Clinical trial NCT03139838: Prognosticating Outcomes and Nudging Decisions With Electronic Records in the ICU Trial
Official title: Behavioral Economic Approaches to Improve Palliative Care for Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Keywords: Palliative Care
Pragmatic Clinical Trial
Electronic Health Records
Economics, Behavioral
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Wake Forest University Health Sciences
name: Donaghue Medical Research Foundation
First posted: 2017-05-04
Enrollment: 3500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a pragmatic, stepped-wedge, cluster randomized trial testing the real-world effectiveness of two different electronic health record (EHR) behavioral interventions in improving a number of patient- and family-centered processes and outcomes of care among seriously ill hospitalized patients. The investigators hypothesize that outcomes can be improved without raising costs by requiring intensive care unit clinicians to (i) document a prognostic estimate and (ii) provide a justification if they choose not to offer patients the option of comfort-oriented care. To test this hypothesis the investigators will conduct a 33-month trial at 17 intensive care units in 10 hospitals using the same Cerner EHR within Atrium Health System.

Detailed description: The PONDER-ICU trial aims to generate large-scale, experimental evidence regarding the real-world effectiveness of two different electronic health record (EHR) behavioral interventions in improving a number of patient- and family-centered processes and outcomes of care among seriously ill hospitalized patients. The interventions are designed to increase intensive care unit (ICU) physicians' and advanced practitioners' (physician assistants and nurse practitioners) engagement of critically ill patients and caregivers in discussions about alternative treatment options, including care focused on comfort. To achieve this goal, the investigators will conduct a 33-month pragmatic, stepped-wedge cluster randomized clinical trial at 17 ICUs within 10 Atrium Health System hospitals. The investigators hypothesize that outcomes can be improved without raising costs by requiring ICU clinicians to (i) document a prognostic estimate (Intervention A) and (ii) provide a justification if they choose not to offer patients the option of comfort-oriented care (Intervention B). Approximately 4,750 adult patients (1) with chronic life-limiting illness and receiving continuous mechanical ventilation for ≥48 hours will be enrolled. Participating hospitals will be randomized into 5 clusters of 2 hospitals each. Each hospital will first contribute a minimum of 5 months of data collection during usual care in a control phase. Then, using the step-wedge design, all hospitals will implement the two EHR-based interventions. The order in which the interventions will be adopted and the timing of adoption at each hospital will both be determined by random assignment. After 12 months of utilizing Intervention A or Intervention B, each hospital will adopt and implement the second intervention in combination with the other. By the end of the trial, all hospitals will have utilized the combined interventions for at least 4 months. The primary outcome is a composite measure of hospital length of stay and mortality. Secondary outcomes include an array of clinical outcomes, as well as palliative care-related process measures.

Eligibility criteria: Inclusion Criteria:

1. ≥18 years old; AND
2. Admitted to 1 of the 17 participating ICUs; AND
3. Receipt of continuous mechanical ventilation for ≥ 48 hours (without interruption); AND
4. ≥ 1 life-limiting illness present on admission (ICD-9/10 code or discrete medical history data from EHR in prior 12 months):

   1. Chronic obstructive pulmonary disease
   2. Cirrhosis
   3. Congestive heart failure
   4. Dementia (all types)
   5. End-stage renal disease
   6. Hematologic malignancy
   7. Metastatic malignancy
   8. Motor neuron disease
   9. Pulmonary fibrosis
   10. Solid organ malignancy

Exclusion Criteria:

1) Patients younger than 18 years old are excluded.

Primary outcomes:
measure: Composite Measure: Length of Stay and In-Hospital Mortality
timeFrame: Duration of hospital stay, an expected average of 16 days
Secondary outcomes:
measure: Change in code status
timeFrame: Duration of hospital stay, an expected average of 16 days
measure: Initiation of additional forms of life-support
timeFrame: Duration of hospital stay, an expected average of 16 days
measure: Palliative care consult
timeFrame: Duration of hospital stay, an expected average of 16 days
measure: Time to palliative care consult
timeFrame: Duration of hospital stay, an expected average of 16 days
measure: Palliative withdrawal of mechanical ventilation
timeFrame: Duration of hospital stay, an expected average of 16 days
measure: Receipt of cardiopulmonary resuscitation (CPR)
timeFrame: Duration of hospital stay, an expected average of 16 days
measure: ICU mortality
timeFrame: Duration of hospital stay, an expected average of 16 days
measure: ICU length of stay
timeFrame: Duration of hospital stay, an expected average of 16 days
measure: ICU readmission
timeFrame: Duration of hospital stay, an expected average of 16 days
measure: Duration of mechanical ventilation
timeFrame: Duration of hospital stay, an expected average of 16 days
measure: Time to withdrawal of life-support
timeFrame: Duration of hospital stay, an expected average of 16 days
measure: Hospital discharge disposition
timeFrame: Duration of hospital stay, an expected average of 16 days
measure: Quality of Dying & Death (1-item)
timeFrame: 48-72 hours following an in-hospital death
measure: 30-day hospital readmission
timeFrame: 30 days
measure: 90-day hospital readmission
timeFrame: 30 days
measure: 180-day hospital readmission
timeFrame: 30 days
measure: 30-day mortality
timeFrame: 30 days
measure: 90-day mortality
timeFrame: 90 days
measure: 180-day mortality
timeFrame: 180 days
measure: Hospital free days
timeFrame: 180 days
Other outcomes:
Locations:
city: Albemarle
country: United States
facility: Carolinas HealthCare System Stanly
state: North Carolina
city: Charlotte
country: United States
facility: Carolinas HealthCare System, NorthEast
state: North Carolina
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Charlotte
country: United States
facility: Atrium Health CMC-Mercy
state: North Carolina
city: Charlotte
country: United States
facility: Atrium Health Pineville
state: North Carolina
city: Charlotte
country: United States
facility: Atrium Health University City
state: North Carolina
city: Lincolnton
country: United States
facility: Atrium Health Lincoln
state: North Carolina
city: Monroe
country: United States
facility: Atrium Health Union
state: North Carolina
city: Morganton
country: United States
facility: Carolinas HealthCare System Blue Ridge-Morganton
state: North Carolina
city: Shelby
country: United States
facility: Atrium Health Cleveland
state: North Carolina
Study officials:
affiliation: University of Pennsylvania
name: Scott D Halpern, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Courtright KR, Dress EM, Singh J, Bayes BA, Chowdhury M, Small DS, Hetherington T, Plickert L, Detsky ME, Doctor JN, Harhay MO, Burke HL, Green MB, Huynh T, Sullivan DM, Halpern SD; PONDER-ICU Investigative Team. Prognosticating Outcomes and Nudging Decisions with Electronic Records in the Intensive Care Unit Trial Protocol. Ann Am Thorac Soc. 2021 Feb;18(2):336-346. doi: 10.1513/AnnalsATS.202002-088SD.