Advance Care PlanningNCT04756583
Advance Care Planning Notifications in General Inpatient Medicine
A study testing Notification system in people with Advance Care Planning, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Advance Care Planning
- What is being tested?
- Notification system
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2021to 30 Jun 2023
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Attending Physician on the Hospital Medicine or General Internal Medicine Service at Duke University Hospital
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Hospital
Durham, North Carolina, 27705
About this study
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.
- Conditions
- Advance Care Planning
- Being tested
- Notification system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Notification systemOther
Email and page notification sent to clinicians for patients at high-risk of mortality in 30 days and 6 months
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Other: Notification system |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of advance care planning notes as measured by electronic health record data during hospitalization
Measured: Up to 30 days
Secondary outcomes (10)
Proportion of advance care planning codes billed as measured by electronic health record data
Measured: Up to 30 days
Proportion of Palliative Care Consults (Inpatient/Outpatient) as measured by electronic health record data
Measured: Up to 90 days
Proportion of patients discharged to hospice as measured by electronic health record data
Measured: Up to 30 days
Proportion of patients' code status changed to Do-Not-Resuscitate as measured by electronic health record data
Measured: Up to 30 days
Proportion of patient deaths as measured by electronic health record data
Measured: Up to 14 days
Proportion of patient deaths as measured by electronic health record data
Measured: Up to 30 days
Proportion of patient deaths as measured by electronic health record data
Measured: Up to 6 months
Proportion of patient re-admitted to the hospital as measured by electronic health record data
Measured: Up to 30 days
Proportion of patient re-admitted to the hospital as measured by electronic health record data
Measured: Up to 6 months
Proportion of advance care planning paperwork filed as measured by electronic health record data
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start15 Feb 2021
- Primary completion31 Dec 2022
- Study completion30 Jun 2023
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Casarett, MD, Principal investigator, Duke UniversityJessica Ma, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04756583
- Sponsor's protocol ID
- Pro00107026
- Status last verified
- Jan 2023
- First submitted
- 12 Feb 2021
- Last updated
- 17 Oct 2024
- 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 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advance Care Planning Notifications in General Inpatient Medicine
- ClinicalTrials.gov ID
- NCT04756583
- Acronym / sponsor ID
- Pro00107026
- Conditions
- Advance Care Planning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 16 Feb 2021 (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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Notification system |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- At least 18 years of age
- Attending Physician on the Hospital Medicine or General Internal Medicine Service at Duke University Hospital
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Notification systemEmail and page notification sent to clinicians for patients at high-risk of mortality in 30 days and 6 months | Other | Intervention |
Primary outcome
Proportion of advance care planning notes as measured by electronic health record data during hospitalization
Time frame: Up to 30 days
10 secondary outcomes
Proportion of advance care planning codes billed as measured by electronic health record data
Time frame: Up to 30 days
Proportion of Palliative Care Consults (Inpatient/Outpatient) as measured by electronic health record data
Time frame: Up to 90 days
Proportion of patients discharged to hospice as measured by electronic health record data
Time frame: Up to 30 days
Proportion of patients' code status changed to Do-Not-Resuscitate as measured by electronic health record data
Time frame: Up to 30 days
Proportion of patient deaths as measured by electronic health record data
Time frame: Up to 14 days
Proportion of patient deaths as measured by electronic health record data
Time frame: Up to 30 days
Proportion of patient deaths as measured by electronic health record data
Time frame: Up to 6 months
Proportion of patient re-admitted to the hospital as measured by electronic health record data
Time frame: Up to 30 days
Proportion of patient re-admitted to the hospital as measured by electronic health record data
Time frame: Up to 6 months
Proportion of advance care planning paperwork filed as measured by electronic health record data
Time frame: Up to 30 days
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 17 Oct 2024.
- Individual participant dataSharing planned: No
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Using a Conversation Game to Engage Native American Washoe Tribe Members in Advance Care Planning: Preparation for a Clinical Trial
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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
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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.
David Casarett, MD principal investigator
Duke University
Jessica Ma, MD 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?
A study testing Notification system in people with 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 2 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 17 Oct 2024. 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 advance care planning notes as measured by electronic health record data during hospitalization (time frame: Up to 30 days). 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 17 Oct 2024.