Rounding Summaries for Families of Critically Ill Patients
2021年3月8日 更新者：Jared Greenberg、Rush University Medical Center
Many patients in intensive care units (ICUs) rely on family members or surrogates to make medical decisions on their behalf. One of the recommended ways to improve a surrogate's experience is to invite him or her to participate in daily, multidisciplinary ICU rounds. In practice, this is often a challenging way for clinicians to engage with the patient's surrogates.
Surrogates of non-decisional ICU patients will be randomized to receive a written rounding summary every day or every other day that the patient is in the ICU. The summary will be organized as follows for each of the most important ICU problems: 1) Description of the problem, 2) Ways the ICU team is addressing the problem i.e. consultations, diagnostic tests, and treatments. 3) An assessment of whether the problem is improving or worsening.
The investigators hypothesize that surrogates who receive written rounding summaries will be more satisfied with ICU care than surrogates who receive usual care. Satisfaction will be measured by the Critical Care Family Needs Inventory (CCFNI) questionnaire.
調査の概要
研究の種類
介入
入学 (実際)
252
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
-
-
Illinois
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Chicago、Illinois、アメリカ、60612
- Rush University Medical Center
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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
18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
Patients in the adult Medical and Cardiac ICUs at Rush University Medical Center will be prospectively screened.
Inclusion criteria (Patient characteristics required for surrogate inclusion) At least one of the following
- The patient has required invasive or non-invasive mechanical ventilation for at least three consecutive days.
- The patient has an expected in-hospital mortality rate of at least 25% according to the primary ICU physician.
Exclusion criteria (Patient characteristics that will exclude surrogates from study enrollment):
- The patient possesses decisional capacity at the time of enrollment.
- The patient has required invasive or non-invasive mechanical ventilation for more than the previous 14 days
- The patient is expected to die or transition to comfort care within the next 48 hours based on ICU physician estimate.
- The patient is expected to be liberated from mechanical ventilation (if applicable) or discharged from the ICU within the next 24 hours.
- There is no identifiable surrogate.
- The patient is member of a vulnerable population i.e. pregnant, prisoner.
- The ICU physician refuses permission to approach surrogates for consent
The investigators will hand out fliers that describe the study to surrogates of patients who are expected to meet the above criteria. Surrogates can ask the nurse to contact the lead investigator if they are interested in learning more about the study. If no surrogate is present prior to the patient meeting the inclusion criteria, the investigators will attempt to contact the surrogate by phone to provide information on the study.
One surrogate will be approached for informed consent and enrolled based on the following criteria.
Inclusion criteria for surrogate decision maker:
- Age ≥ 18 years old
- Self-identified as participating directly in health care decision making for the incapable patient
Exclusion criteria for surrogate decision makers:
- The surrogate does not agree to participate in study procedures (surveys, interviews)
- The surrogate needs translation assistance because of poor English fluency
- The surrogate has history of a clinically important neurological disorder (e.g., dementia)
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：Rounding Summary
Surrogates who are assigned to the intervention group will receive a written rounding summary every day or every other day that the patient is in the ICU. The summary will be organized as follows for each of the most important ICU problems: 1) Description of the problem, 2) Ways the ICU team is addressing the problem i.e. consultations, diagnostic tests, and treatments. 3) An assessment of whether the problem is improving or worsening. For patients assigned to the intervention group, the investigators will forward the previous day's summary to the ICU nurse at the beginning of each day shift. After participating in morning rounds, ICU nurses will be asked to modify the summary based on the plan for the day. Nurses will be asked to use the written summary to guide communication with surrogates that day. |
Written summary of rounds
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介入なし：Usual Care
Usual ICU care
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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 |
|---|---|---|
|
Surrogate Satisfaction with Patient Care: Critical Care Family Needs Inventory (CCFNI) questionnaire
時間枠：Measured once 5-7 days after enrollment (or within 24 hours of ICU discharge if this occurs first). For patients who remain in the ICU an additional 5 days after first measurement, the outcome will be measured again.
|
Score on the Critical Care Family Needs Inventory (CCFNI) questionnaire.
