- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07599735
The Feasibility and Acceptability of a Collaborative Deprescribing Intervention to Reduce Anticholinergic Burden Among Hospitalised Older Patients (DART)
연구 개요
상태
상세 설명
Why this research is important? It is estimated that over one third of all older adults are prescribed medication which are known to have "anticholinergic" side effects. These anticholinergic side effects can include an increased risk of falls, delirium, and memory problems. People who have a high number of anticholinergic medications have an increased risk of these side effects. This can be measured as their anticholinergic burden (ACB). Several tools have been developed to assess the ACB score, by checking a person's medication list, with the aim of reducing these medications where possible (deprescribing).
The study aim The project team worked with a company to design an online tool which can calculate the total ACB score for patients using their electronic medication list. It can also list the individual anticholinergic medications contributing to that score. Patients with high ACB score will be highlighted to healthcare staff including pharmacists, nurses, and doctors. In this project, we plan to understand how this tool can be used by clinicians in older persons wards to reduce the number of anticholinergic medications prescribed where appropriate.
Our approach Working with doctors and pharmacists in one large hospital, we agreed how the tool should be used. First, pharmacists with check weekly using the digital tool how many patients have high ACB scores. Then they would highlight in patients' medical notes the list of medications with high anticholinergic effects using a sticker note. The doctor looking after the patient then sees the note which would prompt him/her to either stop the drug, reduce the dose or switch to a safer drug.
We will test this intervention among 50 patients admitted to older people wards. We will collect information before and after receiving the intervention including number and type of medications prescribed, quality of life, and cognition. We will also talk to staff and patients to understand their views about the intervention, any challenges, and how to improve the process.
Involving patients and public Two patient and public contributors have been actively involved in developing this research proposal. They represent an older person with comorbidity and polypharmacy and a carer, and both have lived experience of managing polypharmacy following hospital admission. They will continue to provide input on study procedures and materials and contribute to plans for sharing the findings.
Sharing the study findings We will share the findings with public, health professionals, researchers and policymakers through plain English summaries, social media, policy briefing documents, scientific papers, conferences and other meetings.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Southampton, 영국
- University Hospital Southampton
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참여기준
자격 기준
공부할 수 있는 나이
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Eligible patients aged 65 years or more admitted to one of the five Medicine for Older People wards, who have ACB score of 3 or more
Exclusion Criteria:
- Those who are expected to have a limited life expectancy, receiving palliative care will be excluded.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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number of medications
기간: Baseline and 3 months
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number of medications
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Baseline and 3 months
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anticholinergic burden scores
기간: baseline and 3 months
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anticholinergic burden scores
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baseline and 3 months
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Activities of Daily Living
기간: Baseline and 3 months
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Activities of Daily Living
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Baseline and 3 months
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frailty status
기간: Baseline and 3 months
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frailty status
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Baseline and 3 months
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cognition
기간: Baseline and 3 months
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cognition
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Baseline and 3 months
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Health related quality of life (SF36)
기간: Baseline and 3 months
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Heath related quality of life (SF36)
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Baseline and 3 months
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delirium
기간: Baseline and 3 months
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delirium
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Baseline and 3 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Healthcare resouce use
기간: Baseline and 3 months
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Healthcare resource use
|
Baseline and 3 months
|
|
adverse events
기간: Baseline and 3 months
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adverse events
|
Baseline and 3 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Kinda Ibrahim, PhD, University of Southampton
간행물 및 유용한 링크
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 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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