Musculoskeletal PainBETTER_PilotNCT02438384
Patient Education to Improve Pain Management in Older Adults With Acute Musculoskeletal Pain: A Pilot Randomized Trial
A study testing Video and Phone follow-up in people with Musculoskeletal Pain, run by University of North Carolina, Chapel Hill at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Musculoskeletal Pain
- What is being tested?
- Video and Phone follow-up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to 17 Jun 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 50 and older; ED visit for acute musculoskeletal pain
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC Hospitals Emergency Department
Chapel Hill, North Carolina, 27599
About this study
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
Read the 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
- Conditions
- Musculoskeletal Pain
- Being tested
- Video, Phone follow-up
- Medical subject headings
- Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VideoBehavioural
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-upBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Pts will receive education and follow-up based on judgment of emergency provider. |
| Video | Experimental | Patients will watch 10 minute educational video Receives: Behavioral: Video |
| Video plus Phone Follow-up | Experimental | 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. Receives: Behavioral: Video; Behavioral: Phone follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: ED visit and 30 days post-ED visit
Secondary outcomes (3)
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.
Measured: 30 days after ED visit
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.
Measured: 30 days after ED visit
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.
Measured: 30 days after ED visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2015 (estimated)
- Study startSep 2015
- Primary completion17 Jun 2017
- Study completion17 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal PainStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- American Federation for Aging Research, The John A. Hartford Foundation
- Responsible party
- Sponsor
- Investigators
- Tim Platts-Mills, MD, MSc, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02438384
- Sponsor's protocol ID
- 15-0986
- Acronym
- BETTER_Pilot
- Status last verified
- Mar 2019
- First submitted
- 5 May 2015
- Last updated
- 26 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29304831
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Education to Improve Pain Management in Older Adults With Acute Musculoskeletal Pain: A Pilot Randomized Trial
- ClinicalTrials.gov ID
- NCT02438384
- Acronym / sponsor ID
- BETTER_Pilot / 15-0986
- Conditions
- Musculoskeletal Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- American Federation for Aging Research, The John A. Hartford Foundation
- Study start
- Sep 2015 (actual)
- Primary completion
- 17 Jun 2017 (actual)
- Study completion
- 17 Jun 2017 (actual)
- First posted
- 8 May 2015 (estimated)
- Results
- Posted 26 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –Pts will receive education and follow-up based on judgment of emergency provider. |
| Video | Experimental | Behavioral: VideoPatients will watch 10 minute educational video |
| Video plus Phone Follow-up | Experimental | Behavioral: Video, Behavioral: Phone follow-upPatients 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 50 and older; ED visit for acute musculoskeletal pain
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VideoThis 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. | Behavioural | Video, Video plus Phone Follow-up |
| Phone follow-upThe 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. | Behavioural | Video plus Phone Follow-up |
Primary outcome
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.
3 secondary outcomes
Number of Participants Experiencing Medication Side Effects
Time frame: 30 days after ED visit
Average Overall Pain at One Month
Time frame: 30 days after ED visit
Mean Physical Function Scores
Time frame: 30 days after ED visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29304831Platts-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.
- Randomized controlled pilot study of an educational video plus telecare for the early outpatient management of musculoskeletal pain among older eme... - PubMed - NCBILink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tim Platts-Mills, MD, MSc principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video and Phone follow-up in people with Musculoskeletal Pain, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Score (time frame: ED visit and 30 days post-ED visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02438384, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2020.