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Published in: Trials 1/2015

Open Access 01-12-2015 | Study protocol

The advance care planning PREPARE study among older Veterans with serious and chronic illness: study protocol for a randomized controlled trial

Authors: Rebecca Sudore, Gem M. Le, Ryan McMahan, Mariko Feuz, Mary Katen, Deborah E. Barnes

Published in: Trials | Issue 1/2015

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Abstract

Background

Advance care planning (ACP) is a process whereby patients prepare for medical decision-making. The traditional objective of ACP has focused on the completion of advance directives. We have developed a new paradigm of ACP focused on preparing patients and their loved ones for communication and informed medical decision-making. To operationalize this new paradigm of ACP, we created an interactive, patient-centered website called PREPARE (www.​prepareforyourca​re.​org) designed for diverse older adults.

Methods/Design

This randomized controlled trial with blinded outcome assessment is designed to determine the efficacy of PREPARE to engage older Veterans in the ACP process. Veterans who are ≥ 60 years of age, have ≥ two medical conditions, and have seen a primary care physician ≥ two times in the last year are being randomized to one of two study arms. The PREPARE study arm reviews the PREPARE website and an easy-to-read advance directive. The control arm only reviews the advance directive. The primary outcome is documentation of an advance directive and ACP discussions. Other clinically important outcomes using validated surveys include ACP behavior change process measures (knowledge, contemplation, self-efficacy, and readiness) and a full range of ACP action measures (identifying a surrogate, identifying values and goals, choosing leeway or flexibility for the surrogate, communicating with clinicians and surrogates, and documenting one’s wishes). We will also assess satisfaction with decision-making and Veteran activation within primary care visits by direct audio recording. To examine the outcomes at 1 week, 3 months, and 6 months between the two study arms, we will use mixed effects linear, Poisson, or negative binomial regression and mixed effects logistic regression.

Discussion

This study will determine whether PREPARE increases advance directive completion rates and engagement with the ACP process. If PREPARE is efficacious, it could prove to be an easy and effective intervention to help older adults engage in the ACP process within or outside of the medical environment. PREPARE may also help older adults communicate their medical wishes and goals to their loved ones and clinicians, improve medical decision-making, and ensure their wishes are honored over the life course.

