Short summary

This study investigates the implementation of the "AmpDecide" patient decision aid (PtDA) for partial foot vs. transtibial amputation in Denmark. It addresses challenges in shared decision-making (SDM), especially for vulnerable patients. Through five sub-studies, it explores translation, strategy development, evaluation, patient experiences, and a national survey to assess PtDA use and its integration in clinical practice.

Rationale

Introduction: Patients undergoing partial foot amputation (PFA) due to diabetes or peripheral artery disease are often inadequately informed about long-term outcomes, including healing time, risks of complications, and the possibility of further amputations. Some may prefer a transtibial amputation (TTA) if they understood the prognosis and quality of life implications. Shared decision-making (SDM) and the use of patient decision aids (PtDAs), like the U.S.-developed AmpDecide tool, can support informed choices. However, integrating PtDAs into Danish clinical practice faces contextual barriers, including limited SDM tradition, patient vulnerabilities, and healthcare system constraints. Aim of the Study: The aim of this project is to explore the implementation of the AmpDecide PtDA in a Danish context through five sub-studies: 1)Translation and cultural adaptation of AmpDecide. 2)Co-design and pilot testing of implementation strategies. 3)Evaluation trial of implementation strategies. 4)Exploration of SDM experiences among vulnerable patients. 5)National survey on SDM among patients and surgeons.

Description of the cohort

Nurses and surgeons from two sites in different regions/hospitals, with and without on-site vascular departments, will be invited to participate in co-designing implementation strategies. These strategies will be applied to implement AmpDecide PtDAs in four orthopedic/vascular departments, with two departments testing one version and two departments testing another. To explore how patients in vulnerable positions experience the SDM conversations supported by AmpDecide, we approach patients from the four different sites involved in study 3. All vascular and orthopedic surgeons specializing in treating patients at risk of amputation, as well as patients who have undergone amputation will be included in study 5.

Data and biological material

Data sources include forward-backward translations and video recordings with Danish patients and clinicians for cultural adaptation. Cognitive interviews with patients and healthcare providers will assess comprehensibility. Co-design workshops and pilot tests with clinicians and patients will inform implementation strategies. Quantitative data will come from SDM questionnaires, website analytics, and national surveys, while qualitative data will be collected via interviews, observations, and focus groups to explore experiences, barriers, and feasibility.

Collaborating researchers and departments

Ane Simony, MD, PhD, Associate Professor,

• Kolding Hospital and Institute of Regional Health Research, University of Southern Denmark.

Ulla Riis Madsen, Nurse, PhD, Associate Professor,

• Steno Diabetes Center Zealand and University of Southern Denmark.

Cecilie Lindstrøm, MSc Public Health, Implementation Researcher, Ph.D., Associate Professor,

• National Knowledge Center for Rehabilitation and Palliative Care, REHPA.

Charlotte Abrahamsen, RN, MHS, PhD and Associate Professor,

• Department of Orthopaedic Surgery, Lillebaelt Hospital and the Department of Regional Health Research, University of Southern Denmark.

Publications associated with the project

Støvring KR., Simony A., Abrahamsen C., Madsen UR. Shared decision-making when deciding on lower extremity amputation level - perceived facilitators and barriers among surgeons. Journal of Wound Management.

Støvring KR., Simony A. Madsen UR., Abrahamsen C. Patient Experiences with Pre-amputation Communication and Shared Decision-making - A National Cross-sectional Survey. Journal of Wound Management.