enabled decision support tools may provide a means to improve pain management in primary care.
The objective of this study was to evaluate a novel electronic health record (EHR)-based decision support tool-plus-education intervention for pain management in primary care.
Detailed Description
This randomized, wait-list controlled trial evaluated a novel EHR-based system for pain management among patients with chronic pain in six practices of a Federally Qualified Health Center network in New York.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Treated at the Institute for Family Health
- •Spoke English or Spanish
- •Received one or more prescriptions for an opioid or nonopioid analgesic during the past three months
- •Pain screening at the prior three office visits documented scores >3 on the 0-6 scale (FACES, Hicks et al., 2001).
- •Willingness to complete questionnaires three times
- •A commitment to return to the practice
- •Reachable by phone
- •No evidence of psychopathology or cognitive impairment severe enough to prevent informed consent or completing the survey instruments
Exclusion Criteria
- Not provided
Arms & Interventions
Early intervention
Three sites received the Pain Management Support System for Primary Care (PMSS-PC) integrated into the Electronic Health Record.
Intervention: Early intervention (Other)
Delayed intervention
Delayed wait-list control group. Three additional sites received the intervention 6 months after the first arm.
Intervention: Delayed intervention (Other)
Outcomes
Primary Outcomes
Worst Pain Intensity
Time Frame: From baseline to 6 months following intervention implementation
Worst pain intensity score on the Brief Pain Inventory-Short Form. Scores range from 0-10, with higher scores indicating more severe worst pain intensity.
Pain Interference with Function
Time Frame: From baseline to 6 months following intervention implementation
Pain interference T-score, measured on the PROMIS Pain Interference Short Form. Higher scores indicate more pain interference with function.
Average Pain Intensity
Time Frame: From baseline to 6 months following intervention implementation
Average pain intensity score on the Brief Pain Inventory-Short Form. Scores range from 0-10, with higher scores indicating more severe average pain intensity.
Secondary Outcomes
- Worst Pain Intensity(From 6 to 12 months following intervention implementation)
- Average Pain Intensity(From 6 to 12 months following intervention implementation)
- Pain Interference with Function(From 6 to 12 months following intervention implementation)
- Uptake of the PMSS-PC intervention tool(From baseline to 12 months following intervention implementation)