Randomized Evaluation of Default Access to Palliative Services (REDAPS)
2020년 9월 10일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
34239
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
Connecticut
-
Bridgeport, Connecticut, 미국, 06606
- St. Vincent's Medical Center
-
-
Florida
-
Jacksonville, Florida, 미국, 32204
- St. Vincent's Medical Center, Riverside
-
Jacksonville, Florida, 미국, 32216
- St. Vincent's Medical Center, Southside
-
-
Kansas
-
Wichita, Kansas, 미국, 67214
- Via Christi Hospital, St. Francis
-
Wichita, Kansas, 미국, 67218
- Via Christi Hospital, St. Joseph
-
-
Michigan
-
Kalamazoo, Michigan, 미국, 49048
- Borgess Medical Center
-
-
New York
-
Binghamton, New York, 미국, 13905
- Our Lady of Lourdes Memorial Hospital
-
-
Tennessee
-
Nashville, Tennessee, 미국, 37205
- St. Thomas West Hospital
-
-
Texas
-
Austin, Texas, 미국, 78701
- University Medical Center Brackenridge
-
-
Wisconsin
-
Mequon, Wisconsin, 미국, 53097
- Columbia St. Mary's, Ozaukee
-
Milwaukee, Wisconsin, 미국, 53211
- Columbia St. Mary's, North Lake
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
65년 이상 (고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: 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.
|
|
|
간섭 없음: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Composite Measure: Length of Stay and In-Hospital Mortality
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Goals of care assessment
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 30 days
|
30-day hospital re-admissions documented within the Premier database
|
30 days
|
|
Direct cost per day
기간: 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
기간: 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Scott D Halpern, PhD,MD, University of Pennsylvania
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2016년 3월 1일
기본 완료 (실제)
2018년 11월 1일
연구 완료 (실제)
2020년 9월 1일
연구 등록 날짜
최초 제출
2015년 7월 16일
QC 기준을 충족하는 최초 제출
2015년 7월 20일
처음 게시됨 (추정)
2015년 7월 22일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 9월 11일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 9월 10일
마지막으로 확인됨
2020년 9월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .