Purpose: IPDAS developed an instrument (IPDASi) to assess the quality of patient decision aids (PDAs). There have been calls in the US for these tools to be certified. The aims were to: (1) correlate IPDASi scores with outcome measurements in RCTs (included in Cochrane systematic review of PDAs); (2) conduct a Delphi consensus process for expert agreement on minimum standards for PDAs, based on IPDASi items.

Method: Aim 1: The PDAs were included if the RCT measured at least one of the following outcomes: knowledge, accurate risk perceptions, preference congruence with choice (attributes of decision), participation in decision-making or satisfaction with decision-making process (attributes of decision process). IPDASi quality scores were produced (two independent raters per PDA). Correlation analyses were conducted between adjusted mean global IPDASi scores and effect sizes. Aim 2: Two-stage Delphi voting process considered the inclusion of IPDASi items as minimum standards. Item mean scores and qualitative comments were analysed, followed by expert multidisciplinary group discussion.

Result: Aim 1: 31 PDAs were included in the sample, 26 were accessible for evaluation. A significant correlation was found between quality scores and accurate patient risk perceptions (rho = 0.8, p = 0.02). No other correlations were significant, but the positive direction of all but one outcome correlation provides support for the view that PDA quality scores, as judged by IPDASi, is associated with better outcomes in RCTs. Aim 2: 101 people voted in round 1; 87/101 (88%) voted in round 2. The 47 items in IPDASi v3.0 were reduced to 45 items (3 items combined) and were placed in three categories, namely: qualifying criteria (6 items); certification criteria (11 items) and quality criteria (28 items). The following operationalisation was adopted: 1) qualifying criteria would be assessed on a binary (yes or no) scale; to qualify, i.e. be considered for certification, tools should meet all these 6 criteria; 2) certification criteria would be scored on a 4-point Likert (agreement) scale and tools should score positively to meet a certification threshold (minimum standards); 3) quality criteria would be scored on a 4 point Likert (agreement) scale.

Conclusion: To ensure ‘fitness for use’ and for the protection of patients, this study provides minimum standards criteria for PDAs, standards that need to be tested and ratified.

Purpose: The decision about whether to perform or not perform a gastric fundoplication has enormous clinical and cost implications. Children who are having a gastrostomy procedure are often considered candidates for fundoplication, yet there is no clinical consensus as to who needs a fundoplication.  Our purpose was to examine subjective and objective factors influencing the decision of pediatric surgeons to perform or not perform a gastric fundoplication in children undergoing a gastrostomy procedure.

Method: A pre-operative self-administered 34 item questionnaire on objective and subjective decisional influences was completed by the attending pediatric surgeon on two groups of patients:  those having a gastrostomy with a fundoplication, and those having a gastrostomy without a fundoplication.  All six surgeons who perform fundoplication at a major children’s hospital participated.

Result: From July 1, 2009 through June 30, 2010, 169 patients met eligibility criteria and 161 surveys (95%) were completed. The mean age of the patients was 2.9 years (median=0.8 years), 59% were male, 57% had Medicaid, and 62% were neurologically impaired. Of the cohort, 66% were referred as an inpatient, and >50% had at least two pediatric subspecialists involved in their care. For 86% of cases the surgeons reported that the input of another physician had somewhat or a lot of influence on their decision about fundoplication. Specifically, they mentioned the input of several pediatric specialists: Neonatologists (24%), Hospitalists (25%), Pulmonologists (18%), Primary Care Physicians (16%), and Gastroenterologists (9%). The opinion of parents contributed somewhat or a lot to the decision 72% of the time. Among the 89% of the cohort that had an upper GI contrast study, surgeons stated that the results had a lot of influence 45% of the time. Multivariable logistic regression showed the following factors were associated with the patient receiving a fundoplication, involvement of a pulmonologist (OR 1.7, 95% CI: 1.1-2.6), neonatologist (OR 1.9, 95% CI: 1.3-2.9) and PCP (OR 0.6, 95% CI: 0.4-0.9).

Conclusion: Most decisions to perform a fundoplication occur in the inpatient setting and are impacted by a variety of objective and subjective factors, most notably the opinions of other physicians. The high level of input that pediatric subspecialists have on the decision and the patterns of referral to the surgeons have important implications for the development and implementation of a shared decision making tool.

