Shared Decision Making in Prostate-Specific Antigen Testing: The Effect of a Mailed Patient Flyer Prior to an Annual Exam

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1 447074JPCXXX / Landr ey et aljournal of Primary Care & Community Health 2012 The Author(s) 2010 Reprints and permission: sagepub.com/journalspermissions.nav Shared Decision Making in Prostate-Specific Antigen Testing: The Effect of a Mailed Patient Flyer Prior to an Annual Exam Journal of Primary Care & Community Health 4(1) The Author(s) 2013 Reprints and permission: sagepub.com/journalspermissions.nav DOI: / Alison R. Landrey 1, Daniel D. Matlock 1, Laura Andrews 1, Michael Bronsert 1, and Tom Denberg 2 Abstract Introduction and aims: Professional societies recommend that the decision to screen for prostate cancer involves a shared discussion between patient and provider. Many men are tested without this discussion. Prostate cancer screening decision aids increase patient knowledge and participation in prostate-specific antigen (PSA) testing decisions under ideal circumstances but are often resource intensive and elaborate. There is a need for evaluation of interventions that are low cost, low literacy, and practical for widespread distribution. The authors evaluated the effect of a mailed low-literacy informational patient flyer about the PSA test on measures of shared decision making. Methods: A pragmatic randomized controlled trial comparing the mailed flyer versus usual care was conducted among 303 men aged 50 to 74 years who were scheduled for annual health maintenance exams in 2 general internal medicine clinics (University of Colorado and University of Colorado Hospital). Charts were reviewed after the visits for documentation of PSA screening discussions and PSA testing rates. Follow-up patient surveys assessed include perceived participation in PSA screening decisions, knowledge of the PSA test, and flyer acceptability. Results: Rates of chart-documented PSA discussions were low with no difference between the flyer and control groups (17.7% and 13.6%, respectively; P =.28). Rates of PSA testing were also similar in both groups (62.5% vs 58.5%; P =.48). Rates of patient-reported PSA discussions were higher than the documented rates but also without differences between the groups (71.8% vs 62.3%; P =.22). The intervention had no effect in the PSA knowledge scores (3.5/5 vs 3.3/5, P =.60). Patients found the flyer to be highly acceptable. Conclusions: A mailed lowliteracy informational flyer was well received by patients but had no effect on rates of PSA discussions, PSA testing, or patient knowledge of prostate cancer screening. Keywords shared decision making, pragmatic trial, health literacy, prostate cancer screening Introduction The prostate-specific antigen (PSA) test is commonly performed to screen for prostate cancer. 1 However, evidence has not demonstrated a population-based benefit of this practice. 2-4 In addition, diagnostic workup and treatment of positive results, many of which represent indolent and harmless cancers, are often associated with significant downstream harms. 2 Thus, a patient-centered approach to prostate cancer screening has been advocated. The American Cancer Society, the American Urological Association, and the American College of Preventive Medicine all recommend that men make informed decisions about PSA testing. 5-7 Although the U.S. Preventive Services Task Force recently drafted a recommendation against routine PSA screening, they also recommend patient-centered informed decision making if PSA screening is considered. 8 Shared decision making entails patients and providers coming together to discuss the risks, benefits, and burdens of medical tests and intervention with the ultimate goal of reaching decisions that are concordant with a patient s goals and values Currently, shared discussions about PSA testing rarely occur. 1,12 Barriers include inadequate time 1 Department of General Internal Medicine, University of Colorado, Denver, CO, USA 2 Atrius Health, Newton, MA, USA Corresponding Author: Daniel D. Matlock, E 17th Ave Aurora, CO Daniel.Matlock@ucdenver.edu

2 68 Journal of Primary Care & Community Health 4(1) for discussions during the clinical encounter; poor patient comprehension of medical terminology; and the topical complexity Several PSA patient decision aids have been developed, some of which have been associated with increased patient knowledge, increased patient participation in decision making, and lower rates of PSA testing. 15 However, many of these decision aids were evaluated in research settings that are difficult to replicate in the real world of clinical practice. More pragmatic studies evaluating interventions to improve patient participation in PSA screening decisions and knowledge of the PSA test are needed. Based on studies demonstrating that clinicians prefer previsit distribution of a PSA screening decision aid or informational material, and that paper forms of such tools are just as effective as higher cost forms, we developed and evaluated a strategy involving a flyer mailed to men prior to annual exams. We designed a single page flyer written at the fourth grade level whose purpose was to furnish basic information about the PSA test to men eligible for PSA screening. The flyer also advised men to discuss the test in face-to-face clinic visits with their providers. We conducted a pragmatic trial to evaluate the hypothesis that, in comparison with patients