Trial registration

ClinicalTrials.gov NCT01550731. Registered on 8 December 2011. 
Literature
1.
2.
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;324:889–95.PubMedCrossRef
3.
Hofmann JC, Wenger NS, Davis RB, Teno J, Connors Jr AF, Desbiens N, et al. Patient preferences for communication with physicians about end-of-life decisions. SUPPORT Investigators. Study to Understand Prognoses and Preference for Outcomes and Risks of Treatment. Ann Intern Med. 1997;127:1–12.PubMedCrossRef
4.
Perkins HS. Controlling death: the false promise of advance directives. Ann Intern Med. 2007;147:51–7.PubMedCrossRef
5.
Fried TR, O’Leary JR. Using the experiences of bereaved caregivers to inform patient- and caregiver-centered advance care planning. J Gen Intern Med. 2008;23:1602–7.PubMedPubMedCentralCrossRef
6.
Anderson WG, Arnold RM, Angus DC, Bryce CL. Posttraumatic stress and complicated grief in family members of patients in the intensive care unit. J Gen Intern Med. 2008;23:1871–6.PubMedPubMedCentralCrossRef
7.
Vig EK, Starks H, Taylor JS, Hopley EK, Fryer-Edwards K. Surviving surrogate decision-making: what helps and hampers the experience of making medical decisions for others. J Gen Intern Med. 2007;22:1274–9.PubMedPubMedCentralCrossRef
8.
Wright AA, Zhang B, Ray A, Mack JW, Trice E, Balboni T, et al. Associations between end-of-life discussions, patient mental health, medical care near death, and caregiver bereavement adjustment. JAMA. 2008;300:1665–73.PubMedPubMedCentralCrossRef
9.
Paasche-Orlow MK, Parker RM, Gazmararian JA, Nielsen-Bohlman LT, Rudd RR. The prevalence of limited health literacy. J Gen Intern Med. 2005;20:175–84.PubMedPubMedCentralCrossRef
10.
Kutner M, Greenbery E, Baer J. A first look at the literacy of America’s adults in the 21st century. Washington DC: National Center for Education Statistics, U.S. Department of Education; 2005.
11.
Sudore RL, Fried TR. Redefining the “planning” in advance care planning: Preparing for end-of-life decision-making. Ann Intern Med. 2010;153:256–61.PubMedPubMedCentralCrossRef
12.
Sudore RL, Landefeld CS, Barnes DE, Lindquist K, Williams BA, Brody R, et al. An advance directive redesigned to meet the literacy level of most adults: a randomized trial. Patient Educ Couns. 2007;69:165–95.PubMedPubMedCentralCrossRef
13.
14.
Sudore RL, Schickedanz AD, Landefeld CS, Williams BA, Lindquist K, Pantilat SZ, et al. Engagement in multiple steps of the advance care planning process: A descriptive study of diverse older adults. J Am Geriatr Soc. 2008;56:1006–13.PubMedCrossRef
15.
Sudore RL, Knight SJ, McMahan RD, Feuz M, Farrell D, Miao Y, et al. A novel website to prepare diverse older adults for decision-making and advance care planning: A pilot study. J Pain Symptom Manage. 2014;47:674–86.PubMedPubMedCentralCrossRef
16.
Fried TR, Redding CA, Robbins ML, Paiva A, O’Leary JR, Iannone L. Promoting advance care planning as health behavior change: development of scales to assess Decisional Balance, Medical and Religious Beliefs, and Processes of Change. Patient Educ Couns. 2012;86:25–32.PubMedPubMedCentralCrossRef
17.
Fried TR, Redding CA, Robbins ML, Paiva A, O’Leary JR, Iannone L. Stages of change for the component behaviors of advance care planning. J Am Geriatr Soc. 2010;58:2329–36.PubMedPubMedCentralCrossRef
18.
Bandura A. Self-efficacy: Toward a unifying theory of behavioral change. Psychol Rev. 1977;84:191–215.PubMedCrossRef
19.
Street Jr RL. Interpersonal Communication Skills in Health Care Contexts. In: Greene JO, Burleson BR, editors. Handbook of Communication and Social Interaction Skills. Mawah, New Jersey: Lawrence Erlbaum Associates; 2003. p. 909–33.
20.
Spitzburgh BH, Cupach WR. Interpersonal Communication Competence. Beverly Hills, CA: Sage; 1984.
21.
Prochaska JO, Velicer WF. The transtheoretical model of health behavior change. Am J Health Promot. 1997;12:38–48.PubMedCrossRef
22.
Sudore RL, Stewart AL, Knight SJ, McMahan RD, Feuz M, Miao Y, et al. Development and validation of a questionnaire to detect behavior change in multiple advance care planning behaviors. PLoS One. 2013;8:e72465.PubMedPubMedCentralCrossRef
