- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04296136
Quality Improvement Project for Advance Care Planning Tool in Hospital Medicine
May 11, 2022 updated by: Duke University
Quality Improvement Project: Assessing the Use of Advanced Care Planning Documentation for Patients at High Risk of 30-day Mortality on Hospital Medicine Services
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
743
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
-
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North Carolina
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Durham, North Carolina, United States, 27705
- Duke University
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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
No
Genders Eligible for Study
All
Sampling Method
Non-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.
Description
Inclusion Criteria:
- All patients admitted to the inpatient medicine service with high risk of mortality.
Exclusion Criteria:
- Involuntary commitment during the index admission
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
High risk of mortality
Adult patients admitted to the hospital medicine service with a high risk of mortality
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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.
|
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High risk of mortality (pre-implementation)
Adult patients admitted to the hospital medicine service with a high risk of mortality
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of patients who have advanced care planning notes completed during the admission
Time Frame: Hospital admission, up to 7 days
|
As measured by medical record review (Pre-implementation)
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Hospital admission, up to 7 days
|
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Proportion of patients who have advanced care planning notes completed during the admission
Time Frame: Hospital admission, up to 7 days
|
As measured by medical record review (Post-implementation)
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Hospital admission, up to 7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of patient who have documentation utilizing the electronic health record dotphrase note template
Time Frame: Hospital admission, up to 7 days
|
As measured by medical record review (Pre-implementation)
|
Hospital admission, up to 7 days
|
|
Proportion of patient who have documentation utilizing the electronic health record dotphrase note template
Time Frame: Hospital admission, up to 7 days
|
As measured by medical record review (Post-implementation)
|
Hospital admission, up to 7 days
|
|
Proportion of patients who are billed for advanced care planning
Time Frame: Hospital admission, up to 7 days
|
As measured by medical record review (Pre-implementation)
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Hospital admission, up to 7 days
|
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Proportion of patients who are billed for advanced care planning
Time Frame: Hospital admission, up to 7 days
|
As measured by medical record review (Post-implementation)
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Hospital admission, up to 7 days
|
|
Proportion of patients who receive palliative care consults
Time Frame: Hospital admission, up to 7 days
|
As measured by medical record review (Pre-implementation)
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Hospital admission, up to 7 days
|
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Proportion of patients who receive palliative care consults
Time Frame: Hospital admission, up to 7 days
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As measured by medical record review (Post-implementation)
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Hospital admission, up to 7 days
|
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Proportion of patients who are discharged to hospice
Time Frame: Hospital discharge, up to 7 days
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As measured by medical record review (Pre-implementation)
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Hospital discharge, up to 7 days
|
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Proportion of patients who are discharged to hospice
Time Frame: Hospital discharge, up to 7 days
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As measured by medical record review (Post-implementation)
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Hospital discharge, up to 7 days
|
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Proportion of patients who have an appointment to the palliative care clinic
Time Frame: Up to 1 month
|
As measured by medical record review (Pre-implementation)
|
Up to 1 month
|
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Proportion of patients who have an appointment to the palliative care clinic
Time Frame: Up to 1 month
|
As measured by medical record review (Post-implementation)
|
Up to 1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sendak Mark, 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)
November 26, 2019
Primary Completion (Actual)
September 15, 2021
Study Completion (Actual)
March 15, 2022
Study Registration Dates
First Submitted
March 3, 2020
First Submitted That Met QC Criteria
March 3, 2020
First Posted (Actual)
March 5, 2020
Study Record Updates
Last Update Posted (Actual)
May 18, 2022
Last Update Submitted That Met QC Criteria
May 11, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- Pro00104527
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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