Comparing the Stanford Letter Project Form to Traditional Advance Directives (SLP)

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.

Study Overview

• Status: Recruiting
• Conditions: Palliative Care; Advance Directives
• Intervention / Treatment: Other: Randomized clinical study

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 Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: VJ Periyakoil, MD; Phone Number: 66209 (650) 493-5000; Email: Periyakoil@stanford.edu

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Recruiting
      • Stanford School of Medicine
      • Contact: VJ Periyakoil, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Over 18 years of age

Exclusion Criteria:

• Under 18

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Participants in the intervention arm complete the Stanford letter advance directive	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; Other Names: Advance Directive
Active Comparator: Control; Participants in the control arm complete the California state traditional advance directive	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; Other Names: Advance Directive

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ease of use to describe how decisions are made	Advance form helped me to describe how decisions are made	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.	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).	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.	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 .	1 year
Ease of use of the form itself.	I feel comfortable using form for advance care planning .	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?	1 year

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: VJ Periyakoil, MD, Stanford University

Publications and helpful links

Helpful 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: June 7, 2016
• First Submitted That Met QC Criteria: June 9, 2016
• First Posted (Estimated): June 15, 2016

Study Record Updates

• Last Update Posted (Actual): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: palliative care; supportive care; advance care planning; advance directives; goals of care
• Other Study ID Numbers: 36786

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO