Team Approach to Polypharmacy Evaluation and Reduction in a Long-Term Care Setting (TAPER-LTC)
2021년 6월 2일 업데이트: Derelie Mangin, McMaster University
Team Approach to Polypharmacy Evaluation and Reduction in a Long-Term Care Setting: A Feasibility Randomized Controlled Trial
Medication side effects and interactions between medications are very common in older adults and are related to negative health outcomes.
In this study, the investigators will test a new process aimed at reducing unnecessary medication use and drug side effects in seniors using the best medical evidence and patient preferences for treatment.
This study will assess how feasible the implementation of this intervention is within a long-term care facility as well as if it is possible.
Participants in two long-term care facilities will participate in this study.
Measures will include feasibility outcomes regarding the logistics of the intervention as well as patients outcomes (falls, hospitalizations, and medications) collected before and after implementation.
This trial will be a randomized control trial with an adaptive trial design.
연구 개요
상세 설명
There are substantial associations between polypharmacy and reduced function from older adults and this is likely to be important in frail older adults both in long term care and in the community.
The reversibility of drug-induced mobility impairment is unclear therefore the investigators plan to investigate signals of any impact of reducing polypharmacy on mobility.
The investigators chose the long-term care setting given the presence of complete medication administration records and this patient population's high prevalence of polypharmacy and risk of adverse drug events.
TaperMD is an electronic tool for systematic medication reduction that incorporates patient priorities, electronic screening for potentially harmful medicines,supporting evidence tools and a monitoring pathway to support medication reduction.
This study will examine the feasibility of this tool in a long-term care setting as well as examine.
Participants in two long-term care facilities will participate in this study.
Measures will include feasibility outcomes regarding the logistics of the intervention as well as patients outcomes (falls, hospitalizations, and medications) collected before and after implementation.
The study will be an adaptive trial design with two phases.
Phase 1 will be an internal pilot.
This will allow the investigators to re-evaluate and modify outcome measures and processes as necessary.
Phase 2 of this trial will allow for continuation after adjustments to the process or design has been made in a larger randomized controlled trial.
연구 유형
중재적
등록 (실제)
15
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Ontario
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Brampton, Ontario, 캐나다, L6Y 5P2
- Holland Christian Homes - Faith Manor
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Brampton, Ontario, 캐나다, L6Y 5P2
- Holland Christian Homes - Grace Manor
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
70년 이상 (고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- residing in 2 long-term care facilities in Brampton, ON
- on 5 or more long-term medications
- 70 years of age or older
- adequate English language
Exclusion Criteria:
- terminal illness or other circumstance precluding 6 month study period
- recent (within 12 months) comprehensive medication review
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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간섭 없음: Control Group
Standard of Care as wait list control.
Control group will be offered intervention as part of usual clinical care at 6 months.
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실험적: TAPER
The intervention is medication reduction. This arm is comprised of:
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Systematic approach to reduction in polypharmacy
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Successful Discontinuation (Difference in mean number of medications; reduction in dose)
기간: 6 months
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Difference in mean number of medications; number of medications reduced in dose
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6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Difference in level of cognition
기간: Baseline, 6 months
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The Mini Mental Status Examination
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Baseline, 6 months
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Difference in level of quality of life
기간: Baseline, 6 months
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EuroQol five dimensions questionnaire (EQ5D-5L) will measure quality of life.
Scores range from 0 (low quality of life) to 1 (high quality of life).
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Baseline, 6 months
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Difference in number of falls
기간: Baseline, 6 months
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Total number of falls resulting in medication consultation or treatment recorded in hospital admission and primary care records, and by patient
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Baseline, 6 months
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Difference in level of sleep
기간: Baseline, 6 months
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The sleep question on the 15-Dimensional (15-D) scale will be used.
Scores range from 1 (no sleep problems) to 5 (severe sleep problems).
