Randomized Evaluation of Default Access to Palliative Services (REDAPS)
2020年9月10日 更新者：University of Pennsylvania
Default Palliative Care Consultation for Seriously Ill Hospitalized Patients
This is a large pragmatic, randomized controlled trial to test the real-world effectiveness of inpatient palliative care consultative services in improving a number of patient- and family-centered processes and outcomes of care among seriously ill hospitalized patients.
The investigators hypothesize that improved patient-centered outcomes can be achieved without higher costs by simply changing the default option for inpatient palliative care consultation for eligible patients from an opt-in to an opt-out system.
To test this hypothesis the investigators will conduct a clinical trial at 11 hospitals using the same electronic health record within Ascension Health, the largest non-profit health system in the U.S.
調査の概要
詳細な説明
The REDAPS trial aims to generate large-scale, experimental evidence regarding the real-world effectiveness of inpatient palliative consultative services (IPCS) and to test the incremental effectiveness and costs of a simple, scalable method to increase IPCS utilization among properly selected patients.
The REDAPS trial will also compare the effectiveness of different palliative care team structures and services and identify patient subgroups most likely to benefit from IPCS.
To achieve these goals, the investigators will conduct a clinical trial at 11 Ascension Health hospitals using the same electronic health record.
Participating hospitals first contribute a minimum of 4 months of data under the control paradigm (opt-in model), where physicians must identify patients who may benefit from palliative care consultation and actively order such services.
Then, using a stepped-wedge design, the hospitals are randomly assigned to begin the intervention in intervals spaced approximately 2.7 months apart.
During the intervention, patients meeting consensus criteria for eligibility for palliative care consultation are identified by the electronic health record, a consultation is ordered by default, physicians may cancel the order after being alerted to it, and patients or family members may decline such services.
By the end of the trial, all hospitals will have utilized the intervention paradigm of palliative care consultation for at least 4 months.
The REDAPS trial will compare outcomes (clinical, economic, and process measures) before and after implementation within hospitals, as well as comparisons among hospitals at given time points.
研究の種類
介入
入学 (実際)
34239
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
-
-
Connecticut
-
Bridgeport、Connecticut、アメリカ、06606
- St. Vincent's Medical Center
-
-
Florida
-
Jacksonville、Florida、アメリカ、32204
- St. Vincent's Medical Center, Riverside
-
Jacksonville、Florida、アメリカ、32216
- St. Vincent's Medical Center, Southside
-
-
Kansas
-
Wichita、Kansas、アメリカ、67214
- Via Christi Hospital, St. Francis
-
Wichita、Kansas、アメリカ、67218
- Via Christi Hospital, St. Joseph
-
-
Michigan
-
Kalamazoo、Michigan、アメリカ、49048
- Borgess Medical Center
-
-
New York
-
Binghamton、New York、アメリカ、13905
- Our Lady of Lourdes Memorial Hospital
-
-
Tennessee
-
Nashville、Tennessee、アメリカ、37205
- St. Thomas West Hospital
-
-
Texas
-
Austin、Texas、アメリカ、78701
- University Medical Center Brackenridge
-
-
Wisconsin
-
Mequon、Wisconsin、アメリカ、53097
- Columbia St. Mary's, Ozaukee
-
Milwaukee、Wisconsin、アメリカ、53211
- Columbia St. Mary's, North Lake
-
-
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
65年歳以上 (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 65 years or older
- Current hospitalization of at least 3 calendar days (modified ITT)
Diagnosis of one or more of the following:
- End-stage renal disease (ESRD) on dialysis
- Chronic obstructive pulmonary disease (COPD) with home oxygen dependence or 2 or more hospitalizations in the past 12 months
- Dementia admitted from a long-term care facility or prior placement of a surgical feeding tube or 2 or more additional hospitalizations in the past 12 months
Exclusion criteria:
1. Patients younger than 65 years old will not receive the intervention
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：クロスオーバー割り当て
- 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 |
|---|---|
|
アクティブコンパレータ：Default ordering of palliative consult
Hospitals randomized to the intervention arm will adopt a system whereby eligible patients are identified by the electronic health record, a consultation is ordered by default, and physicians may cancel the order after being alerted to it, and patients or family members may decline such services.
|
|
|
介入なし：Usual care
There will be no trial-driven approach to care.
