Jonathan Inselman

Shared decision making in patients with low risk chest pain: prospective randomized pragmatic trial.

Objective To compare the effectiveness of shared decision making with usual care in choice of admission for observation and further cardiac testing or for referral for outpatient evaluation in patients with possible acute coronary syndrome. Design Multicenter pragmatic parallel randomized controlled trial. Setting Six emergency departments in the United States. Participants 898 adults (aged >17 years) with a primary complaint of chest pain who were being considered for admission to an observation unit for cardiac testing (451 were allocated to the decision aid and 447 to usual care), and 361 emergency clinicians (emergency physicians, nurse practitioners, and physician assistants) caring for patients with chest pain. Interventions Patients were randomly assigned (1:1) by an electronic, web based system to shared decision making facilitated by a decision aid or to usual care. The primary outcome, selected by patient and caregiver advisers, was patient knowledge of their risk for acute coronary syndrome and options for care; secondary outcomes were involvement in the decision to be admitted, proportion of patients admitted for cardiac testing, and the 30 day rate of major adverse cardiac events. Results Compared with the usual care arm, patients in the decision aid arm had greater knowledge of their risk for acute coronary syndrome and options for care (questions correct: decision aid, 4.2 v usual care, 3.6; mean difference 0.66, 95% confidence interval 0.46 to 0.86), were more involved in the decision (observing patient involvement scores: decision aid, 18.3 v usual care, 7.9; 10.3, 9.1 to 11.5), and less frequently decided with their clinician to be admitted for cardiac testing (decision aid, 37% v usual care, 52%; absolute difference 15%; P<0.001). There were no major adverse cardiac events due to the intervention. Conclusions Use of a decision aid in patients at low risk for acute coronary syndrome increased patient knowledge about their risk, increased engagement, and safely decreased the rate of admission to an observation unit for cardiac testing. Trial registration ClinicalTrials.gov NCT01969240.

Impact of Sociodemographic Patient Characteristics on the Efficacy of Decision Aids A Patient-Level Meta-Analysis of 7 Randomized Trials

Background—Decision aids (DAs) increase patient knowledge, reduce decisional conflict, and promote shared decision making (SDM). The extent to which they do so across diverse sociodemographic patient groups is unknown. Methods and Results—We conducted a patient-level meta-analysis of 7 randomized trials of DA versus usual care comprising 771 encounters between patients and clinicians discussing treatment options for chest pain, myocardial infarction, diabetes mellitus, and osteoporosis. Using a random effects model, we examined the impact of sociodemographic patient characteristics (age, sex, education, income, and insurance status) on the outcomes of knowledge transfer, decisional conflict, and patient involvement in SDM. Because of small numbers of people of color in the study population, we were not powered to investigate the role of race. Most patients were aged ≥65 years (61%), white (94%), and women (59%); two thirds had greater than a high school education. Compared with usual care, DA patients gained knowledge, were more likely to know their risk, and had less decisional conflict along with greater involvement in SDM. These gains were largely consistent across sociodemographic patient groups, with DAs demonstrating similar efficacy when used with vulnerable patients such as the elderly and those with less income and less formal education. Differences in efficacy were found only in knowledge of risk in 1 subgroup, with greater efficacy among those with higher education (35% versus 18%; P=0.02). Conclusions—In this patient-level meta-analysis of 7 randomized trials, DAs were efficacious across diverse sociodemographic groups as measured by knowledge transfer, decisional conflict, and patient involvement in SDM. To the extent that DAs increase patient knowledge and participation in SDM, they have potential to impact health disparities related to these factors.

