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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

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Page 1: Wayne State University | Detroit Medical Center Physician Communication and Patient Participation in Clinical Trials Teri Albrecht, Ph.D. Professor and

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

Page 2: Wayne State University | Detroit Medical Center Physician Communication and Patient Participation in Clinical Trials Teri Albrecht, Ph.D. Professor and

Wayne State University | Detroit Medical Center

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)

Specific Aim

Page 3: Wayne State University | Detroit Medical Center Physician Communication and Patient Participation in Clinical Trials Teri Albrecht, Ph.D. Professor and

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).

Page 4: Wayne State University | Detroit Medical Center Physician Communication and Patient Participation in Clinical Trials Teri Albrecht, Ph.D. Professor and

Wayne State University | Detroit Medical Center

Background—The Problem

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

Page 5: Wayne State University | Detroit Medical Center Physician Communication and Patient Participation in Clinical Trials Teri Albrecht, Ph.D. Professor and

Wayne State University | Detroit Medical Center

Why Patients Accrue or Resist Clinical Trials

DO ENROLL: 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

Trust in their physician

Physician recommended study

Physician responsive to questions and issues

Encouragement by family

Manageable side effects

Altruism

Desire to live

Page 6: Wayne State University | Detroit Medical Center Physician Communication and Patient Participation in Clinical Trials Teri Albrecht, Ph.D. Professor and

Wayne State University | Detroit Medical Center

Communication Occurs in Context:Community Level Interaction Level

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

Page 7: Wayne State University | Detroit Medical Center Physician Communication and Patient Participation in Clinical Trials Teri Albrecht, Ph.D. Professor and

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.

“Patient-Centered Communication”

Page 8: Wayne State University | Detroit Medical Center Physician Communication and Patient Participation in Clinical Trials Teri Albrecht, Ph.D. Professor and

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 Patient-Centered Communication

Page 9: Wayne State University | Detroit Medical Center Physician Communication and Patient Participation in Clinical Trials Teri Albrecht, Ph.D. Professor and

Wayne State University | Detroit Medical Center

Effective Communication is Based on Convergence…

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)

Page 10: Wayne State University | Detroit Medical Center Physician Communication and Patient Participation in Clinical Trials Teri Albrecht, Ph.D. Professor and

Wayne State University | Detroit Medical Center

Achieving Relative Degrees of Convergence

FAMILY/COMPANION

PATIENTPHYSICIAN

Shared accuracy and agreement

Page 11: Wayne State University | Detroit Medical Center Physician Communication and Patient Participation in Clinical Trials Teri Albrecht, Ph.D. Professor and

Wayne State University | Detroit Medical Center

Our Resources

• 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

Page 12: Wayne State University | Detroit Medical Center Physician Communication and Patient Participation in Clinical Trials Teri Albrecht, Ph.D. Professor and

Wayne State University | Detroit Medical Center

Convergence-Related Factors

•Initial Expectations•Pathways to Interaction•Participant Configurations•Agreement/Accuracy•Information Seeking

Types of Factors include:

Page 13: Wayne State University | Detroit Medical Center Physician Communication and Patient Participation in Clinical Trials Teri Albrecht, Ph.D. Professor and

Wayne State University | Detroit Medical Center

Degree of Convergence Outcomes

Proximal and Distal Outcomes Related to Diagnosis and Treatment:•Treatment Decision Making •Informed Consent/Informed Refusal•Treatment Adherence/Compliance•Psychosocial Adjustment

Page 14: Wayne State University | Detroit Medical Center Physician Communication and Patient Participation in Clinical Trials Teri Albrecht, Ph.D. Professor and

Wayne State University | Detroit Medical CenterAdult Cancer Clinics

Page 15: Wayne State University | Detroit Medical Center Physician Communication and Patient Participation in Clinical Trials Teri Albrecht, Ph.D. Professor and

Wayne State University | Detroit Medical Center

Reliability/Validity

• 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.

Page 16: Wayne State University | Detroit Medical Center Physician Communication and Patient Participation in Clinical Trials Teri Albrecht, Ph.D. Professor and

Wayne State University | Detroit Medical Center

Data Collection

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)

Page 17: Wayne State University | Detroit Medical Center Physician Communication and Patient Participation in Clinical Trials Teri Albrecht, Ph.D. Professor and

Wayne State University | Detroit Medical CenterObservational Coding

• 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

Page 18: Wayne State University | Detroit Medical Center Physician Communication and Patient Participation in Clinical Trials Teri Albrecht, Ph.D. Professor and

Wayne State University | Detroit Medical Center

KAAS Coding of Communication Behavior

• 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

Page 19: Wayne State University | Detroit Medical Center Physician Communication and Patient Participation in Clinical Trials Teri Albrecht, Ph.D. Professor and

Wayne State University | Detroit Medical Center

Final Sample (n=35)

Demographics Patients (n=35)

Companions (n=26)

Mean Age 58.9 (11.2) 50.8 (13.6)

