1. 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

2. 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

3. 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).

4. 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

5. 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

6. 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

7. 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”

8. 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

9. 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)

10. Wayne State University | Detroit Medical Center Achieving Relative Degrees of Convergence Shared accuracy and agreement

11. 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

12. Wayne State University | Detroit Medical Center Convergence-Related Factors Initial Expectations Pathways to Interaction Participant Configurations Agreement/Accuracy Information Seeking Types of Factors include:

13. 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

14. Wayne State University | Detroit Medical Center Adult Cancer Clinics

15. 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.

16. Wayne State University | Detroit Medical Center Data Collection Baseline Characteristics (T 1 ) – Patient/Family Self-reports of Sociodemographics Physician-Patient-Family Interaction (T 2 ) –Real-Time Video Recording of Clinic Encounter Follow-up Interview (T 3 ) –Patient Self-reports about Decision Making (Phone Interviews 1-2 Weeks After Clinic Encounter)

17. Wayne State University | Detroit Medical Center Observational 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

18. 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

19. Wayne State University | Detroit Medical Center Final Sample (n=35) DemographicsPatients (n=35) Companions (n=26) Mean Age58.9 (11.2)50.8 (13.6) Female46%68% White69%91% African American17%6% H.S. Completion89%92% Employed29%54% Median Reported Annual Household Income = $60,000

20. 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

21. 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

22. Wayne State University | Detroit Medical Center Relationship between Observational and Self Report Data Relational Communication Time 2 Patients’ Self-Reported Decision Outcomes Decision 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 Time 1 Observed Physician/Patient/Family Communication r =.40 r =.40 to.51 r = -.49 to -.58

23. Wayne State University | Detroit Medical Center Relationship between Observational and Self Report Data Time 2 Patients’ Self-Reported Decision Outcomes Decision 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 Message Content Time 1 Observed Physician/Patient/Family Communication r =.47 r=.38 to.53

24. Wayne State University | Detroit Medical Center Relationship between Observational and Self Report Data Relational Communication PT Interaction Control FM Interaction Control MD-PT Relational Affiliation MD-FM Relational Affiliation Time 2 Patients’ Self-Reported Decision Outcomes Decision 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 Message Content Legal-Informational Messages Benefits of Clinical Trial Messages Legal-Informational/Support Messages Side Effects Messages Side 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

25. Wayne State University | Detroit Medical Center Alone/Accrues… Minority patients more likely to come to visit alone… (p<.001) Alone/Does Not Accrue

26. Wayne State University | Detroit Medical Center “Uninformed Refusal” Decision Maker Not Involved in Discussion

27. 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

28. Wayne State University | Detroit Medical Center Clinical Trials Office (CTO) Research Nurse Physicians’ Tumor Board (Breast, Prostate, Thoracic) CTO Research Nurse Physician Patient Family Member /Companion CTO Research Nurse 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) Tumor Board Meeting In Clinic (prior to visit with patient) During Visit With Patient Next Steps: An Intervention

29. 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.

30. Wayne State University | Detroit Medical Center Questions?