The effect of the Ajcc 7th edition change in T1 melanoma substaging on national utilization and outcomes of sentinel lymph node biopsy for thin melanoma

T1 melanomas, despite their favorable prognosis, account for 25% of melanoma deaths. The American Joint Committee on Cancer (AJCC) 7th edition melanoma staging, implemented in 2010, replaced the level of invasion with the mitotic rate for T1 substaging, on the basis of prognostic modeling, not prediction of occult lymph node metastasis. Previously, sentinel lymph node biopsy (SLNB) was recommended for T1b patients, whereas current guidelines suggest SLNB for select high-risk T1 melanomas. We investigated the effect of this staging change on the performance and outcomes of SLNB for T1 melanoma. Using 2004–2010 data from the Surveillance, Epidemiology, and End Results (SEER) Registry, we identified 32 527 cases of T1 melanoma and compared pre-2010 (N=27 170) with 2010 (N=5357) data. We used &khgr;2-tests, t-tests, and logistic regression models for analysis. After implementation of the 2010 AJCC staging system, SLNB for T1 patients increased from 12.1% (2004) to 14.4% (2010), despite a decrease for T1b melanomas (40.9 to 33.3%; both P values<0.001), and there was no change in SLNB for melanomas that were 0.7 mm or thicker (38.3 and 39.3%). T-stage, thickness, level, ulceration, age, and geographic region were correlated with SLNB performance (all P values<0.001). For T1 patients, overall SLN positivity rates were 6.1% pre-2010 and 7.8% in 2010 (P=0.12), while nearly doubling for T1a patients (3.6 to 6.6%, P=0.03). SLN-positive patients had diminished cancer-specific survival (P<0.001). SLNB for T1b melanomas decreased after AJCC T1 reclassification, without changing for melanomas that were 0.7 mm or thicker. SLN positivity rates increased for T1a melanomas, and SLN status was prognostic for T1 patients. Improved strategies to identify high-risk T1 melanoma patients most likely to benefit from SLN surgery and to minimize clinical practice variation would be valuable.

Genders of patients and clinicians and their effect on shared decision making: a participant-level meta-analysis

BackgroundGender differences in communication styles between clinicians and patients have been postulated to impact patient care, but the extent to which the gender dyad structure impacts outcomes in shared decision making remains unclear.MethodsParticipant-level meta-analysis of 775 clinical encounters within 7 randomized trials where decision aids, shared decision making tools, were used at the point of care. Outcomes analysed include decisional conflict scale scores, satisfaction with the clinical encounter, concordance between stated decision and action taken, and degree of patient engagement by the clinician using the OPTION scale. An estimated minimal important difference was used to determine if nonsignificant results could be explained by low power.ResultsWe did not find a statistically significant interaction between clinician/patient gender mix and arm for decisional conflict, satisfaction with the clinical encounter or patient engagement. A borderline significant interaction (p = 0.05) was observed for one outcome: concordance between stated decision and action taken, where encounters with female clinician/male patient showed increased concordance in the decision aid arm compared to control (8% more concordant encounters). All other gender dyads showed decreased concordance with decision aid use (6% fewer concordant encounters for same-gender, 16% fewer concordant encounters for male clinician/female patient).ConclusionsIn this participant-level meta-analysis of 7 randomized trials, decision aids used at the point of care demonstrated comparable efficacy across gender dyads. Purported barriers to shared decision making based on gender were not detected when tested for a minimum detected difference.Trial registrationsClinicalTrials.gov NCT00888537, NCT01077037, NCT01029288, NCT00388050, NCT00578981, NCT00949611, NCT00217061.

Implementation of a new prenatal care model to reduce office visits and increase connectivity and continuity of care: protocol for a mixed-methods study

