Development of an Emergency Department Patient-Centered Intervention for the Primary Prevention of Long-Term Opioid Use
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- Combined Pain Severity and Interference Scores
Study Overview
Brief Summary
This project tests a brief evidence-based video to help educate patients regarding effective and safe pharmacologic and non-pharmacologic therapies for acute musculoskeletal pain (MSP). Subjects will be randomly placed into one of two study arms: intervention (educational video) and usual care. Patients will be contacted at baseline and at 1 and 3 months after the date of an emergency department (ED) or urgent care encounter for follow-up. The aim of this study is to evaluate the success of the intervention for improving pain recovery and preventing long-term opioid use among adults with musculoskeletal pain.
The overarching hypothesis of this work is that complementing prescribing policies with patient education based on a shared decision-making approach to pain management can improve pain recovery and reduce progression to long-term opioid use. The proposed study is innovative because it will be the first clinical trial of a patient-centered intervention designed for the primary prevention of long-term opioid use.
Detailed Description
This study will use a two-arm, blinded, randomized controlled trial to estimate the effect of the adapted telehealth video intervention on pain recovery and opioid use at 3 months among opioid-naïve adult Emergency Department (ED) and urgent care patients with musculoskeletal pain.
This 2-year study will encompass the conduct and analysis of an assessor-blinded two-arm randomized controlled trial among 200 ED/urgent care patients with acute MSP. Randomization will be block stratified by the subject's age (18-40 years; 41+ years).
To test the efficacy of the intervention subjects will be randomized to one of two arms:
- Intervention (video)
- Usual Care (standard care provided by ED/urgent care provider and staff) Intervention: The telehealth intervention consists of an interactive video (~15 minutes) given to the patient after an ED/urgent care visit that provides essential pain treatment information and encourages patients to discuss treatment options with their ED/urgent care provider.
Following the video, the participant will contact the research team with his/her answers to the multiple choice questions posed during the video and/or confirm having watched the video within, at most, 5 days of the participant's discharge / acute care visit.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Follow-up assessments will be conducted by study staff who will be blinded to treatment arm allocation at 1 and 3 months
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •≥18 years of age
- •primary complaint of acute MSP
- •if in the ED, discharge to home is anticipated
- •average pain score ≥4 (0-10 scale) since pain onset
Exclusion Criteria
- •patient does not speak English
- •primary pain located in the head, chest, or abdomen
- •pain due to ischemia, infection, or some other cause not due to MSP (blood clot, kidney stone, etc.)
- •primary pain due to self-injury
- •patient is critically ill, including current diagnosis of cancer
- •diagnosis of somatoform disorder, schizophrenia, dementia, or bipolar disorder
- •patient is a prisoner or in police custody
- •patient is currently pregnant
- •self-reported daily opioid use for more than seven consecutive days during the prior 30 days to the acute care visit
- •resides in a nursing home or is homeless
- •at-risk alcohol use
- •speech, hearing, vision problems
- •cognitively impaired (6-item Brief Screener)
- •nonworking phone number (follow-up occurs via phone calls)
Outcomes
Primary Outcomes
Combined Pain Severity and Interference Scores
Time Frame: Baseline (following ED or orthopedic urgent care visit) to month 3
The Brief Pain Inventory-short form (BPI-SF) is an 11-item measure of pain severity and pain interference. Patients will rate pain severity and interference over the past week on a 0-10 numeric scale at 3 discrete time periods (baseline, 1 month, and 3 months). End points for the severity items include 0 which equals "no pain" and 10 which equals "pain as bad as you can imagine." End points for the interference items include 0 which equals "does not interfere" and 10 "completely interferes." Higher scores reflect more pain severity and more pain interference. A composite score will be calculated by averaging scores from both the pain severity and interference items (all 11-items). Results from the 3 time periods will be analyzed longitudinally.
Secondary Outcomes
- Pain Severity on the BPI-SF(Up to 3 months)
- Healthcare Utilization, Number of Visits to ED/urgent care(Up to 3 months)
- PROMIS Measure: Global Health-Physical 2a(Up to 3 months)
- Pain Interference on the BPI-SF(Up to 3 months)
- Opioid Use During the Past Week(Up to 3 months)
- Healthcare Utilization, Number of Visits to non-ED or Urgent Care Physicians(Up to 3 months)
- PROMIS Measure: Physical Function-4(Up to 3 months)