Improving Dysvascular Amputee Outcomes by Enhancing Shared Decision Making Through the Development and Implementation of a Patient Decision Aid and a Decision Support Tool

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The choice of amputation level in patients with peripheral arterial disease and diabetes can have profound effects on many functional outcomes. There are no clinical guidelines or evidence that clearly define a recommended amputation level in any individual patient. There has been an increased emphasis on preserving a portion of the foot (transmetatarsal [TM] amputation) in an effort to minimize the anatomic loss of the extremity with the hope of preserving mobility. This fundamental assumption has been questioned due to the high rate of delayed or failure of healing, which results in the need for prolonged wound care, repeated surgery and in the end, the need for a transtibial (TT) level amputation. The transtibial amputation is associated with a much-reduced risk of failure of healing, a similar mobility outcome, but somewhat higher mortality. However, transtibial amputation may have adverse effects on other outcomes, such as body image, quality of life, prosthetic fitting demands, and/or rehabilitation treatment intensity. Each patient will likely prioritize these outcomes in different ways based upon their values and preferences. The Veterans Health Administration (VHA) has emphasized the importance of patient-centric care, which is defined as “health care that establishes a partnership among practitioners, patients, and their families (when appropriate) to ensure that decisions respect patients' wants, needs and preferences and solicit patients' input on the education and support they need to make decisions and participate in their own care.” The use of Patient Decision Aids (PtDA) and physician decision support tools (DST) have been advocated as critical components that can be used to enhance patient participation in important decisions, and to ensure that the choice they make is aligned with the outcomes that are most important to them. The purpose of this research, therefore, is to improve the rehabilitation outcome of Veterans who require a dysvascular lower extremity amputation, where either a dysvascular TM or TT amputation is being considered. We propose to develop two point of care “tools” to enhance shared decision making at the time of amputation level selection that will be integrated into a web- based portal called AMPDECIDE: 1) the DST will utilize our validated AMPREDICT prediction models to inform providers of patient specific risks/probabilities for functional mobility, mortality, and failure of healing at each major amputation level, and 2) the PtDA will educate patients about amputation surgery, prosthetic use, inform them about the outcome differences, and help them determine and rank their outcome priorities. We will then perform a pilot trial using the tools in the AMPDECIDE portal in a shared decision making process that will inform a future large scale clinical trial to determine if their use results in reduced numbers of reamputations, preservation of functional life years, and enhanced patient satisfaction. To accomplish these aims we will use a mixed methods approach. The development of both the DST and PtDA will be informed by a qualitative needs assessment of patients who have undergone dysvascular amputation at the two proposed levels, as well as, physicians who are involved in amputation level selection. A systematic review will also be performed to provide the necessary evidence related to outcomes differences defined by the needs assessment. The needs assessment and systematic review will then form the underpinnings of the iterative PtDA development. A key component of the PtDA will be a values clarification exercise to ensure that patients are able to define their outcome priorities and, therefore, choose between the two amputation levels. The values clarification exercise we propose is the use of a MultiCriteria Decision Analysis (MCDA). The DST will be developed with physician input to ensure that the format, structure and output will meet their clinical care needs. The pilot study will utilize these tools in the AMPDECIDE portal with a group of patient/physician dyads who are facing the amputation level decision. The outcomes evaluation will assess its effect on the near-term outcomes of decisional conflict, knowledge, concordance with patient values, and patients' actual amputation level choice.