- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04756583
Advance Care Planning Notifications in General Inpatient Medicine
October 15, 2024 updated by: Duke University
This study will evaluate the impact of and response by physicians on Hospital Medicine/General Internal Medicine service to a notification identifying seriously ill patients at high risk of death within 30 days as well as within 6 months in a cluster randomized control trial.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
73
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
-
Durham, North Carolina, United States, 27705
- Duke University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- At least 18 years of age
- Attending Physician on the Hospital Medicine or General Internal Medicine Service at Duke University Hospital
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
|
Email and page notification sent to clinicians for patients at high-risk of mortality in 30 days and 6 months
|
|
No Intervention: Control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Proportion of advance care planning notes as measured by electronic health record data during hospitalization
Time Frame: Up to 30 days
|
Up to 30 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Proportion of advance care planning codes billed as measured by electronic health record data
Time Frame: Up to 30 days
|
Up to 30 days
|
|
Proportion of Palliative Care Consults (Inpatient/Outpatient) as measured by electronic health record data
Time Frame: Up to 90 days
|
Up to 90 days
|
|
Proportion of patients discharged to hospice as measured by electronic health record data
Time Frame: Up to 30 days
|
Up to 30 days
|
|
Proportion of patients' code status changed to Do-Not-Resuscitate as measured by electronic health record data
Time Frame: Up to 30 days
|
Up to 30 days
|
|
Proportion of patient deaths as measured by electronic health record data
Time Frame: Up to 14 days
|
Up to 14 days
|
|
Proportion of patient deaths as measured by electronic health record data
Time Frame: Up to 30 days
|
Up to 30 days
|
|
Proportion of patient deaths as measured by electronic health record data
Time Frame: Up to 6 months
|
Up to 6 months
|
|
Proportion of patient re-admitted to the hospital as measured by electronic health record data
Time Frame: Up to 30 days
|
Up to 30 days
|
|
Proportion of patient re-admitted to the hospital as measured by electronic health record data
Time Frame: Up to 6 months
|
Up to 6 months
|
|
Proportion of advance care planning paperwork filed as measured by electronic health record data
Time Frame: Up to 30 days
|
Up to 30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: David Casarett, MD, Duke University
- Principal Investigator: Jessica Ma, MD, Duke University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 15, 2021
Primary Completion (Actual)
December 31, 2022
Study Completion (Actual)
June 30, 2023
Study Registration Dates
First Submitted
February 12, 2021
First Submitted That Met QC Criteria
February 12, 2021
First Posted (Actual)
February 16, 2021
Study Record Updates
Last Update Posted (Actual)
October 17, 2024
Last Update Submitted That Met QC Criteria
October 15, 2024
Last Verified
January 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- Pro00107026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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