search
Back to results

Patient Education to Improve Pain Management in Older Adults With Acute Musculoskeletal Pain: A Pilot Randomized Trial (BETTER_Pilot)

Primary Purpose

Musculoskeletal Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Video
Phone follow-up
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Musculoskeletal Pain

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Sites / Locations

  • UNC Hospitals Emergency Department

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Usual care

Video

Video plus Phone Follow-up

Arm Description

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

Patients will watch 10 minute educational video

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of Participants Experiencing Medication Side Effects
Patients were asked if they experienced any of the following side effects: fatigue, drowsiness, trouble sleeping, trouble thinking, dizziness, unsteadiness, nausea, vomiting, constipation, abdominal pain, black or bloody stool, trouble urinating, loss of appetite, itching or shortness of breath. Patients were also queried about any other side effects they had that were not on the list. Participants reporting at least one side effect were included.
Average Overall Pain at One Month
Determined using 0-10 numerical rating scale to answer the question "What is the average amount of pain you have experienced over the last week on a scale of 0-10. where 0 means no pain and 10 means pain as severe as it could possibly be.
Mean Physical Function Scores
Using a measure of higher-level physical function based on walking, climbing stairs, and carrying bags - scores range from 0 to 12 with higher score indicating higher function.

Full Information

First Posted
May 5, 2015
Last Updated
February 24, 2020
Sponsor
University of North Carolina, Chapel Hill
Collaborators
American Federation for Aging Research, The John A. Hartford Foundation
search

1. Study Identification

Unique Protocol Identification Number
NCT02438384
Brief Title
Patient Education to Improve Pain Management in Older Adults With Acute Musculoskeletal Pain: A Pilot Randomized Trial
Acronym
BETTER_Pilot
Official Title
Patient Education to Improve Pain Management in Older Adults With Acute Musculoskeletal Pain: A Pilot Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
June 17, 2017 (Actual)
Study Completion Date
June 17, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
American Federation for Aging Research, The John A. Hartford Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a three arm pilot randomized trial. Patients will be assigned to: Usual care Video education in the Emergency Department (ED) Video education in the ED plus phone follow-up at three days with geriatric pain management specialist for all patients with pain >=4/10
Detailed Description
This is a three arm pilot randomized trial. Patients will be assigned to: Usual care Video education in the ED (10 minute interactive video) Video education in the ED plus phone follow-up at three days with geriatric pain management specialist for all patients with pain >=4/10

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Pts will receive education and follow-up based on judgment of emergency provider.
Arm Title
Video
Arm Type
Experimental
Arm Description
Patients will watch 10 minute educational video
Arm Title
Video plus Phone Follow-up
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Video
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Phone follow-up
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Pain Score
Description
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.
Time Frame
ED visit and 30 days post-ED visit
Secondary Outcome Measure Information:
Title
Number of Participants Experiencing Medication Side Effects
Description
Patients were asked if they experienced any of the following side effects: fatigue, drowsiness, trouble sleeping, trouble thinking, dizziness, unsteadiness, nausea, vomiting, constipation, abdominal pain, black or bloody stool, trouble urinating, loss of appetite, itching or shortness of breath. Patients were also queried about any other side effects they had that were not on the list. Participants reporting at least one side effect were included.
Time Frame
30 days after ED visit
Title
Average Overall Pain at One Month
Description
Determined using 0-10 numerical rating scale to answer the question "What is the average amount of pain you have experienced over the last week on a scale of 0-10. where 0 means no pain and 10 means pain as severe as it could possibly be.
Time Frame
30 days after ED visit
Title
Mean Physical Function Scores
Description
Using a measure of higher-level physical function based on walking, climbing stairs, and carrying bags - scores range from 0 to 12 with higher score indicating higher function.
Time Frame
30 days after ED visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 50 and older; ED visit for acute musculoskeletal pain Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tim Platts-Mills, MD, MSc
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNC Hospitals Emergency Department
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29304831
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.
Results Reference
derived
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/29304831
Description
Randomized controlled pilot study of an educational video plus telecare for the early outpatient management of musculoskeletal pain among older eme... - PubMed - NCBI

Learn more about this trial

Patient Education to Improve Pain Management in Older Adults With Acute Musculoskeletal Pain: A Pilot Randomized Trial

We'll reach out to this number within 24 hrs