NCT02799537

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Feb 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Feb 2016Dec 2026

Study Start

First participant enrolled

February 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 15, 2016

Completed
10.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

April 8, 2024

Status Verified

April 1, 2024

Enrollment Period

10.5 years

First QC Date

June 7, 2016

Last Update Submit

April 4, 2024

Conditions

Keywords

supportive carepalliative caregoals of careadvance care planningadvance directives

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Ease of use to describe how decisions are made

    1year

  • Ease of use about the type of treatment and care.

    1year

  • Ease of use about letting my doctors about my wishes.

    1 year

  • Ease of use if I cannot make decisions for myself then the form says it.

    1 year

  • Ease of use about my future preferences.

    1 year

  • +2 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Participants in the intervention arm complete the Stanford letter advance directive

Other: Randomized clinical study

Control

ACTIVE COMPARATOR

Participants in the control arm complete the California state traditional advance directive

Other: Randomized clinical study

Interventions

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

Also known as: Advance Directive
ControlIntervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Over 18 years of age

You may not qualify if:

  • Under 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford School of Medicine

Stanford, California, 94305, United States

RECRUITING

Related Links

MeSH Terms

Interventions

Advance Directives

Intervention Hierarchy (Ancestors)

JurisprudenceSocial Control, FormalHealth Care Economics and OrganizationsAdvance Care PlanningPatient Care PlanningComprehensive Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • VJ Periyakoil, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor of Medicine

Study Record Dates

First Submitted

June 7, 2016

First Posted

June 15, 2016

Study Start

February 1, 2016

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

April 8, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations