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Prognosticating Outcomes and Nudging Decisions With Electronic Records in the ICU Trial

NCT03139838 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3500

Last updated 2022-08-08

No results posted yet for this study

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.

Conditions

  • Critical Illness

Interventions

BEHAVIORAL

EHR-Based Intervention A

Intervention A will be a prompt for clinicians to document an estimated prognosis for patients at 6 months, and an assessment of predicted functional outcome if expected to survive.

BEHAVIORAL

EHR-Based Intervention B

Intervention B will entail a prompt for clinicians to provide a reason for not offering patients and their families the alternative of care focused entirely on comfort despite recommendations from critical care professional societies to do so for patients at high risk for death or severely impaired functional recovery.

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    collaborator OTHER

  • Donaghue Medical Research Foundation

    collaborator OTHER

  • University of Pennsylvania

    lead OTHER

Principal Investigators

  • Scott D Halpern, PhD, MD · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-01
Primary Completion
2021-04-24
Completion
2022-06-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03139838 on ClinicalTrials.gov