Trial Outcomes & Findings for Patient Education to Improve Pain Management in Older Adults With Acute Musculoskeletal Pain: A Pilot Randomized Trial (NCT NCT02438384)

Last Updated: 2020-02-26

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

75 participants

Primary outcome timeframe

ED visit and 30 days post-ED visit

Results posted on

2020-02-26

Participant Flow

Participants were enrolled in an academic emergency department between September 2015 and March 2017 and the last participant was enrolled in March 2017. Due to unavailability of research assistants, the study was suspended during the winter of 2015 and 2017 and summer 2016.

Participant milestones

Participant milestones
Measure	Usual Care Pts will receive education and follow-up based on judgment of emergency provider.	Video Patients will watch 10 minute educational video 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.	Video Plus Phone Follow-up 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. 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.
Overall Study STARTED	25	25	25
Overall Study COMPLETED	17	19	21
Overall Study NOT COMPLETED	8	6	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Usual Care Pts will receive education and follow-up based on judgment of emergency provider.	Video Patients will watch 10 minute educational video 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.	Video Plus Phone Follow-up 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. 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.
Overall Study Lost to Follow-up	8	6	4

Baseline Characteristics

data unavailable for one participant in usual care group n=24 Patients self-reported health as good, very good or excellent; fair or poor

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: ED visit and 30 days post-ED visit

Outcome measures

Outcome measures
Measure	Usual Care n=17 Participants Pts will receive education and follow-up based on judgment of emergency provider.	Video n=19 Participants Patients will watch 10 minute educational video 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.	Video Plus Phone Follow-up n=21 Participants 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. 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.
Change in Pain Score	-1.3 score on a scale Standard Deviation 2.9	-2.4 score on a scale Standard Deviation 3.2	-3.0 score on a scale Standard Deviation 2.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Usual Care n=17 Participants Pts will receive education and follow-up based on judgment of emergency provider.	Video n=19 Participants Patients will watch 10 minute educational video 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.	Video Plus Phone Follow-up n=21 Participants 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. 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.
Number of Participants Experiencing Medication Side Effects	12 Participants	9 Participants	8 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Usual Care n=17 Participants Pts will receive education and follow-up based on judgment of emergency provider.	Video n=19 Participants Patients will watch 10 minute educational video 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.	Video Plus Phone Follow-up n=21 Participants 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. 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.
Average Overall Pain at One Month	5.8 score on a scale Standard Deviation 2.8	4.9 score on a scale Standard Deviation 3.5	4.5 score on a scale Standard Deviation 2.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Usual Care n=17 Participants Pts will receive education and follow-up based on judgment of emergency provider.	Video n=19 Participants Patients will watch 10 minute educational video 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.	Video Plus Phone Follow-up n=21 Participants 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. 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.
Mean Physical Function Scores	2.8 score on a scale Standard Deviation 2.8	4.3 score on a scale Standard Deviation 4.0	5.2 score on a scale Standard Deviation 3.9

Adverse Events

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Video

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Video Plus Phone Follow-up

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Tim Platts-Mills, MD

Department of Emergency Medicine, UNC School of Medicine

Phone: 559-240-6073

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Usual Care n=25 Participants Pts will receive education and follow-up based on judgment of emergency provider.	Video n=25 Participants Patients will watch 10 minute educational video 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.	Video Plus Phone Follow-up n=25 Participants 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. 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.	Total n=75 Participants Total of all reporting groups
Age, Continuous	66 years STANDARD_DEVIATION 2.1 • n=25 Participants	63 years STANDARD_DEVIATION 2.1 • n=25 Participants	61 years STANDARD_DEVIATION 2.1 • n=25 Participants	63 years STANDARD_DEVIATION 2.1 • n=75 Participants
Sex: Female, Male Female	18 Participants n=25 Participants	19 Participants n=25 Participants	13 Participants n=25 Participants	50 Participants n=75 Participants
Sex: Female, Male Male	7 Participants n=25 Participants	6 Participants n=25 Participants	12 Participants n=25 Participants	25 Participants n=75 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=75 Participants
Race (NIH/OMB) Asian	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=75 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=75 Participants
Race (NIH/OMB) Black or African American	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=75 Participants
Race (NIH/OMB) White	20 Participants n=25 Participants	19 Participants n=25 Participants	17 Participants n=25 Participants	56 Participants n=75 Participants
Race (NIH/OMB) More than one race	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=75 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=25 Participants	6 Participants n=25 Participants	8 Participants n=25 Participants	19 Participants n=75 Participants
Region of Enrollment United States	25 Participants n=25 Participants	25 Participants n=25 Participants	25 Participants n=25 Participants	75 Participants n=75 Participants
Formal Education	25 Participants n=25 Participants	25 Participants n=25 Participants	25 Participants n=25 Participants	75 Participants n=75 Participants
Home Private Home	24 Participants n=25 Participants	25 Participants n=25 Participants	25 Participants n=25 Participants	74 Participants n=75 Participants
Home Assisted Living	1 Participants n=25 Participants	0 Participants n=25 Participants	0 Participants n=25 Participants	1 Participants n=75 Participants
Daily Medications	4.8 number of medications STANDARD_DEVIATION 0.8 • n=25 Participants	4.5 number of medications STANDARD_DEVIATION 0.8 • n=25 Participants	4.2 number of medications STANDARD_DEVIATION 0.8 • n=25 Participants	4.5 number of medications STANDARD_DEVIATION 0.8 • n=75 Participants
Self-Reported Health of Excellent, Very Good, or Good	20 Participants n=24 Participants • data unavailable for one participant in usual care group n=24 Patients self-reported health as good, very good or excellent; fair or poor	20 Participants n=25 Participants • data unavailable for one participant in usual care group n=24 Patients self-reported health as good, very good or excellent; fair or poor	19 Participants n=25 Participants • data unavailable for one participant in usual care group n=24 Patients self-reported health as good, very good or excellent; fair or poor	59 Participants n=74 Participants • data unavailable for one participant in usual care group n=24 Patients self-reported health as good, very good or excellent; fair or poor
Chronic Musculoskeletal Pain	11 Participants n=25 Participants	13 Participants n=25 Participants	11 Participants n=25 Participants	35 Participants n=75 Participants
Pain Due to Musculoskeletal Injury	10 Participants n=25 Participants	12 Participants n=25 Participants	13 Participants n=25 Participants	35 Participants n=75 Participants