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 estimated 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, the forms are difficult to understand and often fail to prepare patients with concrete skills, such as how to identify one's values and communicate with surrogates and clinicians. We published a new paradigm of advance care planning focused on preparing patients to communicate with their surrogates and to participate with clinicians in making the best possible in-the-moment decisions. To do this effectively, Veterans need to prepare. However, an easy-to-use, culturally-appropriate preparation guide does not exist. We have created an easy-to-understand (5th grade reading level) preparation guide based on our new paradigm called 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, DVD, 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, we will ask Veterans randomized to the PREPARE arm and their surrogates and clinicians how best to implement PREPARE within the clinical setting. We 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 we will assess differences in engagement and satisfaction by race/ethnicity, literacy, and gender.
We enrolled 414 Veterans, 205 in the PREPARE intervention group and 209 in the control group. There were no differences in gender or race/ethnicity of veterans who refused; however, those who refused were older than those who enrolled. The mean age of enrolled participants was 71.1 (7.8) years, 38 (9%) were women, 179 (43%) were nonwhite, 120 (29%) reported fair-to-poor health status, and 212 (51%) had evidence of prior ACP documentation.
The mean ACP documentation rate 6 months prior to intervention exposure was 0.8%(0.6%) for both groups. There were no differences in participant characteristics between arms, and then number of enrolled veterans per clinician was 5(6) [range, 1-28]. At 6 months, 184 participants in the PREPARE plus AD arm and 188 in the AD-only arm completed follow-up interviews (a 90% retention rate). There were no significant differences between groups in the rates of, or reasons for, withdrawal (9 patients [7%] in each arm).
At 9 months, in mixed-effects adjusted analysis, new over-all ACP documentation was higher in the PREPARE plus AD vs the AD-only arm (unadjusted analyses, 37% vs 27%, P =.04; and adjusted analyses, 35% vs 25%, adjusted odds ratio [OR], 1.61; 95% CI, 1.03-2.51, P = .04), including higher documentation for legal forms and orders (20% vs 13%; P = .04) and for documented discussions (26% vs 20%; P = .13).
Self-reported ACP engagement including mean process and action scores increased significantly more in the PREPARE plus AD arm compared with the AD-only arm, group x time P < .001. Effect size estimates were moderate for PREPARE plus AD (0.59 to 0.68 SDs for process scores, 0.49 to 0.59 SDs for action scores) and were small for the AD-only arm (0.24 to 0.39 for process scores, 0.20 to 0.39 SDs for action scores).
There were no significant interaction effects observed for ACP documentation or ACP engagement as a function of age, gender, race/ethnicity, US acculturation, health literacy, presence of a surrogate decision maker, health status, access to or confidence using the internet, or prior ACP documentation.
There were no significant differences in the 10-point self-reported ease-of-use scales for PREPARE plus AD vs the AD-only intervention (9.0[1.4] vs 8.7 [1.7]; P = .31) or for the 5-point satisfaction scales including comfort reviewing the interventions (4.5 [0.7]) vs 4.4[0.8]; P = .57); helpfulness (4.4[0.8] vs 4.3 [0.9]; P = .19); and likelihood of recommending the guides (4.4 [0.9] vs 4.2 [1.1]; P = .10). After controlling for baseline scores, there were no differences in depression or anxiety between arms at 6 months.
In the absence of clinician- or systems-level interventions, the easy-to-read advance directive (AD) increased new documentation of ACP legal forms and discussions in the medical chart to 25%. The addition of the novel PREPARE website increased new documentation of ACP legal forms and discussions in the medical chart to 35%; a statistically significant increase from the AD alone. Self-reported ACP engagement, including validated mean ACP process and action scores, increased significantly more in the PREPARE plus AD arm compared to the AD-only arm. Both tools were rated highly in terms of ease-of-use, satisfaction, and helpfulness, suggesting that PREPARE and the easy-to-read AD could serve as scalable, easy-to-disseminate tools to improve the ACP process, especially in busy and resource-poor primary care clinics. Prior studies have shown that passive ACP education with written materials is less effective than ongoing education by a trained health care professional. One reason may be the use of ADs and other materials written beyond a 12th grade reading level. The success of both PREPARE and the easy-to-read AD may be explained by their attention to both literacy and cultural considerations designed with and for diverse communities. The PREPARE website may also help patients engage in ACP by providing "how-to" videos that model behavior based on behavior change and social cognitive theories.
