Impact of Decision Quality by Using Question Prompt List
2021年8月1日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (予想される)
154
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
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Xindian
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Taipei City、Xindian、台湾、231
- National Taiwan University Hospital
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
20年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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)
|
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.
|
|
介入なし：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)
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Decision conflict
時間枠：before the counseling (T0), immediately after counseling(T1)
|
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
時間枠：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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Decision control preference
時間枠：one month after treatment (T2)
|
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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (予想される)
2021年8月15日
一次修了 (予想される)
2022年6月30日
研究の完了 (予想される)
2022年8月31日
試験登録日
最初に提出
2021年7月26日
QC基準を満たした最初の提出物
2021年7月26日
最初の投稿 (実際)
2021年8月2日
学習記録の更新
投稿された最後の更新 (実際)
2021年8月9日
QC基準を満たした最後の更新が送信されました
2021年8月1日
最終確認日
2021年5月1日
詳しくは
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