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Background: Although percutaneous coronary intervention (PCI) has not been shown to reduce the risk of death and myocardial infarction (MI) for stable coronary artery disease (CAD), many patients believe that PCI is a life-saving procedure. PCI for stable CAD is known to improve patients’ quality of life more rapidly than medications alone. We conducted a randomized trial to assess the impact of a decision aid (DA) compared to usual care (UC) for the treatment of stable CAD when there is a choice between PCI and optimal medical therapy (OMT). Methods: The PCI Choice trial was a prospective, randomized trial comparing the effects of DA versus UC. The DA was designed with a user-centered approach for an in-visit consultation, involving patients and clinicians throughout the development process. The final DA included information on myocardial infarction (MI), death and quality of life outcomes for PCI with OMT vs. OMT alone in the treatment of stable angina, stratified by angina type. Risks of procedure, bleeding, stent thrombosis, and need for future procedures were also depicted. The primary outcome was patient knowledge, measured by pre- and post-visit surveys. Additional outcomes included decisional conflict, patient satisfaction, preferred decision making style, and treatment decision. Results: A total of 110 patients were enrolled; mean age was 68.3 years and 26% of patients were women. At baseline, most patients had CCS Class I/II angina and were on a mean of two anti-anginal medications (2.3, SD 1.2). Knowledge increased among patients receiving DA compared to UC (63% vs. 44% p=0.0003). Specific knowledge about the impact of PCI for stable angina on death and MI was higher in both groups compared to prior studies (54% DA, 46% UC, p=0.45; 12% prior). Patient satisfaction was significantly higher in the DA group vs. UC (72% vs 40%, p=0.004). Decisional conflict was greater than in non-procedural DA trials, and was not different between the two arms (p=.43). Following exposure to DA, patients’ preference for sharing decision making tended to change more with DA (55% to 65%) than with UC (56% to 59%). While the proportion of patients choosing PCI over OMT was nearly half in both groups, there were fewer patients that remained undecided with DA (18% vs. 4%; p=0.14 overall difference). Conclusions: Exposure to a DA for the choice of PCI vs. optimal medical therapy in stable CAD improved patient knowledge and satisfaction and decreased uncertainty, without reducing the rate of PCI. Use of the DA in a larger patient population may further delineate impact on outcomes such as treatment choice, geographic variation and cost.

Background: Blunt head trauma is a common cause of death and disability in children worldwide. Cranial computed tomography (CT), the reference standard for the diagnosis of traumatic brain injury (TBI), exposes children to ionizing radiation which has been linked to the development of brain tumors, leukemia, and other cancers. We describe the methods used to develop and test the effectiveness of a decision aid to facilitate shared decision-making with parents regarding whether to obtain a head CT scan or to further observe their child at home. Methods/Design: This is a protocol for a multicenter clinician-level parallel randomized trial to compare an intervention group receiving a decision aid, ‘Head CT Choice’, to a control group receiving usual care. The trial will be conducted at five diverse emergency departments (EDs) in Minnesota and California. Clinicians will be randomized to decision aid or usual care. Parents visiting the ED with children who are less than 18-years-old, have experienced blunt head trauma within 24 hours, and have one or two risk factors for clinically-important TBI (ciTBI) from the Pediatric Emergency Care Applied Research Network head injury clinical prediction rules will be eligible for enrollment. We will measure the effect of Head CT Choice on: (1) parent knowledge regarding their child’s risk of ciTBI, the available diagnostic options, and the risks of radiation exposure associated with a cranial CT scan (primary outcome); (2) parent engagement in the decision-making process; (3) the degree of conflict parents experience related to feeling uninformed; (4) patient and clinician satisfaction with the decision made; (5) the rate of ciTBI at seven days; (6) the proportion of patients in whom a cranial CT scan is obtained; and (7) seven-day healthcare utilization. To capture these outcomes, we will administer parent and clinician surveys immediately after each clinical encounter, obtain video recordings of parent-clinician discussions, administer parent healthcare utilization diaries, analyze hospital billing records, review the electronic medical record, and conduct telephone follow-up. Discussion: This multicenter trial will robustly assess the effectiveness of a decision aid on patient-centered outcomes, safety, and healthcare utilization in parents of children with minor head trauma in five diverse EDs. Trial registration: ClinicalTrials.gov registration number: NCT02063087. Registration date February 13, 2014.

BACKGROUND: Percutaneous coronary intervention (PCI) and optimal medical therapy (OMT) are comparable, alternative therapies for many patients with stable angina; however, patients may have misconceptions regarding the impact of PCI on risk of death and myocardial infarction (MI) in stable coronary artery disease (CAD). METHODS AND RESULTS: We designed and developed a patient-centered decision aid (PCI Choice) to promote shared decision making for patients with stable CAD. The estimated benefits and risks of PCI+OMT as compared to OMT were displayed in a decision aid using pictographs with natural frequencies and text. We engaged patients, clinicians, health service researchers, and designers with over 20 successive iterations of the decision aid, which were field tested during real-world clinical encounters involving clinicians and patients. The decision aid is intended to facilitate knowledge transfer, deliberation based on patient values and preferences, and shared decision making. CONCLUSIONS: We describe the methods and outcomes of the design and development of a decision aid (PCI Choice) to promote shared decision making between clinicians and patients regarding the choice of PCI+OMT vs. OMT for treatment of stable CAD. We will evaluate the impact of PCI Choice on patient knowledge, decisional conflict, participation in decision-making, and treatment choice in an upcoming randomized trial.