Comparison of an Easy to Read Advance Directive Versus a Standard Advance Directive
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Aging |
Behavioral: AD-Easy (Advance Directive-Easy) Behavioral: AD-Standard (Advance Directive-Standard) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind |
| Official Title: | Effects of an Easy to Read Advance Directive on Acceptability, Knowledge, and Self-efficacy Compared to a Standard Advance Directive |
- Acceptability
- self-efficacy
- attitudes about the forms utility
- comprehension
- preference
- 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
| Estimated Enrollment: | 200 |
| Study Start Date: | August 2004 |
| Estimated Study Completion Date: | July 2005 |
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.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| United States, California | |
| San Francisco General Hospital | |
| San Francisco, California, United States, 94110 | |
| Principal Investigator: | Rebecca Sudore, MD | University of California, San Francisco |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00328055 History of Changes |
| Other Study ID Numbers: | AG0066, 5T32AG000212-14, 5K07AG000912-05, 5R01AG023626-02, 5K23RR016539-05 |
| Study First Received: | May 18, 2006 |
| Last Updated: | April 21, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute on Aging (NIA):
|
functional ability patient care management communication literacy |
ClinicalTrials.gov processed this record on June 18, 2013