Comparing the Stanford Letter Project Form to Traditional Advance Directives

NCT02799537 — Not applicable, Recruiting, 1000 participants, Stanford University

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RegistryNCT02799537, acronym SLP
StatusRecruiting
PhaseNot applicable
Study typeInterventional; randomized, single group, masking: double, other
Enrollment1000 (Estimated)
SponsorStanford University (Other)
ConditionsAdvance Directives, Palliative Care
InterventionsRandomized clinical study (Other)
Datesstart 2016-02-01, primary completion 2026-08-01 (estimated), completion 2026-12-01 (estimated), first posted 2016-06-15, last updated 2024-04-08
Locations1 site in United States

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-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
InterventionExperimentalOther: Randomized clinical studyParticipants in the intervention arm complete the Stanford letter advance directive
ControlActive comparatorOther: Randomized clinical studyParticipants in the control arm complete the California state traditional advance directive
  • Randomized clinical study (Other), also known as 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

+Outcome measures

Primary outcomes

  • Ease of use of Questionnaire. more patient-centered and family oriented [1year]: It was easy to read and understand the form of advance directive .â—¦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).

Secondary outcomes

  • Ease of use to describe how decisions are made [1year]: Advance form helped me to describe how decisions are made
  • Ease of use about the type of treatment and care. [1year]: Advance form stimulated my own thinking about the type of treatment and care they wish to receive in my last days of life.
  • Ease of use about letting my doctors about my wishes. [1 year]: 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).
  • Ease of use if I cannot make decisions for myself then the form says it. [1 year]: 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.
  • Ease of use about my future preferences. [1 year]: There were issues with my future preferences that were not covered in the form of advance directive .
  • Ease of use of the form itself. [1 year]: I feel comfortable using form for advance care planning .
  • Ease of use and the comments participants may have. [1 year]: Any comments participants may have about the form of advance directive ? What can investigators do for patients and their families understand it better?

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

Inclusion Criteria:

* Over 18 years of age

Exclusion Criteria:

* Under 18

+Locations (1)

FacilityCityCountryStatus
Stanford School of MedicineStanford, CaliforniaUnited StatesRecruiting

+Investigators