Prostate Cancer Resource Center

A Patient Decision Aid for Men With Localized Prostate Cancer

A Comparative Case Study of Natural Implementation Approaches

Cancer Nursing

Dawn Stacey, RN, PhD Monica Taljaard, PhD Rodney H. Breau, MSc, MD, FRCSC Nicole Baba, RN Terry Blackmore, BScPT Laura Boland, MSc, SLP-C, PhD(c) Meg Carley, BSc Robert Chi Wu, MSc, MD, FRCSC Jennifer Smylie, RN, BN, MHSM France Le´gare´, MD, PhD


Abstract

Background: There are multiple options for men diagnosed with localized prostate cancer. Patient decision aids (PtDAs) help empower individuals and reduce unwarranted practice variation, but few are used in clinical practice.

Objective: We compared 2 programs implementing PtDAs for men with localized prostate cancer.

Methods: This was a comparative case study. Case 1 was a hospital prostate pathway and case 2 was a provincial prostate pathway with 2 locations (2a, 2b). Nurses provided the men with PtDAs and answered questions. Data sources were as follows: (a) 2 years administrative data for men with localized prostate cancer, (b) clinicians survey and interviews, and (c) patients/spouses interviews. Analysis was within and across cases.

Results: The PtDA was used with 23% of men in case 1 (95% confidence interval, 19.8%–26.1%) and 98% of men in case 2a (95% confidence interval, 96.5%–99.8%). The pathway was not implemented in case 2b. Men given the PtDA had positive experiences. Many clinicians supported the use of PtDAs, some adapted their discussions with patients, and others did not support the use of PtDAs. To increase use in case 1, participants identified needing a Canadian PtDA available electronically and endorsed by all clinicians. In case 2b, the provincial prostate pathway needed to be implemented.

Conclusions: There was variable uptake of the PtDAs between the cases. Men who received the PtDA had positive outcomes. Several strategies were identified to increase or sustain PtDA use.

Implications of Practice: Nurses have a key role in supporting men making decisions about prostate cancer treatment by providing PtDAs, answering questions, and advocating for men's preferences.


Background

Men diagnosed with localized prostate cancer often have multiple management options, each with potential benefits and harms.1–3 Given little evidence to indicate that one option is better than another, the chosen option should be consistent with men's informed preferences.2–4 When faced with these difficult decisions, men often experience decisional conflict and have unrealistic expectations.5–9 Unresolved decisional conflict leads to delayed decisions, feelings of regret, dissatisfaction, and blaming doctors for bad outcomes.10,11 Furthermore, practice variations in rates of prostatectomy for prostate cancer are 11% to 82%.12,13 This variation maybe unwarranted.14 Without effective support for making decisions, patients may not be exposed to all available options.15,16

For adults facing difficult decisions, providing a structured approach to decision making such as patient decision aids (PtDAs) helps empower individuals, resolves decisional conflict, and may reduce unwarranted practice variation.14,16 Patient decision aids are booklets and/or videos that provide balanced information on options (benefits/harms), help clarify patients' preferences, and guide patients making decisions with their clinicians.17 They are adjuncts to clinician counseling and are used to facilitate shared decision making in which decisions are based on the best available evidence, patients' preferences, and clinicians' advice. A systematic review of 105 trials of PtDAs found that patients exposed to PtDAs are more involved in decision making, with improved knowledge, more realistic expectations of outcomes, and enhanced agreement between options chosen and patients' values.16,18

Despite strong evidence of benefit, few PtDAs are used in clinical practice.19 In 17 implementation studies, factors interfering with PtDA use were clinicians having inadequate training, clinicians being indifferent about use, clinicians lacking confidence in PtDA content, and clinicians being concerned about disrupting workflows.19 Only 1 implementation study involved men with prostate cancer.20 In this study, conducted in Britain, men rated the PtDA positively, had improved knowledge, and chose a treatment that matched their values. As well, treatment rates shifted, with fewer men having surgery and more men having radiation.

