Impact of Decision Quality by Using Question Prompt List
2021년 8월 1일 업데이트: National Taiwan University Hospital
Impact of Decision Quality by Using Question Prompt List on the Shared Decision Making in End-stage Renal Disease Patients
To investigate the effects of a question prompt list (QPL) on a shared decision-making consultation among facing decision for dialysis in end-stage renal disease (ESRD) patients.
A randomized controlled trial was conducted at the university medical center of North Taiwan.
Subjects were randomized assigned to QPL group or usual care group.
Decisional quality and decision control preferences were assessed with questionnaires.
Measurements were performed at before the counseling (T0), immediately after counseling (T1), and evaluate decision regret at one month after treatment.
연구 개요
상세 설명
The aim of this study was to investigate the effectiveness of decisional quality and decisional control preferences by using a specific question prompt list (QPL) during a shared decision-making consultation among facing decision for dialysis in end-stage renal disease (ESRD) patients.
A randomized controlled trial was conducted at the university medical center of North Taiwan.
Recruit subjects are those who are about to receive the nurse-led coaching of shared decision-making (SDM) for patients with ESRD and attend the program.
By using blocked Randomization design, the investigators assigned participants to QPL group or usual care.
Prior to a clinic visit to discuss treatment, two-pages ESRD QPL leaflets are provided to QPL group, while usual care group without receiving provision of QPL.
Measurements of outcome included decision quality (decision conflict, decisional self-efficiency) and decision control preference at before the counseling (T0), immediately after counseling (T1), and evaluate decision regret at one month after treatment (T2), at this time the patient has decided and started to accept the selected treatment (hemodialysis, peritoneal dialysis or conservative treatment).
All statistical analyses were performed in SAS statistical software, version 9.4 (SAS, Cary, NC).
The effects of the intervention were assessed by generalized estimating equation (GEE) analysis with the coefficient of interaction ( group × time) term.
Statistical tests were two-sided with a significance level of 0.05.
Hierarchical Linear Model was used to detect the impact of nested within physician.
연구 유형
중재적
등록 (예상)
154
단계
- 해당 없음
연락처 및 위치
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연구 장소
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Xindian
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Taipei City, Xindian, 대만, 231
- National Taiwan University Hospital
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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
20년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Patients with stage 5 chronic kidney disease who facing decision for dialysis;
- normal cognitive functions;
- be able to read, communicate in Mandarin or Taiwanese;
- ability to express willingness;
Exclusion Criteria:
- vision or hearing function impairment;
- Severe illness;
- Urgent to dialysis for extend life;
- Dialysis modalities Already decided.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: QPL group
receive 2-pages ESRD QPL leaflets, circle the questions they want to ask before consultation.
encourage asking questions with doctor during consultation.
receive the nurse-led coaching of shared decision-making (SDM)
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The specific QPS was a one page leaflet for chronic kidney disease which developed by applied literature and public QPL from the National Health Agency.
It contains 3 domains 25 questions related to treatment, dialysis, and Kidney transplant.
The QPL group participants were asked to read and mark those questions they concerned or write down additional problems.
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간섭 없음: Usual care group
without receiving provision of QPL encourage asking questions with doctor during consultation.
receive the nurse-led coaching of shared decision-making (SDM)
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Decision conflict
기간: before the counseling (T0), immediately after counseling(T1)
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Decision conflict was measured by Decision conflict scale(DCS).
The scale consists of 16 items into 5 subscales: Uncertainty(3 items), Informed(3 items), values clarity(3 items), support(3 items), and effective decision(4 items) that are rated on a 5-point likert-scale from "strongly agree" (0) to "strongly disagree" (4).
The sum of scores are calculated from 0 to 100.
The higher the score, the higher the level of decision conflict.
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before the counseling (T0), immediately after counseling(T1)
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Decisional self-efficiency
기간: before the counseling (T0), immediately after counseling(T1)
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Decision self-efficiency was measured by Decisional Self-Efficiency Scale(DSES).
The scale represents self-confidence or belief in decision making.
The scale consists of 11 items that are rated on a 5-point likert-scale from "not at all confident" (0) to" very confident "(4) .
The sum of scores are calculated from 0 to 100.
The higher the score, the higher the level of self-confidence.
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before the counseling (T0), immediately after counseling(T1)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Decision control preference
기간: one month after treatment (T2)
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Decision regret was measured by Decision regret Scale(DRS) .The scale consists of 5 items that are rated on a 5-point likert-scale from "strongly agree "(1) to" strongly disagree" (5) .
The sum of scores are calculated from 0 to 100.
The higher the score, the higher the level of regret.
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one month after treatment (T2)
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Decision control preference
기간: before the counseling (T0), immediately after counseling(T1)
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Decision control preference was measured by Decision control preference Scale(DCPS) .The scale asks two question:(1)control preference measured at before the counseling; (2) actual decision control level measured after counseling immediately.
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before the counseling (T0), immediately after counseling(T1)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
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 (예상)
2021년 8월 15일
기본 완료 (예상)
2022년 6월 30일
연구 완료 (예상)
2022년 8월 31일
연구 등록 날짜
최초 제출
2021년 7월 26일
QC 기준을 충족하는 최초 제출
2021년 7월 26일
처음 게시됨 (실제)
2021년 8월 2일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 8월 9일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 8월 1일
마지막으로 확인됨
2021년 5월 1일
추가 정보
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