Advance DirectivesSLPNCT02799537
Comparing the Stanford Letter Project Form to Traditional Advance Directives
A study testing Randomized clinical study in people with Advance Directives and Palliative Care, run by Stanford University at 1 site in United States.
Trial summary
Our goal is to compare two types of advance directives forms available in English and Spanish to determine which is more easy to use for patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Advance Directives, Palliative Care
- What is being tested?
- Randomized clinical study
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Over 18 years of age
Who cannot join
- Under 18
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford School of Medicine
Stanford, California, 94305
VJ Periyakoil, MD
About this study
Our goal is to compare two types of advance directives forms available in English and Spanish to determine which is more easy to use for patients.
Read the detailed description
Step1: Any adult participant who is interested in completing advance directives and able to read and write in English and or Spanish will be eligible to participate in the study
Step 2:
Online Stanford consent form will be presented before the participants. Only after they read the consent and click on the participation link will they be able to enter the study.Those who are willing to participate will be randomly assigned to either the letter or traditional advance directives in Spanish and study measures. They will also answer questions as to how much they liked and understood the documents.
Step 4: The investigators will collect data until the investigators reach an n=1000
Step 5: The investigators will analyze the results and submit for publication.
In this protocol, we are assessing whether patients prefer the traditional advance directives or the letter directive. As it is just an questionnaire based study, there no risk for patients.
- Conditions
- Advance Directives, Palliative Care
- Being tested
- Randomized clinical study
- Keywords
- supportive care, palliative care, goals of care, advance care planning, advance directives
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Randomized clinical studyOther
Also called Advance Directive
Participants will be randomly assigned to one of two advance directives and we will assess which they prefer. This is not a human health intervention
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants in the intervention arm complete the Stanford letter advance directive Receives: Other: Randomized clinical study |
| Control | Active comparator | Participants in the control arm complete the California state traditional advance directive Receives: Other: Randomized clinical study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ease of use of Questionnaire. more patient-centered and family oriented
It was easy to read and understand the form of advance directive .◦This is a feasibility trail. On completion of the advance directive they were assigned ( letter directive or traditional directive, we are asking questions to participants about whether the directive was clear and easy to understand).
Measured: 1year
Secondary outcomes (7)
Ease of use to describe how decisions are made
Advance form helped me to describe how decisions are made
Measured: 1year
Ease of use about the type of treatment and care.
Advance form stimulated my own thinking about the type of treatment and care they wish to receive in my last days of life.
Measured: 1year
Ease of use about letting my doctors about my wishes.
This form can help my doctors understand what treatments would like to receive and what not wish to receive in my last days of life ( resuscitation , respirators , artificial feeding , renal dialysis).
Measured: 1 year
Ease of use if I cannot make decisions for myself then the form says it.
In the future, if I can not make decisions for myself, this form will help my family / friends understand exactly what treatments ( resuscitation , respirators , artificial feeding , renal dialysis) would like to receive and what treatments do not wish to receive so they can make decisions medical for me.
Measured: 1 year
Ease of use about my future preferences.
There were issues with my future preferences that were not covered in the form of advance directive .
Measured: 1 year
Ease of use of the form itself.
I feel comfortable using form for advance care planning .
Measured: 1 year
Ease of use and the comments participants may have.
Any comments participants may have about the form of advance directive ? What can investigators do for patients and their families understand it better?
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study startFeb 2016
- Primary completionAug 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advance DirectivesStudies of the same condition, open and under way.
- More trials run by Stanford 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
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, VJ Periyakoil, Stanford University
- Investigators
- VJ Periyakoil, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02799537
- Sponsor's protocol ID
- 36786
- Acronym
- SLP
- Status last verified
- Apr 2024
- First submitted
- 7 Jun 2016
- Last updated
- 8 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Stanford Letter Project Form to Traditional Advance Directives
- ClinicalTrials.gov ID
- NCT02799537
- Acronym / sponsor ID
- SLP / 36786
- Conditions
- Advance Directives, Palliative Care
- Keywords
- supportive care, palliative care, goals of care, advance care planning, advance directives
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 15 Jun 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.
Our goal is to compare two types of advance directives forms available in English and Spanish to determine which is more easy to use for patients.
Detailed description
Step1: Any adult participant who is interested in completing advance directives and able to read and write in English and or Spanish will be eligible to participate in the study
Step 2:
Online Stanford consent form will be presented before the participants. Only after they read the consent and click on the participation link will they be able to enter the study.Those who are willing to participate will be randomly assigned to either the letter or traditional advance directives in Spanish and study measures. They will also answer questions as to how much they liked and understood the documents.
Step 4: The investigators will collect data until the investigators reach an n=1000
Step 5: The investigators will analyze the results and submit for publication.
In this protocol, we are assessing whether patients prefer the traditional advance directives or the letter directive. As it is just an questionnaire based study, there no risk for patients.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Randomized clinical studyParticipants in the intervention arm complete the Stanford letter advance directive |
| Control | Active comparator | Other: Randomized clinical studyParticipants in the control arm complete the California state traditional advance directive |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Over 18 years of age
Key exclusion criteria (1 listed)
- Under 18
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 |
|---|---|---|
| Randomized clinical studyAlso: Advance DirectiveParticipants will be randomly assigned to one of two advance directives and we will assess which they prefer. This is not a human health intervention | Other | Control, Intervention |
Primary outcome
Ease of use of Questionnaire. more patient-centered and family oriented
Time frame: 1year
It was easy to read and understand the form of advance directive .◦This is a feasibility trail. On completion of the advance directive they were assigned ( letter directive or traditional directive, we are asking questions to participants about whether the directive was clear and easy to understand).
7 secondary outcomes
Ease of use to describe how decisions are made
Time frame: 1year
Ease of use about the type of treatment and care.
Time frame: 1year
Ease of use about letting my doctors about my wishes.
Time frame: 1 year
Ease of use if I cannot make decisions for myself then the form says it.
Time frame: 1 year
Ease of use about my future preferences.
Time frame: 1 year
Ease of use of the form itself.
Time frame: 1 year
Ease of use and the comments participants may have.
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
- This site contains the English and Spanish versions of the letter directive.Link provided by the sponsor.
- This site contains the English and Spanish versions of the traditional advance directive.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
VJ Periyakoil, MD principal investigator
Stanford 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 Randomized clinical study in people with Advance Directives and Palliative Care, run by Stanford 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: looking for participants now, as of the sponsor's last update on 8 Apr 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact VJ Periyakoil, MD ((650) 493-5000 ext. 66209, Periyakoil@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ease of use of Questionnaire. more patient-centered and family oriented (time frame: 1year). 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 2024.