Clinical trial NCT06035575: The Pain Intervention Via Video Optimization Trial
Official title: Development of an Emergency Department Patient-Centered Intervention for the Primary Prevention of Long-Term Opioid Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Musculoskeletal Pain
Chronic Pain
Keywords: Musculoskeletal Pain
Acute Pain
Emergency Department
Video
Opioid Addiction Prevention
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Elon University
name: Centers for Disease Control and Prevention
First posted: 2023-09-13
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Combined Pain Severity and Interference Scores
timeFrame: Baseline (following ED or orthopedic urgent care visit) to month 3
Secondary outcomes:
measure: Pain Severity on the BPI-SF
timeFrame: Up to 3 months
measure: Pain Interference on the BPI-SF
timeFrame: Up to 3 months
measure: Opioid Use During the Past Week
timeFrame: Up to 3 months
measure: PROMIS Measure: Physical Function-4
timeFrame: Up to 3 months
measure: PROMIS Measure: Global Health-Physical 2a
timeFrame: Up to 3 months
measure: Healthcare Utilization, Number of Visits to ED/urgent care
timeFrame: Up to 3 months
measure: Healthcare Utilization, Number of Visits to non-ED or Urgent Care Physicians
timeFrame: Up to 3 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina Hospitals
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Michelle Meyer, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.