Values and options in cancer care (VOICE): study design and rationale for a patient-centered communication and decision-making intervention for physicians, patients with advanced cancer, and their caregivers

BMC Cancer

Richard L Kravitz⁸  Peter Sullivan⁶  Mark Robinson⁸  Linda Lewis⁸  Blair Leatherwood⁸  Beth Hoh⁶  Don Gaudion⁶  Carol Ferro⁶  Gisela Escalera⁸  Camille Cipri⁸  Alison Venuti⁶  Daniel Tancredi⁸  Anthony L Back¹  Adam Walczak⁵  Sandy Plumb⁶  Wan Tang²  Paul R Kaesberg⁴  Supriya G Mohile⁷  Phyllis N Butow⁵  Robert Gramling⁶  Paul R Duberstein³  Kevin Fiscella⁶  Paul C Winters⁶  Ronald M Epstein⁶  Michael Hoerger⁷ 

[1]Department of Medicine, University of Washington, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA

[2]Department of Biostatistics and Computational Biology, University of Rochester Medical Center, Rochester, New York, USA

[3]Department of Psychiatry, University of Rochester Medical Center, Rochester, New York, USA

[4]Department of Internal Medicine, University of California, Davis, Sacramento, California, USA

[5]Centre for Medical Psychology and Evidence-based Medicine, School of Psychology, The University of Sydney, Sydney, NSW, Australia

[6]Center for Communication and Disparities Research, Department of Family Medicine, University of Rochester Medical Center, Rochester, New York, USA

[7]James P. Wilmot Cancer Center, University of Rochester Medical Center, Rochester, New York, USA

[8]Center for Healthcare Policy and Research, University of California, Davis, Sacramento, California, USA

关键词: Physician-patient relations;    Utilization;    Quality of life;    Palliative care;    Cancer;    Caregivers;    Communication;    End-of-life care;    Decision making;    Patient-centered care;   

Others  :  1079803
DOI  :  10.1186/1471-2407-13-188

 received in 2013-02-25, accepted in 2013-03-26,  发布年份 2013

【 摘 要 】

Background

Communication about prognosis and treatment choices is essential for informed decision making in advanced cancer. This article describes an investigation designed to facilitate communication and decision making among oncologists, patients with advanced cancer, and their caregivers.

Methods/design

The Values and Options in Cancer Care (VOICE) Study is a National Cancer Institute sponsored randomized controlled trial conducted in the Rochester/Buffalo, NY and Sacramento, CA regions. A total of 40 oncologists, approximately 400 patients with advanced cancer, and their family/friend caregivers (one per patient, when available) are expected to enroll in the study. Drawing upon ecological theory, the intervention uses a two-pronged approach: oncologists complete a multifaceted tailored educational intervention involving standardized patient instructors (SPIs), and patients and caregivers complete a coaching intervention to facilitate prioritizing and discussing questions and concerns. Follow-up data will be collected approximately quarterly for up to three years.

Discussion

The intervention is hypothesized to enhance patient-centered communication, quality of care, and patient outcomes. Analyses will examine the effects of the intervention on key elements of physician-patient-caregiver communication (primary outcomes), the physician-patient relationship, shared understanding of prognosis, patient well-being, and health service utilization (secondary outcomes).

Trial registration

Clinical Trials Identifier: NCT01485627

【 授权许可】

   
2013 Hoerger et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

【 参考文献 】

• [1]Epstein RM, Street RL Jr: Patient-centered communication in cancer care: Promoting healing and reducing suffering. Bethesda, MD: National Cancer Institute, NIH; 2007.
• [2]Parker SM, Clayton JM, Hancock K: A systematic review of prognostic/end-of-life communication with adults in advanced stages of a life-limiting illness: Patient/caregiver preferences for the content, style, and timing of information. J Pain Symptom Manage 2007, 34:81-93.
• [3]Wright AA, Zhang B, Ray A: Associations between end-of-life discussions, patient mental health, medical care near death, and caregiver bereavement adjustment. J Am Med Assoc 2008, 300:1665-1673.
• [4]Weeks JC, Catalano PJ, Cronin A: Patients’ expectations about effects of chemotherapy for advanced cancer. N Engl J Med 2012, 367:1616-1625.
• [5]Weeks JC, Cook EF, O’Day SJ: Relationship between cancer patients’ predictions of prognosis and their treatment preferences. J Am Med Assoc 1998, 279:1709-1714.
• [6]Robinson TM, Alexander SC, Hays M: Patient-oncologist communication in advanced cancer: predictors of patient perception of prognosis. Support Care Cancer 2008, 16:1049-1057.
• [7]Mack JW, Nilsson M, Balboni T: Peace, equanimity, and acceptance in the cancer experience (PEACE): validation of a scale to assess acceptance and struggle with terminal illness. Cancer 2008, 112:2509-2517.
• [8]Mack JW, Weeks JC, Wright AA: End-of-life discussions, goal attainment, and distress at the end of life: predictors and outcomes of receipt of care consistent with preferences. J Clin Oncol 2010, 28:1203-1208.
• [9]Temel JS, Greer JA, Muzikansky A: Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med 2010, 363:733-742.
• [10]Haidet P, Hamel MB, Davis RB: Outcomes, preferences for resuscitation, and physician-patient communication among patients with metastatic colorectal cancer. SUPPORT investigators. Study to understand prognoses and preferences for outcomes and risks of treatments. Am J Med 1998, 105:222-229.
• [11]Institute of Medicine: Assessing and improving value in cancer care: Workshop summary. Washington, DC: The National Academy Press; 2009.
• [12]Lewin SA, Skea ZC, Entwistle V: Interventions for providers to promote a patient-centred approach in clinical consultations. Cochrane Database Syst Rev 2001, CD003267.
• [13]Clayton JM, Hancock KM, Butow PN: Clinical practice guidelines for communicating prognosis and end-of-life issues with adults in the advanced stages of a life-limiting illness, and their caregivers. Med J Aust 2007., 186S77, S9, S83–108
• [14]Lamont EB, Christakis NA: Prognostic disclosure to patients with cancer near the end of life. Ann Intern Med 2001, 134:1096-1105.
• [15]Keating NL, Landrum MB, Rogers SO Jr: Physician factors associated with discussions about end-of-life care. Cancer 2010, 116:998-1006.
• [16]Epstein RM, Peters E: Beyond information: exploring patients’ preferences. J Am Med Assoc 2009, 302:195-197.
• [17]Fallowfield LJ, Jenkins VA, Beveridge HA: Truth may hurt but deceit hurts more: communication in palliative care. Palliat Med 2002, 16:297-303.
• [18]Hagerty RG, Butow PN, Ellis PM: Communicating prognosis in cancer care: a systematic review of the literature. Ann Oncol 2005, 16:1005-1053.
• [19]Hagerty RG, Butow PN, Ellis PM: Communicating with realism and hope: incurable cancer patients’ views on the disclosure of prognosis. J Clin Oncol 2005, 23:1278-1288.
• [20]Epstein RM, Franks P, Fiscella K: Measuring patient-centered communication in patient-physician consultations: theoretical and practical issues. Soc Sci Med 2005, 61:1516-1528.
• [21]Institute of Medicine Committee on Quality of Health Care in America: Crossing the quality chasm: A new health system for the 21st century. Washington, D.C: National Academy Press; 2001.
• [22]Kinnersley P, Edwards A, Hood K: Interventions before consultations for helping patients address their information needs. Cochrane Database Syst Rev 2007, CD004565.
• [23]Kalauokalani D, Franks P, Oliver JW: Can patient coaching reduce racial/ethnic disparities in cancer pain control? Secondary analysis of a randomized controlled trial. Pain Med 2007, 8:17-24.
• [24]Lautrette A, Darmon M, Megarbane B: A communication strategy and brochure for relatives of patients dying in the ICU. N Engl J Med 2007, 356:469-478.
• [25]Connors AF, Dawson NV, Desbiens NA: A controlled trial to improve care for seriously ill hospitalized patients. The study to understand prognoses and preferences for outcomes and risks of treatments (SUPPORT). The SUPPORT Principal Investigators. JAMA 1995, 274:1591-1598.
• [26]Clayton JM, Butow PN, Tattersall MH: Randomized controlled trial of a prompt list to help advanced cancer patients and their caregivers to ask questions about prognosis and end-of-life care. J Clin Oncol 2007, 25:715-723.
• [27]Post DM, Cegala DJ, Miser WF: The other half of the whole: teaching patients to communicate with physicians. Fam Med 2002, 34:344-352.
• [28]Cegala DJ, Lenzmeier Broz S: Physician communication skills training: a review of theoretical backgrounds, objectives and skills. Med Educ 2002, 36:1004-1016.
• [29]Street RL Jr, Makoul G, Arora NK, Epstein RM: How does communication heal? Pathways linking clinician-patient communication to health outcomes. Patient Educ Couns 2009, 74:295-301.
• [30]Plsek P: Redesigning health care with insights from the science of complex adaptive systems. In Crossing the quality chasm: A new health system for the 21st century. Washington, DC: National Academy Press; 2001:309-322.
• [31]Cegala DJ, Post DM: The impact of patients’ participation on physicians’ patient-centered communication. Patient Educ Couns 2009, 77:202-208.
• [32]Street RL Jr, Gordon H, Haidet P: Physicians’ communication and perceptions of patients: is it how they look, how they talk, or is it just the doctor? Soc Sci Med 2007, 65:586-598.
• [33]Street RL Jr: Information-giving in medical consultations: the influence of patients’ communicative styles and personal characteristics. Soc Sci Med 1991, 32:541-548.
• [34]Street RL Jr, Slee C, Kalauokalani DK: Improving physician-patient communication about cancer pain with a tailored education-coaching intervention. Patient Educ Couns 2010, 80:42-47.
• [35]Dimoska A, Tattersall MH, Butow PN: Can a “prompt list” empower cancer patients to ask relevant questions? Cancer 2008, 113:225-237.
• [36]Shields CG, Epstein RM, Fiscella K: Influence of accompanied encounters on patient-centeredness with older patients. J Am Board Fam Pract 2005, 18:344-354.
• [37]Powell R, Butow P, Bu S: Good things come in threes? Patient, family, and health professional experiences of triadic communication and decision making in cancer consultations. Psychooncology 2011, 20:98-99.
• [38]Peters E, Dieckmann N, Dixon A: Less is more in presenting quality information to consumers. Med Care Res Rev 2007, 64:169-190.
• [39]Peters E, McCaul KD, Stefanek M, Nelson W: A heuristics approach to understanding cancer risk perception: contributions from judgment and decision-making research. Ann Behav Med 2006, 31:45-52.
• [40]Peters E, Lipkus I, Diefenbach MA: The functions of affect in health communications and in the construction of health preferences. J Commun 2006, 56:S140-S162.
• [41]Reyna VF: A theory of medical decision making and health: fuzzy trace theory. Med Decis Making 2008, 28:850-865.
• [42]Peters E, Hibbard J, Slovic P, Dieckmann N: Numeracy skill and the communication, comprehension, and use of risk-benefit information. Health Aff 2007, 26:741-748.
