Development of an Emergency Department Patient-Centered Intervention for the Primary Prevention of Long-Term Opioid Use
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acute Musculoskeletal Pain
- Sponsor
- University of North Carolina, Chapel Hill
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Combined Pain Severity and Interference Scores
- Status
- Recruiting
- Last Updated
- 2 years ago
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: 1. Intervention (video) 2. 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. Evaluation: Data collection will occur for subjects in all arms of the study according to the schedule below: * Baseline after the ED/urgent care visit via phone call interview * 1 and 3 months after ED/urgent care discharge via phone call interview Outcomes follow-up: A phone call questionnaire will be performed at 1 and 3 months following patient discharge from the ED/urgent care for patients in all arms of the study. This questionnaire will be designed to evaluate current pain as well as average, maximum, and minimum pain in the past week. Additional questions will include opioid use, pain interference with general activity, walking, sleep, and enjoyment of life; side effects; return ED/urgent care visits for pain; and other health care utilization for pain.
Investigators
Eligibility Criteria
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
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)