receiving usual care, those who received the flyer by mail prior to an annual preventive exam would have higher rates of self-reported and electronic health record (EHR) documented discussions about PSA screening decisions. Secondary aims were to assess the flyer s acceptability and effects on rates of PSA testing and patient knowledge. Methods Setting and Participants The study was conducted in 2 general internal medicine practices affiliated with the University of Colorado Hospital. Eligible men were between 50 and 74 years old and were scheduled to have an annual health maintenance exam between October 2009 and August Men were excluded if they had a PSA test within the past 12 months, a history of prostate cancer, or any other diagnosis of cancer, terminal illness or dementia. Intervention One week prior to their upcoming annual health maintenance visits, eligible patients were randomized to receive a mailed flyer (intervention group) or no flyer (usual care group). The flyer (Figure 1) was developed by the study authors with feedback by internal medicine physicians at the University of Colorado. Written at a fourth grade level, it provided basic information about the PSA test, prostate cancer, and risks and benefits of screening, and encouraged patients to talk with their providers about whether a PSA test was appropriate for them Measures Two research assistants blinded to group assignment collected chart outcome information by reviewing clinic notes following patient appointments. These outcomes included documentation of a PSA discussion, documentation of patient preference for testing, and a clinician order for a PSA test. A follow-up telephone survey consisting of thirteen items was conducted within 2 weeks of the clinic visit. Up to 3 phone call attempts were made to complete the survey. Patients were asked to recall whether they received the flyer, whether a discussion related to PSA testing took place, and whether they shared their feelings about having a PSA test with their medical provider. Patients role preference for PSA decision making was assessed using the control preferences scale. 19 Patients who either wished to share the screening decision with a clinician or make the decision by themselves were classified as active participants; patients who wanted the provider to make a decision on their behalf were classified as passive participants. 19,20 Knowledge was assessed by means of 5 items extracted from a published PSA and prostate cancer knowledge test. 21 Finally, for patients who remembered receiving a flyer, acceptability was assessed by means of survey items previously developed for this purpose. 22 Statistical Analysis Logistic regression with a random intercept for provider was used to evaluate study group differences in rates of chartdocumented PSA discussions, documentation of patient preferences, and rates of PSA testing. An intraclass correlation coefficient was calculated to assess provider clustering on these primary outcomes. The intraclass correlation coefficient represents the proportion of variability explained by the presence of clusters in the observed population. 23 Values near 0 suggest no clustering of outcomes among providers and values near 1 suggest near complete clustering of outcomes among providers;.05 has been suggested as a value below which clustering effects are insignificant. 24 Using intention-to-treat, Pearson χ 2 tests assessed study group differences in survey responses. A separate flyer-use analysis compared survey responses among patients in the intervention group who did and did not recall receiving the flyer. Human Subjects The intervention was evaluated as part of a quality improvement program that relied on standard methods for creating patient registries and providing patient outreach. There were no patient exclusions based on informed consent requirements. The Colorado Multiple Institution Review Board approved waiver of informed consent and publication of

3 Landrey et al. 69 Figure 1. Patient flyer results following the removal of protected health information. This trial is registered at clinicaltrials.gov (NCT ). Results Population In total, 303 eligible individuals were randomly assigned to 1 of 2 study groups. Figure 2 depicts the study flow per Consolidated Standards of Reporting Trials (CONSORT) recommendations for pragmatic randomized controlled trials. 25 Patients received care from 44 providers. Patients mean age was 62 years, and there were no significant study group differences in baseline characteristics (Table 1). The follow-up survey response rate was 50.2% with no significant differences between study groups. Among respondents assigned to the flyer group, 63% recalled receiving the flyer. Electronic Health Record Outcomes Rates of chart-documented PSA discussions and patient testing preferences were low and similar in both groups. PSA testing rates were higher and similar in both groups (Table 2). There was significant clustering of outcomes among providers for all 3 primary outcomes as indicated by the intraclass correlation coefficients. Follow-up Survey Outcomes When patients were analyzed in their original groups, patients who were mailed the flyer were not more likely to report discussing the PSA test with their provider but more likely to say yes, a lot to a question asking if they shared their feelings about the PSA test with their provider (Table 3). There were no differences between groups in questions about knowledge.

