A bundle of opioid-sparing strategies (BOSS) to eliminate routine opioid prescribing in a urogynecology practice.

BACKGROUND: Current evidence supports that many patients do not use prescribed opioids following reconstructive pelvic surgery, yet it remains unclear if it is feasible to eliminate routine opioid prescriptions without a negative impact on patients or providers. OBJECTIVE: To determine if there is a difference in the proportion of patients discharged without opioids after implementing a bundle of opioid-sparing strategies and tiered prescribing protocol (BOSS) compared to usual care after minimally invasive pelvic reconstructive surgery (transvaginal, laparoscopic or robotic). Secondary objectives include measures of patient-perceived pain control and provider workload. STUDY DESIGN: The BOSS intervention was implemented as a division-wide evidence-based practice change on August 1, 2022. This retrospective cohort compares a 6-month post-intervention (BOSS) cohort to 6- month pre-intervention (usual care) of patients undergoing minimally invasive pelvic reconstructive surgery. A 3-month wash out period was observed after BOSS initiation. We excluded patients <18 years, failure to consent to research, combined surgery with other specialties, urge urinary incontinence or urinary retention procedures alone, and minor procedures not typically requiring opioids. Primary outcome was measured by proportion discharged without opioids and total oral morphine equivalents (OME) prescribed. Pain control was measured by pain scores, post-discharge prescriptions and refills, phone calls and visits related to pain, and satisfaction with pain control. Provider workload was demonstrated by phone calls and post-discharge prescription refills. Data were obtained through chart review on all patients who met inclusion criteria. Primary analysis only included patients prescribed opioids according to the BOSS protocol. Two sample t tests compared continuous variables and chi-square tests compared categorical variables. RESULTS: 416 patients were included in the primary analysis (207 BOSS, 209 Usual Care). Baseline demographics were similar between groups, except a lower proportion of IBS (13% vs 23%; p<0.01) and pelvic pain (15% vs 24.9%; p=0.01), and higher history of prior gynecologic surgery (69.1% vs 58.4%; p=0.02) in the BOSS cohort. The BOSS cohort was more likely to be discharged without opioids (68.1% vs 10.0%; p<.01). In those prescribed opioids, total OME on discharge was significantly lower in the BOSS cohort (48.1 vs 81.8; p<.01). The BOSS cohort had a 20.6 greater odds (CI 11.4, 37.1) of being discharged without opioids after adjusting for surgery type, arthritis/joint pain, IBS, pelvic pain, and contraindication to NSAIDs. The BOSS cohort was also less likely to receive a rescue opioid prescription after discharge (1.4% vs 9.5%; p=0.03). There were no differences in opioid prescription refills (19.7% vs 18.1%; p=0.77), emergency room visits for pain (3.4% vs 2.9%; p=0.76), postoperative pain scores (mean 4.7 vs 4.0; p=0.07), or patient satisfaction with pain control (81.5% vs 85.6%; p=0.21). After BOSS implementation, the proportion of postoperative phone calls for pain also decreased (12.6% vs 21.5%; p=0.02). Similar results were identified when non-adherent prescribing was included in the analysis. CONCLUSIONS: A bundle of evidence-based opioid sparing strategies and tiered prescribing based on inpatient use increases the proportion of patients discharged without opioids after minimally invasive pelvic reconstructive surgery without evidence of uncontrolled pain or increased provider workload.

Maternal COVID-19 vaccination status and association with neonatal congenital anomalies.

Introduction: Despite recommendations for COVID-19 vaccination in pregnant people, the effect of vaccination on neonatal outcomes remains unknown. We sought to determine the association between COVID-19 vaccination status in pregnancy and presence of neonatally diagnosed congenital anomalies. Methods: A comprehensive vaccine registry was combined with a delivery database to create a cohort including all patients aged 16-55 years with a delivery event between December 10, 2020 and December 31, 2021 at a hospital within the Mayo Clinic Health System. Pregnancy and neonatal outcomes were analyzed in relation to vaccination status and timing, including a composite measure of congenital anomalies diagnosed in neonatal life. Comparisons between cohorts were conducted using chi-square test for categorical and Kruskal-Wallis test for continuous variables. A multivariable logistic regression was modeled to assess the association with congenital anomalies. Results: 5,096 mother-infant pairs were analyzed. A total of 1,158 were vaccinated, with 314 vaccinated in the first trimester. COVID-19 vaccination status, including vaccination during the first trimester of pregnancy, was not associated with an increased risk of composite congenital anomalies. When further examining congenital anomalies by organ system, we did demonstrate a significant difference in eye, ear, face, neck anomalies between vaccinated and not vaccinated groups (Table 3, Not vaccinated = 2.3%, Vaccinated = 3.3%, p-value 0.04) however we did not demonstrate this difference between the 1st trimester and not vaccinated groups (Not vaccinated = 2.3%, 1st Trimester = 2.5%, p-value 0.77). No differences were found between not vaccinated, vaccinated, or 1st trimester vaccinated groups for any other organ systems. There were no differences in birthweight by gestational age, APGAR scores, incidence of NICU admission, or living status of the neonate by vaccination status. Conclusion: We add additional information regarding the safety of COVID-19 vaccination status and timing as it pertains to neonatal composite congenital anomalies, with no association demonstrated. Our findings agree with prior literature that COVID-19 vaccination is not associated with adverse pregnancy outcomes or small for gestational age neonates. Further research is needed to elucidate the association between COVID-19 vaccination and eye, ear, face, neck, anomalies.