Other studies have shown that few clinicians attempt to involve patients in decision making and fewer adjust care to patients' preferences,21 thus leading to a “silent misdiagnosis of clients' preferences,” a key determinant of health system performance as a whole.22 Hence, it is important to study implementation of PtDAs to understand the approaches that increase sustained use of PtDAs.

The aim of this study was to compare 2 strategies for implementing PtDAs in clinical pathways for men with localized prostate cancer by (a) evaluating use of PtDAs over a 2-year period after implementation, (b) evaluating the impact of the PtDA on men, clinicians, and health system outcomes; and (c) determining factors influencing sustained use.

Methods

We conducted a comparative case study using mixed methods and guided by the 3 final phases in the Knowledge to Action Framework, namely, monitor use, evaluate outcomes, and sustained use.23,24 Following Yin's approach,25 the cases were bound by location (prostate cancer clinical pathway at an academic teaching hospital in [named province] and prostate cancer surgical pathway in the Canadian province [other named province]) and time period (2 years after PtDA implementation).25

Guided by the final phases in the Knowledge to Action Framework23 we evaluated the implementation of the PtDA within the prostate cancer clinical pathway by using administrative data to monitor the proportion of men who were given the PtDA and qualitative interviews to explore men's experience with using it. To evaluate outcomes, we measured the impact of PtDA use on men's decisional conflict using administrative data, impact on clinicians' and patients' consultations using qualitative interviews, and impact on healthcare systems using administrative data (eg, uptake of treatment and types of clinicians consulted). For sustained use, we assessed the pattern of PtDA use over the 2-year period and reported barriers interfering with PtDA use identified in the clinician survey and qualitative interviews.26

The [name] Research Ethics Board (REB: 20150604-01H) and research ethics boards at case sites approved the study. Research methods are briefly described using the Standards for QUality Improvement Reporting Excellence reporting guidelines for quality improvement studies27; for additional information, the full study protocol is published.28

Context

Case 1 was a Hospital Prostate Pathway in a large academic teaching hospital in [province], and the PtDA was implemented in the pathway in September 2010 (Table 1). Case 2 was a Provincial Prostate Pathway by the Ministry of Health in different Canadian Province with a PtDA included in the pathway that was initiated in May 2013 (Table 1). In case 2, there are 2 academic teaching hospitals that provide regional prostate cancer services: 1 serving central and north (case 2a) and the other serving south regions of the province (case 2b). However, the Provincial Prostate Pathway was not initiated in case 2b.

All programs have urologists and radiation oncologists. Annually, about 400 men have consultations for prostate cancer in case 1 and about 600 in case 2, with both cases serving a population of approximately 1 million. Men in case 1 have access to all routine types of prostate cancer management, including brachytherapy and robotic prostatectomy. Men in case 2 have access to several types of prostate cancer management within the province (excluding robotic surgery), and they must travel out of province for access to brachytherapy. Prostate cancer treatment, delivered in province or out of province, is provided through publicly funded provincial coverage.29

Intervention

A PtDA was provided by the registered nurses to all men diagnosed with localized prostate cancer with the decision quality knowledge test and values clarification exercise (Table 1). In case 1, the PtDA was titled “Treatment choices for Localized Prostate Cancer” (copyright Health Dialog Services Corporation). It included a video and booklet and with only the booklet updated in 2013. The PtDA contained (a) the treatment decision to be made, (b) information on prostate cancer condition and treatment options with benefits and harms (eg, prostatectomy, external radiation therapy, brachytherapy, hormone therapy, active surveillance, and watchful waiting), (c) probabilities of outcomes of options, (d) a table comparing outcomes across options, (e) some information about managing side effects, (f) questions to consider when weighing pros and cons of options (values clarification), and (g) a video that included patient testimonials of their experience making the decision. Patients were also given a questionnaire with decision quality items (6 multiple-choice questions, 9 statements to rate the importance of outcomes of options)30 and the 4-item SURE test31 to complete after using the PtDA.