4 70 Journal of Primary Care & Community Health 4(1) Screened for Inclusion: n=752 Randomized n= 303 Excluded (PSA in past 12 months, prostate cancer diagnosis, terminal illness or dementia) n=449 Flyer n=145 Usual Care n=158 No-Shows/ Cancellations n=9 No-Shows/ Cancellations n=11 Analyzed n=136 PSA tested on routine preappointment labs11 PSA test d/t abnormal DRE: 1 Analyzed n=147 PSA tested on routine preappointment labs: 9 PSA tested d/t abnormal DRE:1 Answered Survey n=74 3 excluded: no shows/cancellations Answered survey n=78 1 excluded: reported receiving flyer Figure 2. Enrollment CONSORT diagram Abbreviations: CONSORT, Consolidated Standards of Reporting Trials; PSA, prostate-specific antigen; DRE, digital rectal examination. Table 1. Baseline Characteristics a Flyer (n = 136) Usual Care (n = 147) Mean age, years Marital status, n (%) Married 108 (79.4) 106 (72.1) Single 19 (14.0) 22 (15.0) Other b 9 (6.6) 19 (12.9) Race, n (%) White 87 (64.0) 73 (49.7) Black 5 (3.7) 10 (6.8) Hispanic 2 (1.4) 4 (2.7) Other 5 (3.7) 3 (2.0) Unknown 37 (27.2) 57 (38.8) Insurance status, n (%) Commercial 55 (40.4) 65 (44.2) Medicaid/Medicare 48 (35.3) 36 (24.5) Tricare/other 33 (24.3) 46 (31.3) a Between-group differences were nonsignificant for all characteristics. b Includes unknown marital status, divorced, and widowed.

