Implementation and evaluation of a complex intervention to improve information availability at the interface between inpatient and outpatient care in older patients with multimorbidity and polypharmacy (HYPERION-TransCare) — study protocol for a pilot and feasibility cluster-randomized controlled trial in general practice in Germany

Pilot and Feasibility Studies

Study Protocol

Hanna M. Seidling¹  Sophia Klasing¹  Jenny Petermann²  Karen Voigt²  Franziska Brosse²  Steve Piller²  Astrid-Alexandra Klein²  Martin Kramer²  Nina Timmesfeld³  Truc Sophia Dinh⁴  Maria Hanf⁴  Sylvia Schulz-Rothe⁴  Jennifer Engler⁴  Karola Mergenthal⁴  Marjan van den Akker⁵ 

[1] Cooperation Unit Clinical Pharmacy, Department of Clinical Pharmacology & Pharmacoepidemiology, Heidelberg University Hospital, Im Neuenheimer Feld 410, 69120, Heidelberg, Germany;Department of General Practice/Medical Clinic III, Dresden Medical School, Dresden University of Technology, Dresden, Germany;Department of Medical Informatics, Biometry and Epidemiology, Ruhr University Bochum, Universitätsstraße 105, 44789, Bochum, Germany;Institute of General Practice, Goethe University, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main, Germany;Institute of General Practice, Goethe University, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main, Germany;Department of Public Health and Primary Care, Academic Center for General Practice, KU Leuven, Leuven, Belgium;Department of Family Medicine, School CAPHRI, Maastricht University, Maastricht, the Netherlands;

关键词: Polypharmacy;    Multimorbidity;    Family practice;    Inpatient and outpatient care;    Continuity of care;    Participation;    Older patients;    Randomized controlled trial;    Pilot projects;    Information availability;   

DOI  :  10.1186/s40814-023-01375-2

 received in 2022-04-14, accepted in 2023-08-03,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundDespite attempts to improve the cross-sectoral flow of information, difficulties remain in routine healthcare. The resulting negative impact on continuity of care is often associated with poor health outcomes, especially in older patients. Our intervention aims to increase information availability with respect to medications and health conditions at the interface between inpatient and outpatient care and to contribute towards improving the quality of care in older patients. This pilot study focuses on feasibility and implementability.MethodsThe idea of the complex intervention has been developed in a previous study. This intervention will be tested in a prospective, multicenter, cluster-randomized (via web tool), controlled pilot trial with two parallel study arms (intervention and control group). The pilot study will be conducted in 20 general practices in Hesse and Saxony (Germany) and include 200 patients (≥ 65 years of age with multimorbidity and polypharmacy) recruited by the practices. Practice staff and patients will be blinded. We will use qualitative and quantitative methods to assess the feasibility and implementability of the intervention and the study design in a process evaluation covering topics ranging from expectations to experiences. In addition, the feasibility of proposed outcome parameters for the future definitive trial will be explored. The composite endpoint will include health-related patient outcomes (hospitalization, falls, and mortality using, e.g., the FIMA questionnaire), and we will assess information on medications (SIMS questionnaire), symptoms and side effects of the medication (pro-CTCAE questionnaire), and health literacy (HLQ questionnaire).Data will be collected at study begin (baseline) and after 6 months. Furthermore, the study will include surveys and interviews with patients, general practitioners, and healthcare assistants.DiscussionThe intervention was developed using a participatory approach involving stakeholders and patients. It aims to empower general practice teams as they provide patient-centered care and play a key role in the coordination and continuity of care. We aim to encourage patients to adopt an active role in their health care. Overall, we want to increase the availability of health-related information for patients and healthcare providers. The results of the pilot study will be used in the design and implementation of the future definitive trial.Trial registrationThe study was registered in DRKS-German Clinical Trials Register: registration number DRKS00027649 (date: 19 January 2022).Date and version identifier10.07.2023; Version 1.3

【 授权许可】

CC BY   
© BioMed Central Ltd., part of Springer Nature 2023

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