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| Name | Class |
|---|---|
| American Federation for Aging Research | OTHER |
| The John A. Hartford Foundation | OTHER |
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This is a three arm pilot randomized trial. Patients will be assigned to:
This is a three arm pilot randomized trial. Patients will be assigned to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tim Platts-Mills, MD, MSc | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNC Hospitals Emergency Department | Chapel Hill | North Carolina | 27599 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29304831 | Derived | 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. |
| Label | URL |
|---|---|
| Randomized controlled pilot study of an educational video plus telecare for the early outpatient management of musculoskeletal pain among older eme... - PubMed - NCBI | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | Pts will receive education and follow-up based on judgment of emergency provider. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | Pts will receive education and follow-up based on judgment of emergency provider. |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | ED visit and 30 days post-ED visit |
|
Beginning at the time of the emergency department visit and continuing through 30 days afterwards
Medication side effects were not considered adverse events. Patients who reported 1 or more side effects received a call from the study physician per protocol procedures.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care | Pts will receive education and follow-up based on judgment of emergency provider. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tim Platts-Mills, MD | Department of Emergency Medicine, UNC School of Medicine | 559-240-6073 | tim_platts-mills@med.unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 27, 2015 | Feb 17, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 25, 2015 | Feb 24, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D059352 | Musculoskeletal Pain |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D014743 | Videotape Recording |
| ID | Term |
|---|---|
| D013637 | Tape Recording |
| D001296 | Audiovisual Aids |
| D018961 | Educational Technology |
| D013672 | Technology |
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| 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. |
|
| 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. | 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. | 30 days after ED visit |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Formal Education | Categorized as: \ | Count of Participants | Participants |
|
| Home | Categorized as: Private Home or Assisted Living or Nursing Home Self-reported by patients | Count of Participants | Participants |
|
| Daily Medications | Self-reported by patients. Patients asked: How many different prescription medications do you take daily? | Mean | Standard Deviation | number of medications |
|
| Self-Reported Health of Excellent, Very Good, or Good | Patients were asked: In general, how do you rate your health? excellent, very good, good, fair, poor. Reported number of patients with excellent, very good, or good response. | data unavailable for one participant in usual care group n=24 Patients self-reported health as good, very good or excellent; fair or poor | Count of Participants | Participants |
|
| Chronic Musculoskeletal Pain | Self-reported. Patients were asked: have you had daily pain in your bones, muscles, tendons, ligaments or joints (also known as musculoskeletal pain) for the past six months or longer? | Count of Participants | Participants |
|
| Pain Due to Musculoskeletal Injury | Self reported by patients. Patients were asked: Where is the pain that brought you into the emergency department located (abdomen, chest, head, skin, eye, ear, jaw, neck, chest (traumatic), shoulder, arm , back, hip, leg, other. Research assistant indicated if pain was musculoskeletal or not. Limb pain was excluded if it was known to be caused by a blood clot or ischemia. | Count of Participants | Participants |
|
| OG002 | 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. |
|
|
|
| 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. | Posted | Count of Participants | Participants | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 30 days after ED visit |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | 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. | 0 | 25 | 0 | 25 | 0 | 25 |
| EG002 | 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. | 0 | 25 | 0 | 25 | 0 | 25 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013676 |
| Technology, Industry, and Agriculture |
| D013690 | Television |
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Assisted Living |
|