For case 2a, the prostate cancer team created a PtDA formatted as a PowerPoint presentation that was easier to send by e-mail. It had similar content to the Health Dialog prostate cancer treatment PtDA. The only differences were that it did not include patient testimonials and the decision quality items and SURE test questions were included within the PtDA.

In case 1, the PtDA was initially implemented within the prostate pathway in September 2010. At the in-person appointment, the urologist counseled the patient and asked the nurse to provide the PtDA for review at the next in-person appointment. The PtDA and other prostate cancer resources were provided to the patient to use at home in preparation for the next appointment with their urologist. Their responses to the decision quality items and SURE test were collected on their next visit to the urologist. These results were summarized on a 1-page preference report with their clinical data for the physician and patient.32 Nurses were also available by telephone or at the next appointment if the patient had questions. Nurses were trained to provide decision coaching as part of an interprofessional approach to shared decision making.33 This training is a 3.5-hour workshop that uses the Interprofessional Shared Decision Making Model and was based on a previously evaluated training workshop about supporting patients making tough health decisions.34,35 Although the training was available for all healthcare professionals, only nurses (case 1, 2a), social workers (case 1), and policy makers (case 2a) attended.

For case 2a, nurses telephoned the patients to inform them of their biopsy results, and for men with confirmed localized prostate cancer, the nurse sent the PtDA by e-mail (or mailed the Health Dialog PtDA to those without e-mail access) and also provided links to the provincial Ministry of Health website with more information on prostate cancer. Men were asked to review the PtDA in preparation for an individual decision coaching session. Trained nurses, using the same training as described in case 1, reviewed the PtDA with the patient and answered their questions. Then, the nurse (a) reviewed decision quality items (6 multiple-choice questions they answer together), (b) asked the patient to rate the importance of 9 statements about outcomes of options,30 and (c) scheduled the appointment with the urologist and/or radiation oncologist depending on the patient's preference. Nurses are available by telephone or at the next appointment if the patient has questions. When patients are not referred through the pathway, “they go [directly] to radiation and they don't necessarily get all the benefits of the nurse navigator [and the PtDA]” (urologist). For case 2b, there was no PtDA used.

Procedures of Data Collection

For cases 1 and 2a, there were 3 main data sources: administrative data, a survey of healthcare professionals, and interviews with healthcare professionals and patients. For case 2b, there were no data collected because the Prostate Pathway, including a PtDA, was not initiated.

We collected administrative data from clinical databases and electronic/paper-based health records in regions that implemented the PtDA. This involved reviewing routinely collected data to identify men newly diagnosed with localized prostate cancer for calendar years 2011 to 2012 in case 1 and 2014 to 2015 in case 2a. Data on the following were retrieved: (a) patient age at diagnosis, comorbidities with severity, prostate cancer characteristics (eg, prostate-specific antigen [PSA], tumor grade); (b) clinicians consulted; (c) uptake of treatment or surveillance; (d) whether he was given the PtDA; and (e) screening for decisional conflict (eg, SURE test31).

We sent a survey to nurses (5 in case 1, 2 in case 2a), urologists (10, 9), and radiation oncologists (7, 4) to assess their use of PtDA and the factors influencing its use when implemented within the prostate pathway. To enhance response rates, the Dillman approach was used, with reminders at 2, 4, and 5 weeks.36

We conducted 13 semistructured interviews with nurses, urologists, and radiation oncologists and 17 men diagnosed with prostate cancer (and/or their spouses) (Table 2). Men may or may not have been given the PtDA, had chosen various options (including surveillance), had a range of educational levels, worked mainly full-time, or were retired.