14 questions.
Total score range 14-56 with lower scores indicating better satisfaction.
|
Measured once 5-7 days after enrollment (or within 24 hours of ICU discharge if this occurs first). For patients who remain in the ICU an additional 5 days after first measurement, the outcome will be measured again.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Surrogate Anxiety and Depression
時間枠：Measured once 5-7 days after enrollment (or within 24 hours of ICU discharge if this occurs first). For patients who remain in the ICU an additional 5 days after first measurement, the outcome will be measured again.
|
Score on Hospital Anxiety and Depression Scale (HADS).
Total score 0-21 for anxiety (7 questions) and 0-21 for depression (7 questions).
Higher scores indicate greater symptom burden.
|
Measured once 5-7 days after enrollment (or within 24 hours of ICU discharge if this occurs first). For patients who remain in the ICU an additional 5 days after first measurement, the outcome will be measured again.
|
|
Surrogate Symptoms of Post-Traumatic Stress Disorder (PTSD)
時間枠：Measured once 5-7 days after enrollment (or within 24 hours of ICU discharge if this occurs first). For patients who remain in the ICU an additional 5 days after first measurement, the outcome will be measured again.
|
Score on Impact of Events Scale Revised (IES-R) questionnaire.
22 questions.
Score 0-88 with higher scores indicating more stress.
|
Measured once 5-7 days after enrollment (or within 24 hours of ICU discharge if this occurs first). For patients who remain in the ICU an additional 5 days after first measurement, the outcome will be measured again.
|
|
Surrogate and physician agreement regarding the patient's condition
時間枠：Measured once 5-7 days after enrollment (or within 24 hours of ICU discharge if this occurs first). For patients who remain in the ICU an additional 5 days after first measurement, the outcome will be measured again.
|
Surrogates and ICU physicians will be provided with a list of common medical ICU diagnoses.
Respondents will be asked to indicate which of these diagnoses, if any, pertain to the patient.
When the respondent picks a diagnosis, he or she will be prompted to indicate whether common treatments for that condition are being provided.
Finally, for each checked diagnosis, the respondent will indicate whether he or she believes the problem is "getting better, getting worse, or staying the same."
Members of the research team, blinded to the surrogates' treatment arm, will evaluate for inter-rater agreement between surrogates and ICU physician responses.
|
Measured once 5-7 days after enrollment (or within 24 hours of ICU discharge if this occurs first). For patients who remain in the ICU an additional 5 days after first measurement, the outcome will be measured again.
|
|
Change in Surrogate Satisfaction with Patient Care: Critical Care Family Needs Inventory (CCFNI) questionnaire
時間枠：From enrollment to 5-7 days after enrollment (or within 24 hours of ICU discharge if this occurs first).
|
Change in Score on the Critical Care Family Needs Inventory (CCFNI) questionnaire.
14 questions.
Total score range 14-56 with lower scores indicating better satisfaction.
|
From enrollment to 5-7 days after enrollment (or within 24 hours of ICU discharge if this occurs first).
|
|
Change in Surrogate Anxiety and Depression
時間枠：From enrollment to 5-7 days after enrollment (or within 24 hours of ICU discharge if this occurs first).
|
Change in Score on Hospital Anxiety and Depression Scale (HADS).
Total score 0-21 for anxiety (7 questions) and 0-21 for depression (7 questions).
Higher scores indicate greater symptom burden.
|
From enrollment to 5-7 days after enrollment (or within 24 hours of ICU discharge if this occurs first).
|
|
Change in Surrogate Symptoms of Post-Traumatic Stress Disorder (PTSD)
時間枠：From enrollment to 5-7 days after enrollment (or within 24 hours of ICU discharge if this occurs first).
|
Change in score on Impact of Events Scale Revised (IES-R) questionnaire.
22 questions.
Score 0-88 with higher scores indicating more stress.
|
From enrollment to 5-7 days after enrollment (or within 24 hours of ICU discharge if this occurs first).
