Clinical trial NCT02505035: Randomized Evaluation of Default Access to Palliative Services
Official title: Default Palliative Care Consultation for Seriously Ill Hospitalized Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
ESRD
Dementia
Keywords: Palliative care
Pragmatic trial
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2015-07-22
Enrollment: 34239
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Age 65 years or older
2. Current hospitalization of at least 3 calendar days (modified ITT)
3. 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

Primary outcomes:
measure: Composite Measure: Length of Stay and In-Hospital Mortality
timeFrame: Duration of hospital stay, an expected average of 8 days
Secondary outcomes:
measure: Goals of care assessment
timeFrame: Duration of hospital stay, an expected average of 8 days
measure: Pain assessment
timeFrame: Duration of hospital stay, an expected average of 8 days
measure: Dyspnea assessment
timeFrame: Duration of hospital stay, an expected average of 8 days
measure: Code status
timeFrame: Duration of hospital stay, an expected average of 8 days
measure: Mechanical ventilation
timeFrame: Duration of hospital stay, an expected average of 8 days
measure: Cardiopulmonary resuscitation
timeFrame: Duration of hospital stay, an expected average of 8 days
measure: Inpatient dialysis
timeFrame: Duration of hospital stay, an expected average of 8 days
measure: ICU admission
timeFrame: Duration of hospital stay, an expected average of 8 days
measure: Hospital discharge status
timeFrame: Duration of hospital stay, an expected average of 8 days
measure: Discharge planning orders
timeFrame: Duration of hospital stay, an expected average of 8 days
measure: Hospital readmission
timeFrame: 30 days
measure: Direct cost per day
timeFrame: Duration of hospital stay, an expected average of 8 days
measure: Direct cost per hospitalization
timeFrame: Duration of hospital stay, an expected average of 8 days
Other outcomes:
Locations:
city: Bridgeport
country: United States
facility: St. Vincent's Medical Center
state: Connecticut
city: Jacksonville
country: United States
facility: St. Vincent's Medical Center, Riverside
state: Florida
city: Jacksonville
country: United States
facility: St. Vincent's Medical Center, Southside
state: Florida
city: Wichita
country: United States
facility: Via Christi Hospital, St. Francis
state: Kansas
city: Wichita
country: United States
facility: Via Christi Hospital, St. Joseph
state: Kansas
city: Kalamazoo
country: United States
facility: Borgess Medical Center
state: Michigan
city: Binghamton
country: United States
facility: Our Lady of Lourdes Memorial Hospital
state: New York
city: Nashville
country: United States
facility: St. Thomas West Hospital
state: Tennessee
city: Austin
country: United States
facility: University Medical Center Brackenridge
state: Texas
city: Mequon
country: United States
facility: Columbia St. Mary's, Ozaukee
state: Wisconsin
city: Milwaukee
country: United States
facility: Columbia St. Mary's, North Lake
state: Wisconsin
Study officials:
affiliation: University of Pennsylvania
name: Scott D Halpern, PhD,MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Courtright KR, Madden V, Gabler NB, Cooney E, Small DS, Troxel A, Casarett D, Ersek M, Cassel JB, Nicholas LH, Escobar G, Hill SH, O'Brien D, Vogel M, Halpern SD. Rationale and Design of the Randomized Evaluation of Default Access to Palliative Services (REDAPS) Trial. Ann Am Thorac Soc. 2016 Sep;13(9):1629-39. doi: 10.1513/AnnalsATS.201604-308OT.