 

Measurement Instruments

For men who received the PtDA in the prostate pathways, the 4-item SURE test was used to screen for decisional conflict as part of clinical practice.31,37,38 The SURE test is a simple, inversely coded version of the original Decisional Conflict Scale. Previous evaluation of psychometric properties demonstrated content validity (correlated negatively with the original Decisional Conflict Scale scores) and good internal reliability (Cronbach α coefficients ranging from .78 to .92).38 The key constructs are certainty and modifiable factors influencing certainty (informed, clear values, and supported). The SURE test has previously discriminated between those who had/had not made a choice indicating construct validity and demonstrated moderate internal reliability (Cronbach α = .65 for English-speaking patients facing a range of treatment decisions in a study conducted in New Hampshire31 .78 in this study).

For the survey of factors influencing PtDA use in this context, the 12-item Continuing Professional Development Reaction Questionnaire was used. This questionnaire is based on the Theory of Planned Behaviour and when evaluated with physicians and residents in Quebec, Canada, demonstrated good internal reliability (Cronbach α = .79–.8939 .88 in this study). Added to this questionnaire were questions on potential environmental barriers influencing PtDA use. These questions were taken from the Barriers questionnaire used for assessing factors influencing implementation of innovations in clinical practice.40

Analysis

We developed cases with comparisons within and across the cases.25 For PtDA use, the proportion of men given the PtDA was calculated by case with 95% confidence intervals (CIs). We anticipated about 600 men diagnosed with localized prostate cancer over 2 years at the hospital prostate pathway (case 1) and 400 in the provincial pathway central north (case 2a). Using conservative estimates for proportions given the PtDA of 50% and 90% in case 1 and case 2, respectively, these sample sizes were adequate to estimate the true proportions given the PtDA with margins of error +4.0% in case 1 and +2.9% in case 2a using 2-sided 95% CIs. The characteristics and outcomes of patients who received and did not receive the PtDA were described using mean and standard deviation (or median and interquartile range) for continuous variables and frequencies and proportions for categorical variables. We categorized comorbidities according to the International Classification of Diseases diagnoses codes and weighted according to the Charlson index to obtain a single summary score. Differences between those who did and those did not receive the PtDA were tested using Student t (age, Gleason score, and Charlson index), χ2 (clinical stage), and Wilcoxon 2-sample (PSA level) tests.

Decisional conflict for those given the PtDA was described using mean and standard deviation. Uptake of treatment and type of clinician consulted were compared between those given and those not given the PtDA using frequency and proportions, with significance assessed using χ2 tests. For impact on clinician outcomes, we identified the remaining barriers influencing clinician PtDA use with the survey and interview data. To assess sustained use, we used visual inspection of observed rates of PtDA use over time, together with the fitted least square regression trendline. Transcriptions of taped interviews were analyzed qualitatively by 2 team members using thematic analysis.41

Results

We present a brief summary of the mixed-methods findings for each case and then compare findings between cases.

Case 1: Hospital Prostate Pathway

From January 2011 to December 2012, there were 688 men with localized prostate cancer in case 1, of whom 158 (23%; 95% CI, 19.8%–26.1%) received the PtDA (Figure 1;Table 3). Over 2 years, there was a consistent pattern of PtDA use (Figure 1). Men who received the PtDA were, on average, 61 years old and had a PSA level of 4.2, a total Gleason score of 7, primarily clinical stage T1c, and a mean Charleson index of 2.20. Compared with men who did not get the PtDA, men who received the PtDA were statistically significantly younger and had lower total Gleason scores. In the interviews, nurses indicated that they had a database of who received the PtDA but “we didn't track them that well” and “it gets overlooked if someone's covering in the clinic.”

 

Men's Experiences Using the PtDA

In the interviews, men described getting a “wheelbarrow full of information” from the nurses and not knowing what the PtDA was. One radiation oncologist said, it was “not usually completely obvious right from the get-go whether they've received this PtDA or not.” When men received the PtDA, themes from interviews were as follows: men were receptive, more likely to consider all options in a balanced way, better informed, more understanding of side effects, shared the PtDA with others, and had time to think about their options (Table 4). Men reported a poor response from some radiation oncologists when referring to the PtDA or asking for decision-making advice.

