- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02438384
Patient Education to Improve Pain Management in Older Adults With Acute Musculoskeletal Pain: A Pilot Randomized Trial (BETTER_Pilot)
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
연구 개요
상세 설명
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
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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North Carolina
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Chapel Hill, North Carolina, 미국, 27599
- UNC Hospitals Emergency Department
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
간섭 없음: Usual care
Pts will receive education and follow-up based on judgment of emergency provider.
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실험적: Video
Patients will watch 10 minute educational video
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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.
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실험적: 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.
|
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.
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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Change in Pain Score
기간: ED visit and 30 days post-ED visit
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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.
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ED visit and 30 days post-ED visit
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Number of Participants Experiencing Medication Side Effects
기간: 30 days after ED visit
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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. |
30 days after ED visit
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Average Overall Pain at One Month
기간: 30 days after ED visit
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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.
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30 days after ED visit
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Mean Physical Function Scores
기간: 30 days after ED visit
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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.
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30 days after ED visit
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공동 작업자 및 조사자
수사관
- 수석 연구원: Tim Platts-Mills, MD, MSc, University of North Carolina, Chapel Hill
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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