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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
High risk of mortality
Adult patients admitted to the hospital medicine service with a high risk of mortality
Other: Advance Care Planning Discussion
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 (pre-implementation)
Adult patients admitted to the hospital medicine service with a high risk of mortality

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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)
Hospital admission, up to 7 days
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)
Hospital admission, up to 7 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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)
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 (Post-implementation)
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)
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 (Post-implementation)
Hospital admission, up to 7 days
Proportion of patients who are discharged to hospice
Time Frame: Hospital discharge, up to 7 days
As measured by medical record review (Pre-implementation)
Hospital discharge, up to 7 days
Proportion of patients who are discharged to hospice
Time Frame: Hospital discharge, up to 7 days
As measured by medical record review (Post-implementation)
Hospital discharge, up to 7 days
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
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duke University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 26, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 15, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 15, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 3, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 5, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 18, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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