 

Impact on the Consultation

Some urologists and radiation oncologists described an easier consultation with less need for “education required in my consultation” (urologist). Alternatively, some clinicians described providing the same information, as indicated by 1 radiation oncologist: “I would discuss in detail their radio-therapeutic management options…standard part of the visit regardless of whether or not they've received a decision aid.” One nurse said, when they noticed men “really struggling with their decision, we can bring them back for a nurse-only visit.” Some clinicians appreciated the 1-page preference report: “2 most important aspect of it are the patient's preference and then the values” (urologist). In the administrative data, the PtDA and 1-page summary report were available for only 82 patients (12%).

Impact on Men's Decisional Conflict

After using the PtDA, and before discussing treatment options with the urologist or radiation oncologist, the SURE test, completed by 82 patients, showed that more than 80% felt informed (n = 66, 82%), clear about their values (n = 66, 81%), and supported (n = 65, 80%), but only 48 (59%) felt sure of the best option (Table 3). Half (n = 40, 49%) had total SURE test scores indicating that they were at risk of clinically significant decisional conflict.

Impact on the Healthcare System

Patients who received the PtDA, compared with those who did not, were statistically significantly more likely to have a consultation with a radiation oncologist (P < .0001; Table 3). Use of a PtDA was significantly associated with increased uptake of surgical treatment. When patients used the PtDA, urologists described the visits as “streamlining your practice” and more efficient because “they take it home, they look it over, and when they come back, this is done…doesn't really slow anything down.”

Factors Influencing Sustained Use

The survey of healthcare professionals indicated high intentions to continue using PtDAs, and they had moderate to high beliefs about their capabilities, moral norms, and beliefs about the consequences of using them (Table 5). There was moderate social influence. Environmental factors were rated as having high support from the organization and colleagues with adequate access to PtDAs. The main barrier identified was time. Interview findings revealed themes interfering with sustained use: not all physicians are on board, loss of momentum since initial implementation, PtDA issues (eg, limited supply, English only, and American origin), need for an online PtDA, and PtDA needs to be the norm for use with all men diagnosed with localized prostate cancer across the health region rather than limited to those who come through the prostate cancer assessment centre the hospital (Table 6). Another suggestion was to have a video PtDA for men having lower literacy, similar to the PtDA used in 2010 before it became outdated.

 

Case 2: Provincial Prostate Pathway

In May 2013, the Provincial Prostate Pathway committee released the new clinical pathway for localized prostate cancer in [name of province], and the pathway includes a PtDA given to men newly diagnosed with localized prostate cancer (Table 1). This pathway was implemented in the academic teaching hospital serving central and north regions (case 2a), but not in the academic teaching hospital that provided prostate services for the south of the province (case 2b). As a result, none of the men were given the PtDA and no further data are available for case 2b. After data collection was completed, case 2b hired a registered nurse in the Prostate Assessment Centre to be able to implement the pathway being used in case 2a and men newly diagnosed with prostate cancer are supposed to receive the PtDA routinely within the prostate pathway.

PtDA Use

From January 2014 to December 2015, in case 2a, there were 270 men with localized prostate cancer, of whom 265 (98%; 95% CI, 96.5%–99.8%) received the PtDA (Figure 1;Table 3). Over 2 years, there was a consistent pattern of PtDA use, although there was some evidence of a decline in the volume used over time (Figure 1). Because only 5 men did not receive the PtDA, no statistical significance analysis was done between those with and those without the PtDA. Men who received the PtDA were, on average, 63 years old and had PSA of 7.9, a total Gleason score of 7, primarily clinical stage T1c, and a mean Charlson index of 2.19.