• [43]Maly RC, Frank JC, Marshall GN: Perceived efficacy in patient-physician interactions (PEPPI): validation of an instrument in older persons. J Am Geriatr Soc 1998, 46:889-894.
• [44]Bandura A: Health promotion by social cognitive means. Health Educ Behav 2004, 31:143-164.
• [45]Clayton JM, Butow PN, Arnold RM, Tattersall MH: Fostering coping and nurturing hope when discussing the future with terminally ill cancer patients and their caregivers. Cancer 2005, 103:1965-1975.
• [46]Hoerger M: Coping strategies and immune neglect in affective forecasting: direct evidence and key moderators. Judgm Decis Mak 2012, 7:86-96.
• [47]Goldstein MG, Niaura R, Willey C: An academic detailing intervention to disseminate physician-delivered smoking cessation counseling: smoking cessation outcomes of the physicians counseling smokers project. Prev Med 2003, 36:185-196.
• [48]Bransford JD, Brown A, Cocking RR: How people learn: Brain, mind, experience, and school. Wasington DC: National Academy Press; 2000.
• [49]Epstein RM, Shields CG, Franks P: Exploring and validating patient concerns: relation to prescribing for depression. Ann Fam Med 2007, 5:21-28.
• [50]Fiscella K, Meldrum S, Franks P: Patient trust: is it related to patient-centered behavior of primary care physicians? Medical Care 2004, 42:1049-1055.
• [51]Butow PN, Brown RF, Cogar S: Oncologists’ reactions to cancer patients’ verbal cues. Psychooncology 2002, 11:47-58.
• [52]Mauksch LB, Hillenburg L, Robins L: The establishing focus protocol: training for collaborative agenda setting and time management in the medical interview. Fam Syst Health 2001, 19:147-157.
• [53]Marvel MK, Epstein RM, Flowers K, Beckman HB: Soliciting the patient’s agenda: have we improved? JAMA 1999, 281:283-287.
• [54]Brown RF, Butow PN, Dunn SM, Tattersall MH: Promoting patient participation and shortening cancer consultations: a randomised trial. Br J Cancer 2001, 85:1273-1279.
• [55]Butow P, Devine R, Boyer M: Cancer consultation preparation package: changing patients but not physicians is not enough. J Clin Oncol 2004, 22:4401-4409.
• [56]Morse DS, Edwardsen EA, Gordon HS: Missed opportunities for interval empathy in lung cancer communication. Arch Intern Med 2008, 168:1853-1858.
• [57]Ryan H, Schofield P, Cockburn J: How to recognize and manage psychological distress in cancer patients. Eur J Cancer Care 2005, 14:7-15.
• [58]Back AL, Arnold RM, Baile WF: Efficacy of communication skills training for giving bad news and discussing transitions to palliative care. Arch Intern Med 2007, 167:453-460.
• [59]Back AL, Arnold RM, Baile WF: Approaching difficult communication tasks in oncology. CA Cancer J Clin 2005, 55:164-177.
• [60]Walczak A, Mazer B, Butow P: A question prompt list for patients with advanced cancer in the final year of life: development and cross-cultural evaluation. Palliat Medin press
• [61]Oliver JW, Kravitz RL, Kaplan SH, Meyers FJ: Individualized patient education and coaching to improve pain control among cancer outpatients. J Clin Oncol 2001, 19:2206-2212.
• [62]Cox K, Wilson E: Follow‐up for people with cancer: nurse‐led services and telephone interventions. J Adv Nurs 2003, 43:51-61.
• [63]Kravitz RL, Tancredi DJ, Grennan T: Cancer health empowerment for living without pain (Ca-HELP): effects of a tailored education and coaching intervention on pain and impairment. Pain 2011, 152:1572-1582.
• [64]Del Piccolo L, De Haes H, Heaven C: Development of the verona coding definitions of emotional sequences to code health providers’ responses (VR-CoDES-P) to patient cues and concerns. Patient Educ Couns 2011, 82:149-155.
• [65]Shields CG, Coker CJ, Poulsen SS: Patient-centered communication and prognosis discussions with cancer patients. Patient Educ Couns 2009, 77:437-442.
• [66]Elwyn G, Edwards A, Mowle S: Measuring the involvement of patients in shared decision-making: a systematic review of instruments. Patient Educ Couns 2001, 43:5-22.
• [67]Elwyn G, Hutchings H, Edwards A: The OPTION scale: measuring the extent that clinicians involve patients in decision‐making tasks. Health Expect 2005, 8:34-42.
• [68]Mack JW, Block SD, Nilsson M: Measuring therapeutic alliance between oncologists and patients with advanced cancer: the human connection scale. Cancer 2009, 115:3302-3311.
• [69]Gremigni P, Sommaruga M, Peltenburg M: Validation of the health care communication questionnaire (HCCQ) to measure outpatients’ experience of communication with hospital staff. Patient Educ Couns 2008, 71:57-64.
• [70]Mishel MH: The measurement of uncertainty in illness. Nurs Res 1981, 30:258-263.
• [71]Sutherland HJ, Llewellyn-Thomas HA, Lockwood GA: Cancer patients: their desire for information and participation in treatment decisions. J R Soc Med 1989, 82:260-263.
• [72]Degner LF, Sloan JA: Decision making during serious illness: what role do patients really want to play? J Clin Epidemiol 1992, 45:941-950.
• [73]Cohen SR, Mount BM, Strobel MG, Bui F: The McGill quality of life questionnaire: a measure of quality of life appropriate for people with advanced disease. A preliminary study of validity and acceptability. Palliat Med 1995, 9:207-219.
• [74]Cella DF, Tulsky DS, Gray G: The functional assessment of cancer therapy scale: development and validation of the general measure. J Clin Oncol 1993, 11:570-579.
• [75]Balboni TA, Paulk ME, Balboni MJ: Provision of spiritual care to patients with advanced cancer: associations with medical care and quality of life near death. J Clin Oncol 2010, 28:445-452.
• [76]Munn JC, Zimmerman S, Hanson LC: Measuring the quality of dying in long-term care. J Am Geriatr Soc 2007, 55:1371-1379.
• [77]Goodman D, Fisher E, Chang C: Quality of end-of-life cancer care for Medicare beneficiaries: Regional and hospital-specific analyses. In Dartmouth Atlas of Health Care Report Hanover. NH: Dartmouth College; 2010:1-51.
• [78]Pirl WF, Muriel A, Hwang V: Screening for psychosocial distress: a national survey of oncologists. J Support Oncol 2007, 5:499-504.
• [79]Velikova G, Booth L, Smith AB: Measuring quality of life in routine oncology practice improves communication and patient well-being: a randomized controlled trial. J Clin Oncol 2004, 22:714-724.
• [80]Currow DC, Ward AM, Plummer JL: Comfort in the last 2 weeks of life: relationship to accessing palliative care services. Support Care Cancer 2008, 16:1255-1263.
• [81]Bensing JM, Roter DL, Hulsman RL: Communication patterns of primary care physicians in the United States and the Netherlands. J Gen Intern Med 2003, 18:335-342.
• [82]Levinson W, Roter D: Physicians’ psychosocial beliefs correlate with their patient communication skills. J Gen Intern Med 1995, 10:375-379.
• [83]Curtis JR, Patrick DL, Engelberg RA: A measure of the quality of dying and death. Initial validation using after-death interviews with family members. J Pain Symptom Manage 2002, 24:17-31.
• [84]Frison L, Pocock SJ: Repeated measures in clinical trials: analysis using mean summary statistics and its implications for design. Stat Med 1992, 11:1685-1704.
• [85]Murray DM, Varnell SP, Blitstein JL: Design and analysis of group-randomized trials: a review of recent methodological developments. Am J Public Health 2004, 94:423-432.
• [86]Garcia L: Controlling the false discovery rate in ecological research. Trends Ecol Evol 2003, 18:553-554.
• [87]Clever SL, Novack DH, Cohen DG, Levinson W: Evaluating surgeons’ informed decision making skills: pilot test using a videoconferenced standardised patient. Med Educ 2003, 37:1094-1099.
• [88]Novack DH, Cohen D, Peitzman SJ: A pilot test of WebOSCE: a system for assessing trainees’ clinical skills via teleconference. Med Teach 2002, 24:483-487.