5 Landrey et al. 71 Table 2. EHR Outcomes Flyer (n = 136); n (%) Usual Care (n = 147); n (%) P ICC a Patient provider PSA discussion (EHR documentation) 24 (17.7) 20 (13.6) Patient PSA testing preference (EHR documentation) 24 (17.7) 21 (14.3) PSA test ordered 85 (62.5) 86 (58.5) Abbreviations: EHR, electronic health record; PSA, prostate-specific antigen; ICC, intraclass correlation coefficient. a ICC is a measure that reflects the proportion of variance in a sample that is explained by clustering of outcomes among providers; for example, 30% of the variability in documentation of PSA discussions was explained by clustering of outcomes among providers. Table 3. Responses to Survey Items About Discussions and Knowledge of Prostate Cancer Screening Questions Flyer; n = 71 (%) Usual Care; n = 77 (%) P a Did you discuss the prostate-specific antigen (PSA) test with your health care provider at your recent visit? Yes No Did you share your feelings about the PSA test with your health care provider? Yes, a lot Yes, a little No How is the PSA test conducted? By a blood test 47.9 By a prostate biopsy By a doctor s physical exam I am not sure Does having a PSA test result that is higher than normal always mean a man has prostate cancer? No I am not sure About how many men with prostate cancer will eventually die of prostate cancer? Most will die of something else About half will die of prostate cancer I am not sure If a prostate test is normal is it still possible a man could have prostate cancer? Yes No I am not sure Composite knowledge score; mean (SD) 3.5 (1.5) 3.3 (1.4).60 a P values are based on 2 2 tables for the correct answer versus incorrect answers except for the composite correct. In our flyer-use analysis, patients who recalled receiving a flyer reported having PSA discussions with their providers more often than those who did not recall receiving a flyer (91.5% vs 57.1%; P <.001). Similarly, a larger percentage reported sharing their feelings about PSA testing a lot (51.1% vs 11.5%, P <.0001), and scored better on a composite test of PSA knowledge (3.9/5 vs 3.2/5, P =.01). Control Preferences Scale A large majority of patients in both groups preferred an active role in PSA decision making (91.5% in the intervention group and 93.5% in the usual care group, P =.87). Flyer Acceptability Among patients who reported receiving the flyer, 86.4% felt the content was clearly presented, 86.4% felt it contained about the right amount of information, 45.5% felt the information was completely balanced, and 43.2% viewed it as biased against PSA testing; 88.6% would recommend it to others. Discussion We evaluated the effects of a mailed, single-page, low-literacy flyer on measures of shared decision making for PSA

6 72 Journal of Primary Care & Community Health 4(1) testing among men completing annual physical examinations. When compared with usual care, the flyer was not associated with differences in rates of EHR-documented discussions about PSA testing, patient-reported participation in PSA decision making, PSA testing rates or levels of patient knowledge about PSA testing. Rates of PSA testing were relatively high and similar to rates reported in recent observational studies. 1,26 The flyer was brief, yet most patients felt its content was clear and easy to understand and that it contained the right amount of information. Most would to recommend it to others. To our knowledge, only one other pragmatic trial of informational materials on the pros and cons of PSA testing has been performed. 17 The negative outcomes seen in our study contrast with several previous nonpragmatic studies evaluating the effects of more detailed patient pamphlets and brochures surrounding PSA screening, most of which used voluntary participation and assessed knowledge outcomes without patient participation outcomes Voluntary participation in such studies selects for engaged patients who use the materials. In our study, 38% of the survey respondents who were mailed the flyer did not report receiving it. Those who did recall receiving the flyer were significantly more likely to report participating in PSA screening decisions and scored significantly higher on the knowledge test, findings that parallel those in previous studies that used voluntary participation. 17,28-30 Like the benefits seen in the prior studies, the differences in outcomes observed in this group may not have been related to the interventions but to special characteristics of the patients enrolled who read their mail. Nevertheless, those who recalled the flyer found it to be both acceptable and helpful. This is important in the context of the finding that the vast majority of patients surveyed in our study preferred an active role in PSA decision making. Perhaps routine mailing of the flyer did not effectively reach some patients who would have been interested in active decision making. Additionally, it is unclear whether the length of the flyer was most appropriate for our population. Baseline knowledge of prostate cancer was high among our patients compared to previous studies. 28 As our flyer is short and written at a fourth-grade reading level, perhaps there is a floor effect where a flyer with information that is too basic will not significantly impact an already relatively high level of patient knowledge in our population. The finding that rates of PSA testing and discussions were strongly clustered around individual providers is also important. PSA screening has been shown to be largely driven by provider patterns, with 60% of primary care providers in a recent study reporting consistent routine screening without discussion. 