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Qualitative feedback from participating surrogates
時間枠：Measured once 5-7 days after enrollment (or within 24 hours of ICU discharge if this occurs first). For patients who remain in the ICU an additional 5 days after first measurement, the outcome will be measured again.
|
All surrogates will be asked to participate in a 10-15 minute phone or in-person interview.
This interview will deal with their satisfaction with the patient's care and communication with the ICU staff.
|
Measured once 5-7 days after enrollment (or within 24 hours of ICU discharge if this occurs first). For patients who remain in the ICU an additional 5 days after first measurement, the outcome will be measured again.
|
|
Feedback from participating nurses
時間枠：Daily while patient is in the ICU
|
Nurses of enrolled patients/surrogates will be asked to complete an online survey regarding communication with the patient and/or surrogates that day.
Nurses will also be invited to participate in focus groups to provide feedback.
|
Daily while patient is in the ICU
|
|
Surrogate Satisfaction with Patient Care
時間枠：Measured once 10-14 days after enrollment if patient still in ICU
|
Score on the Critical Care Family Needs Inventory (CCFNI) questionnaire.
14 questions.
Total score range 14-56 with lower scores indicating better satisfaction.
|
Measured once 10-14 days after enrollment if patient still in ICU
|
|
Surrogate Anxiety and Depression
時間枠：Measured once 10-14 days after enrollment if patient still in ICU
|
Score on Hospital Anxiety and Depression Scale (HADS).
Total score 0-21 for anxiety (7 questions) and 0-21 for depression (7 questions).
Higher scores indicate greater symptom burden.
|
Measured once 10-14 days after enrollment if patient still in ICU
|
|
Surrogate Symptoms of Post-Traumatic Stress Disorder (PTSD)
時間枠：Measured once 10-14 days after enrollment if patient still in ICU
|
Score on Impact of Events Scale Revised (IES-R) questionnaire.
22 questions.
Score 0-88 with higher scores indicating more stress.
|
Measured once 10-14 days after enrollment if patient still in ICU
|
|
Surrogate and physician agreement regarding the patient's condition
時間枠：Measured once 10-14 days after enrollment if patient still in ICU
|
Surrogates and ICU physicians will be provided with a list of common medical ICU diagnoses.
Respondents will be asked to indicate which of these diagnoses, if any, pertain to the patient.
When the respondent picks a diagnosis, he or she will be prompted to indicate whether common treatments for that condition are being provided.
Finally, for each checked diagnosis, the respondent will indicate whether he or she believes the problem is "getting better, getting worse, or staying the same."
Members of the research team, blinded to the surrogates' treatment arm, will evaluate for inter-rater agreement between surrogates and ICU physician responses.
|
Measured once 10-14 days after enrollment if patient still in ICU
|
|
Patient length of mechanical ventilation (if applicable)
時間枠：Measured during hospitalization, up to 90 days after enrollment.
|
Patient length of mechanical ventilation (if applicable)
|
Measured during hospitalization, up to 90 days after enrollment.
|
|
Patient failed extubation attempt (yes/no) (if applicable)
時間枠：Measured during hospitalization, up to 90 days after enrollment.
|
Failed extubation attempt (yes/no) (if applicable)
|
Measured during hospitalization, up to 90 days after enrollment.
|
|
Tracheostomy placement during ICU admission (yes/no)
時間枠：Measured during hospitalization, up to 90 days after enrollment.
|
Tracheostomy placement during ICU admission (yes/no)
|
Measured during hospitalization, up to 90 days after enrollment.
|
|
Days from intubation to tracheostomy placement (if applicable)
時間枠：Measured during hospitalization, up to 90 days after enrollment.
|
Days from intubation to tracheostomy placement (if applicable)
|
Measured during hospitalization, up to 90 days after enrollment.
|
|
ICU discharge requiring invasive mechanical ventilation (yes/no)
時間枠：Measured during hospitalization, up to 90 days after enrollment.
|
ICU discharge requiring invasive mechanical ventilation (yes/no)
|
Measured during hospitalization, up to 90 days after enrollment.
|
|
ICU discharge requiring new artificial nutritional supplementation (yes/no)
時間枠：Measured during hospitalization, up to 90 days after enrollment.