Patient Characteristics and the Extent to Which Clinicians Involve Patients in Decision Making: Secondary Analyses of Pooled Data.

BACKGROUND: The occurrence of shared decision making (SDM) in daily practice remains limited. Various patient characteristics have been suggested to potentially influence the extent to which clinicians involve patients in SDM. OBJECTIVE: To assess associations between patient characteristics and the extent to which clinicians involve patients in SDM. METHODS: We conducted a secondary analysis of data pooled from 10 studies comparing the care of adult patients with (intervention) or without (control) a within-encounter SDM conversation tool. We included studies with audio(-visual) recordings of clinical encounters in which decisions about starting or reconsidering treatment were discussed. MAIN MEASURES: In the original studies, the Observing Patient Involvement in Decision Making 12-items (OPTION12 item) scale was used to code the extent to which clinicians involved patients in SDM in clinical encounters. We conducted multivariable analyses with patient characteristics (age, gender, race, education, marital status, number of daily medications, general health status, health literacy) as independent variables and OPTION12 as a dependent variable. RESULTS: We included data from 1,614 patients. The between-arm difference in OPTION12 scores was 7.7 of 100 points (P < 0.001). We found no association between any patient characteristics and the OPTION12 score except for education level (p = 0.030), an association that was very small (2.8 points between the least and most educated), contributed mostly by, and only significant in, control arms (6.5 points). Subanalyses of a stroke prevention trial showed a positive association between age and OPTION12 score (P = 0.033). CONCLUSIONS: Most characteristics showed no association with the extent to which clinicians involved patients in SDM. Without an SDM conversation tool, clinicians devoted more efforts to involve patients with higher education, a difference not observed when the tool was used. HIGHLIGHTS: Most sociodemographic patient characteristics show no association with the extent to which clinicians involve patients in shared decision making.Clinicians devoted less effort to involve patients with lower education, a difference that was not observed when a shared decision-making conversation tool was used.SDM conversation tools can be useful for clinicians to better involve patients and ensure patients get involved equally regardless of educational background.

Effect of Anti-TNF Biologic Exposure During Pregnancy on Villitis of Unknown Etiology Diagnoses in Patients with Autoimmune Disease.

Tumor necrosis factor-α (TNF-α) antagonists are highly effective in controlling autoimmune diseases. This has led to speculation that they might also be useful in treating inflammatory placental conditions, such as chronic villitis of unknown etiology (VUE). VUE affects 10-15% of term placentas and is associated with recurrent fetal growth restriction (FGR) and pregnancy loss. We aimed to evaluate outcomes in patients with autoimmune diseases with and without anti-TNF-α biologic exposure during gestation. This retrospective cohort study compared pregnant women with autoimmune disease taking anti-TNF-α biologics (n = 89) to pregnant women with autoimmune disease but not taking a biologic (n = 53). We extracted data on all patients meeting our inclusion criteria over a 20-year period. Our primary outcome was the diagnosis of VUE by histology. Our secondary outcomes were maternal and neonatal complications such as preeclampsia, FGR, and neonatal intensive care admission. Kruskal-Wallis and chi-squared tests were performed as appropriate for statistical analysis. Maternal characteristics were comparable between groups, and there was no increase in adverse pregnancy outcomes based on anti-TNF-α treatment. Exposure to anti-TNF-α therapy had no significant effect on the incidence of VUE or other obstetric complications. Within the cohort exposed to anti-TNF-α biologics during pregnancy, the rate of VUE was 9.3%, which is comparable to the reported general population risk. Our data support the safety profile of biologic use in pregnancy.