Men's Experience Using the PtDA

Men had positive experiences (Table 4). Themes arising from the interviews were as follows: men were open to PtDAs, were more likely to consider all options in a balanced way, were better informed, were more understanding of the side effects, shared the PtDA with others, had time to think about their options, and they were stimulated to learn more. Some men liked getting all the information and then “did a lot of research on the Internet, got books out of the library.” Another man said it was “really overwhelming with the volume of information we were given right off the bat…better to have 2 to 3 sessions and sort of reinforce things.” There was consistent information provided for all patients and across the various sources. One patient said, “there wasn't any more information there [Provincial health website] than the nurse had already shared with me.”

Impact on the Consultation

Some urologists and radiation oncologists described having to change their approach to discussing treatment. One radiation oncologist stated, “I build on the discussion that was done by the nurse navigator.” “I find it quite different because we used to have a long spiel about…all the different options…but now the discussion is much more unstructured, more specific than in the past [and] it's a bit more in-depth” (urologist). Some physicians do not change their “spiel,” as indicated by a patient who said, “with the cancer doctor…it was basically just to go over everything again…he didn't really need to explain the 3 different options I had. I knew all that.” The nurses' role on the team evolved: “First, we started just learning about doing the discussion to teach the patients about the options. And then we started taking over the role of giving the results.”

Impact on Men's Decisional Conflict

After using the PtDA and discussing treatment options with the urologist and/or radiation oncologist, the SURE test was available for 201 men. Results showed that more than 95% felt informed (n = 198, 99%), clear about their values (n = 196, 98%), supported (n = 196, 98%), and sure of the best option (n = 194, 97%) (Table 3). Total SURE test scores (n = 192, 96%) indicated that only 9 men were at risk of clinically significant decisional conflict. Almost all men (n = 258) had agreement between their preferred and actual choice (96.6%; 95% CI, 94.5–98.8).

Impact on the Healthcare System

Patients were almost equally likely to see the urologist (n = 196, 73%) or radiation oncologist (n = 188, 70%) (Table 3). Treatments were split among surgery (n = 70, 26%), radiation therapy (n = 60, 22%), brachytherapy (n = 85, 31%), and active surveillance (n = 49,18%). Although the intervention requires time for the nurses to deliver the PtDA coaching intervention, it is also described as “a timesaver for me because I will really just focus my discussion” (urologist). A radiation oncologist and urologist suggested that, ideally, they should be colocated so the patient can see them “at the same time.”

Factors Influencing Sustained Use

The survey of healthcare professionals indicated high intentions to continue using PtDAs and they had strong positive beliefs about their capabilities, moral norms, social influences, and beliefs about the consequences of using them (Table 5). Known environmental factors were rated as having high level of support from the organization and colleagues with adequate access to the PtDAs. The only barrier was time, described by 1 nurse as “we don't always have that extra time to contact and reach out you know support them.” Interview themes related to sustained use were to have the prostate pathway with the PtDA implemented across the province (Table 6). More specifically, “the whole idea is to have something across the province but you have a pathway for [case 2a], and a pathway for [case 2b] that completely defeats the purpose” (radiation oncologist). Another suggestion was to inform family physicians about directly referring patients into the prostate pathway rather than to community urologists. Specific to the PtDA were to have the opportunity to review and update the evidence every 6 months and to consider developing a video-based version for those with low literacy.

Case Comparisons

The following describes the comparison across the cases (Tables 1–35, and 6).

 

PtDA use was lower in case 1 compared to case 2a (23% vs 98%) and they were not used at all in case 2b (Table 3). In case 1, access to the PtDA depended on the urologist notifying the nurse, then the nurse had to locate a hardcopy of the PtDA and subsequently monitored that patients returned copies of the PtDA. Three key factors unique in the way PtDAs were integrated in the prostate cancer pathway for case 2a were (a) an automatic delivery of the PtDA by e-mail when patients were notified of the biopsy results, (b) one-on-one meeting with the nurse to review the PtDA, and (c) an electronic version of the PtDA that could be easily sent to patients.

