Cons - The Prostate Net

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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
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