Advance Care PlanningNCT04296136
Quality Improvement Project for Advance Care Planning Tool in Hospital Medicine
An observational study of Advance Care Planning, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advance Care Planning
- What is being tested?
- Advance Care Planning Discussion
- How many people
- 743 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Nov 2019to 15 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- All patients admitted to the inpatient medicine service with high risk of mortality.
Who cannot join
- Involuntary commitment during the index admission
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Advance Care Planning
- Being tested
- Advance Care Planning Discussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advance Care Planning DiscussionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| High risk of mortality | Adult patients admitted to the hospital medicine service with a high risk of mortality Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who have advanced care planning notes completed during the admission
As measured by medical record review (Pre-implementation)
Measured: 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)
Measured: Hospital admission, up to 7 days
Secondary outcomes (10)
Proportion of patient who have documentation utilizing the electronic health record dotphrase note template
As measured by medical record review (Pre-implementation)
Measured: Hospital admission, up to 7 days
Proportion of patient who have documentation utilizing the electronic health record dotphrase note template
As measured by medical record review (Post-implementation)
Measured: Hospital admission, up to 7 days
Proportion of patients who are billed for advanced care planning
As measured by medical record review (Pre-implementation)
Measured: Hospital admission, up to 7 days
Proportion of patients who are billed for advanced care planning
As measured by medical record review (Post-implementation)
Measured: Hospital admission, up to 7 days
Proportion of patients who receive palliative care consults
As measured by medical record review (Pre-implementation)
Measured: Hospital admission, up to 7 days
Proportion of patients who receive palliative care consults
As measured by medical record review (Post-implementation)
Measured: Hospital admission, up to 7 days
Proportion of patients who are discharged to hospice
As measured by medical record review (Pre-implementation)
Measured: Hospital discharge, up to 7 days
Proportion of patients who are discharged to hospice
As measured by medical record review (Post-implementation)
Measured: Hospital discharge, up to 7 days
Proportion of patients who have an appointment to the palliative care clinic
As measured by medical record review (Pre-implementation)
Measured: Up to 1 month
Proportion of patients who have an appointment to the palliative care clinic
As measured by medical record review (Post-implementation)
Measured: Up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start26 Nov 2019
- Primary completion15 Sep 2021
- Study completion15 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advance Care PlanningStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 743 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sendak Mark, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04296136
- Sponsor's protocol ID
- Pro00104527
- Status last verified
- May 2022
- First submitted
- 3 Mar 2020
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality Improvement Project: Assessing the Use of Advanced Care Planning Documentation for Patients at High Risk of 30-day Mortality on Hospital Medicine Services
- ClinicalTrials.gov ID
- NCT04296136
- Acronym / sponsor ID
- Pro00104527
- Conditions
- Advance Care Planning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 743 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 26 Nov 2019 (actual)
- Primary completion
- 15 Sep 2021 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 5 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High risk of mortality | – | Other: Advance Care Planning DiscussionAdult patients admitted to the hospital medicine service with a high risk of mortality |
| High risk of mortality (pre-implementation) | – | –Adult patients admitted to the hospital medicine service with a high risk of mortality |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All patients admitted to the inpatient medicine service with high risk of mortality.
Key exclusion criteria (1 listed)
- Involuntary commitment during the index admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Advance Care Planning DiscussionGoals 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. | Other | High risk of mortality |
Primary outcome
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)
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)
10 secondary outcomes
Proportion of patient who have documentation utilizing the electronic health record dotphrase note template
Time frame: 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
Proportion of patients who are billed for advanced care planning
Time frame: Hospital admission, up to 7 days
Proportion of patients who are billed for advanced care planning
Time frame: Hospital admission, up to 7 days
Proportion of patients who receive palliative care consults
Time frame: Hospital admission, up to 7 days
Proportion of patients who receive palliative care consults
Time frame: Hospital admission, up to 7 days
Proportion of patients who are discharged to hospice
Time frame: Hospital discharge, up to 7 days
Proportion of patients who are discharged to hospice
Time frame: Hospital discharge, up to 7 days
Proportion of patients who have an appointment to the palliative care clinic
Time frame: Up to 1 month
Proportion of patients who have an appointment to the palliative care clinic
Time frame: Up to 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Individual participant dataSharing planned: No
Related trials for Advance Care Planning
Active, not recruiting
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Patient Navigation and the Planning Advance Care Together Website to Improve Goals of Care Conversations in Hematopoietic Cell Transplant Survivors, IMPACT-HCT Trial
Hematopoietic and Lymphatic System Neoplasm
Not yet recruiting
Development and Evaluation of a Disease-oriented Scenario Game to Promote ACP Among Older Adults and Family Caregivers
Heart Failure, Older Adults (65 Years and Older)
Not yet recruiting
Using a Conversation Game to Engage Native American Washoe Tribe Members in Advance Care Planning: Preparation for a Clinical Trial
Advance Care Planning, American Indian or Alaska Native
Active, not recruiting
Longitudinal Early Advance Care Planning Discussions and Documentation (LEADD) Program: An Exploratory Study in Adolescents and Young Adults (AYAs) Receiving Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplantation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sendak Mark principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advance Care Planning, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who have advanced care planning notes completed during the admission (time frame: Hospital admission, up to 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.