The Pain Intervention Via Video Optimization Trial

NCT ID: NCT06035575

Last Updated: 2024-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 225 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-26
• Study Completion Date: 2024-09-11

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.

Conditions

Acute Musculoskeletal Pain; Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention (video)

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.

Group Type: EXPERIMENTAL

Educational video

Intervention Type: 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.

Usual Care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Educational video

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 Type: BEHAVIORAL

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
• at-risk alcohol use
• speech, hearing, vision problems
• cognitively impaired (6-item Brief Screener)
• nonworking phone number (follow-up occurs via phone calls)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Elon University

OTHER

Sponsor Role: collaborator

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michelle Meyer, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

University of North Carolina Hospitals

Chapel Hill, North Carolina, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 29304831 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15352969 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35550175 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

R49CE003092

Identifier Type: NIH

Identifier Source: secondary_id

View Link

5114616

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

22-1551

Identifier Type: -

Identifier Source: org_study_id