Advanced Directive PlanningNCT02692950
Patient Perception of Video Advance Care Planning
A study testing Honor My Decisions Advance Care Planning Video and Post-video questionnaire in people with Advanced Directive Planning, run by Mayo Clinic at 1 site in United States.
Trial summary
Rates of advance directive completion among Americans, even those suffering from serious chronic illness, are notoriously poor. Moreover, the contents of completed advance directives are often difficult to interpret in the face of a medical crisis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Directive Planning
- What is being tested?
- Honor My Decisions Advance Care Planning Video and Post-video questionnaire
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to 5 Jun 2016
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing dialysis treatment
- 18 years of age or older
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perceptions of Advance Directive Formats-A Pilot Study
Rates of advance directive completion among Americans, even those suffering from serious chronic illness, are notoriously poor. Moreover, the contents of completed advance directives are often difficult to interpret in the face of a medical crisis. The study aims to examine patient perceptions of electronic, interactive versions of advance care planning documentation.
Read the detailed description
The investigators are studying the video platform of a commercially available advance directive application, Honor My Decisions. This application was generated with funding from patient advocacy groups. The application allows a person to create a legally valid advance directive on his or her own tablet or smart phone and share that directive (either by printing or emailing a secure link to family and/or health care providers). Additionally, the app includes a feature by which individuals may record several 2-4 minute videos to memorialize their health preferences, and also to leave a more personal message for loved ones (a video legacy).
The research team has compiled a list of question prompts for these advance care planning videos with the assistance of a panel of experts on communication, palliative care, critical care, ethics and the law. The investigators collected prompt suggestions from these 9 experts with a modified Delphi technique, using iterative surveys to generate consensus. The experts were instructed to consider both contents and phrasing of question prompts, to promote usability and also later utility (if the patient later became unable to speak for him- or herself). These question prompts will form the basis of this pilot study.
The investigators aim to assess the experiences of patients completing electronic advance directives and documenting their care preferences and personal legacy via video. Renal dialysis patients have been selected as a patient population with frequent hospitalizations and low rates of advance directive completion. Patients will be given the opportunity to interact with the application and record their own videos. They will then provide immediate and long-term feedback about the video question prompts via interview.
- Conditions
- Advanced Directive Planning
- Being tested
- Honor My Decisions Advance Care Planning Video, Post-video questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Honor My Decisions Advance Care Planning VideoOther
Honor My Decisions is a commercial computer application which allows a person to record a video of his/her advanced care planning and legacy information.
Post-video questionnaireBehavioural
Questions regarding the video process, changes to previous answers and reaction received by others viewing the video
| Study group | Role | What they receive |
|---|---|---|
| Dialysis Patients | Other | Honor My Decisions Advance Care Planning Videos, self-recorded by a patient using a computer application, followed immediately by a post-video questionnaire and a follow-up questionnaire 2-4 weeks later. Receives: Other: Honor My Decisions Advance Care Planning Video; Behavioral: Post-video questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of advanced care planning videos completed
Measured: Approximately 2-4 weeks after consenting
Secondary outcomes (1)
Number of completed post-video questionnaires
Measured: Approximately 2-4 weeks after recording video
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completion5 Jun 2016
- Study completion5 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Directive PlanningStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul S. Mueller, Mayo Clinic
- Investigators
- Paul Mueller, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02692950
- Sponsor's protocol ID
- 15-008704
- Status last verified
- Feb 2022
- First submitted
- 23 Feb 2016
- Last updated
- 21 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perceptions of Advance Directive Formats-A Pilot Study
- ClinicalTrials.gov ID
- NCT02692950
- Acronym / sponsor ID
- 15-008704
- Conditions
- Advanced Directive Planning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- 5 Jun 2016 (actual)
- Study completion
- 5 Jun 2016 (actual)
- First posted
- 26 Feb 2016 (estimated)
- 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.
Rates of advance directive completion among Americans, even those suffering from serious chronic illness, are notoriously poor. Moreover, the contents of completed advance directives are often difficult to interpret in the face of a medical crisis. The study aims to examine patient perceptions of electronic, interactive versions of advance care planning documentation.
Detailed description
The investigators are studying the video platform of a commercially available advance directive application, Honor My Decisions. This application was generated with funding from patient advocacy groups. The application allows a person to create a legally valid advance directive on his or her own tablet or smart phone and share that directive (either by printing or emailing a secure link to family and/or health care providers). Additionally, the app includes a feature by which individuals may record several 2-4 minute videos to memorialize their health preferences, and also to leave a more personal message for loved ones (a video legacy).
The research team has compiled a list of question prompts for these advance care planning videos with the assistance of a panel of experts on communication, palliative care, critical care, ethics and the law. The investigators collected prompt suggestions from these 9 experts with a modified Delphi technique, using iterative surveys to generate consensus. The experts were instructed to consider both contents and phrasing of question prompts, to promote usability and also later utility (if the patient later became unable to speak for him- or herself). These question prompts will form the basis of this pilot study.
The investigators aim to assess the experiences of patients completing electronic advance directives and documenting their care preferences and personal legacy via video. Renal dialysis patients have been selected as a patient population with frequent hospitalizations and low rates of advance directive completion. Patients will be given the opportunity to interact with the application and record their own videos. They will then provide immediate and long-term feedback about the video question prompts via interview.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dialysis Patients | Other | Other: Honor My Decisions Advance Care Planning Video, Behavioral: Post-video questionnaireHonor My Decisions Advance Care Planning Videos, self-recorded by a patient using a computer application, followed immediately by a post-video questionnaire and a follow-up questionnaire 2-4 weeks later. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing dialysis treatment
- 18 years of age or older
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Honor My Decisions Advance Care Planning VideoHonor My Decisions is a commercial computer application which allows a person to record a video of his/her advanced care planning and legacy information. | Other | Dialysis Patients |
| Post-video questionnaireQuestions regarding the video process, changes to previous answers and reaction received by others viewing the video | Behavioural | Dialysis Patients |
Primary outcome
Number of advanced care planning videos completed
Time frame: Approximately 2-4 weeks after consenting
1 secondary outcome
Number of completed post-video questionnaires
Time frame: Approximately 2-4 weeks after recording video
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 21 Feb 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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.
Paul Mueller, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Honor My Decisions Advance Care Planning Video and Post-video questionnaire in people with Advanced Directive Planning, run by Mayo Clinic 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 21 Feb 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?
Number of advanced care planning videos completed (time frame: Approximately 2-4 weeks after consenting). 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 21 Feb 2022.