Mixed Methods Study Web-based Life Support Decision Aid (eLSDA)
Development of an Individualized, Web-Based Life Support Decision Aid (eLSDA) Concerning Goals of Care for the Seriously Ill Patient
調査の概要
詳細な説明
A concurrent mixed method study of a life support decision aid (eLSDA) intends to prepare hospitalized, seriously ill older adult patients and their families to participate in shared decision-making. The study includes 1) randomized controlled trial and 2) a qualitative (naturalistic observation) study. The experimental study compares a convenience cohort of participants who receive usual care (n=60 patients or patient/surrogate pairs) to a cohort of participants who receive the intervention (n=60 patients or patient/surrogate pairs). The investigators intend to measure a) knowledge of life-sustaining technologies, b) clarity of values, c) congruence between documented physician's orders and patient choice, d) decisional conflict, and e) quality of communication. For the intervention group only, investigators will measure comprehensibility and acceptability of the eLSDA. The observational qualitative study derived from naturalistic observation will involve participant observation to examine dialogue about life support between hospitalized, seriously ill older adult patients, families and their healthcare professionals. Quantitative and qualitative data will be collected to better understand the comprehensibility, acceptability, usability, feasibility and impact of the eLSDA used in routine clinical practice.
Questionnaires, patient/family/physician discussions and web based tool viewing will be completed in a hospital setting. The investigator will administer pre-intervention questionnaires to the participants, which will take approximately 15 minutes. Participants will then be randomized to groups, and be invited to use the web based eLSDA or usual care materials on a laptop computer or tablet (30 minutes). This will be followed by post-intervention questionnaires in a second interview (15 minutes). Physicians and nurses/social workers will be asked to complete a survey to examine the barriers to discussions about goals of care (15 minutes). The investigator will also fill out the chart abstraction tool after the participants give consent.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Saskatchewan
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Saskatoon、Saskatchewan、カナダ、S7N 0W8
- Royal University Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Potential users of eLSDA, which are those who are hospitalized, seriously ill, older patients, their families, and their health care providers.
Age 55 + with one or more of the following diseases:
- Chronic obstructive lung disease
- Congestive heart failure
- Cirrhosis
- Cancer
- End-stage dementia
- Renal failure
- Any patient 70 + admitted to the hospital from the community because of an acute medical or surgical condition.
- Any patient 55 - 69 years of age admitted to the hospital, who has high likelihood of death in the next 6 months, in the opinion of the treating physician.
Exclusion Criteria:
- People who are not hospitalized or do not have family members that are hospitalized and are not a potential user of the eLSDA.
研究計画
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：ヘルスサービス研究
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：Intervention
Patient/family are randomized to either the active intervention (web based life support patient decision aid - eLSDA and decision coaching) or usual care comparison.
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The web-based life support decision aid (eLSDA) was adapted from a print-based decision aid.
The eLSDA includes information on the pros and cons of both life support and comfort care.
The eLSDA lays out the decision about life support for an individual patient/family in a logical stepwise fashion to permit discussion, ask questions, and permit reflection on each step.
At the end of the eLSDA, unmet decision-making needs are identified to seek support from the healthcare team.
他の名前：
During the interactive process of using the eLSDA, the study nurse provides decision coaching for patient/family, specifically a facilitated values clarification exercise.
他の名前：
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介入なし：Usual Care Comparison
Patients may also randomized to review current web based resources provided by the health region for seriously ill patients.
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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 |
|---|---|---|
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Acceptability & Usability of the eLSDA
時間枠：up to 15 minutes
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The acceptability and usability is assessed by conducting an Acceptability Survey which asks participants 8 validated questions about the use, amount of information, length, clarity, balance in presentation, willingness to recommend to others and overall suitability for decision making.
The intervention will be considered acceptable if score of the acceptability survey exceeds 80%.
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up to 15 minutes
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Knowledge about life-sustaining technologies
時間枠：up to 15 minutes
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This knowledge of life-sustaining technologies will be measured after using the eLSDA using the self-report questionnaire.
The knowledge questionnaire was developed for this study based on the eLSDA to test users' knowledge of life-sustaining technologies.
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up to 15 minutes
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Clarity of values regarding life-sustaining technologies
時間枠：up to 30 minutes
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The patient's values will be collected in the eLSDA.
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up to 30 minutes
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Congruence between the documented physician's orders and patient choice
時間枠：up to 5 minutes
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Congruence between documented physician orders and patient choice when participants use the eLSDA and/or based on patient communication during the discussion with their physician will be reported as simple agreement: (Yes/No)
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up to 5 minutes
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Feasibility of Evaluation Process
時間枠：up to 30 minutes
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The measures of feasibility are established by the rate of completion of the eLSDA, debriefing and study procedures.
The study will be considered feasible if 60% of those approached agreed to participate in the study; >75% of participants discuss the decision about life support during the encounter, <5% of the participants are distressed by the eLSDA, and 80% of participants complete data collection.
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up to 30 minutes
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協力者と研究者
捜査官
- 主任研究者：Jennifer Kryworuchko, PhD RN CNCC、University of British Columbia
- スタディディレクター：Wanda Martin, PhD RN、University of Saskatchewan
- スタディチェア：Donna Goodridge、University of Saskatchewan
- スタディチェア：Petrina McGrath、Saskatoon Health Region
- スタディチェア：Karen Levesque、Saskatoon Health Region
出版物と役立つリンク
一般刊行物
- Elwyn G, O'Connor A, Stacey D, Volk R, Edwards A, Coulter A, Thomson R, Barratt A, Barry M, Bernstein S, Butow P, Clarke A, Entwistle V, Feldman-Stewart D, Holmes-Rovner M, Llewellyn-Thomas H, Moumjid N, Mulley A, Ruland C, Sepucha K, Sykes A, Whelan T; International Patient Decision Aids Standards (IPDAS) Collaboration. Developing a quality criteria framework for patient decision aids: online international Delphi consensus process. BMJ. 2006 Aug 26;333(7565):417. doi: 10.1136/bmj.38926.629329.AE. Epub 2006 Aug 14.
- The Change Foundation. Consumers and Canadian Health Care Trending Analysis 2004. The Change Foundation: Toronto. 2005.
- Heyland DK, Groll D, Rocker G, Dodek P, Gafni A, Tranmer J, Pichora D, Lazar N, Kutsogiannis J, Shortt S, Lam M; Canadian Researchers at the End of Life Network (CARENET). End-of-life care in acute care hospitals in Canada: a quality finish? J Palliat Care. 2005 Autumn;21(3):142-50.
- O'Connor AM, Graham ID, Visser A. Implementing shared decision making in diverse health care systems: the role of patient decision aids. Patient Educ Couns. 2005 Jun;57(3):247-9. doi: 10.1016/j.pec.2005.04.010. No abstract available.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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