|
ICU discharge requiring new artificial nutritional supplementation (yes/no)
|
Measured during hospitalization, up to 90 days after enrollment.
|
|
ICU discharge requiring new renal replacement therapy (yes/no)
時間枠：Measured during hospitalization, up to 90 days after enrollment.
|
ICU discharge requiring new renal replacement therapy (yes/no)
|
Measured during hospitalization, up to 90 days after enrollment.
|
|
Change in code status or limitations to care during ICU stay (yes/no)
時間枠：Measured during hospitalization, up to 90 days after enrollment.
|
Change in code status or limitations to care during ICU stay (yes/no)
|
Measured during hospitalization, up to 90 days after enrollment.
|
|
Days from ICU admission to change in code status or new limitations to care (if applicable)
時間枠：Measured during hospitalization, up to 90 days after enrollment.
|
Days from ICU admission to change in code status or new limitations to care (if applicable)
|
Measured during hospitalization, up to 90 days after enrollment.
|
|
ICU length of stay (days)
時間枠：Measured during hospitalization, up to 90 days after enrollment.
|
ICU length of stay (days)
|
Measured during hospitalization, up to 90 days after enrollment.
|
|
Hospital length of stay (days)
時間枠：Measured during hospitalization, up to 90 days after enrollment.
|
Hospital length of stay (days)
|
Measured during hospitalization, up to 90 days after enrollment.
|
|
Hospital disposition
時間枠：Measured during hospitalization, up to 90 days after enrollment.
|
Hospital disposition
|
Measured during hospitalization, up to 90 days after enrollment.
|
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。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Brown SM, Rozenblum R, Aboumatar H, Fagan MB, Milic M, Lee BS, Turner K, Frosch DL. Defining patient and family engagement in the intensive care unit. Am J Respir Crit Care Med. 2015 Feb 1;191(3):358-60. doi: 10.1164/rccm.201410-1936LE. No abstract available.
- Davidson JE, Aslakson RA, Long AC, Puntillo KA, Kross EK, Hart J, Cox CE, Wunsch H, Wickline MA, Nunnally ME, Netzer G, Kentish-Barnes N, Sprung CL, Hartog CS, Coombs M, Gerritsen RT, Hopkins RO, Franck LS, Skrobik Y, Kon AA, Scruth EA, Harvey MA, Lewis-Newby M, White DB, Swoboda SM, Cooke CR, Levy MM, Azoulay E, Curtis JR. Guidelines for Family-Centered Care in the Neonatal, Pediatric, and Adult ICU. Crit Care Med. 2017 Jan;45(1):103-128. doi: 10.1097/CCM.0000000000002169.
- Davidson JE, Jones C, Bienvenu OJ. Family response to critical illness: postintensive care syndrome-family. Crit Care Med. 2012 Feb;40(2):618-24. doi: 10.1097/CCM.0b013e318236ebf9.
- Nelson JE, Hanson LC, Keller KL, Carson SS, Cox CE, Tulsky JA, White DB, Chai EJ, Weiss SP, Danis M. The Voice of Surrogate Decision-Makers. Family Responses to Prognostic Information in Chronic Critical Illness. Am J Respir Crit Care Med. 2017 Oct 1;196(7):864-872. doi: 10.1164/rccm.201701-0201OC.
- Greenberg JA, Basapur S, Quinn TV, Bulger JL, Schwartz NH, Oh SK, Shah RC, Glover CM. Challenges faced by families of critically ill patients during the first wave of the COVID-19 pandemic. Patient Educ Couns. 2022 Feb;105(2):297-303. doi: 10.1016/j.pec.2021.08.029. Epub 2021 Aug 27.
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 (実際)
2019年6月1日
一次修了 (実際)
2021年1月11日
研究の完了 (実際)
2021年2月12日
試験登録日
最初に提出
2019年5月10日
QC基準を満たした最初の提出物
2019年5月29日
最初の投稿 (実際)
2019年5月31日
学習記録の更新
投稿された最後の更新 (実際)
2021年3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3月8日
最終確認日
2021年3月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。