BackgroundMost low-risk pregnant women receive the standard model of prenatal care with frequent office visits. Research suggests that a reduced schedule of visits among low-risk women could be implemented without increasing adverse maternal or fetal outcomes, but patient satisfaction with these models varies. We aim to determine the effectiveness and feasibility of a new prenatal care model (OB Nest) that enhances a reduced visit model by adding virtual connections that improve continuity of care and patient-directed access to care.Methods and designThis mixed-methods study uses a hybrid effectiveness-implementation design in a single center randomized controlled trial (RCT). Embedding process evaluation in an experimental design like an RCT allows researchers to answer both “Did it work?” and “How or why did it work (or not work)?” when studying complex interventions, as well as providing knowledge for translation into practice after the study. The RE-AIM framework was used to ensure attention to evaluating program components in terms of sustainable adoption and implementation.Low-risk patients recruited from the Obstetrics Division at Mayo Clinic (Rochester, MN) will be randomized to OB Nest or usual care. OB Nest patients will be assigned to a dedicated nursing team, scheduled for 8 pre-planned office visits with a physician or midwife and 6 telephone or online nurse visits (compared to 12 pre-planned physician or midwife office visits in the usual care group), and provided fetal heart rate and blood pressure home monitoring equipment and information on joining an online care community.Quantitative methods will include patient surveys and medical record abstraction. The primary quantitative outcome is patient-reported satisfaction. Other outcomes include fidelity to items on the American Congress of Obstetricians and Gynecologists standards of care list, health care utilization (e.g. numbers of antenatal office visits), and maternal and fetal outcomes (e.g. gestational age at delivery), as well as validated patient-reported measures of pregnancy-related stress and perceived quality of care. Quantitative analysis will be performed according to the intention to treat principle. Qualitative methods will include interviews and focus groups with providers, staff, and patients, and will explore satisfaction, intervention adoption, and implementation feasibility. We will use methods of qualitative thematic analysis at three stages. Mixed methods analysis will involve the use of qualitative data to lend insight to quantitative findings.DiscussionThis study will make important contributions to the literature on reduced visit models by evaluating a novel prenatal care model with components to increase patient connectedness (even with fewer pre-scheduled office visits), as demonstrated on a range of patient-important outcomes. The use of a hybrid effectiveness-implementation approach, as well as attention to patient and provider perspectives on program components and implementation, may uncover important information that can inform long-term feasibility and potentially speed future translation.Trial registrationTrial registration identifier: NCT02082275Submitted: March 6, 2014

PCI Choice Decision Aid for Stable Coronary Artery Disease: A Randomized Trial

Background— Percutaneous coronary intervention (PCI) for stable coronary artery disease does not reduce the risk of death and myocardial infarction compared with optimal medical therapy (OMT), but many patients think otherwise. PCI Choice, a decision aid (DA), was designed for use during the clinical visit and includes information on quality of life and mortality outcomes for PCI with OMT versus OMT alone for stable coronary artery disease. Methods and Result— We conducted a randomized trial to assess the impact of the PCI Choice DA compared with usual care when there is a choice between PCI and optimal medical therapy. Primary outcomes were patient knowledge and decisional conflict, and the secondary outcome was an objective measure of shared decision making. A total of 124 patients were eligible for final analysis. Knowledge was higher among patients receiving the DA compared with usual care (60% DA; 40% usual care; P =0.034), and patients felt more informed ( P =0.043). Other measures of decisional quality were not improved, and engagement of the patient by the clinician in shared decision making did not change with use of the DA. There was evidence that clinicians used the DA as an educational tool. Conclusion— The PCI choice DA improved patient knowledge but did not significantly impact decisional quality. Further work is needed to effectively address clinician knowledge gaps in shared decision-making skills, even in the context of carefully designed DAs. Clinical Trial Registration— URL: . Unique identifier: [NCT01771536][1]. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT01771536&atom=%2Fcirccvoq%2Fearly%2F2016%2F11%2F01%2FCIRCOUTCOMES.116.002641.atomBackground—Percutaneous coronary intervention (PCI) for stable coronary artery disease does not reduce the risk of death and myocardial infarction compared with optimal medical therapy (OMT), but many patients think otherwise. PCI Choice, a decision aid (DA), was designed for use during the clinical visit and includes information on quality of life and mortality outcomes for PCI with OMT versus OMT alone for stable coronary artery disease. Methods and Results—We conducted a randomized trial to assess the impact of the PCI Choice DA compared with usual care when there is a choice between PCI and optimal medical therapy. Primary outcomes were patient knowledge and decisional conflict, and the secondary outcome was an objective measure of shared decision making. A total of 124 patients were eligible for final analysis. Knowledge was higher among patients receiving the DA compared with usual care (60% DA; 40% usual care; P=0.034), and patients felt more informed (P=0.043). Other measures of decisional quality were not improved, and engagement of the patient by the clinician in shared decision making did not change with use of the DA. There was evidence that clinicians used the DA as an educational tool. Conclusions—The PCI Choice DA improved patient knowledge but did not significantly impact decisional quality. Further work is needed to effectively address clinician knowledge gaps in shared decision-making skills, even in the context of carefully designed DAs. Clinical Trial Registration—URL: https://www.clinicaltrials.gov/. Unique identifier: NCT01771536.

