Comparison of an Easy to Read Advance Directive Versus a Standard Advance Directive

NCT ID: NCT00328055

Last Updated: 2011-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2005-07-31

Brief Summary

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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.

Detailed Description

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Advance directives are forms that allow patients to document their medical treatment preferences and to designate another person to help make medical decisions if they were to become too sick to make their own decisions. Most patients, even seriously ill older adults, do not fill out advance directive forms. Since the mean reading level in the US is at the 8th grade level (5th grade for elders) and since most advance directive documents are written beyond a 12th grade reading level, many patients may not be able to read, much less complete, the standard advance directive forms.

This study hypothesized that an advance directive form written at a 5th grade reading level (AD-Easy) that included culturally appropriate graphics explaining the text, and also included questions concerning patients' values, would be preferred over the standard advance directive form being used in California (AD-Standard).

The participant's literacy level and baseline knowledge of advance directive topics were assessed. Participants were then stratified by literacy level to be randomized to first attempt to read and complete either the AD-Easy or the AD-Standard. Then the participant's acceptance of the forms, self-efficacy or confidence with treatment decisions, attitudes about the form's utility, and post form review comprehension were assessed. Participants then crossed over to review the alternate form and were asked to state which form they preferred to take home. Six months later participants were called and asked if they had thought about their medical treatment preferences, spoken to their family, friends, or doctor about their treatment preferences, or if they filled out the advance directive form.

Conditions

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Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

SINGLE

Interventions

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AD-Easy (Advance Directive-Easy)

Intervention Type BEHAVIORAL

AD-Standard (Advance Directive-Standard)

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Blind
* Deaf
* Delirious
* Demented
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role lead

Principal Investigators

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Rebecca Sudore, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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San Francisco General Hospital

San Francisco, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 2000111 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9127541 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12624865 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10517717 (View on PubMed)

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.

Reference Type BACKGROUND

Other Identifiers

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5T32AG000212-14

Identifier Type: NIH

Identifier Source: secondary_id

View Link

5K07AG000912-05

Identifier Type: NIH

Identifier Source: secondary_id

View Link

5R01AG023626-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

5K23RR016539-05

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AG0066

Identifier Type: -

Identifier Source: org_study_id

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