NCT04296136

Brief Summary

Hospitalized patients and their families are often unprepared regarding end-of-life care. Even patients with high risk of mortality within the index admission or 30 days after admission often do not have clearly defined goals of care. This lack of clarity can create difficult scenarios for patients, their families, and care providers. Lack of communication and documentation of these goals can lead to unnecessary tests, procedures, and readmissions. By creating advanced care planning education for the hospital medicine department, a standardized note template, and EMR utilization for storage and reference of patient's goals of care documentation we aim to facilitate the conveyance of patient's wishes/preferences across different care providers and across separate encounters within the healthcare system. For this study, we will use a pre-post study design to evaluate the implementation of this quality improvement intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
743

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2019

Typical duration for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 26, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 5, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2022

Completed
Last Updated

May 18, 2022

Status Verified

May 1, 2022

Enrollment Period

1.8 years

First QC Date

March 3, 2020

Last Update Submit

May 11, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Proportion of patients who have advanced care planning notes completed during the admission

    As measured by medical record review (Pre-implementation)

    Hospital admission, up to 7 days

  • Proportion of patients who have advanced care planning notes completed during the admission

    As measured by medical record review (Post-implementation)

    Hospital admission, up to 7 days

Secondary Outcomes (10)

  • Proportion of patient who have documentation utilizing the electronic health record dotphrase note template

    Hospital admission, up to 7 days

  • Proportion of patient who have documentation utilizing the electronic health record dotphrase note template

    Hospital admission, up to 7 days

  • Proportion of patients who are billed for advanced care planning

    Hospital admission, up to 7 days

  • Proportion of patients who are billed for advanced care planning

    Hospital admission, up to 7 days

  • Proportion of patients who receive palliative care consults

    Hospital admission, up to 7 days

  • +5 more secondary outcomes

Study Arms (2)

High risk of mortality

Adult patients admitted to the hospital medicine service with a high risk of mortality

Other: Advance Care Planning Discussion

High risk of mortality (pre-implementation)

Adult patients admitted to the hospital medicine service with a high risk of mortality

Interventions

Goals of care discussion with patient, documentation with electronic health record note and advance care planning billing. This will also include: pharmacy review of medications, case management review, and coding specialist review.

High risk of mortality

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population for the QI project will include two groups (pre and post-implementation) in order to evaluate the effectiveness of the program. Both the pre-implementation and the intervention (post-implementation) groups consist of adult patients admitted to the hospital medicine service with a high risk of mortality; clinicians providing care for patients in the post-implementation group will also receive a notification of the patient's high risk of mortality and recommendation for a serious illness conversation. The evaluation has been narrowed to a pre-post study design, which will enable our team to identify the impact of the intervention.

You may qualify if:

  • All patients admitted to the inpatient medicine service with high risk of mortality.

You may not qualify if:

  • Involuntary commitment during the index admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University

Durham, North Carolina, 27705, United States

Location

Study Officials

  • Sendak Mark

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2020

First Posted

March 5, 2020

Study Start

November 26, 2019

Primary Completion

September 15, 2021

Study Completion

March 15, 2022

Last Updated

May 18, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations