Decision Support and Shared Decision Making

in Prostate Cancer Care

Ronald E. Myers, PhDProfessor and Director, Division of Population Science, Department of Medical Oncology and Associate Directorof Population Science, Kimmel Cancer Center,Thomas Jefferson University(ronald.myers@jefferson.edu)

February 23, 2013

• 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 whenfateful health care decisions must be made – when an individual patient arrives at a crossroads of medical options, where the diverging pathshave different and important consequences withlasting implications.”

(Barry and Edgman-Levitan, NEJM, 2012)

Patient-Centered Care

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 one-way 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

Intervention Endpoint

Survey AuditBaselineSurvey

Eligibility assessment

PotentialParticipants

N = 776

Responders n = 313

Controln= 157

Treatmentn= 156

Mailed booklet In-office patient satisfaction survey Chart prompt

Mailed booklet In-office decision counseling session Chart prompt

X X

X X

RandomAssignment

Characteristics of Study Participants (N=313)

Variable Category N (%)

Study Site A 157 (50.2)B 156 (49.8)

Age 50-59 years 216 (69.0)60-69 years 97 (31.0)

Race White 176 (56.4)Nonwhite 136

(43.6)

Education HS or Less 101 (32.6)Greater than HS 209

(67.4)

Marital Status Married 197 (63.3)Not Married 114 (36.7)

• 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)

Hypotheses

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

• 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

Pro Con Weight Decision Factors

Factor 1 Select WeightFactor 2 Select WeightFactor 3 Select Weight

Compare Decision Factors

Factor 1-2 Select WeightFactor 2-3 Select WeightFactor 1-3 Select Weight

Weight of Influence: None, A Little, Some, Much, Very Much, Overwhelming

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 Scoreand Level of Factor Influence Range

Preference

Con– Overwhelming 1.9 0.000 – 0.333– Very Much 1.7 0.334 - 0.356– Much 1.5 0.357 - 0.383– Somewhat 1.3 0.384 - 0.416– A little 1.1 0.417 - 0.454

Neutral 1.0 0.455 - 0.545

Pro– A little 1.1 0.546 - 0.583– Somewhat 1.3 0.584 - 0.616– Much 1.5 0.617 - 0.643– Very Much 1.7 0.644 - 0.666– Overwhelming 1.9 0.667 - 1.000

Neutral

Moderate

Moderate

High

High

Low

Low

Results: Patient Knowledge*

Baseline Endpoint DifferenceStudy from Baseline ChangeGroup Mean (SD) Mean (SD) to Endpoint (SD) (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)

IDMStudy IDM Rate Ratio*Group Rate (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

ScreenedStudyGroup 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 Hoffman- Censits, 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 multi-disciplinary 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

Periodic PSA/Annual Biopsy

Active Surveillance 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 “I’m afraid my cancer will turn out to be the aggressive type.” “I just want the cancer out.” “Having treatment at a younger age might be better than

when I’m older.”

Pros: 53%

Cons: 47%

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

Endpoint

Mean

MeanDifferenc

e

Knowledge 75.0% 84.3% +9.3%

Decisional Conflict*

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*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”

“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.”

“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. ”

“Any information is good information”

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