Decision Support and Shared Decision Making in Prostate Cancer Care Ronald E. Myers, PhD Professor and Director, Division of Population Science, Department of Medical Oncology and Associate Director of Population Science, Kimmel Cancer Center, Thomas Jefferson University (ronald.myers@jefferson.edu) February 23, 2013 Patient-Centered Care • Patient-centered care is “care that is respectful of and responsive to individual patient preferences, needs, and values (and ensures) that patient values guide all clinical decisions.” (Crossing the Quality Chasm, IOM, 2001) “the most important attribute of patient-centered care is the active engagement of patients when fateful health care decisions must be made – when an individual patient arrives at a crossroads of medical options, where the diverging paths have different and important consequences with lasting implications.” (Barry and Edgman-Levitan, NEJM, 2012) Decision Aids (DAs) to Promote Patient-Centered Care • DAs – Pamphlets, brochures, and booklets; oral, scripted presentations; audiovisual or digital recordings; and computer or Web-based software applications • Impact of DAs – Increased patient knowledge, decreased decisional conflict, increased satisfaction, and decreased use of aggressive care Implementing DAs in Practice: Are We There Yet? • Population-based survey mailed to 878 physicians: surgeons, medical oncologists, & radiation oncologists • 69% of respondents aware of decision aids, and 46% were aware of decision aids relevant to their practice • Only 24% were currently using decision aids • Main barriers to the use of decision aids in practice – Lack of awareness – Limited resources/time (J Clin Oncol., 2010;28:2286-2292) New Methods in Shared Decision Making • Need for research on interventions that provide essential information, elicit value-based patient preference, and engage patients and providers in shared decision making . . . Need to develop and test DECISION SUPPORT INTERVENTIONS THAT CAN BE INTEGRATED INTO ROUTINE CARE Decision Support Interventions • “Decision support interventions help people think about choices they face; they describe where and why choice exists; (and) they provide information about options, including where reasonable, the option of taking no action.” • Decision support interventions can be used for oneway delivery of information to patients (non-mediated) or in the context of a two-way interaction between a patient and a health care provider (mediated) (Elwyn et al., 2010) Mediated Decision Support: Decision Counseling • Initiate dialogue with patient to provide information about the decision to be made • Clarify patient preference – – – – – Review information Identify and rank important decision factors (1-2-3) Determine decision factor weights (level of influence) Compute preference score Interpret and verify preference • Use session results in shared decision making Ronald E. Myers, Constantine Daskalakis, Elisabeth J.S. Kunkel, James R. Cocroft, Jeffrey M. Riggio, Mark Capkin, Clarence H. Braddock III Mediated Decision Support in Prostate Cancer Screening Patient Education and Counseling 83 (2011) 240–246 Supported by Centers for Disease Control and Prevention (M-0554) Study Setting and Patient Population • Urban primary care practices – Site A: An internal medicine practice and a family medicine practice – Site B: An internal medicine practice • Asymptomatic male patients – – – – 50 to 69 years of age Office visit within past year Eligible for prostate cancer screening Scheduled appointment for non-acute care Study Design Eligibility assessment Potential Participants N = 776 Baseline Survey Random Assignment Intervention Control n= 157 Mailed booklet In-office patient satisfaction survey Chart prompt Treatment n= 156 Mailed booklet In-office decision counseling session Chart prompt Endpoint Survey Audit X X X X Responders n = 313 Characteristics of Study Participants (N=313) Variable Category N (%) Study Site A B 157 156 (50.2) (49.8) Age 50-59 years 60-69 years 216 97 (69.0) (31.0) Race White Nonwhite 176 136 (56.4) (43.6) Education HS or Less Greater than HS 101 209 (32.6) (67.4) Marital Status Married Not Married 197 114 (63.3) (36.7) Hypotheses • Primary Outcomes – Treatment Group patients will have higher knowledge (endpoint-baseline survey) – Treatment Group patients will have lower decisional conflict (endpoint survey) • Secondary Outcomes – Treatment Group patients will have more complete informed decision making (encounter audio-recording) – Treatment Group patients will have lower screening (medical records) Decision Counseling Session: Information • • • • Introduction Learn about the prostate Common prostate problems Prostate cancer screening tests • For men in the general population, what happens? • Early and late prostate cancer • To sum up Decision Counseling: Preference Clarification Pro Con Weight Decision Factors Factor 1 Select Weight Factor 2 Select Weight Factor 3 Select Weight Weight of Influence: None, A Little, Some, Much, Very Much, Overwhelming Compare Decision Factors • • • • • Review prostate cancer screening brochure Identify top decision factors (pros and cons) Rank factors and determine factor weights Compute preference score (0.000-1.000) Verify preference Factor 1-2 Select Weight Factor 2-3 Select Weight Factor 1-3 Select Weight Relative Weight of Influence: About the Same, A Little More, Somewhat More Much More, Very Much More, Overwhelmingly More Patient Decision Factors • Pros – “I think it’s important to know if I am OK.” – “I want to be screened, so that I won’t die from prostate cancer.” – “I want to screen, so I have peace of mind.” – “I