Musculoskeletal Pain
Conditions
Brief 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
Detailed 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
Interventions
BEHAVIORALVideo
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.
BEHAVIORALPhone 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.
Sponsors
American Federation for Aging Research
The John A. Hartford Foundation
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Score | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing Medication Side Effects | 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. |
| Average Overall Pain at One Month | 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. |
| Mean Physical Function Scores | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Pts will receive education and follow-up based on judgment of emergency provider. | 25 |
| 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. | 25 |
| 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. | 25 |
| Total | 75 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 8 | 6 | 4 |
Baseline characteristics
| Characteristic | Total | Usual Care | Video Plus Phone Follow-up | Video |
|---|---|---|---|---|
| Age, Continuous | 63 years STANDARD_DEVIATION 2.1 | 66 years STANDARD_DEVIATION 2.1 | 61 years STANDARD_DEVIATION 2.1 | 63 years STANDARD_DEVIATION 2.1 |
| Chronic Musculoskeletal Pain | 35 Participants | 11 Participants | 11 Participants | 13 Participants |
| Daily Medications | 4.5 number of medications STANDARD_DEVIATION 0.8 | 4.8 number of medications STANDARD_DEVIATION 0.8 | 4.2 number of medications STANDARD_DEVIATION 0.8 | 4.5 number of medications STANDARD_DEVIATION 0.8 |
| Formal Education | 75 Participants | 25 Participants | 25 Participants | 25 Participants |
| Home Assisted Living | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Home Private Home | 74 Participants | 24 Participants | 25 Participants | 25 Participants |
| Pain Due to Musculoskeletal Injury | 35 Participants | 10 Participants | 13 Participants | 12 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 19 Participants | 5 Participants | 8 Participants | 6 Participants |
| Race (NIH/OMB) White | 56 Participants | 20 Participants | 17 Participants | 19 Participants |
| Region of Enrollment United States | 75 Participants | 25 Participants | 25 Participants | 25 Participants |
| Self-Reported Health of Excellent, Very Good, or Good | 59 Participants | 20 Participants | 19 Participants | 20 Participants |
| Sex: Female, Male Female | 50 Participants | 18 Participants | 13 Participants | 19 Participants |
| Sex: Female, Male Male | 25 Participants | 7 Participants | 12 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 25 | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 | 0 / 25 |
Outcome results
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.
Time frame: ED visit and 30 days post-ED visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Change in Pain Score | -1.3 score on a scale | Standard Deviation 2.9 |
| Video | Change in Pain Score | -2.4 score on a scale | Standard Deviation 3.2 |
| Video Plus Phone Follow-up | Change in Pain Score | -3.0 score on a scale | Standard Deviation 2.6 |
95% CI: [1.2, 2.1]
95% CI: [0.6, 1.6]
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.
Time frame: 30 days after ED visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Average Overall Pain at One Month | 5.8 score on a scale | Standard Deviation 2.8 |
| Video | Average Overall Pain at One Month | 4.9 score on a scale | Standard Deviation 3.5 |
| Video Plus Phone Follow-up | Average Overall Pain at One Month | 4.5 score on a scale | Standard Deviation 2.9 |
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.
Time frame: 30 days after ED visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Mean Physical Function Scores | 2.8 score on a scale | Standard Deviation 2.8 |
| Video | Mean Physical Function Scores | 4.3 score on a scale | Standard Deviation 4 |
| Video Plus Phone Follow-up | Mean Physical Function Scores | 5.2 score on a scale | Standard Deviation 3.9 |
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.
Time frame: 30 days after ED visit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Number of Participants Experiencing Medication Side Effects | 12 Participants |
| Video | Number of Participants Experiencing Medication Side Effects | 9 Participants |
| Video Plus Phone Follow-up | Number of Participants Experiencing Medication Side Effects | 8 Participants |