The Pain Intervention Via Video Optimization Trial (PIVOT)

University of North Carolina (UNC)

Status

Completed

Conditions

Acute Musculoskeletal Pain

Chronic Pain

Treatments

Behavioral: Educational video

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT06035575

22-1551

5114616 (Other Grant/Funding Number)

R49CE003092 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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:

Intervention (video)
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.

Enrollment

225 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

225 participants in 2 patient groups

Intervention (video)

Experimental group

Description:

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.

Treatment:

Behavioral: Educational video

Usual Care

No Intervention group

Description:

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

Trial documents