23.
Southern DA, Quan H, Ghali WA. Comparison of the Elixhauser and Charlson/Deyo methods of comorbidity measurement in administrative data. Med Care. 2004;42:355–60.PubMedCrossRef
24.
Deyo RA, Cherkin DC, Ciol MA. Adapting a clinical comorbidity index for use with ICD-9-CM administrative databases. J Clin Epidemiol. 1992;45:613–9.PubMedCrossRef
25.
Schickedanz AD, Schillinger D, Landefeld CS, Knight SJ, Williams BA, Sudore RL. A clinical framework for improving the advance care planning process: start with patients’ self-identified barriers. J Am Geriatr Soc. 2009;57:31–9.PubMedPubMedCentralCrossRef
26.
Whooley MA, Avins AL, Miranda J, Browner WS. Case-finding instruments for depression. Two questions are as good as many. J Gen Intern Med. 1997;12:439–45.PubMedPubMedCentralCrossRef
27.
Kuslansky G. The Mini-Cog compares well with longer screening tests for detecting dementia in older people. Evid Based Ment Health. 2004;7:38.PubMedCrossRef
28.
Pfeiffer E. A short portable mental status questionnaire for the assessment of organic brain deficit in elderly patients. J Am Geriatr Soc. 1975;23:433–41.PubMedCrossRef
29.
Sudore RL, Landefeld CS, Williams BA, Barnes DE, Lindquist K, Schillinger D. Use of a modified informed consent process among vulnerable patients: a descriptive study. J Gen Intern Med. 2006;21:867–73.PubMedPubMedCentralCrossRef
30.
Chew LD, Griffin JM, Partin MR, Noorbaloochi S, Grill JP, Snyder A, et al. Validation of screening questions for limited health literacy in a large VA outpatient population. J Gen Intern Med. 2008;23:561–6.PubMedPubMedCentralCrossRef
31.
32.
Volandes AE, Levin TT, Slovin S, Carvajal RD, O’Reilly EM, Keohan ML, et al. Augmenting advance care planning in poor prognosis cancer with a video decision aid: A preintervention-postintervention study. Cancer. 2012;118:4331–8.PubMedPubMedCentralCrossRef
33.
Street Jr RL, Millay B. Analyzing patient participation in medical encounters. Health Commun. 2001;13:61–73.PubMedCrossRef
34.
Street Jr RL, Slee C, Kalauokalani DK, Dean DE, Tancredi DJ, Kravitz RL. Improving physician-patient communication about cancer pain with a tailored education-coaching intervention. Patient Educ Couns. 2010;80:42–7.PubMedCrossRef
35.
Kaplan SH, Greenfield S, Gandek B, Rogers WH, Ware Jr JE. Characteristics of physicians with participatory decision-making styles. Ann Intern Med. 1996;124:497–504.PubMedCrossRef
36.
Ramsaroop SD, Reid MC, Adelman RD. Completing an advance directive in the primary care setting: what do we need for success? J Am Geriatr Soc. 2007;55:277–83.PubMedCrossRef
37.
Pearlman RA, Starks H, Cain KC, Cole WG. Improvements in advance care planning in the Veterans Affairs System: Results of a multifaceted intervention. Arch Intern Med. 2005;165:667–74.PubMedCrossRef
38.
Ockene JK, Adams A, Pbert L, Luippold R, Hebert JR, Quirk M, et al. The Physician-Delivered Smoking Intervention Project: Factors that determine how much the physician intervenes with smokers. J Gen Intern Med. 1994;9:379–84.PubMedCrossRef
39.
Pocock SJ, Assmann SE, Enos LE, Kasten LE. Subgroup analysis, covariate adjustment and baseline comparisons in clinical trial reporting: Current practice and problems. Stat Med. 2002;21:2917–30.PubMedCrossRef
40.
Hicks R, Tingley D. Causal mediation analysis. Stata J. 2011;11:1–15.
41.
Gordon HS, Street Jr RL, Sharf BF, Souchek J. Racial differences in doctors’ information-giving and patients’ participation. Cancer. 2006;107:1313–20.PubMedCrossRef
42.
Bergman B, Sjostrand J. A longitudinal study of visual acuity and visual rehabilitation needs in an urban Swedish population followed from the ages of 70 to 97 years of age. Acta Ophthalmol Scand. 2002;80:598–607.PubMedCrossRef
43.
Erkinjuntti T, Sulkava R, Wikstrom J, Autio L. Short Portable Mental Status Questionnaire as a screening test for dementia and delirium among the elderly. J Am Geriatr Soc. 1987;35:412–6.PubMedCrossRef
44.
Borson S, Scanlan JM, Chen P, Ganguli M. The Mini-Cog as a screen for dementia: Validation in a population-based sample. J Am Geriatr Soc. 2003;51:1451–4.PubMedCrossRef
