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

Study Overview
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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.

Official Title
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Effects of an Easy to Read Advance Directive on Acceptability, Knowledge, and Self-efficacy Compared to a Standard Advance Directive

Conditions
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Aging

Intervention / Treatment
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* Behavioral: AD-Easy (Advance Directive-Easy)
* Behavioral: AD-Standard (Advance Directive-Standard)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: AD-Easy (Advance Directive-Easy)|nan|
|Behavioral: AD-Standard (Advance Directive-Standard)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability |  |  | 
| self-efficacy |  |  | 
| attitudes about the forms utility |  |  | 
| comprehension |  |  | 
| preference |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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functional ability, patient care management, communication, literacy