Advance Care Planning Notifications in General Inpatient Medicine

• Sponsor: Duke University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04756583
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 24.4
• Patients Per Site Per Month: 4.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Advance Care Planning	Other: Notification system	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Advance Care Planning Notifications in General Inpatient Medicine
• Actual Study Start Date: Feb 15, 2021
• Anticipated Primary Completion Date: Oct 1, 2022
• Anticipated Study Completion Date: Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention	Other: Notification system; Email and page notification sent to clinicians for patients at high-risk of mortality in 30 days and 6 months
No Intervention: Control

Outcome Measures

Primary Outcome Measures

1. Number of advance care planning notes as measured by electronic health record data [Up to 30 days]

2. Number of advance care planning codes billed as measured by electronic health record data [Up to 30 days]

Secondary Outcome Measures

1. Number of Palliative Care Consults (Inpatient/Outpatient) as measured by electronic health record data [Up to 90 days]

2. Number of patients discharged to hospice as measured by electronic health record data [Up to 30 days]

3. Number of patients' code status changed to Do-Not-Resuscitate as measured by electronic health record data [Up to 30 days]

4. Number of patient deaths as measured by electronic health record data [Up to 14 days]

5. Number of patient deaths as measured by electronic health record data [Up to 30 days]

6. Number of patient deaths as measured by electronic health record data [Up to 6 months]

7. Number of patient re-admitted to the hospital as measured by electronic health record data [Up to 30 days]

8. Number of patient re-admitted to the hospital as measured by electronic health record data [Up to 6 months]

9. Number of advance care planning paperwork filed as measured by electronic health record data [Up to 30 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• At least 18 years of age

• Clinician on the Hospital Medicine or General Internal Medicine Service at Duke University Hospital

Exclusion Criteria:

• None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke University Hospital	Durham	North Carolina	United States	27705

Sponsors and Collaborators

• Duke University

Investigators

• Principal Investigator: David Casarett, MD, Duke University
• Principal Investigator: Jessica Ma, MD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT04756583
• Other Study ID Numbers: Pro00107026
• First Posted: Feb 16, 2021
• Last Update Posted: Jan 24, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jan 24, 2022