Uptake and Documentation of the Use of an Encounter Decision Aid in Usual Practice: A Retrospective Analysis of the Use of the Statin/Aspirin Choice Decision Aid

Shared decision making, a key feature of patientcentered care, is a process through which patients and their clinicians work together in a collaborative environment to deliberate about reasonable options for patient care. In the United States, under the Affordable Care Act, in which shared decision making is to become a prominent quality metric, clinicians will need to find ways to practice it and document its usage in patient medical records. Decision aids are evidence-based tools designed to engage patients in a shared decision-making process. One such decision aid, Statin Choice, has been found in randomized trials to improve the quality of the decision-making process and increase patient understanding and accurate estimation of their cardiovascular risk and risk reduction with statins. To facilitate integration into clinical practice, in 2010, Statin/Aspirin Choice was incorporated into the electronic medical record (EMR) at Mayo Clinic, Rochester, Minnesota, placing the tool right in the middle of the workflow (https://statindecisionaid .mayoclinic.org/). Since the completion of the original Statin Choice trial, members of our team have had discussions with primary care key opinion leaders, as well as given medical grand rounds and division-specific academic presentations (i.e., passive dissemination). We aimed to determine the use and uptake by clinicians of the electronic Statin/Aspirin Choice in clinical encounters and how they documented its use in primary care practices.

Percutaneous Coronary Intervention Choice Decision Aid for Stable Coronary Artery Disease: A Randomized Trial.

Background— Percutaneous coronary intervention (PCI) for stable coronary artery disease does not reduce the risk of death and myocardial infarction compared with optimal medical therapy (OMT), but many patients think otherwise. PCI Choice, a decision aid (DA), was designed for use during the clinical visit and includes information on quality of life and mortality outcomes for PCI with OMT versus OMT alone for stable coronary artery disease. Methods and Result— We conducted a randomized trial to assess the impact of the PCI Choice DA compared with usual care when there is a choice between PCI and optimal medical therapy. Primary outcomes were patient knowledge and decisional conflict, and the secondary outcome was an objective measure of shared decision making. A total of 124 patients were eligible for final analysis. Knowledge was higher among patients receiving the DA compared with usual care (60% DA; 40% usual care; P =0.034), and patients felt more informed ( P =0.043). Other measures of decisional quality were not improved, and engagement of the patient by the clinician in shared decision making did not change with use of the DA. There was evidence that clinicians used the DA as an educational tool. Conclusion— The PCI choice DA improved patient knowledge but did not significantly impact decisional quality. Further work is needed to effectively address clinician knowledge gaps in shared decision-making skills, even in the context of carefully designed DAs. Clinical Trial Registration— URL: . Unique identifier: [NCT01771536][1]. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT01771536&atom=%2Fcirccvoq%2Fearly%2F2016%2F11%2F01%2FCIRCOUTCOMES.116.002641.atomBackground—Percutaneous coronary intervention (PCI) for stable coronary artery disease does not reduce the risk of death and myocardial infarction compared with optimal medical therapy (OMT), but many patients think otherwise. PCI Choice, a decision aid (DA), was designed for use during the clinical visit and includes information on quality of life and mortality outcomes for PCI with OMT versus OMT alone for stable coronary artery disease. Methods and Results—We conducted a randomized trial to assess the impact of the PCI Choice DA compared with usual care when there is a choice between PCI and optimal medical therapy. Primary outcomes were patient knowledge and decisional conflict, and the secondary outcome was an objective measure of shared decision making. A total of 124 patients were eligible for final analysis. Knowledge was higher among patients receiving the DA compared with usual care (60% DA; 40% usual care; P=0.034), and patients felt more informed (P=0.043). Other measures of decisional quality were not improved, and engagement of the patient by the clinician in shared decision making did not change with use of the DA. There was evidence that clinicians used the DA as an educational tool. Conclusions—The PCI Choice DA improved patient knowledge but did not significantly impact decisional quality. Further work is needed to effectively address clinician knowledge gaps in shared decision-making skills, even in the context of carefully designed DAs. Clinical Trial Registration—URL: https://www.clinicaltrials.gov/. Unique identifier: NCT01771536.

