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NCT04118595 · ClinicalTrials.gov registry record · NA
Reducing the Transition From Acute to Chronic Musculoskeletal Pain Among Older Adults
A NA study of Chronic Pain and Acute Musculoskeletal Pain, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- NA
- Development phase
- 330
- Enrollment target
- 1
- Study location
NCT04118595 is a NA study of Chronic Pain and Acute Musculoskeletal Pain that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 330 participants, below the 771-participant average among 301 other Chronic Pain trials with a reported enrollment target (57% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04118595, a NA study of Chronic Pain and Acute Musculoskeletal Pain, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- NA
- Development phase
- 330 participants
- Enrollment target
- 1
- Study location
Study 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
Conditions Studied
Interventions
- BEHAVIORAL Educational Video
- BEHAVIORAL Telecare
- BEHAVIORAL Correspondence with Primary Care Provider
Study Locations (1)
North Carolina
- University of North Carolina Hospitals - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 330 participants |
| Start Date | 2020-02-03 |
| Est. Completion | 2023-06-22 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04118595
The ClinicalTrials.gov registry entry for NCT04118595 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 330 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 771-participant average among 301 other Chronic Pain trials with a reported enrollment target (57% lower). The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Chronic Pain appearing as the primary indexed condition, and to 3 interventions - of which Educational Video is the first listed.
NCT04118595 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT04118595 about?
NCT04118595 is a clinical study titled "Reducing the Transition From Acute to Chronic Musculoskeletal Pain Among Older Adults". 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 ...
What is the current status of trial NCT04118595?
This trial is currently completed. It is a NA study. The enrollment target is 330 participants. The study started on 2020-02-03. Estimated completion is 2023-06-22.
What conditions does trial NCT04118595 study?
This clinical trial studies the following conditions: Chronic Pain, Acute Musculoskeletal Pain.
What interventions are being tested in trial NCT04118595?
The interventions under investigation include: Educational Video (BEHAVIORAL), Telecare (BEHAVIORAL), Correspondence with Primary Care Provider (BEHAVIORAL).
Who is sponsoring clinical trial NCT04118595?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04118595 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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