Wayne State University | Detroit Medical Center
Physician Communication and
Patient Participation in Clinical Trials
Teri Albrecht, Ph.D.
Professor and Interim Associate Center Director, Population Sciences
Karmanos Cancer Institute
Department of Family Medicine and Public Health Sciences
Wayne State University School of Medicine
April 30, 2009
Specific Aim
To investigate how communication
occurring between and among
physicians, patients, and
family/companions influences
patients’ decision making
about participating in clinical trials.
NCI R01CA075003 “Effects of Physician
Communication on Patient Accrual”
(T. Albrecht, Principal Investigator)
Wayne State University | Detroit Medical Center
Editorial Commentary on Our Article
(Siminoff, 2008)
• Emphasized:
– Primacy of physician’s role
– Medical schools and residency
programs must invest in training
– “It is critical that physicians be trained
to communicative effectively and
efficiently with patients and their
families by mastering the skills of
relational communication. Pinpointing
the content and information needs of
patients for decision making should
add efficiency and effectiveness to
this process” (p. 2615).
Wayne State University | Detroit Medical Center
Background—The Problem
Wayne State University | Detroit Medical Center
1. Patient accrual rates for oncology trials continue to
be inadequate (reported as only 2-20% of all cancer
patients)
•
•
•
Lack of available trials
Overly stringent eligibility criteria
Complex social /institutional barriers delaying trial
implementation
2. Special populations are underrepresented in most
national trials
3. To know why patients who are eligible for available,
clinically appropriate trials do not enroll, it is critical
to assess the actual process of communication
Why Patients Accrue or Resist
Clinical Trials
DO ENROLL:


Trust in their physician
Physician recommended study
Physician responsive to
questions and issues


