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

Musculoskeletal Pain Clinical Trial

— BETTER_Pilot  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02438384
• Other study ID #: 15-0986
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: June 17, 2017

Study information

• Verified date: March 2019
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

1. Usual care

2. Video education in the Emergency Department (ED)

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

Description:

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

1. Usual care

2. Video education in the ED (10 minute interactive video)

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: June 17, 2017
• Est. primary completion date: June 17, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Musculoskeletal Pain

Intervention

Behavioral:
• Video
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.
• Phone follow-up
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.

Locations

Country	Name	City	State
United States	UNC Hospitals Emergency Department	Chapel Hill	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	American Federation for Aging Research, The John A. Hartford Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	30 days after ED visit
Secondary	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.	30 days after ED visit
Secondary	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.	30 days after ED visit

External Links

•   Randomized controlled pilot study of an educational video plus telecare for the early outpatient management of musculoskeletal pain among older eme... - PubMed - NCBI