Preparing Older Veterans With Serious and Chronic Illness for Decision Making
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 60 - Any |
| Updated: | 10/20/2017 |
| Start Date: | July 2012 |
| End Date: | June 2016 |
Millions of diverse Veterans live with severe and chronic illness for which they will face
complex, ongoing decisions. Although the VHA has been at the forefront of patient-centered
chronic care, interventions to prepare Veterans for complex decision-making over the course
of chronic illness are lacking. This proposal addresses this gap by testing the efficacy of a
novel preparation guide designed to prepare Veterans to communicate with their surrogates and
to work with clinicians to make complex, ongoing decisions. The multi-media guide teaches
communication and preparation skill behaviors (e.g., how to choose a surrogate and ask
clinicians questions) in a culturally appropriate, easy-to-use format (targeted to a 5th
grade reading level). This study aims to provide an impetus for changing the paradigm of
advance care planning policies within the VA by moving beyond documentation of end-of-life
wishes to the activation of Veterans to participate in ongoing communication of their values
and goals - a process that is essential to fully realize patient-centered care.
complex, ongoing decisions. Although the VHA has been at the forefront of patient-centered
chronic care, interventions to prepare Veterans for complex decision-making over the course
of chronic illness are lacking. This proposal addresses this gap by testing the efficacy of a
novel preparation guide designed to prepare Veterans to communicate with their surrogates and
to work with clinicians to make complex, ongoing decisions. The multi-media guide teaches
communication and preparation skill behaviors (e.g., how to choose a surrogate and ask
clinicians questions) in a culturally appropriate, easy-to-use format (targeted to a 5th
grade reading level). This study aims to provide an impetus for changing the paradigm of
advance care planning policies within the VA by moving beyond documentation of end-of-life
wishes to the activation of Veterans to participate in ongoing communication of their values
and goals - a process that is essential to fully realize patient-centered care.
4.5 million Veterans are over age 65 and an increasing number are living with chronic and
serious illness. Most older Veterans and their surrogate decision makers will eventually face
complex, ongoing decisions over the course of chronic illness. These decisions are difficult,
especially for the 50% of older Veterans with limited health literacy. The old paradigm of
advance care planning has focused on making decisions about life- prolonging procedures
(e.g., resuscitation) by completing advance directives. Yet, this old paradigm is
problematic. The forms are difficult to understand and often culturally insensitive. They
also fail to prepare patients with concrete skills, such as how to identify one's values and
communicate with surrogates and clinicians. The investigators have published a new paradigm
of advance care planning that focuses instead on preparing patients to communicate with their
surrogates and to actively participate with clinicians in making the best possible
in-the-moment decisions. The new paradigm seeks to ensure that complex, ongoing decisions are
based on a comprehensive set of considerations including the current clinical context,
evolving goals, and patients' and surrogates' needs. To do this effectively, Veterans need to
prepare. However, an easy-to-use, culturally-appropriate preparation guide does not exist.
The investigators have created an easy-to-understand (5th grade reading level) preparation
guide based on the investigators' new paradigm called PREParation, Activation, Reflection,
and Engagement in advance care planning or PREPARE. PREPARE is designed to teach Veterans
preparation skills including how to choose a surrogate and discuss surrogate decision making,
clarify personal values for specific health states, and ask clinicians questions to make
informed choices. The aims of this study are: (1) to conduct a randomized control trial to
determine the efficacy of PREPARE to engage older Veterans with chronic illness in
preparation skill behaviors (i.e., did they choose a surrogate, clarify their values, ask
clinicians questions); (2) to determine the efficacy of PREPARE to activate Veterans and
clinicians within clinical encounters (i.e., did Veterans ask clinicians questions or discuss
preparation topics and did clinicians respond) and to improve satisfaction with decision
making; and (3) to obtain input from Veterans, surrogates, and clinicians about
implementation of PREPARE within the VA. To achieve Aim 1, 205 Veterans will be randomly
assigned to the intervention (PREPARE materials plus an advance directive) and 205 will be
assigned to the control group (advance directive only). Veterans in the PREPARE arm will view
the easy-to-understand, multi-media PREPARE website during the study interview and then take
home PREPARE materials in photo booklet and pamphlet format to ensure universal access to the
information. The primary outcome is Veteran-reported engagement in preparation skill
behaviors at 3 and 6 months, which will be measured with standard cognitive behavioral
measures. For Aim 2, activation within the clinical encounters will be measured with
validated quantitative analysis techniques of audio-recordings. Satisfaction with decision
making will be measured with validated, self-reported measures. For Aim 3, the investigators
will ask Veterans randomized to the PREPARE arm and their surrogates and clinicians how best
to implement PREPARE within the clinical setting. The investigators will use standard
parametric or non-parametric statistical tests to assess group differences, will control for
demographic or other variables that differ between randomization groups, and adjust for
potential clustering by clinician. For Aims 1 and 2 the investigators will assess differences
in engagement and satisfaction by race/ethnicity, literacy, and gender. The research team has
extensive experience testing literacy-appropriate, multi-media health education materials in
randomized trials. The study team is poised to test the efficacy of PREPARE, and findings
from this study will pave the way for multi-site effectiveness testing and widespread VA
dissemination of PREPARE.
