Effectiveness and cost-effectiveness of a structured integrated post-pulmonary embolism follow-up care model (Attend-PE): a rationale and protocol for a multicentre clinical pre-post study
BMJ Open, vol. 14, pp. e088533
Abstract
INTRODUCTION: Patients with pulmonary embolism (PE) experience impaired functional ability and reduced quality of life long after discharge from the hospital. However, there are no structured follow-up programmes in Denmark for these patients, and there is considerable variation in practice patterns of post-PE management. No studies have investigated the effectiveness of structured follow-up care models in patients with PE. This study aims to investigate the effect and cost-effectiveness of a structured integrated post-pulmonary embolism follow-up care model (Attend-PE) compared with usual care. The Attend-PE model outlines a structured approach for in-hospital follow-up, involving group-based patient education, individual consultations and systematic use of patient-reported outcome measures to assess the patient's physical and psychological well-being. METHODS AND ANALYSIS: The study is conducted in Denmark, where the healthcare system is tax-funded and services are freely available for all citizens, with an expected inclusion of 2000 patients in total. A pre-post-intervention study design is used to compare outcomes in the post-implementation cohort with the pre-implementation cohort. The co-primary outcomes are (1) health-related quality of life (patient-reported outcome, PRO) and (2) adherence to medical treatment (register-based data). Secondary outcomes include PROs on disability, treatment satisfaction, self-management, anxiety, depression and work productivity, and register-based outcomes, including recurrent PE, bleeding, mortality and healthcare use. Register-based data will be assessed at baseline (date of PE event), 6 and 12 months, while PRO-data will be assessed at 6 and 12 months after the PE event. The health economic evaluation of the Attend-PE model will include a cost-effectiveness analysis and a cost-utility analysis. ETHICS AND DISSEMINATION: The project will be conducted by the Declaration of Helsinki. In accordance with the Danish Act on Health Research Ethics §14, the study is exempt from approval. The use of survey responses in research (in anonymous form) is, however, contingent on participants' consent, and the invitation letter therefore included information about the purpose of the study and participants' rights to withdraw consent at any time, and that completion of the questionnaire is considered as consent to their survey data to be included in research.Study findings will be disseminated in scientific peer-reviewed journals, at national and international conferences, and for staff and decision-makers at participating hospitals and patients and relatives via the Danish Heart Association. TRIAL REGISTRATION NUMBER: Clinicaltrials.gov NCT06037096.
Authors 10
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Nanna Rolving corresponding
Aarhus University · Aarhus University Hospital
Affiliation as printed
Department of Publich Health, Aarhus University, Aarhus, Denmark
Physiotherapy and Occupational Therapy, Aarhus University Hospital, Aarhus N, Denmark Nanna.Rolving@rm.dk
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Affiliation as printed
Danish Center for Health Services Research, Aalborg University Hospital, Aalborg, Denmark
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Affiliation as printed
Danish Center for Health Services Research, Aalborg University, Aalborg, Denmark
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Aarhus University · Aarhus University Hospital
Affiliation as printed
Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark
Department of Clinical Medicine, Aarhus University, Aarhus, Denmark
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Herlev Hospital · Steno Diabetes Center Copenhagen
Affiliation as printed
Department of Cardiology, Herlev-Gentofte University Hospital, Herlev, Denmark
Steno Diabetes Center Copenhagen, Herlev, Denmark
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Affiliation as printed
Danish Center for Health Services Research, Aalborg University, Aalborg, Denmark
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Central Denmark Region · Aalborg University
Affiliation as printed
DEFACTUM, Corporate Quality, Central Denmark Region, Aarhus N, Denmark
Danish Center for Health Services Research, Aalborg University, Aalborg, Denmark
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Leiden University · Leiden University Medical Center
Affiliation as printed
Department of Thrombosis and Hemostasis, Leiden University Medical Centre, Leiden, The Netherlands
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University Medical Center of the Johannes Gutenberg University Mainz
Affiliation as printed
Center for Thrombosis and Hemostasis (CTH), University Medical Center Mainz, Mainz, Germany
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Affiliation as printed
Danish Center for Health Services Research, Aalborg University Hospital, Aalborg, Denmark
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