Maternal Factors and Placental Pathologies Associated with a Diagnosis of Chronic Villitis.

OBJECTIVE: To evaluate maternal risk factors associated with chronic villitis of unknown etiology (VUE) and to describe cooccurring placental pathologies. STUDY DESIGN: A retrospective case-control study was conducted using placental pathology records from deliveries ≥ 20 weeks between 2010 and 2018. Cases were placentas with documented chronic villitis without infectious cause, hereafter called VUE. Controls were placentas without this diagnosis, matched to the cases 2:1. Maternal and neonatal demographic and clinical data were collected. Descriptive statistics are reported with Fisher's exact test or a chi-squared test, as appropriate, and multivariable conditional logistic regression was conducted. RESULTS: Our study included 352 cases with VUE and 657 controls. A diagnosis of gestational diabetes (p = 0.03) and gestational hypertension (p = 0.06) was 1.5 times more likely to occur in those with a VUE diagnosis. A trend was also seen for chronic hypertension (odds ratio [OR] = 1.7, p = 0.07) and preeclampsia (OR = 1.5, p = 0.09) compared with controls. Placentas with VUE, specifically high-grade VUE, were more likely to be small for gestational age (p = 0.01), and to be diagnosed with other placental findings including lymphoplasmacytic or chronic deciduitis (p < 0.01), maternal (p < 0.01) and fetal vascular malperfusion (p = 0.02), and chorionitis (acute or chronic; p < 0.01). CONCLUSION: Gestational diabetes and hypertension were associated with a diagnosis of VUE, and overall, VUE placentas have more abnormal placental findings compared with control. Understanding VUE risk factors may facilitate prenatal care strategies and counseling to achieve the best outcomes for pregnant patients and their neonates. KEY POINTS: · VUE is a common inflammatory lesion of the placenta.. · Gestational diabetes and hypertension are associated with a VUE diagnosis.. · Findings of other placental pathologies increase in VUE..

Efficacy of Rubella Vaccination after Co-Inoculation with Rhogam.

Congenital rubella syndrome is a constellation of birth defects that can have devastating consequences, impacting approximately 100,000 births worldwide each year. The incidence is much lower in countries that routinely vaccinate their population. In the US, postnatal immunization of susceptible women is an important epidemiological strategy for the prevention of rubella as the Center for Disease Control (CDC) does not recommend administering this vaccine during pregnancy due to its nature as a live attenuated virus vaccine. However, concerns that the co-administration of rubella vaccine with other immunoglobins (i.e., Rhogam) could compromise vaccine efficacy has produced warnings that can delay the administration of rubella vaccination postpartum, leaving women susceptible to the disease in subsequent pregnancies. We aimed to address whether the co-administration of the measles, mumps, and rubella (MMR) vaccine and Rhogam decreased antibody responses compared to those receiving only MMR vaccination. This retrospective cohort study utilized clinical data from 78 subjects who received the MMR vaccine and Rhogam after delivery and 45 subjects who received the MMR vaccine alone. Maternal demographics, pregnancy complications and rubella status at the start of a subsequent pregnancy were recorded for analysis. Overall, the two cohorts had similar baseline characteristics; however, lower parity was noted in the participants that received both MMR vaccination and Rhogam. Making assessments based on maternal antibody IgG index for rubella during the next pregnancy, we observed that 88% of the Rhogam + MMR vaccine group had positive serology scores, which was not significantly different from the 80% rate in the MMR-vaccine-only cohort (p = 0.2). In conclusion, no differences were observed in rubella immunity status in subsequent pregnancies in those mothers given both the MMR vaccine and Rhogam concurrently. Given these findings, warnings against co-administration of vaccines in combination with Rhogam appear unwarranted.

Baseline Quality of Life is a Strong and Independent Prognostic Factor for Overall Survival in Metastatic Colorectal Cancer.