26 Routine screening was noted during chart review for this study where some providers ordered annual PSA tests prior to the clinical encounter. If the decision to screen for prostate cancer is largely driven by providers, then our simple, patient-focused intervention may not have been enough to significantly change decision-making outcomes. Limitations There are several limitations to consider in this study. First, chart documentation has been shown to omit important discussion content, 32 and the low rate of documented discussions in our study likely underestimates the true rate of discussions and limits our ability to detect meaningful differences between study groups. Second, we cannot say whether the discussions reported by patients or documented by providers represent truly shared decisions. Prior literature suggests that when decision-making discussions occur, they are often not patient centered or balanced between pros and cons. 1 Third, although health literacy was an important consideration in the intervention development, we were unable to analyze differences in baseline education or literacy levels, which are important determinants of benefit from PSA screening informational materials. 33 Further Studies To address the possibility that the mailed flyer did not reach all the patients who would want an active role in the decision to screen for prostate cancer, other means of delivering this flyer should be explored. Handing the flyer to all male patients between 50 and 75 years old to read a few minutes prior to their annual visit could be a more effective approach to engage a higher percentage of patients. Additionally, we feel that activating providers in this process may be necessary to promote patient-centered conversations about prostate cancer screening. Competing demands for providers time would have to be balanced against potential benefit to patients in designing provider-based interventions. A simple intervention could be an in-service or workshop for providers on implementing shared-decision-making in PSA testing during annual visits. Conclusions Our brief, low-literacy informational patient flyer distributed routinely prior to an annual exam was easy to implement and well received by patients. However, neither did it result in different rates of documentation of PSA discussions, documentation of patient testing preferences, or PSA testing, nor did it significantly improve patients knowledge or change patients reports of participation in discussions. The clustering of outcomes among providers in our study suggests that interventions targeting providers will be important to expand our knowledge of decision

7 Landrey et al. 73 making in PSA testing. More pragmatic trials are needed to determine the real-world benefit of tools promoting shared decision making in PSA testing. Declaration of Conflicting Interests The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. Funding The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This project was funded by a Health Literacy Award from the American College of Physician s Foundation. Dr. Matlock was funded as a Hartford Geriatrics Health Outcomes Research Scholar and by the National Institutes on Aging 1 K23 AG References 1. Hoffman RM, Couper MP, Zikmund-Fisher BJ, et al. Prostate cancer screening decisions: results from the National Survey of Medical Decisions (DECISIONS study). Arch Intern Med. 2009;169: Harris R, Lohr KN. 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8 74 Journal of Primary Care & Community Health 4(1) a brief patient decision aid on men s knowledge, attitudes and intention to be tested. Patient Educ Couns. 2006;63: Wilt TJ, Paul J, Murdoch M, Nelson D, Nugent S, Rubins HB. Educating men about prostate cancer screening. A randomized trial of a mailed pamphlet. Eff Clin Pract. 2001;4: Schapira MM, VanRuiswyk J. The effect of an illustrated pamphlet decision-aid on the use of prostate cancer screening tests. J Fam Pract. 2000;49: Kripalani S, Sharma J, Justice E, et al. Low-literacy interventions to promote discussion of prostate cancer: a randomized controlled trial. Am J Prev Med. 2007;33: Langewitz WA, Loeb Y, Nubling M, Hunziker S. From patient talk to physician notes: comparing the content of medical interviews with medical records in a sample of outpatients in internal medicine. Patient Educ Couns. 2009;76: Kim SP, Knight SJ, Tomori C, et al. Health literacy and shared decision making for prostate cancer patients with low socioeconomic status. Cancer Invest. 2001;19: Bios Alison R. Landrey, MD is a primary care internal medicine resident at the University of Colorado, Denver. Daniel D. Matlock, MD, MPH is an Assistant Professor in the Department of Internal Medicine at the University of Colorado, Denver. Laura Andrews, BA is a former research assistant in the Department of Internal Medicine at the University of Colorado, Denver. Michael Bronsert, MS, PhD is a biostatistician in the Department of Internal Medicine at the University of Colorado, Denver. Tom Denberg, MD, PhD is vice president of Quality and Patient Safety at Harvard Vanguard Medical Associates and Atrius Health in Newton, Massachusetts.