Inpatient palliative care consultative services will be actively requested by physicians as in usual care.
|
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 |
|---|---|---|
|
Composite Measure: Length of Stay and In-Hospital Mortality
時間枠：Duration of hospital stay, an expected average of 8 days
|
The primary outcome is a composite measure of in-hospital mortality and hospital length-of-stay that ranks deaths along the length-of-stay distribution.
Data is extracted from the electronic health record.
|
Duration of hospital stay, an expected average of 8 days
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Goals of care assessment
時間枠：Duration of hospital stay, an expected average of 8 days
|
Documented assessments of patients' goals of care within the electronic health record
|
Duration of hospital stay, an expected average of 8 days
|
|
Pain assessment
時間枠：Duration of hospital stay, an expected average of 8 days
|
Documented assessments of patients' pain scores within the electronic health record
|
Duration of hospital stay, an expected average of 8 days
|
|
Dyspnea assessment
時間枠：Duration of hospital stay, an expected average of 8 days
|
Documented assessments of patients' dyspnea within the electronic health record
|
Duration of hospital stay, an expected average of 8 days
|
|
Code status
時間枠：Duration of hospital stay, an expected average of 8 days
|
Code status documented within the electronic health record
|
Duration of hospital stay, an expected average of 8 days
|
|
Mechanical ventilation
時間枠：Duration of hospital stay, an expected average of 8 days
|
Documented orders for mechanical ventilation within the electronic health record
|
Duration of hospital stay, an expected average of 8 days
|
|
Cardiopulmonary resuscitation
時間枠：Duration of hospital stay, an expected average of 8 days
|
Documented orders for cardiopulmonary resuscitation within the electronic health record
|
Duration of hospital stay, an expected average of 8 days
|
|
Inpatient dialysis
時間枠：Duration of hospital stay, an expected average of 8 days
|
Documented orders for dialysis during inpatient stay within the electronic health record
|
Duration of hospital stay, an expected average of 8 days
|
|
ICU admission
時間枠：Duration of hospital stay, an expected average of 8 days
|
Transferal to an intensive care unit documented within the electronic health record
|
Duration of hospital stay, an expected average of 8 days
|
|
Hospital discharge status
時間枠：Duration of hospital stay, an expected average of 8 days
|
Hospital discharge disposition code documented within the electronic health record
|
Duration of hospital stay, an expected average of 8 days
|
|
Discharge planning orders
時間枠：Duration of hospital stay, an expected average of 8 days
|
Discharge orders for home care services documented within the electronic health record
|
Duration of hospital stay, an expected average of 8 days
|
|
Hospital readmission
時間枠：30 days
|
30-day hospital re-admissions documented within the Premier database
|
30 days
|
|
Direct cost per day
時間枠：Duration of hospital stay, an expected average of 8 days
|
Direct cost per day documented within the Premier database
|
Duration of hospital stay, an expected average of 8 days
|
|
Direct cost per hospitalization
時間枠：Duration of hospital stay, an expected average of 8 days
|
Direct cost per hospitalization documented within the Premier database
|
Duration of hospital stay, an expected average of 8 days
|
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, PhD,MD、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。
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)
2016年3月1日
一次修了 (実際)
2018年11月1日
研究の完了 (実際)
2020年9月1日
試験登録日
最初に提出
2015年7月16日
QC基準を満たした最初の提出物
2015年7月20日
最初の投稿 (見積もり)
2015年7月22日
学習記録の更新
投稿された最後の更新 (実際)
2020年9月11日
QC基準を満たした最後の更新が送信されました
2020年9月10日
最終確認日
2020年9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。