Men's experiences using the PtDA were positive in both case 1 and case 2a. The only negative experience reported in case 1 was men trying to discuss decision making with some radiation oncologists. Impact on the consultations varied by clinicians within the cases, with some changing their approach to discussing options in the consultation whereas others continued their usual approach. In case 1, some physicians did not agree that PtDAs should be used and these men were not given PtDAs. One reason is they disagreed with the probabilities presented in the PtDA. To improve urologists' awareness of their patients' actual outcomes in case 1, they recently started receiving report cards every 3 months with incidence and severity of erectile dysfunction and incontinence. Radiation oncologists in case 2a were concerned about the nurses discussing radiation therapy in the coaching session. However, rates of radiation therapy in patients who received the PtDA were similar between cases 1 and 2a (20% and 22%, respectively).

Impact on men's decisional conflict was measured to be lowest after using the PtDA and having seen the urologist and/or radiation oncologist (>95% case 2a). When measured after the PtDA only, half continued to experience decisional conflict (51% case 1).

Impact on the healthcare system to ensure appropriate use of healthcare resources was unclear in case 1. Men who received the PtDA, compared with those who did not, were younger and significantly more likely to have a consultation with the radiation oncologist; some would argue that this would have allowed men to hear directly from both specialists. In case 2a, the PtDA seemed to have a positive impact on appropriate use of health system resources based on patient preferences: almost all men received the PtDA and 97% of them achieved agreement between their preferred and actual treatment.

Factors influencing sustained use differed across cases. In case 1, despite high intentions among clinicians who responded to the survey, barriers interfering with PtDA use for all patients were the limited access to the PtDA and the need for urologists and radiation oncologists to agree that the PtDA is part of the prostate cancer pathway. In case 2a, the survey and interviews indicated high intentions to continue using the PtDA and no strong barriers interfering with its use. However, there were concerns about not having a consistent provincial approach.

Discussion

 

Our comparative case study evaluated the natural implementation of PtDAs in 2 prostate cancer pathways in 2 different Canadian provinces. Administrative data indicated that the PtDA was given to less than a quarter of men with localized prostate cancer in case 1, and despite the PtDA being in the provincial pathway for case 2, the pathway was implemented in nearly all men in case 2a but was not implemented at all in case 2b. Overall, there was a positive impact on patients who used the PtDA. The use of the health system resources seemed to be consistent with patient preferences in case 2a. There was mixed impact on clinicians. Sustained use depended on the acceptability of the PtDAs to clinicians and how well the PtDA was integrated into routine clinical processes. There is the need for a PtDA that is more easily accessible in case 1, and a Canadian online PtDA is now available.42,43 Our results lead us to make 3 main observations.

First, the PtDA had a positive impact on patients, clinicians who agreed with the use of PtDAs, and health system resources, as indicated by more consistent use of resources and informed patient preferences. Patients in case 2a had a low likelihood of experiencing clinically significant decisional conflict after using a PtDA and consulting with the clinician(s) and half the patients in case 1 screened positive for decisional conflict immediately after using the PtDA that was consistent with trials evaluating PtDAs compared with usual care.16 Previous studies have shown that the PtDA is expected to improve elements of decisional conflict (eg, patients feeling informed, sure about their values, and supported), but they felt sure only after seeing the surgeon.44

The SURE test is an easy-to-deliver 4-item questionnaire used to screen for decisional conflict in clinical practice.37 At both sites, it was used to monitor for patients' level of decisional conflict and it could be used to establish more specific strategies to address their remaining decisional needs.