Purpose: Considerable scholarship has focused on physician communication skills for shared decision making, but little is known about why patients are sometimes reluctant to engage in a collaborative dialogue with physicians.

Method: An online panel of respondents (N=1,340; Mean age = 56.5, SD=9.9) read a vignette describing a treatment decision making scenario focused on moderate coronary artery disease. The vignette emphasized that three treatment options exist with equivalent long-term mortality outcomes.  Respondents answered theory-based questions, building on Fishbein’s Integrative Model, focused on three key communication behaviors that facilitate shared decision making: (1) asking questions, (2) discussing preferences and (3) disagreeing with a recommendation. The first two are necessary for exchanging information. We asked about “disagreeing with a recommendation” as a potentially necessary assertive behavior if a physician’s recommendation is incongruent with patient preferences.  Questions focused on respondents’ intention to engage in these behaviors in response to the scenario, their beliefs about the likely outcomes of doing so, and who would approve or disapprove of these actions. Data were analyzed with analysis of variance.

Result: Respondents had significantly lower intentions to disagree with a recommendation not congruent with their preferences (M=3.1, SD=1.5) than to ask questions (M=6.5, SD=.95) or discuss preferences (M=6.5, SD=.92; p<.0001).  Intentions to disagree were highest among those indicating a preference for autonomous decision making (p<.0001). Intentions to ask questions (p<.003) and discuss preferences (p<.0001) were highest among those indicating a preference for shared decision making. Disagreeing was perceived as more likely to result in the physician viewing the patient as “difficult” (p<.0001), harming the therapeutic relationship (p<.0001), and lowering the likelihood of getting the “treatment that results in outcomes I prefer” (p<.0001).  Respondents indicated that medical staff would be less likely to approve of asking questions (p<.0001), discussing preferences (p<.0001) or disagreeing with a physician (p<.0001) than spouses, family members or friends.

Conclusion: Results from this survey indicate that patients have little difficulty envisioning exchanging information with their physicians, but are much less likely to envision disagreeing with a preference incongruent recommendation.  Paradoxically, respondents felt that disagreeing would lower the likelihood of getting their preferred treatment.  Combined with the perception that medical staff are less supportive of active patient communication, these results provide evidence of considerable medical-cultural barriers to shared decision making.

Purpose:    It is widely recognized that use of decision aids (DAs) and decision support in clinical practice results in greater knowledge, participation in decision making, and decision comfort for patients.  To increase patient engagement and effective self-care at MMC Medical Clinic, which serves a vulnerable multicultural, multilingual population (49% Medicaid, 9% Medicare, 16% dual eligible, 16% free care; >30% refugee/ESL), we implemented a collaborative shared decision making (SDM) program.

Method:    Primary care providers partnered with an onsite Learning Resource Center (LRC) health educator to order DVD-based decision aids (DAs) in an effort to: (1) inform patients regarding screening, treatment, and self-care options for selected conditions; and (2) create a structured SDM process to elicit patient values and preferences regarding these options.  Following referral of patients to the LRC, the SDM-trained health educator provided one-on-one encounters for DA viewing and decision support regarding diabetes, prostate and colorectal cancer screening, back pain, and depression.  The SDM process included identification of eligible patients; creation of an electronic DA order enabling the health educator to contact consenting patients; an approximately one-hour DA viewing consult with the educator and sometimes an interpreter; completion of DA pretests and posttests; and documentation of the LRC encounter.  Pretest and posttest data were gathered beginning in July 2010, and were used to identify key follow-up issues and assess patient satisfaction with the SDM process.

Result:

	MMC Clinic (n=45 patients)	All SDM pilot practices (n=154 patients)
Less than HS education	27%	12%
Watched all of DA DVD	87%	62%
DA perceived as “very/extremely useful” for clarifying values	73%	54%
Change in certainty about health care decisions: before and after SDM	18% → 59%	26% → 47%
“Very/extremely important” for providers to give DAs to patients	87%	64%

Conclusion:    Our experience shows that primary care providers, health educators, and interpreters can work together to engage “hard to reach” multicultural, multilingual populations in shared decision making.  Despite challenges to integrating SDM into routine clinical practice including systematic identification of patients to use DAs, efficient tracking and sharing of SDM process data, and limited provider time for quality improvement activities, we recommend that providers who care for multicultural populations adopt innovative SDM strategies to ensure that patients’ values and preferences are central to health care decision making.