BACKGROUND: Previous studies have established that higher baseline quality of life (QOL) scores are associated with improved survival in patients with metastatic colorectal cancer (mCRC). We examined the relationship between overall survival (OS) and baseline QOL. PATIENTS AND METHODS: A total of 1 247 patients with mCRC participating in N9741 (comparing bolus 5-FU/LV, irinotecan [IFL] vs infusional 5-FU/leucovorin [LV]/oxaliplatin [FOLFOX] vs. irinotecan/oxaliplatin [IROX]) provided data at baseline on overall QOL using a single-item linear analogue self-assessment (LASA) 0-100 point scale. The association of OS according to clinically deficient (defined as CD-QOL, score 0-50) vs not clinically deficient (nCD-QOL, score 51-100) baseline QOL scores was tested. A multivariable analysis using Cox proportional hazards modeling was performed to adjust for the effects of multiple baseline factors. An exploratory analysis was performed evaluating OS according to baseline QOL status among patients who did or did not receive second-line therapy. RESULTS: Baseline QOL was a strong predictor of OS for the whole cohort (CD-QOL vs nCD-QOL: 11.2 months vs 18.4 months, P < .0001), and in each arm IFL 12.4 vs 15.1 months, FOLFOX 11.1 months vs 20.6 months, and IROX 8.9 months vs 18.1 months. Baseline QOL was associated with baseline performance status (PS) (P < .0001). After adjusting for PS and treatment arm, baseline QOL was still associated with OS (P = .017). CONCLUSIONS: Baseline QOL is an independent prognostic factor for OS in patients with mCRC. The demonstration that patient-assessed QOL and PS are independent prognostic indicators suggests that these assessments provide important complementary prognostic information.

Problem-based shared decision-making in diabetes care: a secondary analysis of video-recorded encounters.

OBJECTIVES: To describe the range of collaborative approaches to shared decision-making (SDM) observed in clinical encounters of patients with diabetes and their clinicians. DESIGN: A secondary analysis of videorecordings obtained in a randomised trial comparing usual diabetes primary care with or without using a within-encounter conversation SDM tool. SETTING: Using the purposeful SDM framework, we classified the forms of SDM observed in a random sample of 100 video-recorded clinical encounters of patients with type 2 diabetes in primary care. MAIN OUTCOME MEASURES: We assessed the correlation between the extent to which each form of SDM was used and patient involvement (OPTION12-scale). RESULTS: We observed at least one instance of SDM in 86 of 100 encounters. In 31 (36%) of these 86 encounters, we found only one form of SDM, in 25 (29%) two forms, and in 30 (35%), we found ≥3 forms of SDM. In these encounters, 196 instances of SDM were identified, with weighing alternatives (n=64 of 196, 33%), negotiating conflicting desires (n=59, 30%) and problemsolving (n=70, 36%) being similarly prevalent and developing existential insight accounting for only 1% (n=3) of instances. Only the form of SDM focused on weighing alternatives was correlated with a higher OPTION12-score. More forms of SDM were used when medications were changed (2.4 SDM forms (SD 1.48) vs 1.8 (SD 1.46); p=0.050). CONCLUSIONS: After considering forms of SDM beyond weighing alternatives, SDM was present in most encounters. Clinicians and patients often used different forms of SDM within the same encounter. Recognising a range of SDM forms that clinicians and patients use to respond to problematic situations, as demonstrated in this study, opens new lines of research, education and practice that may advance patient-centred, evidence-based care.

Fetal surgery is not associated with increased inflammatory placental pathology.

OBJECTIVE: Fetal surgery has improved neonatal outcomes; however, it is unknown if the intervention contributes to the developmental of inflammatory pathologies in the placenta. Here, an association between fetal surgery and placental pathology was examined. METHOD: This case-control study compared pregnancies with fetal surgery (n = 22), pregnancies with an indication for fetal surgery but without an intervention being done (n = 13), and gestational-age and fetus-number matched controls (n = 36). Data on maternal, infant, and placental outcomes were abstracted. Additionally, immunohistochemistry identified expression of lymphoid and myeloid cells in the placenta on a subset of cases. Comparisons were performed using Kruskal-Wallis or Pearson's chi-squared tests. RESULTS: Maternal characteristics were comparable between groups. Most fetal interventions were for diaphragmatic hernia, spina bifida, or twin-to-twin transfusion syndrome. Fetuses who were operated on before birth were more likely to be born preterm (p = 0.02). There was no increase in the rate of observed placental pathologies or immune cell infiltration in fetal surgery cases compared to controls. CONCLUSION: The data suggest that fetal surgery is not associated with increased inflammatory or morphologic pathology in the placenta. This observation supports the growing field of fetal surgery.

Problem-based shared decision making: The role of canonical SDM steps.