Female 46% 68%

White 69% 91%

African American 17% 6%

H.S. Completion 89% 92%

Employed 29% 54%Median Reported Annual Household Income = $60,000

Page 20: Wayne State University | Detroit Medical Center Physician Communication and Patient Participation in Clinical Trials Teri Albrecht, Ph.D. Professor and

Wayne State University | Detroit Medical Center

Final Sample

• Physicians:– N= 15– Male– Mean Age=47 (12.40)– >1 year experience accruing patients to

protocols– 60% had offered trials for >10 years

Page 21: Wayne State University | Detroit Medical Center Physician Communication and Patient Participation in Clinical Trials Teri Albrecht, Ph.D. Professor and

Wayne State University | Detroit Medical Center

Results:

• 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

Page 22: Wayne State University | Detroit Medical Center Physician Communication and Patient Participation in Clinical Trials Teri Albrecht, Ph.D. Professor and

Wayne State University | Detroit Medical Center

Relationship between Observational and Self Report Data

Relational Communication

Time 2Patients’ Self-Reported Decision Outcomes

Decision

Decision Related Affect/CognitionDecision ConfidenceTherapeutic AlliancePositive Relationship SynchronyDecision Agreement Synchrony

Factors Influencing DecisionCosts ManageableMD Listened/Was SupportiveSide Effects ManageableFamily Opinion

Time 1 Observed Physician/Patient/Family Communication

r =.40

r =.40 to .51

r = -.49 to -.58

Page 23: Wayne State University | Detroit Medical Center Physician Communication and Patient Participation in Clinical Trials Teri Albrecht, Ph.D. Professor and

Wayne State University | Detroit Medical Center

Relationship between Observational and Self Report Data

Time 2Patients’ Self-Reported Decision Outcomes

Decision

Decision Related Affect/CognitionDecision ConfidenceTherapeutic AlliancePositive Relationship SynchronyDecision Agreement Synchrony

Factors Influencing DecisionCosts ManageableMD Listened/Was SupportiveSide Effects ManageableFamily Opinion

Message Content

Time 1 Observed Physician/Patient/Family Communication

r =.47

r=.38 to .53

Page 24: Wayne State University | Detroit Medical Center Physician Communication and Patient Participation in Clinical Trials Teri Albrecht, Ph.D. Professor and

Wayne State University | Detroit Medical Center

Relationship between Observational and Self Report Data

Relational Communication PT Interaction ControlFM Interaction ControlMD-PT Relational AffiliationMD-FM Relational Affiliation

Time 2Patients’ Self-Reported Decision Outcomes

Decision

Decision Related Affect/CognitionDecision ConfidenceTherapeutic AlliancePositive Relationship SynchronyDecision Agreement Synchrony

Factors Influencing DecisionCosts ManageableMD Listened/Was SupportiveSide Effects ManageableFamily Opinion

Message ContentLegal-Informational MessagesBenefits of Clinical Trial MessagesLegal-Informational/Support MessagesSide Effects MessagesSide Effects Support Messages

Time 1 Observed Physician/Patient/Family Communication

r =.40

r =.40 to .51

r = -..49 to -.58

r =.47

r=.38 to .53

Page 25: Wayne State University | Detroit Medical Center Physician Communication and Patient Participation in Clinical Trials Teri Albrecht, Ph.D. Professor and

Wayne State University | Detroit Medical Center

Alone/Accrues…

Minority patients more likely to come to

visit alone… (p< .001)

Alone/Does NotAccrue

Page 26: Wayne State University | Detroit Medical Center Physician Communication and Patient Participation in Clinical Trials Teri Albrecht, Ph.D. Professor and

Wayne State University | Detroit Medical Center

“Uninformed Refusal”Decision Maker Not Involved in Discussion

Page 27: Wayne State University | Detroit Medical Center Physician Communication and Patient Participation in Clinical Trials Teri Albrecht, Ph.D. Professor and

Wayne State University | Detroit Medical Center

Bottom Line Findings:

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

Page 28: Wayne State University | Detroit Medical Center Physician Communication and Patient Participation in Clinical Trials Teri Albrecht, Ph.D. Professor and

Wayne State University | Detroit Medical Center

Clinical Trials Office (CTO) Research Nurse

Physicians’ Tumor Board (Breast, Prostate, Thoracic)

CTOResearch Nurse

Physician

Physician

Patient

Family Member/Companion

CTOResearch Nurse

R21 Intervention Component #1:Use of Informatics (computer databaseof 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 ComponentXXX R21 Expected ConvergenceXXX Previous Convergence (Already tested, reported in Albrecht, et al., in press)

Tumor BoardMeeting

In Clinic (prior to visitwith patient)

During Visit With Patient

Next Steps: An Intervention

Page 29: Wayne State University | Detroit Medical Center Physician Communication and Patient Participation in Clinical Trials Teri Albrecht, Ph.D. Professor and

Wayne State University | Detroit Medical Center

Acknowledgments

• 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.

Page 30: Wayne State University | Detroit Medical Center Physician Communication and Patient Participation in Clinical Trials Teri Albrecht, Ph.D. Professor and

Wayne State University | Detroit Medical Center

Questions?