want to be around for my grand children.” – “My doctor thinks I should be tested.” • Cons – “I don’t want to know if I have a problem.” – “The test would be embarrassing and inconvenient.” – “If it ain’t broke, don’t mess with it.” 81% Pros 19% Cons Computing a Decision Preference Score Decision Factor Direction and Level of Factor Influence Con – – – – – Overwhelming Very Much Much Somewhat A little Neutral Pro – – – – – A little Somewhat Much Very Much Overwhelming Score Range Preference 1.9 1.7 1.5 1.3 1.1 0.000 – 0.333 0.334 - 0.356 0.357 - 0.383 0.384 - 0.416 0.417 - 0.454 Moderate 1.0 0.455 - 0.545 Neutral 1.1 0.546 - 0.583 0.584 - 0.616 0.617 - 0.643 0.644 - 0.666 0.667 - 1.000 1.3 1.5 1.7 1.9 High Low Low Moderate High Results: Patient Knowledge* Baseline Study Group Mean (SD) Endpoint Mean (SD) Difference from Baseline to Endpoint (SD) Change (95% CI)** P-Value 0.001 Control 3.6 (2.1) 4.4 (2.1) +0.8 (1.9) Treatment 3.8 (2.0) 5.3 (2.0) +1.5 (2.1) +0.8 (0.5, 1.2) *10-point scale based on total number correct; **Analysis of change adjusted for site, patient background characteristics, and study group-physician interaction; Control Group (N=142) and Treatment Group (N=144). Results: Informed Decision Making (IDM) Study Group IDM Rate IDM Rate Ratio* (95% CI) P-Value 0.029 Control 2.4 1.00 (reference) Treatment 3.0 1.30 (1.03, 1.64) *9-point scale; IDM rate computed for 15-minute intervals; analyses adjusted for study site, patient characteristics, physician characteristics, and study site*race interaction; Control Group (N=60) and Treatment Group (N=74). Results: Screening Study Group Screened N (%) OR (95% CI) P-Value 0.004 Control 81 (59.1) 1.00 (reference) Treatment 62 (45.2) 0.37 (0.19, 0.73) *Model adjusted for study site, patient characteristics, physician characteristics, and study group*physician knowledge interaction; Control Group (N=137) and Treatment Group (N=137). Active Surveillance vs Active Treatment among Men with Early-Stage, Low-Risk Prostate Cancer • Prostate Cancer Intervention Versus Observation Trial (PIVOT).* - At 10 years, mortality did not differ between men who had radical prostatectomy and men who had observation • Active surveillance (AS) is a reasonable treatment option for men with low-risk prostate cancer - Life expectancy < 10-15 years; cancer not felt on DRE and/or small stage T1c or T2a; PSA < 10ng/ml; Gleason score < 6 with no Gleason pattern 4 or 5 on a 12 core biopsy • 10% of men with low-risk prostate cancer have AS *Wilt et al. N Engl J Med 2012; 367:203-213, July 19, 2012. Decision Counseling about AS and AT (DCAS) Study • Department of Medical Oncology Ronald E. Myers, PhD, Amy Leader, PhD, Jean HoffmanCensits, MD, Anett Petrich, MSN, RN, Anna Quinn, MPH, James Cocroft, MA • Department of Urology Edouard Trabulsi, MD •Department of Radiation Oncology Robert Den, MD • Department of Pharmacology and Experimental Therapeutics Constantine Daskalakis, DSc DCAS Study Procedures • Identify patients with low risk prostate cancer in multidisciplinary clinic appoints • Meet, consent and survey participants • Conduct decision counseling session • Provide decision counseling summary report to patient and clinical team • Deliver follow-up call to patient 5 days after clinic visit • Administer endpoint telephone survey 30 days after clinic visit • Conduct endpoint chart audit 90 days after clinic visit Participant Demographic Characteristics (N=8) Characteristic Frequency Percent White 6 75.0 Black 2 25.0 HS graduate 3 37.5 Associates 1 12.5 Bachelors 3 37.5 Masters or higher 1 12.5 Single/Divorced 1 12.5 Married/Living Together 7 87.5 Decision Counseling Website Options Grid – AS vs AT Active Surveillance Periodic PSA/Annual Biopsy Active Treatment Decision Counseling Summary Report Decision Factors: AS Pros and Cons • Pro Factors “I want to avoid the side effects of radiation and treatment.” “I’m not ready to jump into having surgery or radiation.” “If my doctor thinks active surveillance is a good idea.” • Con Factors Pros: 53% “I’m afraid my cancer will turn out to be Cons: 47% the aggressive type.” “I just want the cancer out.” “Having treatment at a younger age might be better than when I’m older.” Results: Preference for AS versus AT Preference N Percent Equal preference for AS and AT 6 75.0 Prefer AS versus AT 2 25.0 Results: Treatment Decision Post Visit Decision N Percent Active Surveillance 7 87.5 Active Treatment 1 12.5 Results: Knowledge, Decisional Conflict Change Scale Baseline Mean 75.0% Endpoint Mean 84.3% Mean Difference +9.3% 1.73 0.75 -0.98 Uncertain 2.17 0.96 -1.21 Uninformed 1.67 0.63 -1.04 Unclear 1.88 0.67 -1.21 Unsupported 2.17 0.96 -1.21 Knowledge Decisional Conflict* *12 out of 16 questions from scale Feedback on Decision Counseling at 30 Days “Got me thinking about what to do before I went in to see the doctor” “Because it kind of relaxed me. I was upset about things and it helped me make the decision with the doctors. Very rewarding; gave me reassurance” “Any information is good information” “It didn’t sway me but it helped me make the decision. Nothing stands out – weighing the pro’s and con’s – active surveillance seems the easiest choice. ” “It put on paper why I don’t want to have radiation. It put on paper my questions to make it easier to ask the doctors.” Preliminary Observations • Exposure to decision counseling and the clinic visit - Elicited patient pro and con decision factors - Increased patient knowledge - Reduced patient decisional conflict • Participant response to decision counseling was positive • Research is need to determine independent effects of decision counseling and the clinic visit