- Sudore RL, Boscardin J, Feuz MA, McMahan RD, Katen MT, Barnes DE. Effect of the PREPARE Website vs an Easy-to-Read Advance Directive on Advance Care Planning Documentation and Engagement Among Veterans: A Randomized Clinical Trial. JAMA internal medicine. 2017 Aug 1; 177(8):1102-1109.
- Sudore R, Le GM, McMahan R, Feuz M, Katen M, Barnes DE. The advance care planning PREPARE study among older Veterans with serious and chronic illness: study protocol for a randomized controlled trial. Trials. 2015 Dec 12; 16:570.
- Sudore RL, Knight SJ, McMahan RD, Feuz M, Farrell D, Miao Y, Barnes DE. A novel website to prepare diverse older adults for decision making and advance care planning: a pilot study. Journal of pain and symptom management. 2014 Apr 1; 47(4):674-86.
- Su CT, McMahan RD, Williams BA, Sharma RK, Sudore RL. Family matters: effects of birth order, culture, and family dynamics on surrogate decision-making. Journal of the American Geriatrics Society. 2014 Jan 1; 62(1):175-82.
- Sudore RL, Stewart AL, Knight SJ, McMahan RD, Feuz M, Miao Y, Barnes DE. Development and validation of a questionnaire to detect behavior change in multiple advance care planning behaviors. PLoS ONE. 2013 Sep 5; 8(9):e72465.
- McMahan RD, Knight SJ, Fried TR, Sudore RL. Advance care planning beyond advance directives: perspectives from patients and surrogates. Journal of pain and symptom management. 2013 Sep 1; 46(3):355-65.
- Allison TA, Sudore RL. Disregard of patients' preferences is a medical error: comment on "Failure to engage hospitalized elderly patients and their families in advance care planning". JAMA internal medicine. 2013 May 13; 173(9):787.
- Sudore R, Knight SJ, McMahan M, Feuz D, Farrell Y, Miao Y, Barnes DE. Novel Website to Prepare Diverse Older Adults for Decision Making and Advance Care Planning: A Pilot Study. Presented at: National Palliative Care Research Center Annual Kathleen Foley Palliative Care Retreat and Research Symposium; 2013 Oct 1; Sausalito, CA.
- Sudore R, Knight SJ, McMahan M, Feuz D, Farrell Y, Farrell Y, Barnes DE. A Novel Website to Prepare Diverse Older Adults for Decision Making and Advance Care Planning: A Pilot Study. Presented at: University of California San Francisco Health Disparities Research Symposium; 2013 Sep 1; San Francisco, CA.
- Sudore R, Knight SJ, McMahan RD, Feuz D, Farrell Y, Miao Y, Barnes DE. A Novel Website to Prepare Diverse Older Adults for Decision Making and Advance Care Planning: A Pilot Study. Presented at: Society of General Internal Medicine Annual Meeting; 2013 Apr 1; Denver, CO.
- McMahan R, Knight S, Fried TR, Sudore R. Advance care planning beyond advance directives: perspectives from patients and surrogates. Presented at: American Geriatrics Society Annual Meeting; 2012 May 2; Seattle, WA.
- McMahan R, Knight S, Fried TR, Sudore R. Advance care planning beyond advance directives: perspectives from patients and surrogates. Presented at: Society of General Internal Medicine California / Hawaii Regional Annual Meeting; 2012 Jan 1; San Francisco, CA.
- Sudore R, McMahan R, Castillo LS, Knight SJ. New Paradigm of Advance Care Planning Focused on Preparation for Decision Making: Perspectives form Veterans and their Surrogates. Presented at: Bay Area Clinical Research Annual Symposium; 2011 Nov 1; San Francisco, CA.
- Sudore R, McMahan R, Castillo LS, Knight SJ. A New Paradigm of Advance Care Planning Focused on Preparation for Decision Making: Perspectives from Veterans and their Surrogates. Presented at: University of California San Francisco Health Disparities Research Symposium; 2011 Oct 1; San Francisco, CA.
Aging, Older Veterans' Health and Care, Health Systems