Purpose:   To identify facilitators and barriers to implementing shared decision making (SDM) in primary care.

Method:   We conducted 23 semi-structured interviews with leaders and clinicians from nine primary care practice sites participating in a current SDM implementation demonstration.  Using a guide developed with input from demonstration conveners, interviewers queried respondents about their sites’ processes for integrating decision aids (DAs) into ongoing clinical operations, focusing on facilitators and barriers to operational tasks such as engaging clinicians, distributing DAs, and tracking patients through subsequent steps of SDM.  Researchers inductively analyzed interview responses for recurrent themes.

Result:   Facilitators.   All respondents reported that SDM was consistent with their sites’ professional cultures, and most identified “champions” who engaged other clinicians in DA use.  To facilitate DA distribution, some sites developed protocols that empowered non-physician staff: “The most successful sites…developed workflows that take the physician out of making the decision [about DA distribution].”  To identify DA-eligible patients, these sites leveraged existing data (e.g., patient demographic characteristics, for screening decisions) and clinical processes (e.g., specialist referrals, for surgical decisions).  When identifying DA-eligible patients required case-by-case physician judgment, single-click DA order entry and DA viewing by physicians facilitated greater distribution.  Barriers.   Physicians’ lack of prior SDM training was a barrier to participation: “Physicians felt that they were already doing shared decision making [before introducing DAs].”  Physician DA ordering, though sometimes necessary for patient identification, limited distribution in multiple sites: “As long as you have the physicians in the middle of [DA ordering] they have too many other things on their plate to reliably ensure this would happen every time…in a 10-15 minute appointment.”  Medical record systems (paper or electronic) posed significant barriers to tracking patients through the SDM process.  For example, nearly all sites’ records lacked indicators for which patients had received DAs, mechanisms for communicating patient-reported values and preferences, and registry functions to follow patients' progress towards their decisions (e.g., to determine whether patients had timely post-DA decision making conversations with providers).

Conclusion:   Even among highly motivated demonstration sites, there are significant educational, operational, and informatics challenges to implementing SDM in primary care.  Empowering non-physicians may enhance distribution reliability for some DAs.  However, improving post-DA follow-through may require better mechanisms for tracking patients and facilitating information exchange between patients and clinicians.

Purpose: 1) to explore variations in patient-physician conversations about colorectal cancer screening modality preferences and screening modality recommendation by their physician during an annual well visit; 2) to determine whether patients’ intent to follow up on a colorectal cancer screening recommendation is associated with patients’ preferred screening modality and physician recommendations.

Method: Eligible patients were aged 50-80, insured, and due for colorectal cancer screening at a scheduled well visit with an internal or family medicine physician practicing in Southeast Michigan. Study enrollment included a pre- and post-visit interview and office visit audio-recording. Enrolled patients’ (N=415) colorectal cancer screening modality preferences were identified using attribute rankings in the pre-visit interview. Self-reported intent to follow up on screening recommendation was evaluated with a post-visit interview (N=361). 

Result: At baseline 48% of patients indicated a preference for colonoscopy, 30% for FOBT, and 22% had no clear preference. Most (69%) expressed a preference for a shared decision-making approach to colorectal cancer screening. However during the visit only 14% of patients expressed a clear colorectal cancer screening test preference to their physician, and this preference was generally for FOBT (70% of those who expressed a preference). In cases where patients expressed preferences for either FOBT or colonoscopy, these preferences were acknowledged by the physician 93% of the time. The most recommended test by physicians was colonoscopy; it was discussed in all visits, and recommended in 99% of visits. A test other than colonoscopy was mentioned in 47% of visits and recommended in 30% of visits; this other test was most often FOBT. When multiple screening modalities were discussed during the appointment, physicians typically (70% of these visits) offered the patients a choice among them. Following their appointment, an overwhelming majority (95%) of patients reported they were likely to follow up on the screening recommendation. Patient modality preferences and physician modality recommendations were not associated with the intent to be screened, possibly due to a ceiling effect.   

Conclusion: Patients continue to have preferences for different colorectal cancer screening options. On the other hand, physicians appear to be overwhelmingly recommending colonoscopy screening, despite their willingness to acknowledge patient modality preferences if they are raised during appointments. Further efforts to encourage patients to clarify their preferences may improve colorectal cancer screening decision making.