COPDREDAPSNCT02505035
Randomized Evaluation of Default Access to Palliative Services
A study testing Default ordering of palliative consult in people with COPD and ESRD, run by University of Pennsylvania at 11 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- What is being tested?
- Default ordering of palliative consult
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34,239 participants
- Where
- 11 sitesUnited States
- Study dates
- Mar 2016to Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 1. Patients younger than 65 years old will not receive the intervention
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
University Medical Center Brackenridge
Austin, Texas, 78701
Our Lady of Lourdes Memorial Hospital
Binghamton, New York, 13905
St. Vincent's Medical Center
Bridgeport, Connecticut, 06606
St. Vincent's Medical Center, Riverside
Jacksonville, Florida, 32204
St. Vincent's Medical Center, Southside
Jacksonville, Florida, 32216
Borgess Medical Center
Kalamazoo, Michigan, 49048
Columbia St. Mary's, Ozaukee
Mequon, Wisconsin, 53097
Columbia St. Mary's, North Lake
Milwaukee, Wisconsin, 53211
St. Thomas West Hospital
Nashville, Tennessee, 37205
Via Christi Hospital, St. Francis
Wichita, Kansas, 67214
Via Christi Hospital, St. Joseph
Wichita, Kansas, 67218
About this study
Official title: 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.
Read the 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.
- Being tested
- Default ordering of palliative consult
- Keywords
- Palliative care, Pragmatic trial
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Kidney Failure, Chronic, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Default ordering of palliative consultBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Default ordering of palliative consult | Active comparator | 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. Receives: Behavioral: Default ordering of palliative consult |
| Usual care | No intervention | There will be no trial-driven approach to care. Inpatient palliative care consultative services will be actively requested by physicians as in usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Measure: Length of Stay and In-Hospital Mortality
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.
Measured: Duration of hospital stay, an expected average of 8 days
Secondary outcomes (13)
Goals of care assessment
Documented assessments of patients' goals of care within the electronic health record
Measured: Duration of hospital stay, an expected average of 8 days
Pain assessment
Documented assessments of patients' pain scores within the electronic health record
Measured: Duration of hospital stay, an expected average of 8 days
Dyspnea assessment
Documented assessments of patients' dyspnea within the electronic health record
Measured: Duration of hospital stay, an expected average of 8 days
Code status
Code status documented within the electronic health record
Measured: Duration of hospital stay, an expected average of 8 days
Mechanical ventilation
Documented orders for mechanical ventilation within the electronic health record
Measured: Duration of hospital stay, an expected average of 8 days
Cardiopulmonary resuscitation
Documented orders for cardiopulmonary resuscitation within the electronic health record
Measured: Duration of hospital stay, an expected average of 8 days
Inpatient dialysis
Documented orders for dialysis during inpatient stay within the electronic health record
Measured: Duration of hospital stay, an expected average of 8 days
ICU admission
Transferal to an intensive care unit documented within the electronic health record
Measured: Duration of hospital stay, an expected average of 8 days
Hospital discharge status
Hospital discharge disposition code documented within the electronic health record
Measured: Duration of hospital stay, an expected average of 8 days
Discharge planning orders
Discharge orders for home care services documented within the electronic health record
Measured: Duration of hospital stay, an expected average of 8 days
Hospital readmission
30-day hospital re-admissions documented within the Premier database
Measured: 30 days
Direct cost per day
Direct cost per day documented within the Premier database
Measured: Duration of hospital stay, an expected average of 8 days
Direct cost per hospitalization
Direct cost per hospitalization documented within the Premier database
Measured: Duration of hospital stay, an expected average of 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study startMar 2016
- Primary completionNov 2018
- Study completionSep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34,239 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Scott D Halpern, PhD,MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02505035
- Sponsor's protocol ID
- 822134
- Other IDs
- UH2AG050311
- Acronym
- REDAPS
- Status last verified
- Sep 2020
- First submitted
- 16 Jul 2015
- Last updated
- 11 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Courtright KR, Madden V, Bayes B, Chowdhury M, Whitman C, Small DS, Harhay MO, Parra S, Cooney-Zingman E, Ersek M, Escobar GJ, Hill SH, Halpern SD. Default Palliative Care Consultation for Seriously Ill Hospitalized Patients: A Pragmatic Cluster Randomized Trial. JAMA. 2024 Jan 16;331(3):224-232. doi: 10.1001/jama.2023.25092.
PubMed 38227032Courtright 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.
PubMed 27348271
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Default Palliative Care Consultation for Seriously Ill Hospitalized Patients
- ClinicalTrials.gov ID
- NCT02505035
- Acronym / sponsor ID
- REDAPS / 822134
- Keywords
- Palliative care, Pragmatic trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34,239 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Mar 2016 (actual)
- Primary completion
- Nov 2018 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 22 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Default ordering of palliative consult | Active comparator | Behavioral: Default ordering of palliative consultHospitals 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. |
| Usual care | No intervention | –There will be no trial-driven approach to care. Inpatient palliative care consultative services will be actively requested by physicians as in usual care. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Age 65 years or older
- Current hospitalization of at least 3 calendar days (modified ITT)
- Diagnosis of one or more of the following:
Key exclusion criteria (1 listed)
- 1. Patients younger than 65 years old will not receive the intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Default ordering of palliative consult | Behavioural | Default ordering of palliative consult |
Primary outcome
Composite Measure: Length of Stay and In-Hospital Mortality
Time frame: 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.
13 secondary outcomes
Goals of care assessment
Time frame: Duration of hospital stay, an expected average of 8 days
Pain assessment
Time frame: Duration of hospital stay, an expected average of 8 days
Dyspnea assessment
Time frame: Duration of hospital stay, an expected average of 8 days
Code status
Time frame: Duration of hospital stay, an expected average of 8 days
Mechanical ventilation
Time frame: Duration of hospital stay, an expected average of 8 days
Cardiopulmonary resuscitation
Time frame: Duration of hospital stay, an expected average of 8 days
Inpatient dialysis
Time frame: Duration of hospital stay, an expected average of 8 days
ICU admission
Time frame: Duration of hospital stay, an expected average of 8 days
Hospital discharge status
Time frame: Duration of hospital stay, an expected average of 8 days
Discharge planning orders
Time frame: Duration of hospital stay, an expected average of 8 days
Hospital readmission
Time frame: 30 days
Direct cost per day
Time frame: Duration of hospital stay, an expected average of 8 days
Direct cost per hospitalization
Time frame: Duration of hospital stay, an expected average of 8 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2020.
- Derived from this study: PubMed 38227032Courtright KR, Madden V, Bayes B, Chowdhury M, Whitman C, Small DS, Harhay MO, Parra S, Cooney-Zingman E, Ersek M, Escobar GJ, Hill SH, Halpern SD. Default Palliative Care Consultation for Seriously Ill Hospitalized Patients: A Pragmatic Cluster Randomized Trial. JAMA. 2024 Jan 16;331(3):224-232. doi: 10.1001/jama.2023.25092.
- Derived from this study: PubMed 27348271Courtright 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott D Halpern, PhD,MD principal investigator
University of Pennsylvania
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Default ordering of palliative consult in people with COPD and ESRD, run by University of Pennsylvania at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Measure: Length of Stay and In-Hospital Mortality (time frame: Duration of hospital stay, an expected average of 8 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02505035, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2020.