serious illness. Most older Veterans and their surrogate decision makers will eventually face
complex, ongoing decisions over the course of chronic illness. These decisions are difficult,
especially for the 50% of older Veterans with limited health literacy. The old paradigm of
advance care planning has focused on making decisions about life- prolonging procedures
(e.g., resuscitation) by completing advance directives. Yet, this old paradigm is
problematic. The forms are difficult to understand and often culturally insensitive. They
also fail to prepare patients with concrete skills, such as how to identify one's values and
communicate with surrogates and clinicians. The investigators have published a new paradigm
of advance care planning that focuses instead on preparing patients to communicate with their
surrogates and to actively participate with clinicians in making the best possible
in-the-moment decisions. The new paradigm seeks to ensure that complex, ongoing decisions are
based on a comprehensive set of considerations including the current clinical context,
evolving goals, and patients' and surrogates' needs. To do this effectively, Veterans need to
prepare. However, an easy-to-use, culturally-appropriate preparation guide does not exist.
The investigators have created an easy-to-understand (5th grade reading level) preparation
guide based on the investigators' new paradigm called PREParation, Activation, Reflection,
and Engagement in advance care planning or PREPARE. PREPARE is designed to teach Veterans
preparation skills including how to choose a surrogate and discuss surrogate decision making,
clarify personal values for specific health states, and ask clinicians questions to make
informed choices. The aims of this study are: (1) to conduct a randomized control trial to
determine the efficacy of PREPARE to engage older Veterans with chronic illness in
preparation skill behaviors (i.e., did they choose a surrogate, clarify their values, ask
clinicians questions); (2) to determine the efficacy of PREPARE to activate Veterans and
clinicians within clinical encounters (i.e., did Veterans ask clinicians questions or discuss
preparation topics and did clinicians respond) and to improve satisfaction with decision
making; and (3) to obtain input from Veterans, surrogates, and clinicians about
implementation of PREPARE within the VA. To achieve Aim 1, 205 Veterans will be randomly
assigned to the intervention (PREPARE materials plus an advance directive) and 205 will be
assigned to the control group (advance directive only). Veterans in the PREPARE arm will view
the easy-to-understand, multi-media PREPARE website during the study interview and then take
home PREPARE materials in photo booklet and pamphlet format to ensure universal access to the
information. The primary outcome is Veteran-reported engagement in preparation skill
behaviors at 3 and 6 months, which will be measured with standard cognitive behavioral
measures. For Aim 2, activation within the clinical encounters will be measured with
validated quantitative analysis techniques of audio-recordings. Satisfaction with decision
making will be measured with validated, self-reported measures. For Aim 3, the investigators
will ask Veterans randomized to the PREPARE arm and their surrogates and clinicians how best
to implement PREPARE within the clinical setting. The investigators will use standard
parametric or non-parametric statistical tests to assess group differences, will control for
demographic or other variables that differ between randomization groups, and adjust for
potential clustering by clinician. For Aims 1 and 2 the investigators will assess differences
in engagement and satisfaction by race/ethnicity, literacy, and gender. The research team has
extensive experience testing literacy-appropriate, multi-media health education materials in
randomized trials. The study team is poised to test the efficacy of PREPARE, and findings
from this study will pave the way for multi-site effectiveness testing and widespread VA
dissemination of PREPARE.
Inclusion Criteria:
- Veterans
- 60 years of age
- who have been seen in the General Medicine, Geriatrics, and Women's Clinics twice in
the past year
- and have 2 or more serious or chronic medical conditions as determined by ICD-9 codes
Exclusion Criteria:
- Veterans will be excluded if they are:
- deaf
- blind
- demented
We found this trial at
1
site
San Francisco, California 94121
Phone: 415-221-4810
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