Effectiveness of a Decision Aid in Potentially Vulnerable Patients: A Secondary Analysis of the Chest Pain Choice Multicenter Randomized Trial

Background. We test the hypotheses that use of the Chest Pain Choice (CPC) decision aid (DA) would be similarly effective in potentially vulnerable subgroups but increase knowledge more in patients with higher education and trust in physicians more in patients from racial minority groups. Methods. This was a secondary analysis of a multicenter randomized trial in adults with chest pain potentially due to acute coronary syndrome. The trial compared an intervention group engaged in shared decision making (SDM) using CPC to a control group receiving usual care (UC). We assessed for subgroup effects based on age, sex, race, income, insurance, education, literacy, and numeracy. We dichotomized each characteristic and tested for interactions using regression models with indicators for arm assignment and study site. Results. Of 898 patients (451 DA, 447 UC), over 50% were female, over one-third were black, nearly one-third had a high school education or less, and over 60% had “low” health literacy. The DA did not increase knowledge more in patients with higher education (P for interaction = 0.06) but did increase knowledge more in the “typical” than in the “low” numeracy subgroup (10.6% v. 4.7%, absolute difference [AD] = 5.9%, P for interaction = 0.025). The DA did not significantly increase patient trust in physicians in racial minorities (P for interaction = 0.06) but did increase trust more in patients with “low” literacy compared with those with “typical” literacy (3.7% v. –1.4%, AD = 5.1, P for interaction = 0.011). Conclusions. CPC benefited all sociodemographic groups to a similar extent, with greater knowledge transfer in patients with higher numeracy and greater physician trust in patients with “low” health literacy. Tailoring SDM interventions to patient characteristics may be necessary for optimal effectiveness.

Treatment approaches and outcomes in plasmacytomas: analysis using a national dataset

Solitary plasmacytomas are uncommon plasma cell disorders, which may present as a single bone lesion (P-bone) or extramedullary plasmacytoma (P-EM). There is a paucity of large studies analyzing prognostic factors and outcomes of plasmacytomas. While the treatment of choice is radiation therapy (RT), there is a lack of data evaluating optimal RT dose. In this study, we sought to answer these questions by utilizing the National Cancer Database plasmacytoma data from 2000 to 2011. A total of 5056 patients were included in the study (median age 62 years; range 52–72). To obtain a pure plasmacytoma cohort, potential multiple myeloma patients were excluded from the study (bone marrow involvement, systemic chemotherapy use). P-bone constituted 70% of the patients. The median overall survival (OS) of P-EM was significantly longer than P-bone (132 vs. 85 months), and for soft/connective tissue it was worse than remainder of P-EM (82 vs. 148 months). On multivariable analysis, factors associated with worse OS included older age (≥65), presence of P-bone, and treatment with a radiation dose <40 Gy.