NCT02438384

Brief Summary

This is a three arm pilot randomized trial. Patients will be assigned to:

  1. 1.Usual care
  2. 2.Video education in the Emergency Department (ED)
  3. 3.Video education in the ED plus phone follow-up at three days with geriatric pain management specialist for all patients with pain \>=4/10

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 8, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 17, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 17, 2017

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

February 26, 2020

Completed
Last Updated

February 26, 2020

Status Verified

March 1, 2019

Enrollment Period

1.8 years

First QC Date

May 5, 2015

Results QC Date

February 17, 2020

Last Update Submit

February 24, 2020

Conditions

Musculoskeletal Pain

Outcome Measures

Primary Outcomes (1)

  • Change in Pain Score

    Change in Pain from emergency department (ED) visit to 30 day follow-up phone call will be measured by calculating the difference between the maximum pain score in the ED and the patient reported average overall pain severity in the past week using the 0-10 numeric rating scale for both measures.Change in pain will be reported as a negative number if the pain decreases (i.e., 10 to 8 = -2). Higher scores indicate a worse outcome.

    ED visit and 30 days post-ED visit

Secondary Outcomes (3)

  • Number of Participants Experiencing Medication Side Effects

    30 days after ED visit

  • Average Overall Pain at One Month

    30 days after ED visit

  • Mean Physical Function Scores

    30 days after ED visit

Study Arms (3)

Usual care

NO INTERVENTION

Pts will receive education and follow-up based on judgment of emergency provider.

Video

EXPERIMENTAL

Patients will watch 10 minute educational video

Behavioral: Video

Video plus Phone Follow-up

EXPERIMENTAL

Patients will watch 10 minute educational video and receive phone call follow-up at 3 days to assess pain symptoms. Patients with a pain score of 4 or more will receive another call with advice from a geriatric pain specialist.

Behavioral: VideoBehavioral: Phone follow-up

Interventions

VideoBEHAVIORAL

This is a 10 minute interactive video which provided information to the viewer regarding the safe and effective use of analgesics for acute musculoskeletal pain at home. The focus is on acetaminophen, NSAIDs, and opioids.

VideoVideo plus Phone Follow-up
Phone follow-upBEHAVIORAL

The call will be made by the study coordinator, who is a medical student. Any patients reporting a pain score in the past 24 hours of 4 or more will be re-contacted by an emergency physician with special training in geriatric pain management. This individual will provide recommendations to the patient regarding treatment options.

Video plus Phone Follow-up

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 50 and older; ED visit for acute musculoskeletal pain

You may not qualify if:

  • Cognitively impaired; chronic pain (daily opioid use prior to onset of pain or pain symptoms more than one month); prison; injury or pain condition requiring hospital admission.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNC Hospitals Emergency Department

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

  • 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: 29304831DERIVED

Related Links

MeSH Terms

Conditions

Musculoskeletal Pain

Interventions

Videotape Recording

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tape RecordingAudiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and AgricultureTelevision

Results Point of Contact

Title
Tim Platts-Mills, MD
Organization
Department of Emergency Medicine, UNC School of Medicine
tim_platts-mills@med.unc.edu
559-240-6073

Study Officials

  • Tim Platts-Mills, MD, MSc

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2015

First Posted

May 8, 2015

Study Start

September 1, 2015

Primary Completion

June 17, 2017

Study Completion

June 17, 2017

Last Updated

February 26, 2020

Results First Posted

February 26, 2020

Record last verified: 2019-03

Locations

US(1)