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Baseline, 6 months
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Changes in medication side effects and symptoms (adverse)
기간: 1-week, 3 months, 6 months
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Patient self-report of appearance (new or worsening) of side effects associated with medications
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1-week, 3 months, 6 months
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Changes in medication side effects and symptoms (positive)
기간: 1-week, 3 months, 6 months
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Patient self-report of disappearance (improvement or disappearance) of side effects associated with medications
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1-week, 3 months, 6 months
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Difference in number of serious adverse events
기간: 1-week, 3 months, 6 months
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Any event that requires in-patient hospitalization or prolongation of existing hospitalization, causes congenital malformation, results in persistent or significant disability or incapacity, is life-threatening or results in death (Health Canada (2011) Guidance Document for Industry - Reporting Adverse Reactions to Marketed Health Products)
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1-week, 3 months, 6 months
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Difference in level of physical functioning capacity and ability
기간: Baseline, 6 months
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Time on the timed-up-and-go test
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Baseline, 6 months
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Difference in level of performance of activities of daily living
기간: Baseline, 6 months
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Barthel Index will be used to measure performance of activities of daily living.
Ten activities are scored in terms of level of independence or assistance, with higher scores reflecting higher level of independent performance.
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Baseline, 6 months
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Difference in level of frailty
기간: Baseline, 6 months
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The total score on the Edmonton Frail Scale will be used to measure frailty.
The scale included 11 items, with scores ranging from 0 (not frail) to 17 (severe frailty).
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Baseline, 6 months
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Difference in level of healthcare utilization use (hospitalizations)
기간: Baseline, 6 months
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Number of hospitalizations
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Baseline, 6 months
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Difference in level of healthcare utilization use (emergency department visits)
기간: Baseline, 6 months
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Number of emergency department visits
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Baseline, 6 months
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Difference in level of healthcare utilization use (physician visits)
기간: Baseline, 6 months
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Number of physician visits
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Baseline, 6 months
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Enrollment rate
기간: 6 months
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Number of participants that enroll in study relative to number of participant invited to participant
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6 months
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Completion rate
기간: 6 months
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Number of participants that complete 6-month collection relative to number of participants enrolled
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6 months
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Time to complete measures
기간: Baseline, 6 months
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Average duration of data collection appointments
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Baseline, 6 months
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Difference in level of mood
기간: Baseline, 6 months
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The total score on the Geriatric Depression Scale (Short Form) will be used to measure mood.
The scale includes 15 yes/no items and score range from 0 to 15, with high scores indicating depression.
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Baseline, 6 months
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Difference in level of concern over falling
기간: Baseline, 6 months
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The score on the Falls Efficacy Scale-International (Short Version) will be used to measure falling-related concerns.
The scale includes 7 items, with scores ranging from 7 (no concern) to 28 (severe concern of falling)
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Baseline, 6 months
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Difference in level of pain
기간: Baseline, 6 months
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The Brief Pain Inventory (short form) will be used to measure pain severity (mean of 4 items, rated 0-10) and pain interference (mean of 7 items, rated 0-10).
Higher scores represent higher pain severity and interference.
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Baseline, 6 months
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Difference in level of incontinence
기간: Baseline, 6 months
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Frequency of incontinence as recorded in patient electronic medical record
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Baseline, 6 months
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Loved one's perspective of deprescribing
기간: 6 months
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Perspectives from focus groups
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6 months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Dee Mangin, MBChB, DPH, FRNZC, MD, McMaster University
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2019년 10월 15일
기본 완료 (실제)
2021년 3월 30일
연구 완료 (실제)
2021년 3월 30일
연구 등록 날짜
최초 제출
2019년 8월 12일
QC 기준을 충족하는 최초 제출
2019년 8월 12일
처음 게시됨 (실제)
2019년 8월 14일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 6월 7일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 6월 2일
마지막으로 확인됨
2021년 6월 1일
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. .
Medication Reduction에 대한 임상 시험
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mHealth Systems Inc.Boston Children's Hospital; University of North Carolina, Charlotte모병
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Fondazione Poliambulanza Istituto Ospedaliero알려지지 않은
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University of WashingtonNational Institute of Mental Health (NIMH)모병
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Universidad de GranadaChair in Conscience and Development (UGR); Mind, Brain and Behaviour Research Centre (CIMCYC)완전한
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University College CorkUniversity Hospital, Ghent; University Hospital Waterford모집하지 않고 적극적으로
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New York State Psychiatric InstituteNational Institute of Mental Health (NIMH)완전한
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Huazhong University of Science and Technology아직 모집하지 않음