Advance Care PlanningNCT03906773
Advance Care Planning GuideTailored for Primary Care Patients
An observational study of Advance Care Planning and Chronic Disease, run by Ohio State University at 1 site in United States.
Trial summary
this project seeks to: validate results of ACP framework pilot study in a larger randomized controlled trial (rates and quality of ACP documentation) prior to using participatory design to develop an Electronic Health Record (EHR)-tethered patient portal delivered ACP communication guide, tailored for use in busy… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Advance Care Planning, Chronic Disease, Communication Research
- What is being tested?
- Patient Centered Medical Home Based Electronic Framework for Advance Care Planning
- How many people
- 419 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2017to 15 Dec 2018
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The investigators seek to test participant intervention in a pragmatic primary care environment to the patient populations described above.
Who may be able to join
- must have an activated patient portal account over 50 years of age scheduled for a well visit appointment or chronic visit follow up English speaking
Who cannot join
- under 50
- inactive patient portal account
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Wexner Medical Center
Columbus, Ohio, 43212
About this study
Official title: Validation of a Novel EHR Patient Portal Advance Care Planning Delivery System
this project seeks to: validate results of ACP framework pilot study in a larger randomized controlled trial (rates and quality of ACP documentation) prior to using participatory design to develop an Electronic Health Record (EHR)-tethered patient portal delivered ACP communication guide, tailored for use in busy primary care settings, incorporating patients, caregivers, and primary care providers
- Being tested
- Patient Centered Medical Home Based Electronic Framework for Advance Care Planning
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Centered Medical Home Based Electronic Framework for Advance Care PlanningOther
Also called Secure patient portal delivered pre-visit planning for advance care planning
The intervention tested a pre-visit ACP workflow centered around a framework sent via secure Electronic Health Record (EHR)-linked patient portal in a real world clinical setting. The primary objectives were to determine its impact on frequency and quality of ACP documentation.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | The investigators seek to conduct a pragmatic trial including 2 sister clinical sites to test an innovation using a patient portal framework for Advance Care Planning. The intervention site implemented the intervention (secure patient portal delivered pre-visit planning framework for Advance Care Planning communication). The presence of ACP and the quality of documentation will be assessed through post-intervention chart review. Practice level enrollment was sought for the trial, and the framework will be delivered to all patients during a period of roll out. About 250 patients will receive the intervention. Receives: Other: Patient Centered Medical Home Based Electronic Framework for Advance Care Planning | |
| control | The control site delivered usual care during the same period of roll out. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Advance Care Planning (ACP) documentation as noted in description
Presence of Electronic Health Record problem list based ACP documentation or presence of Electronic Health Record scanned completed Advance Directive document
Measured: 4 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study start30 Apr 2017
- Primary completion18 Aug 2017
- Study completion15 Dec 2018
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 Ohio State 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
- Prospective
- Enrolment
- 419 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seuli Brill, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03906773
- Sponsor's protocol ID
- 2015H0350
- Status last verified
- Apr 2019
- First submitted
- 26 Feb 2018
- Last updated
- 8 Apr 2019
- 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 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Novel EHR Patient Portal Advance Care Planning Delivery System
- ClinicalTrials.gov ID
- NCT03906773
- Acronym / sponsor ID
- 2015H0350
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 419 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 30 Apr 2017 (actual)
- Primary completion
- 18 Aug 2017 (actual)
- Study completion
- 15 Dec 2018 (actual)
- First posted
- 8 Apr 2019 (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 project seeks to: validate results of ACP framework pilot study in a larger randomized controlled trial (rates and quality of ACP documentation) prior to using participatory design to develop an Electronic Health Record (EHR)-tethered patient portal delivered ACP communication guide, tailored for use in busy primary care settings, incorporating patients, caregivers, and primary care providers
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | – | Other: Patient Centered Medical Home Based Electronic Framework for Advance Care PlanningThe investigators seek to conduct a pragmatic trial including 2 sister clinical sites to test an innovation using a patient portal framework for Advance Care Planning. The intervention site implemented the intervention (secure patient portal delivered pre-visit planning framework for Advance Care Planning communication). The presence of ACP and the quality of documentation will be assessed through post-intervention chart review. Practice level enrollment was sought for the trial, and the framework will be delivered to all patients during a period of roll out. About 250 patients will receive the intervention. |
| control | – | –The control site delivered usual care during the same period of roll out. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators seek to test participant intervention in a pragmatic primary care environment to the patient populations described above.
Key inclusion criteria (1 listed)
- must have an activated patient portal account over 50 years of age scheduled for a well visit appointment or chronic visit follow up English speaking
Key exclusion criteria (2 listed)
- under 50
- inactive patient portal account
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 |
|---|---|---|
| Patient Centered Medical Home Based Electronic Framework for Advance Care PlanningAlso: Secure patient portal delivered pre-visit planning for advance care planningThe intervention tested a pre-visit ACP workflow centered around a framework sent via secure Electronic Health Record (EHR)-linked patient portal in a real world clinical setting. The primary objectives were to determine its impact on frequency and quality of ACP documentation. | Other | Intervention |
Primary outcome
Presence of Advance Care Planning (ACP) documentation as noted in description
Time frame: 4 weeks post-intervention
Presence of Electronic Health Record problem list based ACP documentation or presence of Electronic Health Record scanned completed Advance Directive document
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 8 Apr 2019.
- Individual participant dataSharing planned: No
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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
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Development and Evaluation of a Disease-oriented Scenario Game to Promote ACP Among Older Adults and Family Caregivers
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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
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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Chronic Disease, run by Ohio State 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 2 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 8 Apr 2019. 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?
Presence of Advance Care Planning (ACP) documentation as noted in description (time frame: 4 weeks post-intervention). 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 8 Apr 2019.