Comparing the Stanford Letter Project Form to Traditional Advance Directives

Palliative Care Clinical Trial

— SLP  

Official title:

Comparing the Stanford Letter Project Form to Traditional Advance Directives

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02799537
• Other study ID #: 36786
• Status: Recruiting
• Phase: N/A
• Start date: February 2016
• Est. completion date: December 2026

Study information

• Verified date: April 2024
• Source: Stanford University
• Contact: VJ Periyakoil, MD
• Phone: (650) 493-5000
• Email: Periyakoil[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2026
• Est. primary completion date: August 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Over 18 years of age

Exclusion Criteria:

• Under 18

Related Conditions & MeSH terms

• Advance Directives
• Palliative Care

Intervention

Other:
• Randomized clinical study
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

Locations

Country	Name	City	State
United States	Stanford School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	1year
Secondary	Ease of use to describe how decisions are made	Advance form helped me to describe how decisions are made	1year
Secondary	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.	1year
Secondary	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).	1 year
Secondary	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.	1 year
Secondary	Ease of use about my future preferences.	There were issues with my future preferences that were not covered in the form of advance directive .	1 year
Secondary	Ease of use of the form itself.	I feel comfortable using form for advance care planning .	1 year
Secondary	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?	1 year

External Links

•   This site contains the English and Spanish versions of the letter directive.
•   This site contains the English and Spanish versions of the traditional advance directive.