N/A
N=330
Reducing the Transition From Acute to Chronic Musculoskeletal Pain Among Older Adults
Acute Musculoskeletal Pain · Chronic Pain
Bottom Line
View on ClinicalTrials.gov: NCT04118595 ↗Enrolled (actual)
330
Serious AEs
6.7%
Results posted
Nov 2023
Primary outcome: Primary: Mean Brief Pain Inventory-Short Form (BPI-SF) Combined Pain Severity and Interference Score — 2.67; 2.99; 2.94; 1.90 score on a scale — p=0.13
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Educational Video (Behavioral); Telecare (Behavioral); Correspondence with Primary Care Provider (Behavioral)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Brief Pain Inventory-Short Form (BPI-SF) Combined Pain Severity and Interference Score |
2.67; 2.99; 2.94; 1.90; 2.18; 2.57 | 0.13 |
| SECONDARY Mean Pain Severity on the Brief Pain Inventory-Short Form (BPI-SF) Score |
2.69; 2.94; 2.90; 1.98; 2.22; 2.53 | 0.41 |
| SECONDARY Mean Pain Interference on the BPI-SF Score |
2.64; 3.04; 2.98; 1.82; 2.14; 2.61 | 0.08 |
| SECONDARY Mean Symptom Distress Score |
0.062; 0.063; 0.043; 0.023; 0.019; 0.015 | 0.64 |
| SECONDARY Percent of Participants With Opioid Use During the Past Week |
5.6; 9.0; 5.7; 1.9; 1.0; 4.9 | 0.57 |
| SECONDARY PROMIS Measure: Mean T-score Physical Function-4 |
42.19; 40.83; 41.17; 45.25; 44.21; 43.49 | 0.43 |
| SECONDARY PROMIS Measure: Mean T-score Global Health-Physical 2a |
47.73; 45.72; 46.75; 49.67; 48.55; 47.47 | 0.19 |
| SECONDARY Healthcare Utilization, Mean Days in the Hospital |
0.04; 0.00; 0.05; 0.16; 0.01; 0.10 | 0.15 |
| SECONDARY Healthcare Utilization, Mean Number of Visits to ED/Urgent Care |
0.09; 0.06; 0.04; 0.25; 0.08; 0.25 | 0.04 sig |
| SECONDARY Healthcare Utilization, Mean Number of Visits to Primary Care Provider |
0.15; 0.22; 0.17; 0.50; 0.42; 0.53 | 0.36 |
Summary
The investigators have developed a three component intervention to support shared decision-making during the early recovery phase for older adults who present to the emergency department (ED) or orthopedic urgent care with acute musculoskeletal pain. The first component is a brief interactive video to enhance patient knowledge and self-efficacy regarding treatment options with the intent of facilitating conversations between patients and emergency providers. The second component is a protocol-guided phone conversation (telecare) between a nurse care manager and the patient at 48-72 hours following discharge to assess pain severity and interference with daily activities, review analgesic use and side effects and recovery-promoting behaviors, and discuss adjustments to the patients treatment. The third component is communication with the patient's primary care provider following the telecare call to inform them of the patient's condition and treatment plan and encourage primary care followup. The short-term objective of this project is to test the efficacy of this intervention to reduce the transition from acute to chronic musculoskeletal pain among older adults and obtain data to inform implementation. The investigators will conduct a three-arm randomized controlled trial with adults aged 50 years and older who present to the ED or orthopedic urgent care with acute musculoskeletal pain. Patients will be randomized to (1) the full intervention (video + telecare + communication with primary provider), (2) video alone, or (3) usual care. The primary outcome will be pain, measured longitudinally over the course of the year following the acute care visit. Secondary outcomes will include physical function, analgesic side effects and adverse events, opioid use, depression and anxiety symptoms, sleep duration and quality, and healthcare utilization at one, three, six, and twelve months. Secondary analyses will (1) examine whether the intervention has its effect by promoting shared decision-making, and (2) estimate the cost-effectiveness of the intervention. The long-term goal of this work is to develop, test, and implement interventions that improve long-term health outcomes for older adults with acute musculoskeletal pain.
Eligibility Criteria
Inclusion Criteria
- Age 50 years and older
- Present to UNC ED patient with primary complaint of acute musculoskeletal pain
- Average pain score >/= 4 on 0-10 scale
- Expected discharge from the ED
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 determined by an acuity score of 1 in the tracking board
- diagnosis of somatoform disorder, schizophrenia, dementia, or bipolar disorder
- patient is a prisoner or in police custody
- self-reported daily opioid use for more than 2 weeks
- 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)
Data sourced from ClinicalTrials.gov (NCT04118595). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.