OBJECTIVE: To evaluate the extent to which the canonical steps of shared decision making (SDM) take place in clinical encounters in practice and across SDM forms. METHODS: We assessed 100 randomly selected video-recorded primary care encounters, obtained as part of a randomized trial of an SDM intervention in patients with type 2 diabetes. Two coders, working independently, noted each instance of SDM, classified it as one of four problem-based forms to SDM (weighing alternatives, negotiating conflicting issues, solving problems, or developing existential insight), and noted the occurrence and timing of each of the four canonical SDM steps: fostering choice awareness, providing information, stating preferences, and deciding. Descriptive analyses sought to determine the relative frequency of these steps across each of the four SDM forms within each encounter. RESULTS: There were 485 SDM steps noted (mean 4.85 steps per encounter), of which providing information and stating preferences were the most common. There were 2.7 (38 steps in 14 encounters) steps per encounter observed in encounters with no discernible SDM form, 3.4 (105 steps in 31 encounters) with one SDM form, 5.2 (129 steps in 25 encounters) with two SDM forms, and 7.1 (213 steps in 30 encounters) when ≥3 SDM forms were observed within the encounter. The prescribed order of the four SDM steps was observed in, at best, 16 of the 100 encounters. Stating preferences was a common step when weighing alternatives (38%) or negotiating conflicts (59.3%) but less common when solving problems (29.2%). The distribution of SDM steps was similar to usual care with or without the SDM intervention. CONCLUSION: The normative steps of SDM are infrequently observed in their prescribed order regardless of whether an SDM intervention was used. Some steps are more likely in some SDM forms but no pattern of steps appears to distinguish among SDM forms. CLINICAL TRIAL REGISTRATION: ClinicalTrial.gov: NCT01293578.

The design and development of an encounter tool to support shared decision making about preventing cardiovascular events.

Patients at high risk for cardiovascular disease (CVD) tend to receive less intensive preventive care. Clinical practice guidelines recommend shared decision making (SDM) to improve the quality of primary CVD prevention. There are tools for use during the clinical encounter that promote SDM, but, to our knowledge, there are no SDM encounter tools that support conversations about available lifestyle and pharmacological options that can lead to preventive care that is congruent with patient goals and CVD risk. Using the best available evidence and human-centered design (iterative design in the context of ultimate use with users), our team developed a SDM encounter tool, CV Prevention Choice. Each subsequent version during the iterative development process was evaluated in terms of content, usefulness, and usability by testing it in real preventive encounters. The final version of the tool includes a calculator that estimates the patient's risk of a major atherosclerotic CVD event in the next 10 years. Lifestyle and medication options are presented, alongside their pros, cons, costs, and other burdens. The risk reduction achieved by the selected prevention program is then displayed to support collaborative deliberation and decision making. A U.S. multicenter trial is estimating the effectiveness of CV Prevention Choice in achieving risk-concordant CV prevention while identifying the best strategies for increasing the adoption of the SDM encounter tool and its routine use in practice.

Encounter-based randomization did not result in contamination in a shared decision-making trial: a secondary analysis.

OBJECTIVES: To estimate the level of contamination in an encounter-randomized trial evaluating a shared decision-making (SDM) tool. STUDY DESIGN AND SETTING: We assessed contamination at three levels: (1) tool contamination (whether the tool was physically present in the usual care encounter), (2) functional contamination (whether components of the SDM tool were recreated in the usual care encounters without directly accessing the tool), and (3) learned contamination (whether clinicians "got better at SDM" in the usual care encounters as assessed by the OPTION-12 score). For functional and learned contamination, the interaction with the number of exposures to the tool was assessed. RESULTS: We recorded and analyzed 830 of 922 randomized encounters. Of the 411 recorded encounters randomized to usual care, the SDM tool was used in nine (2.2%) encounters. Clinicians discussed at least one patient-important issue in 377 usual care encounters (92%) and the risk of stroke in 214 encounters (52%). We found no significant interaction between number of times the SDM tool was used and subsequent functional or learned contamination. CONCLUSION: Despite randomly assigning clinicians to use an SDM tool in some and not other encounters, we found no evidence of contamination in usual care encounters.

Enrolling people of color to evaluate a practice intervention: lessons from the shared decision-making for atrial fibrillation (SDM4AFib) trial.

