NCT00328055

Brief Summary

The purpose of this study is to compare the acceptability, usefulness, self-efficacy and comprehension of an easy-to-read advance directive form versus a standard advance directive form written at a post graduate reading level.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2004

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

August 1, 2004

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 19, 2006

Completed
Last Updated

April 25, 2011

Status Verified

April 1, 2011

First QC Date

May 18, 2006

Last Update Submit

April 21, 2011

Conditions

Aging

Keywords

functional abilitypatient care managementcommunicationliteracy

Outcome Measures

Primary Outcomes (5)

  • Acceptability

  • self-efficacy

  • attitudes about the forms utility

  • comprehension

  • preference

Secondary Outcomes (1)

  • 6 month outcomes included whether participant talked with their doctor about treatment wishes, talked to family, thought about treatment decisions, or filled out an advance directive

Interventions

AD-Easy (Advance Directive-Easy)BEHAVIORAL
AD-Standard (Advance Directive-Standard)BEHAVIORAL

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Over 50 years
  • Primary physician in the General Medicine Clinic at San Francisco General Hospital, San Francisco, CA
  • English- or Spanish-speaking

You may not qualify if:

  • Blind
  • Deaf
  • Delirious
  • Demented

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Francisco General Hospital

San Francisco, California, 94110, United States

Location

Related Publications (5)

  • Emanuel LL, Barry MJ, Stoeckle JD, Ettelson LM, Emanuel EJ. Advance directives for medical care--a case for greater use. N Engl J Med. 1991 Mar 28;324(13):889-95. doi: 10.1056/NEJM199103283241305.

    PMID: 2000111BACKGROUND

  • Ott BB, Hardie TL. Readability of advance directive documents. Image J Nurs Sch. 1997 Spring;29(1):53-7. doi: 10.1111/j.1547-5069.1997.tb01140.x.

    PMID: 9127541BACKGROUND

  • Nolan MT. Could lack of clarity in written advance directives contribute to their ineffectiveness? A study of the content of written advance directives. Appl Nurs Res. 2003 Feb;16(1):65-9. doi: 10.1053/apnr.2003.50007.

    PMID: 12624865BACKGROUND

  • Jacobson TA, Thomas DM, Morton FJ, Offutt G, Shevlin J, Ray S. Use of a low-literacy patient education tool to enhance pneumococcal vaccination rates. A randomized controlled trial. JAMA. 1999 Aug 18;282(7):646-50. doi: 10.1001/jama.282.7.646.

    PMID: 10517717BACKGROUND

  • Kirsch IS, Jungeblut A, Jenkins L, Kolstad A. Adult Literacy in America: A First Look at the Findings of the National Adult Literacy Survey. Washington, DC: Office of Educational Research and Improvement U.S. Department of Education; 1993 http://nces.ed.gov/pubs93/93275.pdf.

    BACKGROUND

MeSH Terms

Conditions

CommunicationLiteracy

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Rebecca Sudore, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Intervention Model
CROSSOVER
Sponsor Type
NIH

Study Record Dates

First Submitted

May 18, 2006

First Posted

May 19, 2006

Study Start

August 1, 2004

Study Completion

July 1, 2005

Last Updated

April 25, 2011

Record last verified: 2011-04

Locations

US(1)