Default Options in Advance Directives
2019年3月29日 更新者：Scott Halpern、University of Pennsylvania
In a multicenter, randomized clinical trial of default options in advance directives among patients with incurable diseases, we will determine whether this simple and readily scalable intervention can improve patients quality of life and reduce resource utilization without reducing the number of days that patients are alive and living outside of an acute-care hospital.
調査の概要
状態
完了
研究の種類
介入
入学 (予想される)
270
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
-
-
Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19104
- Penn Presbyterian Medical Center
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Philadelphia、Pennsylvania、アメリカ、19107
- Pennsylvania Hospital
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Philadelphia、Pennsylvania、アメリカ、19104
- The Perelman Center for Advance Medicine
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Pittsburgh、Pennsylvania、アメリカ、15213
- University of Pittsburgh Medical Center
-
-
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
Inclusion Criteria:
- Age 18 or older
- Fluent in English
- Has seen current physician at least once prior to current visit
- Resident of Pennsylvania or New Jersey
- One or more of the following diagnoses:
- Amyotrophic lateral sclerosis
- Stage IIIB or IV non-small cell lung cancer, pancreatic cancer, or cholangiocarcinoma
- Stage IV breast, colon, esophageal, gastric, pancreatic, prostate, uterine, cervical, ovarian, or urothelial cancer; paraganglioma, or pheochromocytoma
- Stage C or D hepatocellular carcinoma
- Stage IV renal cell carcinoma
- Stage IV or V chronic kidney disease
- Mesothelioma or any malignancy metastatic to the pleura
- Other incurable interstitial lung diseases with at least severe restriction on most recent pulmonary function tests or eligible for long-term oxygen therapy
- Chronic obstructive pulmonary disease with at least severe airflow obstruction on most recent spirometry or eligible for long-term oxygen therapy
- Congestive heart failure with NYHA Class IV status or Class III plus 1 heart failure related hospitalization in the past 12 months or ACC stage D or C classification with 1 heart failure related hospitalization in the past 12 months
Exclusion Criteria:
- Currently listed for or being considered for solid organ transplant
- Patients with a previously signed advance directive or living will.
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：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：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Life-extension default
Subjects in this group will receive an advance directive form that defaults to an overall goal of care directed towards life extension (vs.
comfort oriented care) unless the subject specifies otherwise.
The form also states 4 specific life extending interventions (cardiopulmonary resuscitation, mechanical ventilation, hemodialysis, and feeding tube insertion) will be provided unless patients specifically opt-out from such selections.
It also will state that upon discharge from the hospital, long-term care (vs.
hospice care) will be provided unless the patient chooses otherwise.
|
|
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実験的：Comfort default
Subjects in this group will receive an advance directive form that defaults to an overall goal of care directed towards comfort and relief of pain and suffering (vs.
life extension) unless the subject specifies otherwise.
The form also states 4 specific life extending interventions (cardiopulmonary resuscitation, mechanical ventilation, hemodialysis, and feeding tube insertion) will be not provided unless patients specifically opts into such selections.
It also will state that upon discharge from the hospital, hospice care (vs.
long-term care) will be provided unless the patient chooses otherwise.
|
|
|
介入なし：Standard advance directive
Subjects in the standard advance directive (AD) group will receive an AD that will have no options pre-selected.
|
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 |
|---|---|---|
|
Hospital free days
時間枠：6 months
|
The primary outcome is "Hospital-Free Days" (HFDs), a measure that PI Halpern has been developing in collaboration with Dr. Jeffrey Silber at Penn's Center for Outcomes Research.
As the name describes, HFDs represent the number of days alive and not in an acute care facility.
Although this is a simple concept, and provides an outcome measure of obvious importance to patients, the use of HFDs as a primary outcome in an RCT is highly innovative.
To bolster confidence in the results, we will evaluate two key variations on the theme.
First, we will explore "Healthcare Facility-Free Days," which represents the number of days alive where a patient is in neither an acute care facility, a chronic care facility, or a nursing home.
We will also evaluate HFDs within a defined period of follow-up - 6 months in this case.
This is analogous to the established outcome of ventilator-free days used commonly in RCTs among ICU patients
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6 months
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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 |
|---|---|---|
|
Hospital and ICU admissions
時間枠：up to 1 year
|
The numbers of admissions will be analyzed as count data.
From the dates of hospital and ICU admissions, we will calculate the proportion of each patient's total survival time during study follow-up that was spent in the hospital or ICU.
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up to 1 year
|
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Costs of care
時間枠：up to 1 year
|
We will combine all costs of inpatient and outpatient hospice, hospital stays, and life-sustaining procedures.
The perspective will be that of all potential payers.
Costs will be inflated to the date on which analyses are performed using the U.S. gross domestic product deflator
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up to 1 year
|
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Hospice utilization
時間枠：up to 1 year
|
We will analyze hospice utilization in 2 ways: (a) time from advance directive completion to hospice enrollment; and (b) duration of hospice utilization prior to death.
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up to 1 year
|
|
Choices to receive 4 potentially life-sustaining interventions, and the concordance of these choices with whether the interventions were actually received
時間枠：up to 1 year
|
We will record selections that patients made on their advance directives about 4 specific life-sustaining interventions.
Utilizing data from the Pennsylvania Healthcare Cost Containment Consortium and the New Jersey Department of Health and Senior Services, we will be able to determine which patients received each intervention.
Thus, we will be able to reliably evaluate the proportions of patients who received unwanted interventions.
Because we cannot determine the denominator of patients with indications for these interventions, we will not evaluate the proportions of patients who went without desired services.
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up to 1 year
|
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Choices regarding post-hospitalization care, and the concordance of these choices with the care actually received
時間枠：up to 1 year
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Patients will indicate on their advance directives forms their selections for post-hospitalization care.
We will utilize data from the Pennsylvania Health Care Cost Containment Consortium and New Jersey Department of Health and Senior Services to asses if the care patient indicate is the care they receive.
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up to 1 year
|
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Decision conflict
時間枠：up to 1 year
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The decision conflict scale is a well-validated instrument used to assess patients' certainty in making healthcare decisions.
The DCS will be sent home with consenting patients to complete and return along with their advance directive forms and an instruction sheet explaining to patients that they should complete their advance directive forms first, followed by the DCS, and both should be mailed to the research team in the provided stamped envelope.
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up to 1 year
|
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Decision satisfaction
時間枠：up to 1 year
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Satisfaction will also be measured with the CANHELP instrument's global satisfaction with end-of-life care question.
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up to 1 year
|
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Quality of Life using the McGill Quality of Life (MQOL) instrument.
時間枠：up to 1 year
|
The MQOL is a well-Validated and widely used scale designed specifically for patients with serious illnesses.
The MQOL can be completed by family members on behalf of patients who have lost the capacity to complete it themselves.
Thus, we will have surrogates (the individuals identified on patients' advance directive forms as their appointed healthcare agents) complete the MQOL for incapacitated patients to minimize missing data.
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up to 1 year
|
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Surrogates' Perception of the quality of death and dying
時間枠：within 3 months of patient death
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Because we are recruiting patients with serious life-limiting illnesses, we anticipate that some patients will die over the course of this study period.
We will speak with surrogates of deceased patients to assess their perceived quality of death and dying using Prigerson's Quality of Death measure.
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within 3 months of patient death
|
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Post-traumatic stress in surrogates
時間枠：within 3 months of patient death
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The risk of post-traumatic stress disorder in surrogates among deceased patients will be assessed using the Impact of Events Scale.
The IES is a valid and reliable scale that has been used frequently to assess PTSD risk among family members of critically ill patients.
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within 3 months of patient death
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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。
捜査官
- 主任研究者：Scott D. Halpern, MD, PhD、University of Pennsylvania
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
- Halpern SD, Small DS, Troxel AB, Cooney E, Bayes B, Chowdhury M, Tomko HE, Angus DC, Arnold RM, Loewenstein G, Volpp KG, White DB, Bryce CL. Effect of Default Options in Advance Directives on Hospital-Free Days and Care Choices Among Seriously Ill Patients: A Randomized Clinical Trial. JAMA Netw Open. 2020 Mar 2;3(3):e201742. doi: 10.1001/jamanetworkopen.2020.1742.
- Gabler NB, Cooney E, Small DS, Troxel AB, Arnold RM, White DB, Angus DC, Loewenstein G, Volpp KG, Bryce CL, Halpern SD. Default options in advance directives: study protocol for a randomised clinical trial. BMJ Open. 2016 Jun 6;6(6):e010628. doi: 10.1136/bmjopen-2015-010628.
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)
2014年1月1日
一次修了 (実際)
2016年11月1日
研究の完了 (実際)
2016年11月1日
試験登録日
最初に提出
2013年12月16日
QC基準を満たした最初の提出物
2013年12月16日
最初の投稿 (見積もり)
2013年12月20日
学習記録の更新
投稿された最後の更新 (実際)
2019年4月1日
QC基準を満たした最後の更新が送信されました
2019年3月29日
最終確認日
2019年3月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- UPenn 819325
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。
Life-extension default advance directiveの臨床試験
-
Corporal Michael J. Crescenz VA Medical Center完了特発性肺線維症 | COPD | うっ血性心不全 | 悪性 | 重度または非常に重度の気流閉塞および/または長期酸素療法を受けている、または受ける資格がある | 根治治療のないその他の間質性肺疾患 | -過去1年間にNYHAクラスIVまたはNYHAクラスIIIに加えて1回の入院 | ステージ3Bまたは4の固形腫瘍アメリカ