Encouragement by family

Manageable side effects

Altruism

Desire to live
Wayne State University | Detroit Medical Center
DO NOT ENROLL:
• Perceive their needs not
physician’s priority
• Disrupt quality of life, functional
abilities
• Anxiety about randomization
• Worry might not receive best
treatment
• Concern about logistical difficulties
• Perceive insurance problems
• Concern about excessive toxicity
• Poor understanding of study
• Family against study participation
• Worry about excessive burden on
family/friends
Communication Occurs in Context:
Community Level
Interaction Level
Wayne State University | Detroit Medical Center
Urban Detroit
African American: 81.6%
Largest Arab American population
Living below poverty level: 26.1%
Illiteracy rate: 47.0%; High school graduation rate: ~25%
Children born to single mothers: 72.0%
Unemployment rate: >22.2% (Jan., 2009)
Among highest obesity, murder rates in U.S.
Healthcare System
Institution/Cancer Center
Clinical Interaction
“Patient-Centered
Communication”
Wayne State University | Detroit Medical Center
• Six Core Functions:
–
–
–
–
–
–
Fostering healing relationships
Exchanging information
Responding to emotions
Managing uncertainty
Making decisions
Enabling patient self-management
Source: Epstein, R.M., & Street, R.L., (2007). Patient-centered
communication in cancer care: Promoting healing and reducing
suffering. Bethesda, MD: National Cancer Institute.
Effective Patient-Centered
Communication
Wayne State University | Detroit Medical Center
Is Based on Two Types of Messages:
1. Content Messages
(Expressing information)
2. Relational Messages
(Expressing how individuals view each
other and build a relationship through
interaction)
Effective Communication is Based
on Convergence…
Wayne State University | Detroit Medical Center
Definition:
The extent to which physicians, patients and
family/companions create mutual understanding and
shared perspectives regarding diagnosis and
treatment through exchanging verbal and nonverbal
messages
(adapted from Rogers and Kincaid,1971)
Achieving Relative Degrees of
Convergence
Wayne State University | Detroit Medical Center
FAMILY/COMPANION
PHYSICIAN
PATIENT
Shared accuracy and agreement
Our Resources
Wayne State University | Detroit Medical Center
• Mobile non-reactive video recording equipment
• Editing and coding software and hardware
• Video Library
– Over 245 video recorded of oncologist-patient interactions
– 55 video recorded parent-child interactions during invasive
treatments for pediatric cancer
– 150 video recorded family medicine physician-patient
interactions at a low-income primary care clinic
Convergence-Related Factors
Wayne State University | Detroit Medical Center
Types of
Factors include:
•Initial Expectations
•Pathways to Interaction
•Participant Configurations
•Agreement/Accuracy
•Information Seeking
Degree of Convergence Outcomes
Wayne State University | Detroit Medical Center
Proximal and Distal
Outcomes Related to
Diagnosis and Treatment:
•Treatment Decision Making
•Informed Consent/Informed Refusal
•Treatment Adherence/Compliance
•Psychosocial Adjustment
Adult Cancer
Clinics
Wayne State University | Detroit Medical Center
Reliability/Validity
Wayne State University | Detroit Medical Center
• Added Validity of Video vs Audio Data
• Very Low Participant Reactance
• Riddle, D.L., Albrecht, T.L., Coovert, M.D., Penner, L.A.,
Ruckdeschel, J.C.,et al. (2002). Differences in audiotaped versus
videotaped physician-patient interactions. Journal of Nonverbal
Behavior, 26, 219-240
• Albrecht, T. L., Ruckdeschel, J. C., Ray, F.L., et al. (2005) A
portable, unobtrusive device for video recording clinical interactions.
Behavior Research Methods, 37(1) 165-169
• Penner, L.A., Orom, H., et al. (2007). Camera-related behaviors
during video recorded medical interactions. Journal of Nonverbal
Behavior.
Data Collection
Wayne State University | Detroit Medical Center
Baseline Characteristics (T1)
– Patient/Family Self-reports of Sociodemographics
Physician-Patient-Family Interaction (T2)
– Real-Time Video Recording of Clinic Encounter
Follow-up Interview (T3)
– Patient Self-reports about Decision Making (Phone
Interviews 1-2 Weeks After Clinic Encounter)
Observational Coding
Wayne State University | Detroit Medical Center
• N = 235 video recorded interactions at
two comprehensive cancer centers
• Coding System
– Karmanos Accrual Assessment System
(KAAS)
• Code Physician-Patient Interaction
• Code Physician-Family/Companion
Interaction
KAAS Coding of Communication
Behavior
Wayne State University | Detroit Medical Center
• Content Level Analysis:
– Simple checklist of legal-informational messages (e.g., side
effects, eligibility, voluntariness)
• Relational Level Analysis:
– Ratings of alliance-building
•
•
•
•
•
•
•
•
•
•
•
Hierarchical Rapport (cordial vs. arrogant)
Connectedness (close vs. distant)
Mutual Trust
Responsiveness to Questions
Amount of Information provided (overload/underload)
Organized (vs disorganized)
