NCT04756583

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

February 15, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 16, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

October 17, 2024

Status Verified

January 1, 2023

Enrollment Period

1.9 years

First QC Date

February 12, 2021

Last Update Submit

October 15, 2024

Conditions

Advance Care Planning

Outcome Measures

Primary Outcomes (1)

  • Proportion of advance care planning notes as measured by electronic health record data during hospitalization

    Up to 30 days

Secondary Outcomes (10)

  • Proportion of advance care planning codes billed as measured by electronic health record data

    Up to 30 days

  • Proportion of Palliative Care Consults (Inpatient/Outpatient) as measured by electronic health record data

    Up to 90 days

  • Proportion of patients discharged to hospice as measured by electronic health record data

    Up to 30 days

  • Proportion of patients' code status changed to Do-Not-Resuscitate as measured by electronic health record data

    Up to 30 days

  • Proportion of patient deaths as measured by electronic health record data

    Up to 14 days

  • +5 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL
Other: Notification system

Control

NO INTERVENTION

Interventions

Notification systemOTHER

Email and page notification sent to clinicians for patients at high-risk of mortality in 30 days and 6 months

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 18 years of age
  • Attending Physician on the Hospital Medicine or General Internal Medicine Service at Duke University Hospital

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Hospital

Durham, North Carolina, 27705, United States

Location

Study Officials

  • David Casarett, MD

    Duke University

    PRINCIPAL INVESTIGATOR

  • Jessica Ma, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2021

First Posted

February 16, 2021

Study Start

February 15, 2021

Primary Completion

December 31, 2022

Study Completion

June 30, 2023

Last Updated

October 17, 2024

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)