BACKGROUND: Trial recruitment of Black, indigenous, and people of color (BIPOC) is key for interventions that interact with socioeconomic factors and cultural norms, preferences, and values. We report on our experience enrolling BIPOC participants into a multicenter trial of a shared decision-making intervention about anticoagulation to prevent strokes, in patients with atrial fibrillation (AF). METHODS: We enrolled patients with AF and their clinicians in 5 healthcare systems (three academic medical centers, an urban/suburban community medical center, and a safety-net inner-city medical center) located in three states (Minnesota, Alabama, and Mississippi) in the United States. Clinical encounters were randomized to usual care with or without a shared decision-making tool about anticoagulation. ANALYSIS: We analyzed BIPOC patient enrollment by site, categorized reasons for non-enrollment, and examined how enrollment of BIPOC patients was promoted across sites. RESULTS: Of 2247 patients assessed, 922 were enrolled of which 147 (16%) were BIPOC patients. Eligible Black participants were significantly less likely (p < .001) to enroll (102, 11%) than trial-eligible White participants (185, 15%). The enrollment rate of BIPOC patients varied by site. The inclusion and prioritization of clinical practices that care for more BIPOC patients contributed to a higher enrollment rate into the trial. Specific efforts to reach BIPOC clinic attendees and prioritize their enrollment had lower yield. CONCLUSIONS: Best practices to optimize the enrollment of BIPOC participants into trials that examined complex and culturally sensitive interventions remain to be developed. This study suggests a high yield from enrolling BIPOC patients from practices that prioritize their care. TRIAL REGISTRATION: ClinicalTrials.gov (NCT02905032).

Shared Decision-Making for Patients Hospitalized with Acute Myocardial Infarction: A Randomized Trial.

Objective: Adherence to guideline-recommended medications after acute myocardial infarction (AMI) is suboptimal. Patient fidelity to treatment regimens may be related to their knowledge of the risk of death following AMI, the pros and cons of medications, and to their involvement in treatment decisions. Shared decision-making may improve both patients' knowledge and involvement in treatment decisions. Methods: In a pilot trial, patients hospitalized with AMI were randomized to the use of the AMI Choice conversation tool or to usual care. AMI Choice includes a pictogram of the patient's estimated risk of mortality at 6 months with and without guideline-recommended medications, ie, aspirin, statins, beta-blockers, and angiotensin-converting enzyme inhibitors. Primary outcomes were patient knowledge and conflict with the decision made assessed via post-encounter surveys. Secondary outcomes were patient involvement in the decision-making process (observer-based OPTION12 scale) and 6-month medication adherence. Results: Patient knowledge of the expected survival benefit from taking medications was significantly higher (62% vs 16%, p<0.0001) in the AMI Choice group (n = 53) compared to the usual care group (n = 53). Both groups reported similarly low levels of conflict with the decision to start the medications (13 (SD 24.2) vs 16 (SD 22) out of 100; p=0.16). The extent to which clinicians in the AMI Choice group involved their patients in the decision-making process was high (OPTION12 score 53 out of 100, SD 12). Medication adherence at 6-months was relatively high in both groups and not different between groups. Conclusion: The AMI Choice conversation tool improved patients' knowledge of their estimated risk of short-term mortality after an AMI and the pros and cons of treatments to reduce this risk. The effect on patient fidelity to recommended medications of using this SDM tool and of SDM in general should be tested in larger trials enrolling patients at high risk for nonadherence. Trial Registration Number: NCT00888537.

Effect of Shared Decision-Making for Stroke Prevention on Treatment Adherence and Safety Outcomes in Patients With Atrial Fibrillation: A Randomized Clinical Trial.

Background Guidelines promote shared decision-making (SDM) for anticoagulation in patients with atrial fibrillation. We recently showed that adding a within-encounter SDM tool to usual care (UC) increases patient involvement in decision-making and clinician satisfaction, without affecting encounter length. We aimed to estimate the extent to which use of an SDM tool changed adherence to the decided care plan and clinical safety end points. Methods and Results We conducted a multicenter, encounter-level, randomized trial assessing the efficacy of UC with versus without an SDM conversation tool for use during the clinical encounter (Anticoagulation Choice) in patients with nonvalvular atrial fibrillation considering starting or reviewing anticoagulation treatment. We conducted a chart and pharmacy review, blinded to randomization status, at 10 months after enrollment to assess primary adherence (proportion of patients who were prescribed an anticoagulant who filled their first prescription) and secondary adherence (estimated using the proportion of days for which treatment was supplied and filled for direct oral anticoagulant, and as time in therapeutic range for warfarin). We also noted any strokes, transient ischemic attacks, major bleeding, or deaths as safety end points. We enrolled 922 evaluable patient encounters (Anticoagulation Choice=463, and UC=459), of which 814 (88%) had pharmacy and clinical follow-up. We found no differences between arms in either primary adherence (78% of patients in the SDM arm filled their first prescription versus 81% in UC arm) or secondary adherence to anticoagulation (percentage days covered of the direct oral anticoagulant was 74.1% in SDM versus 71.6% in UC; time in therapeutic range for warfarin was 66.6% in SDM versus 64.4% in UC). Safety outcomes, mostly bleeds, occurred in 13% of participants in the SDM arm and 14% in the UC arm. Conclusions In this large, randomized trial comparing UC with a tool to promote SDM against UC alone, we found no significant differences between arms in primary or secondary adherence to anticoagulation or in clinical safety outcomes. Registration URL: https://www.clinicaltrials.gov; Unique identifier: clinicaltrials.gov. Identifier: NCT02905032.

