The Pain Intervention Via Video Optimization Trial

NCT06035575 | Completed

• 3 other identifiers: 22-1551R49CE0030925114616
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Musculoskeletal Pain; Chronic Pain

Keywords

Musculoskeletal Pain; Acute Pain; Emergency Department; Video; Opioid Addiction Prevention

Outcome Measures

Primary Outcomes (1)

• Combined Pain Severity and Interference Scores

  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.

  Baseline (following ED or orthopedic urgent care visit) to month 3

Secondary Outcomes (7)

• Pain Severity on the BPI-SF

  Up to 3 months

• Pain Interference on the BPI-SF

  Up to 3 months

• Opioid Use During the Past Week

  Up to 3 months

• PROMIS Measure: Physical Function-4

  Up to 3 months

• PROMIS Measure: Global Health-Physical 2a

  Up to 3 months

Study Arms (2)

Intervention (video)

EXPERIMENTAL

Educational Video: Participants in this arm will watch an interactive pain management video, sent as a link to their email. Participants will send back answers to the multiple-choice questions posed during the video and/or confirm having watched the video within 5 days (at most) of their acute care visit or discharge from the ED.

Behavioral: Educational video

Usual Care

NO INTERVENTION

Participants will receive the typical care provided by medical personnel for their acute pain.

Interventions

Educational video BEHAVIORAL

Development of the original video used a systematic approach that included a review of literature and current pain management guidelines and input from emergency physicians, geriatricians, and experts in pharmacology, physical therapy, and risk communication. The video offers information about the pharmacologic management of acute musculoskeletal pain (MSP) and recovery-promoting behaviors. Each video section is followed by a multiple-choice question to promote interaction and reinforce learning. The actress for the 13-minute video is a 56-year-old mixed-race woman who presents herself as a healthcare provider. The video script will typically be shown to the patient within 48-72 hours of the acute care visit, with a maximum window of 5 days post visit.

Intervention (video)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Elon University: collaborator
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

University of North Carolina Hospitals

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (3)

• Platts-Mills TF, Hollowell AG, Burke GF, Zimmerman S, Dayaa JA, Quigley BR, Bush M, Weinberger M, Weaver MA. Randomized controlled pilot study of an educational video plus telecare for the early outpatient management of musculoskeletal pain among older emergency department patients. Trials. 2018 Jan 5;19(1):10. doi: 10.1186/s13063-017-2403-8.

  PMID: 29304831 BACKGROUND

• Gan TJ, Joshi GP, Zhao SZ, Hanna DB, Cheung RY, Chen C. Presurgical intravenous parecoxib sodium and follow-up oral valdecoxib for pain management after laparoscopic cholecystectomy surgery reduces opioid requirements and opioid-related adverse effects. Acta Anaesthesiol Scand. 2004 Oct;48(9):1194-207. doi: 10.1111/j.1399-6576.2004.00495.x.

  PMID: 15352969 BACKGROUND

• Hurka-Richardson K, Platts-Mills TF, McLean SA, Weinberger M, Stearns SC, Bush M, Quackenbush E, Chari S, Aylward A, Kroenke K, Kerns RD, Weaver MA, Keefe FJ, Berkoff D, Meyer ML. Brief Educational Video plus Telecare to Enhance Recovery for Older Emergency Department Patients with Acute Musculoskeletal Pain: an update to the study protocol for a randomized controlled trial. Trials. 2022 May 12;23(1):400. doi: 10.1186/s13063-022-06310-z.

  PMID: 35550175 BACKGROUND

MeSH Terms

Conditions

Chronic Pain; Musculoskeletal Pain; Acute Pain; Emergencies

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Disease Attributes; Pathologic Processes

Study Officials

• Michelle Meyer, PhD, MPH

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Follow-up assessments will be conducted by study staff who will be blinded to treatment arm allocation at 1 and 3 months
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A total of 225 patients will be assigned to one of two treatment arms using 1:1 randomization, stratified by age (18-40 years; 41+ years) into randomly permuted blocks. Individuals will be recruited from orthopedic urgent care clinics and Emergency Departments.

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: September 13, 2023
• Study Start: September 26, 2023
• Primary Completion: September 11, 2024
• Study Completion: September 11, 2024
• Last Updated: September 20, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Deidentified individual data that supports the results will be shared beginning 9 and continuing for 36 months following publication.
• Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

US (1)