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Completed

NCT Number: NCT02438384

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

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

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Key information

Conditions

Musculoskeletal Pain Muscular Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UNC Hospitals Emergency Department

Chapel Hill, North Carolina, 27599, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Video

Behavioral

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

Behavioral

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 outcomes

  1. Change in Pain Score

    Time frame: ED visit and 30 days post-ED visit

    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 outcomes

  1. Number of Participants Experiencing Medication Side Effects

    Time frame: 30 days after ED visit

    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.

  2. Average Overall Pain at One Month

    Time frame: 30 days after ED visit

    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.

  3. Mean Physical Function Scores

    Time frame: 30 days after ED visit

    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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • American Federation for Aging Research
  • The John A. Hartford Foundation

Registry information

Acronym: BETTER_Pilot

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 8, 2015
Registry last updated
Feb 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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