Protocol for the Osteoporosis Choice trial. A pilot randomized trial of a decision aid in primary care practice

Abstract

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

Effectiveness of interventions to improve the detection and treatment of osteoporosis in primary care settings: a systematic review and meta-analysis

“…1). In all, 16 reports regarding 13 different studies met the inclusion/exclusion criteria and were included in the systematic review [10][11][12][13][14][15][16][17][18][37][38][39][40][41][42][43]. Studies were excluded for not meeting the criteria for target intervention (five studies), study design (19 studies), patients (37 studies), follow-up duration (one study), and comparator (eight studies; see Appendix B for the complete list of excluded studies with primary reasons of exclusion).…”

“…Three studies used a quasi-randomized design [10,14,41], six were patient-randomized trials [12,15,18,37,38,42], and four were cluster-randomized trials [11,13,16,17]. Two studies were ongoing [38,41], and two others were methodological papers describing the study protocol [37,42].…”

“…Most studies included patients with a previous fragility fracture (11 studies) [10-12, 14-18, 37, 38, 41], while others involved patients aged 65 years or older (four studies) [13,[16][17][18], oral glucocorticoid users (three studies) [16][17][18], patients with low BMD (one study) [42], a family history of osteoporosis (one study) [18], or early menopause (one study) [18]. Most studies targeted both the primary care physicians and their patients (10 studies) [11-17, 37, 38, 41].…”

“…Three studies used a quasi-randomized design [10,14,41], six were patient-randomized trials [12,15,18,37,38,42], and four were cluster-randomized trials [11,13,16,17]. Two studies were ongoing [38,41], and two others were methodological papers describing the study protocol [37,42]. Interventions included educational material for patients (eight studies) [11-14, 16, 18, 37, 41], physician notification of patients' osteoporosis and fracture risk (eight studies) [10,11,14,15,18,37,38,41], patient notification of osteoporosis and fracture risk (six studies) [10-13, 17, 41], patient counseling (four studies) [14,15,18,41], electronic medical record (EMR) prompts for physicians (two studies) [12,13], list of at-risk patients provided to physicians (two studies) [13,17], physician education by academic detailing (two studies) [16,17], arrangements for BMD testing and bisphosphonate prescription by the study physician (one study) [15], a risk assessment tool provided to physicians and discussion of the tool with the study coordinator before appointments with atrisk patients (one study) [42], and peripheral BMD testing by quantitative ultrasound performed by the patient's community pharmacist (one study) [18] …”

Design and Implementation of Antidepressant Decision Making Aids

“…13 Decision making aids for osteoporosis in the primary care setting are currently being evaluated. 14 The goal of the current study was to create similarly designed decision making aids for depression. These aids would assist patients and providers in the selection of a suitable antidepressant medication by initiating conversations about side effects, costs, and effective treatment of depression.…”