BackgroundBisphosphonates can reduce fracture risk in patients with osteoporosis, but many at-risk patients do not start or adhere to these medications. The aims of this study are to: (1) preliminarily evaluate the effect of an individualized 10-year osteoporotic fracture risk calculator and decision aid (OSTEOPOROSIS CHOICE) for postmenopausal women at risk for osteoporotic fractures; and (2) assess the feasibility and validity (i.e., absence of contamination) of patient-level randomization (vs. cluster randomization) in pilot trials of decision aid efficacy.Methods/DesignThis is a protocol for a parallel, 2-arm, randomized trial to compare an intervention group receiving OSTEOPOROSIS CHOICE to a control group receiving usual primary care. Postmenopausal women with bone mineral density T-scores of <-1.0, not receiving bisphosphonate therapy, and receiving care at participating primary care practices in and around Rochester, Minnesota, USA will be eligible to participate in the trial. We will measure the effect of OSTEOPOROSIS CHOICE on five outcomes: (a) patient knowledge regarding osteoporosis risk factors and treatment; (b) quality of the decision-making process for both the patient and clinician; (c) patient and clinician acceptability and satisfaction with the decision aid; (d) rate of bisphosphonate use and adherence, and (e) trial processes (e.g., ability to recruit participants, collect patient outcomes). To capture these outcomes, we will use patient and clinician surveys following each visit and video recordings of the clinical encounters. These video recordings will also allow us to determine the extent to which clinicians previously exposed to the decision aid were able to recreate elements of the decision aid with control patients (i.e., contamination). Pharmacy prescription profiles and follow-up phone interviews will assess medication start and adherence at 6 months.DiscussionThis pilot trial will provide evidence of feasibility, validity of patient randomization, and preliminary efficacy of a novel approach -- decision aids -- to improving medication adherence for postmenopausal women at risk of osteoporotic fractures. The results will inform the design of a larger trial that could provide more precise estimates of the efficacy of the decision aid.Trial registrationClinical Trials.gov Identifier: NCT00578981
a telephone triage solution for the acute demands of influenza H1N1 demonstrated how patients had needs met telephonically while preserving medical access for others.
Retail medicine clinics have become widely available. However, few studies have been published that compare retail clinic costs of care to standard medical visits for similar patients. The purpose of this study was to compare standard medical costs during a 6-month period after visiting a retail medical clinic to care received in a conventional medical office setting. Medical records of primary care patients (both adults and children) seen in a large group practice in Minnesota in 2008 were analyzed for this study. Two groups of patients were studied: those who used a retail walk-in clinic (N = 141) and a comparison group who used regular office care for same-day, acute visits (N = 137). Patients treated for 5 common conditions (pink eye, sore throat, viral illness, bronchitis, and cough) were selected. The dependent variables were standard costs using federal rates and the rank of standard costs. Multiple linear regression analysis was used to adjust for differences between groups. Median costs did not differ between sites ($126.30 for usual care and $88.10 for retail, P = 0.139); mean cost ranks were 132.5 for usual care and 115.6 for retail (P = 0.088). After adjusting for previous visit history, age, and sex, patients who received care in the retail setting had lower standard costs and lower cost rank than patients who received usual care (b = -52.9 [P = 0.006] and b = -24.5 [P = 0.021], respectively). After selection of cases with common conditions and adjustment for unequal variances, age, sex, and number of office visits in the previous 6 months, our retail clinic appeared to reduce medical costs for patients during the 6-month period after the index visit.
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