Making sense of diabetes medication decisions: a mixed methods cluster randomized trial using a conversation aid intervention.

PURPOSE: To determine the effectiveness of a shared decision-making (SDM) tool versus guideline-informed usual care in translating evidence into primary care, and to explore how use of the tool changed patient perspectives about diabetes medication decision making. METHODS: In this mixed methods multicenter cluster randomized trial, we included patients with type 2 diabetes mellitus and their primary care clinicians. We compared usual care with or without a within-encounter SDM conversation aid. We assessed participant-reported decisions made and quality of SDM (knowledge, satisfaction, and decisional conflict), clinical outcomes, adherence, and observer-based patient involvement in decision-making (OPTION12-scale). We used semi-structured interviews with patients to understand their perspectives. RESULTS: We enrolled 350 patients and 99 clinicians from 20 practices and interviewed 26 patients. Use of the conversation aid increased post-encounter patient knowledge (correct answers, 52% vs. 45%, p = 0.02) and clinician involvement of patients (Mean between-arm difference in OPTION12, 7.3 (95% CI 3, 12); p = 0.003). There were no between-arm differences in treatment choice, patient or clinician satisfaction, encounter length, medication adherence, or glycemic control. Qualitative analyses highlighted differences in how clinicians involved patients in decision making, with intervention patients noting how clinicians guided them through conversations using factors important to them. CONCLUSIONS: Using an SDM conversation aid improved patient knowledge and involvement in SDM without impacting treatment choice, encounter length, medication adherence or improved diabetes control in patients with type 2 diabetes. Future interventions may need to focus specifically on patients with signs of poor treatment fit. CLINICAL TRIAL REGISTRATION: ClinicalTrial.gov: NCT01502891.

Co-creating sensible care plans using shared decision making: Patients' reflections and observations of encounters.

OBJECTIVE: To evaluate how the use of a within-encounter SDM tool (compared to usual care in a randomized trial) contributes to care plans that make sense to patients with atrial fibrillation considering anticoagulation. METHODS: In a planned subgroup of the trial, 123 patients rated post-encounter how much sense their decided-upon care plan made to them and explained why. We explored how sense ratings related to observed patient involvement (OPTION12), patient's decisional conflict, and adherence to their plan based on pharmacy records. We analyzed patient motives using Burke's pentad. RESULTS: Plan sensibility was similarly high in both arms (Usual care n = 62: mean 9.4/10 (SD 1.0) vs SDM tool n = 61: 9.2/10 (SD 1.5); p = .8), significantly and weakly correlated to decisional conflict (rho=-0.28, p = .002), but not to OPTION12 or adherence. Plans made sense to most patients given their known efficacy, safety and what is involved in implementing them. CONCLUSION: Adding an effective intervention to promote SDM did not affect how much, or why, care plans made sense to patients receiving usual care, nor patient adherence to them. PRACTICE IMPLICATIONS: Evaluating the extent to which care plans make sense can improve SDM assessments, particularly when SDM extends beyond selecting from a menu of options.

Cost Conversations About Anticoagulation Between Patients With Atrial Fibrillation and Their Clinicians: A Secondary Analysis of a Randomized Clinical Trial.

