Abstract
BackgroundAchilles tendon ruptures are common injuries in an otherwise healthy, active population. Several treatment options exist, with both surgical and non-surgical options. Each treatment option has a unique set of risks and harms, which may present patients with decisional conflict. The aim of the proposed study is to develop, alpha test and field test a patient decision aid for patients presenting with acute Achilles tendon ruptures.MethodsThis is a three-stage study protocol. First, we will assemble a multi-disciplinary steering group including patients, clinicians, educators, and researchers to develop the patient decision aid prototype using the Ottawa Decision Support Framework. Second, we will perform a mixed-methods alpha test of the decision aid prototype with patients and clinicians experienced in acute Achilles tendon ruptures. Outcomes measured will include acceptability and usability of the patient decision aid measured using validated outcome scales and semi-structured interviews. A minimum of three rounds of feedback will be obtained. Results will be analyzed using descriptive statistics, reviewed by the steering group, to guide revisions to decision aid prototype at each round. The third stage will be field testing the revised decision aid prototype in usual clinical care. A pre-/post-study will be performed with patients with acute Achilles tendon ruptures. Patients will be recruited from the emergency department and complete the pre-consultation decision aid prior to a one-week follow up with their surgeon. The primary outcome of field testing will be feasibility of implementing the decision aid in the clinical setting and will be measured with recruitment and completion metrics. Secondary outcomes include acceptability of the decision aid, knowledge, preparedness for decision making, and decisional conflict, measured using validated outcome measures. Statistical analysis will be performed using descriptive analysis for primary outcomes and a student t-test and Wilcoxon Rank-Sum test for secondary outcomes.DiscussionThis comprehensive study protocol outlines the development, alpha testing, and field testing of a patient decision aid for patients with acute Achilles tendon rupture. Systematic and transparent development and testing of patient decision aids is critical to improve decision aid quality.Trial registration Not Applicable.
Highlights
Achilles tendon ruptures are common injuries in an otherwise healthy, active population
The specific objectives of this study are (a) to develop a Patient decision-aid (PtDA) for patients to use in preparation for the consultation; and (b) to field test the PtDA with patients and clinicians making involved in decisions regarding this treatment
We have determined the following a-priori criteria as determinants for success of the field test: (1) no insurmountable barriers identified from semi-structured interviews or openended feedback based on review from the steering group, (2) minimum of 80% targets for feasibility outcomes, (3) minimum of 66% of participants find the PtDA acceptable and balanced, (4) minimum score of 66 on the Preparation for Decision Making Scale (PDMS) (5) 66% demonstrate nominal improvement on pre-/posttest outcomes for desired impact
Summary
Achilles tendon ruptures are common injuries in an otherwise healthy, active population. Non-operative management has evolved from a period of prolonged immobilization in a cast to allow tendon healing, to early motion and functional rehabilitation protocols. Use of these protocols has led to decreased rerupture rates, but requires early patient enrollment, high patient engagement, and ideally, access to physiotherapy to provide optimal outcomes [1]. Surgical care is evolving, from traditional open surgery, to more percutaneous and minimally invasive options that attempt to decrease wound healing problems. These surgical techniques, come with increased risk of other harms, including nerve injury [3]. Given the evolution in the benefit-to-harm ratio, practice trends in Scandinavia [4] and Canada [5] have shifted towards non-operative functional rehabilitation, with rates of surgery declining
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