Second, working collaboratively as an interprofessional team is more challenging when not colocated. In both programs, the urologists and nurses in the prostate programs were colocated, but the radiation oncologists were located separately in the associated ambulatory oncology centers. There seemed to be tension and lack of trust from radiation oncologists about the information on treatment options as presented in the PtDAs and discussed by the nurses. Our findings were consistent with the systematic review of implementation of PtDA in clinical practice that showed confidence in PtDA content as a barrier to implementation.19 Administrative data from case 1 showed that patients who received the PtDA compared with those who did not had significantly more consultations with radiation oncologists (80% vs 56%). However, case 1 patients expressed concern about some radiation oncologists explicitly stating that it was not their role to support patients with making the decision. In case 2a, there were some concerns about information provided by the nurses who worked collaboratively with the urologists. Previous research showed that respecting and understanding roles and having appropriate resources and procedures are 2 of the key principles of good interdisciplinary team work.45 However, these principles are supported by having structures for team members to work from the same location. In fact, there might be higher success with implementation of shared decision making when clinical teams are trained together in shared decision making.46 Hence, to improve uptake of PtDAs for men with localized prostate cancer, the full team needs to agree on the PtDA being implemented and participate in training as a team.

Third, this study helps inform the debate on the value of bottom-up (initiated by clinicians) or top-down (initiated by policy makers) implementation approaches. In case 1 (bottom-up only), a smaller team obtained internal grant funding to review available PtDAs, rated them against the international quality standards, and selected one relevant to their patient population.28 They started using the PtDA without any formal implementation strategy or extra funding. Interviews as part of this retrospective evaluation study revealed the need for integrating the use of PtDAs and the prostate pathway into the Prostate Community of Practice for the regional healthcare authority.47 As such, all urologists would be expected to use the PtDA within the pathway at the time when patients receive their diagnosis. Case 2a is an example of both: a urologist and a nurse from this location were on the provincial strategy to establish the prostate pathway and then they championed the implementation within their own healthcare facility. However, there was no success with implementing the pathway in case 2b (top-down only). This finding is consistent with evidence indicating the need to have strong leadership support for successful implementation of innovations in clinical practice.48,49

There are several strengths and limitations that should be considered when interpreting the findings. The administrative data for case 1 may not adequately represent the number of patients who actually were given the PtDA. It is likely that more patients were given the PtDA. As such, more efficient mechanisms are required for capturing key clinical data that is innovatively used for informing practice. Furthermore, it is unclear why patients in case 1 who received the PtDA were younger and were more likely to have a consultation with a radiation oncologist than those who did not receive the PtDA. Further evaluation is required to better understand these differences. In case 2b, it was unclear exactly why the prostate pathway was not implemented, but there were some comments from men interviewed who belonged to the prostate support group that the clinicians in case 2b did not support the use of the PtDAs. The response rate on the clinician survey was 57%, and overall, participants had positive intentions, beliefs, and attitudes about using PtDAs. In the interviews, the comments of participants indicated that not all physicians agreed with using the PtDAs. It is possible that we had social desirability bias and/or only those who supported use of PtDAs who responded to the survey. A strength of our study was the use of mixed methods using administrative data, qualitative data from interviews, and surveys allowing us to triangulate findings across sources.

Conclusions

Using natural implementation processes, this study demonstrated some use of PtDAs in case 1 and mixed uptake for the province of case 2, with almost 100% uptake in case 2a and 0% uptake in case 2b. The site with the highest uptake had an electronic version of the PtDA that was routinely sent by e-mail (or postal mail) to all patients when they were informed of their biopsy results and they were booked for an appointment to review PtDA with a nurse. The site with limited uptake of PtDAs had urologists with mixed views on their willingness of giving their patients a PtDA, inconsistent scheduling of nurses that interfered with nurses providing the PtDA, and use of a hardcopy PtDA that was loaned to the patients. In both cases, there was a positive impact on patients, without any harms identified.

Our study contributes to the current evidence supporting the implementation of PtDAs in clinical practice. Our findings reinforce the importance of having clear articulation of roles and responsibilities when integrating the PtDA into the process of care and ensuring easy access to the PtDA. Our study also indicates the need to have full support of all team members from program administrators to healthcare professionals responsible for involving patients in treatment decisions. Further research is required to understand why there were differences between patients given the PtDA and those who were not.


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