Importance: How patients with atrial fibrillation (AF) and their clinicians consider cost in forming care plans remains unknown. Objective: To identify factors that inform conversations regarding costs of anticoagulants for treatment of AF between patients and clinicians and outcomes associated with these conversations. Design, Setting, and Participants: This cohort study of recorded encounters and participant surveys at 5 US medical centers (including academic, community, and safety-net centers) from the SDM4AFib randomized trial compared standard AF care with and without use of a shared decision-making (SDM) tool. Included patients were considering anticoagulation treatment and were recruited by their clinicians between January 30, 2017, and June 27, 2019. Data were analyzed between August and November 2019. Main Outcomes and Measures: The incidence of and factors associated with cost conversations, and the association of cost conversations with patients' consideration of treatment cost burden and their choice of anticoagulation. Results: A total of 830 encounters (out of 922 enrolled participants) were recorded. Patients' mean (SD) age was 71.0 (10.4) years; 511 patients (61.6%) were men, 704 (86.0%) were White, 303 (40.9%) earned between $40 000 and $99 999 in annual income, and 657 (79.2%) were receiving anticoagulants. Clinicians' mean (SD) age was 44.8 (13.2) years; 75 clinicians (53.2%) were men, and 111 (76%) practiced as physicians, with approximately half (69 [48.9%]) specializing in either internal medicine or cardiology. Cost conversations occurred in 639 encounters (77.0%) and were more likely in the SDM arm (378 [90%] vs 261 [64%]; OR, 9.69; 95% CI, 5.77-16.29). In multivariable analysis, cost conversations were more likely to occur with female clinicians (66 [47%]; OR, 2.85; 95% CI, 1.21-6.71); consultants vs in-training clinicians (113 [75%]; OR, 4.0; 95% CI, 1.4-11.1); clinicians practicing family medicine (24 [16%]; OR, 12.12; 95% CI, 2.75-53.38]), internal medicine (35 [23%]; OR, 3.82; 95% CI, 1.25-11.70), or other clinicians (21 [14%]; OR, 4.90; 95% CI, 1.32-18.16) when compared with cardiologists; and for patients with an annual household income between $40 000 and $99 999 (249 [82.2%]; OR, 1.86; 95% CI, 1.05-3.29) compared with income below $40 000 or above $99 999. More patients who had cost conversations reported cost as a factor in their decision (244 [89.1%] vs 327 [69.0%]; OR 3.66; 95% CI, 2.43-5.50), but cost conversations were not associated with the choice of anticoagulation agent. Conclusions and Relevance: Cost conversations were common, particularly for middle-income patients and with female and consultant-level primary care clinicians, as well as in encounters using an SDM tool; they were associated with patients' consideration of treatment cost burden but not final treatment choice. With increasing costs of care passed on to patients, these findings can inform efforts to promote cost conversations in practice. Trial Registration: ClinicalTrials.gov Identifier: NCT02905032.

Increasing risk-concordant cardiovascular care in diverse health systems: a mixed methods pragmatic stepped wedge cluster randomized implementation trial of shared decision making (SDM4IP).

BACKGROUND: The primary prevention of cardiovascular (CV) events is often less intense in persons at higher CV risk and vice versa. Clinical practice guidelines recommend that clinicians and patients use shared decision making (SDM) to arrive at an effective and feasible prevention plan that is congruent with each person's CV risk and informed preferences. However, SDM does not routinely happen in practice. This study aims to integrate into routine care an SDM decision tool (CV PREVENTION CHOICE) at three diverse healthcare systems in the USA and study strategies that foster its adoption and routine use. METHODS: This is a mixed method, hybrid type III stepped wedge cluster randomized study to estimate (a) the effectiveness of implementation strategies on SDM uptake and utilization and (b) the extent to which SDM results in prevention plans that are risk-congruent. Formative evaluation methods, including clinician and stakeholder interviews and surveys, will identify factors likely to impact feasibility, acceptability, and adoption of CV PREVENTION CHOICE as well as normalization of CV PREVENTION CHOICE in routine care. Implementation facilitation will be used to tailor implementation strategies to local needs, and implementation strategies will be systematically adjusted and tracked for assessment and refinement. Electronic health record data will be used to assess implementation and effectiveness outcomes, including CV PREVENTION CHOICE reach, adoption, implementation, maintenance, and effectiveness (measured as risk-concordant care plans). A sample of video-recorded clinical encounters and patient surveys will be used to assess fidelity. The study employs three theoretical approaches: a determinant framework that calls attention to categories of factors that may foster or inhibit implementation outcomes (the Consolidated Framework for Implementation Research), an implementation theory that guides explanation or understanding of causal influences on implementation outcomes (Normalization Process Theory), and an evaluation framework (RE-AIM). DISCUSSION: By the project's end, we expect to have (a) identified the most effective implementation strategies to embed SDM in routine practice and (b) estimated the effectiveness of SDM to achieve feasible and risk-concordant CV prevention in primary care. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04450914 . Posted June 30, 2020 TRIAL STATUS: This study received ethics approval on April 17, 2020. The current trial protocol is version 2 (approved February 17, 2021). The first subject had not yet been enrolled at the time of submission.