Data Orientation
Provides Hope
MD Language (technical jargon vs. lay)
Language Similarity (MD-PT; MD-F/C)
Conversation Dominance (MD vs. PT; MD vs. F/C
Final Sample (n=35)
Demographics
Mean Age
Female
White
African American
H.S. Completion
Employed
Patients
(n=35)
58.9 (11.2)
46%
69%
17%
89%
29%
Wayne State University | Detroit Medical Center
Companions
(n=26)
50.8 (13.6)
68%
91%
6%
92%
54%
Median Reported Annual Household Income = $60,000
Final Sample
Wayne State University | Detroit Medical Center
• Physicians:
– N= 15
– Male
– Mean Age=47 (12.40)
– >1 year experience accruing patients to
protocols
– 60% had offered trials for >10 years
Results:
Wayne State University | Detroit Medical Center
• Of those patients offered a trial, 77% reported
deciding to enroll
• But: What is an “offer”?
– Patient misperceptions: 39% of patients who only
discussed a trial, said they were offered one
– 14% percent of patients who were offered a trial
said they were not offered one
• Patients based their decision to enroll on
– Personal reasons
– Oncologist relational communication behavior (e.g.,
trust, rapport)
– Confidence in physician
Relationship between Observational
and Self Report Data
Wayne State University | Detroit Medical Center
Time 1
Observed Physician/Patient/Family
Communication
Relational
Communication
Time 2
Patients’ Self-Reported
Decision Outcomes
r =.40
Decision
r =.40 to .51
r = -.49 to -.58
Decision Related Affect/Cognition
Decision Confidence
Therapeutic Alliance
Positive Relationship Synchrony
Decision Agreement Synchrony
Factors Influencing Decision
Costs Manageable
MD Listened/Was Supportive
Side Effects Manageable
Family Opinion
Relationship between Observational
and Self Report Data
Wayne State University | Detroit Medical Center
Time 1
Observed Physician/Patient/Family
Communication
Time 2
Patients’ Self-Reported
Decision Outcomes
Decision
r =.47
Decision Related Affect/Cognition
Decision Confidence
Therapeutic Alliance
Positive Relationship Synchrony
Decision Agreement Synchrony
Message Content
r=.38 to .53
Factors Influencing Decision
Costs Manageable
MD Listened/Was Supportive
Side Effects Manageable
Family Opinion
Relationship between Observational
and Self Report Data
Wayne State University | Detroit Medical Center
Time 1
Observed Physician/Patient/Family
Communication
Relational Communication
PT Interaction Control
FM Interaction Control
MD-PT Relational Affiliation
MD-FM Relational Affiliation
Time 2
Patients’ Self-Reported
Decision Outcomes
r =.40
Decision
r =.40 to .51
r = -..49 to -.58
Message Content
r =.47
Legal-Informational Messages
Benefits of Clinical Trial Messages
Legal-Informational/Support Messages
r=.38 to .53
Side Effects Messages
Side Effects Support Messages
Decision Related Affect/Cognition
Decision Confidence
Therapeutic Alliance
Positive Relationship Synchrony
Decision Agreement Synchrony
Factors Influencing Decision
Costs Manageable
MD Listened/Was Supportive
Side Effects Manageable
Family Opinion
Minority patients more likely to come to
visit alone… (p< .001)
Wayne State University | Detroit Medical Center
Alone/Accrues…
Alone/Does Not
Accrue
“Uninformed Refusal”
Decision Maker Not Involved in Discussion
Wayne State University | Detroit Medical Center
Bottom Line Findings:
Wayne State University | Detroit Medical Center
1. Relational Communication Positively Impacts
Patients’ Actual Decisions to Accrue
2. Relational Communication also Positively
Impacts How Patients Feel about Their
Decisions
2. Information About the Protocol/Trial Positively
Affects How Patients Feel About the Decision
and Their Reasons for the Decision
Next Steps: An Intervention
Wayne State University | Detroit Medical Center
In Clinic
(prior to visit
with patient)
Tumor Board
Meeting
Clinical Trials Office
(CTO) Research Nurse
During Visit
With Patient
CTO
Research Nurse
CTO
Research Nurse
Physician
Family Member
/Companion
Physicians’ Tumor Board
(Breast, Prostate,
Thoracic)
Physician
Patient
:
R21 Intervention Component #1
Use of Informatics (computer database
of trials/patient eligibility accessible
through tablet computer at meeting
(to increase convergence (shared
understanding between CTO
office/Research Nurse and physicians
as a group
R21 Intervention Component #2:
•Use of CTO/Research Nurse in
clinic to track specific patients, trial
availability/eligibility, remind physicians
prior to exam visit with patient
•Use of CTO/Research Nurse in visit with
patient to clarify, expand clinical trial
information, arrange next steps, followup
Color Legend:
XXX R21 Intervention Component
XXX R21 Expected Convergence
XXX Previous Convergence (Already tested,
reported in Albrecht, et al., in press)
Acknowledgments
Wayne State University | Detroit Medical Center
• Collaborators:
Susan Eggly, Ph.D.
Louis Penner, Ph.D.
Marci Gleason, Ph.D.
Felicity Harper, Ph.D.
Tanina Foster, M.Ed.
Amy Peterson, M.A.
Anthony Shields, M.D., Ph.D.
John Ruckdeschel, M.D.
Questions?
Wayne State University | Detroit Medical Center