45.
46.
Chew LD, Bradley KA, Boyko EJ. Brief questions to identify patients with inadequate health literacy. Fam Med. 2004;36:588–94.PubMed
47.
Baker DW, Williams MV, Parker RM, Gazmararian JA, Nurss J. Development of a brief test to measure functional health literacy. Patient Educ Couns. 1999;38:33–42.PubMedCrossRef
48.
Wright AA, Stieglitz H, Kupersztoch YM, Paulk ME, Kim Y, Katz IT, et al. United states acculturation and cancer patients’ end-of-life care. PLoS One. 2013;8:e58663.PubMedPubMedCentralCrossRef
49.
Kahn JR, Fazio EM. Economic status over the life course and racial disparities in health. J Gerontol B Psychol Sci Soc Sci. 2005;60(Spec No 2):76–84.PubMedCrossRef
50.
Chen B, Covinsky KE, Stijacic Cenzer I, Adler N, Williams BA. Subjective social status and functional decline in older adults. J Gen Intern Med. 2012;27:693–9.PubMedPubMedCentralCrossRef
51.
Lee SJ, Lindquist K, Segal MR, Covinsky KE. Development and validation of a prognostic index for 4-year mortality in older adults. JAMA. 2006;295:801–8.PubMedCrossRef
52.
Samper-Ternent R, Kuo YF, Ray LA, Ottenbacher KJ, Markides KS, Al SS. Prevalence of health conditions and predictors of mortality in oldest old Mexican Americans and non-Hispanic whites. J Am Med Dir Assoc. 2012;13:254–9.PubMedPubMedCentralCrossRef
53.
Shadbolt B, Barresi J, Craft P. Self-rated health as a predictor of survival among patients with advanced cancer. J Clin Oncol. 2002;20:2514–9.PubMedCrossRef
54.
Zimmerman M, Ruggero CJ, Chelminski I, Young D, Posternak MA, Friedman M, et al. Developing brief scales for use in clinical practice: The reliability and validity of single-item self-report measures of depression symptom severity, psychosocial impairment due to depression, and quality of life. J Clin Psychiatry. 2006;67:1536–41.PubMedCrossRef
55.
Elixhauser A, Steiner C, Harris DR, Coffey RM. Comorbidity measures for use with administrative data. Med Care. 1998;36:8–27.PubMedCrossRef
56.
Moser A, Stuck AE, Silliman RA, Ganz PA, Clough-Gorr KM. The eight-item modified Medical Outcomes Study Social Support Survey: Psychometric evaluation showed excellent performance. J Clin Epidemiol. 2012;65:1107–16.PubMedPubMedCentralCrossRef
57.
Balboni TA, Vanderwerker LC, Block SD, Paulk ME, Lathan CS, Peteet JR, et al. Religiousness and spiritual support among advanced cancer patients and associations with end-of-life treatment preferences and quality of life. J Clin Oncol. 2007;25:555–60.PubMedPubMedCentralCrossRef
58.
Degner LF, Sloan JA, Venkatesh P. The Control Preferences Scale. Can J Nurs Res. 1997;29:21–43.PubMed
59.
Degner LF, Sloan JA. Decision-making during serious illness: What role do patients really want to play? J Clin Epidemiol. 1992;45:941–50.PubMedCrossRef
60.
Gigerenzer G, Gray JAM. Better Doctors, Better Patients, Better Decisions: Envisioning Health Care 2020. Cambridge: MIT Press; 2011.
61.
Singh JA, Sloan JA, Atherton PJ, Smith T, Hack TF, Huschka MM, et al. Preferred roles in treatment decision-making among patients with cancer: A pooled analysis of studies using the Control Preferences Scale. Am J Manag Care. 2010;16:688–96.
62.
Weech-Maldonado R, Carle A, Weidmer B, Hurtado M, Ngo-Metzger Q, Hays RD. The Consumer Assessment of Healthcare Providers and Systems (CAHPS) cultural competence (CC) item set. Med Care. 2012;50(9 Suppl 2):S22–31.PubMedPubMedCentralCrossRef
63.
Lowe B, Wahl I, Rose M, Spitzer C, Glaesmer H, Wingenfeld K, et al. A 4-item measure of depression and anxiety: validation and standardization of the Patient Health Questionnaire-4 (PHQ-4) in the general population. J Affect Disord. 2010;122:86–95.PubMedCrossRef
Metadata
Title
The advance care planning PREPARE study among older Veterans with serious and chronic illness: study protocol for a randomized controlled trial
Authors
Rebecca Sudore
Gem M. Le
Ryan McMahan
Mariko Feuz
Mary Katen
Deborah E. Barnes
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-015-1055-9

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