Shared Decision Aid for Post-Total Knee Arthroplasty Opioid Prescribing
연구 개요
상세 설명
This study will be a randomized controlled trial for primary, unilateral total knee arthroplasty (TKA) patients at Brigham and Women's Faulkner Hospital, Brigham and Women's Hospital and University of Chicago Medical Center to determine the impact of using a SDA on the number of leftover opioid pills on postoperative day 30 and average NRS pain score on postoperative day 7.
The SDA includes factual information about the World Health Organization pain ladder, the 0-10 NRS pain scale, pharmacologic pain management options, opioid medication benefits and risks and predicted post-discharge opioid requirements based on previous modeling in TKA patients. The SDA has been developed by the principal investigator solely for the purpose of this study.
Patients will be enrolled on postoperative day 0 or 1 and randomized to intervention or control groups. The intervention group will view the SDA slides on the study iPad. SDA viewing will be guided by the research assistant, who will read a pre-written script as each slide is viewed. Following the guided viewing of the SDA, subjects in the intervention group will have the opportunity to ask questions to the research assistant to confirm their comprehension of the presented facts. The control group will receive no intervention and will receive standard of care and standard discharge prescriptions. The intervention group subjects will choose the number of opioid pills they wish to include in their discharge opioid prescription (anywhere from 0 to the maximum allowable as determined by clinical practice and/or state law).
Daily analgesic intake, adverse effects and numeric rating scale (NRS) pain scores will be collected and analyzed.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Naida Cole, MD
- 전화번호: 9176576692
- 이메일: nmcole@bsd.uchicago.edu
연구 연락처 백업
- 이름: Laura Mendez, MD
- 전화번호: 8574004065
- 이메일: lmendez-pino@bwh.harvard.edu
연구 장소
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Illinois
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Chicago, Illinois, 미국, 60637
- 모병
- University of Chicago Medical Center
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연락하다:
- Naida Cole, MD
- 이메일: nmcole@bsd.uchicago.edu
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Massachusetts
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Boston, Massachusetts, 미국, 02115
- 모병
- Brigham and Women's Hospital
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연락하다:
- Jose Zeballos, MD
- 이메일: jzeballos@bwh.harvard.edu
-
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Primary unilateral TKA under spinal anesthesia at Brigham & Women's Faulkner Hospital (BWFH), Brigham and Women's Hospital or University of Chicago Medical Center by a participating surgeon
- >18 years of age
Planned discharge with the typical analgesic medications prescribed at discharge:
- standing around-the clock Tylenol with or without an NSAID
- tramadol PRN
- hydromorphone (dilaudid) or oxycodone PRN
Exclusion Criteria:
- Diagnosis of dementia
- <18 years old
- Contraindication or allergy to opioids
- Contraindication or allergy to Tylenol
- Contraindication or allergy to gabapentin
- History of substance use disorder
- Preoperative pain requiring a >1-month prescription for >/=45 daily MMEs
- 4 or more preoperative analgesic prescriptions
- Hospital admission >1 day
- Discharge to a skilled nursing facility/inpatient rehabilitation center
- Non-English speaking patients
- Requirement for general anesthesia intra-operatively
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 단일 그룹 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Decision Aid
The shared decision aid (SDA) includes factual information about the World Health Organization pain ladder, the 0-10 numeric rating score pain scale, pharmacologic pain management options, opioid medication benefits and risks and predicted post-discharge opioid requirements based on previous modeling in total knee arthroplasty patients.
Subjects in the decision aid group will view the decision aid and have the opportunity to participate in shared decision-making for their discharge opioid prescriptions.
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The intervention group will receive a shared decision-making intervention including a decision aid and conversation with a study investigator.
The intervention group will have the opportunity to choose the number of opioid pills they receive at discharge from hospital after total knee arthroplasty.
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간섭 없음: Control
Subjects in the control group will undergo standard care and discharge practices.
Baseline pain and psychosocial factors will be documented as well as postoperative pain and analgesic consumption.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Leftover opioid pills
기간: 30 days postoperatively
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30 days postoperatively
|
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Average 0-10 NRS pain score
기간: postoperative day 7
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postoperative day 7
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Quantity of opioid consumed
기간: 30 days postoperatively
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30 days postoperatively
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Satisfaction with pain management
기간: 30 days postoperatively
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30 days postoperatively
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Quantity of opioid pills prescribed
기간: postoperative day 1 at hospital discharge
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postoperative day 1 at hospital discharge
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공동 작업자 및 조사자
수사관
- 수석 연구원: Naida Cole, MD, University of Chicago
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 2020P002342
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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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