Development of an intervention to improve informational continuity of care in older patients with polypharmacy at the interface between general practice and hospital care: protocol for a participatory qualitative study in Germany.

Older patients with multimorbidity, polypharmacy and related complex care needs represent a growing proportion of the population and a challenge for healthcare systems. Particularly in transitional care (hospital admission and hospital discharge), medical errors, inappropriate treatment, patient concerns and lack of confidence in healthcare are major problems that may arise from a lack of information continuity. The aim of this study is to develop an intervention to improve informational continuity of care at the interface between general practice and hospital care. A qualitative approach will be used to develop our participatory intervention. Overall, 32 semistructured interviews with relevant stakeholders will be conducted and analysed. The stakeholders will include healthcare professionals from the outpatient setting (general practitioners, healthcare assistants, ambulatory care nurses) and the inpatient setting (clinical doctors, nurses, pharmacists, clinical information scientists) as well as patients and informal caregivers. At a series of workshops based on the results of the stakeholder analyses, we aim to develop a participatory intervention that will then be implemented in a subsequent pilot study. The same stakeholder groups will be invited for participation in the workshops. Ethical approval for this study was waived by the Ethics Committee of Goethe University Frankfurt because of the nature of the proposed study. Written informed consent will be obtained from all study participants prior to participation. Results will be tested in a pilot study and disseminated at (inter)national conferences and via publication in peer-reviewed journals. Clinical Trials Register: registration number DRKS00027649.

Brueckle MS ，Dinh TS ，Klein AA ，Rietschel L ，Petermann J ，Brosse F ，Schulz-Rothe S ，Gonzalez-Gonzalez AI ，Kramer M ，Engler J ，Mergenthal K ，Muth C ，Voigt K ，van den Akker M ... -  《BMJ Open》

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

Despite 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. The 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. The 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. The study was registered in DRKS-German Clinical Trials Register: registration number DRKS00027649 (date: 19 January 2022). Date and version identifier 10.07.2023; Version 1.3.

Klein AA ，Petermann J ，Brosse F ，Piller S ，Kramer M ，Hanf M ，Dinh TS ，Schulz-Rothe S ，Engler J ，Mergenthal K ，Seidling HM ，Klasing S ，Timmesfeld N ，van den Akker M ，Voigt K ... -  《-》

Integrating clinical pharmacists within general practice: protocol for a pilot cluster randomised controlled trial.

Managing patients with multiple conditions (multimorbidity) is a major challenge for healthcare systems internationally, particularly in older patients. Multimorbidity and subsequent polypharmacy increase treatment burden and the risk of potentially inappropriate prescribing, and both are complex to manage in primary care. Limited evidence suggests integration of pharmacists into general practice teams could improve medication management for patients with multimorbidity and polypharmacy. Building on findings from a non-randomised, uncontrolled General Practice Pharmacist (GPP) feasibility study conducted in Irish primary care, the aim of this study is to conduct a pilot cluster randomised controlled trial (cRCT) of the GPP study, to assess feasibility, intervention impact, costs and appropriateness of continuing to a definitive cRCT. This pilot cRCT will involve 8 general practitioner (GP) practices and 120 patients. Practices will identify and recruit patients aged ≥65 years, who are taking ≥10 regular medications. Practices will be allocated to intervention or control after baseline data collection. Intervention practices will have a pharmacist integrated within their service, working with GPs, patients and practice staff to optimise prescribing and other medication-related activities. Control practices will provide standard GP care. The primary feasibility outcomes will include recruitment rate, uptake of medication reviews and study retention. For the primary clinical outcome, the number of potentially inappropriate prescribing incidences per patient will be collected. Secondary outcomes will include medication-related outcomes, patient-reported outcome measures, and data pertaining to the role and impact of the pharmacist on prescribing. In addition, economic and process evaluations will be conducted. This trial has been approved by the Irish College of General Practitioners Research Ethics Committee and will be performed in accordance with the Declaration of Helsinki. The results will be reported in peer-reviewed journals and be presented at national and international conferences. ISRCTN Registry (https://doi.org/10.1186/ISRCTN18752158).

Croke A ，Moriarty F ，Boland F ，McCullagh L ，Cardwell K ，Smith SM ，Clyne B ... -  《BMJ Open》

Improving continuity of patient care across sectors: study protocol of the process evaluation of a quasi-experimental multi-centre study regarding an admission and discharge model in Germany (VESPEERA).

Hospital stays are critical events as they often disrupt continuity of care. This process evaluation aims to describe and explore the implementation of the VESPEERA programme (Improving continuity of patient care across sectors: An admission and discharge model in general practices and hospitals, Versorgungskontinuitaet sichern: Patientenorientiertes Einweisungs- und Entlassmanagement in Hausarztpraxen und Krankenhauesern). The evaluation concerns the intervention fidelity, reach in targeted populations, perceived effects, working mechanisms, feasibility, determinants for implementation, including contextual factors, and associations with the outcomes evaluation. The aim of the VESPEERA programme is the development, implementation and evaluation of a structured admission and discharge programme in general practices and hospitals. The process evaluation is linked to the VESPEERA outcomes evaluation, which has a quasi-experimental multi-centre design with four study arms and is conducted in hospitals and general practices in Germany. The VESPEERA programme comprises several components: an assessment before admission, an admission letter, a telephonic discharge conversation between hospital and general practice before discharge, discharge information for patients, structured planning of follow-up care after discharge in the general practice and a telephone monitoring for patients with a risk of rehospitalisation. The process evaluation has a mixed-methods design, incorporating interviews (patients, both care providers who do and do not participate in the VESPEERA programme, total n=75), questionnaires (patients and care providers who participate in the VESPEERA programme, total n=475), implementation plans of hospitals, data documented in general practices, claims-based data and hospital process data. Data analysis is descriptive and explorative. Qualitative data will be transcribed and analysed using framework analysis based on the Consolidated Framework for Implementation Research. Associations between the outcomes of the program and measures in the process evaluation will be explored in regression models. Ethics approval has been obtained by the ethics committee of the Medical Faculty Heidelberg prior to the start of the study (S-352/2018). Results will be disseminated through a final report to the funding agency, articles in peer-reviewed journals and conferences. http://www.drks.de/DRKS00015183. The study protocol on hand is the protocol V.1.1 from 18 June 2018. Recruitment for interviews started on 3 September 2018 and will approximately be completed by the end of May 2019.

Forstner J ，Kunz A ，Straßner C ，Uhlmann L ，Kuemmel S ，Szecsenyi J ，Wensing M ... -  《BMJ Open》

Multimorbidity patterns in chronic older patients, potentially inappropriate prescribing and adverse drug reactions: protocol of the multicentre prospective cohort study MoPIM.

Multimorbidity is a major challenge for current healthcare systems and professionals. From the different approaches that have been proposed to analyse this issue, the hypothesis of the existence of association patterns of different chronic conditions is gaining visibility. In addition, multimorbidity can be associated to polypharmacy, which can lead to a higher risk of potentially inappropriate prescribing (PIP) and consequently to adverse drug reactions (ADRs). The general objective of this novel study is to identify the association between PIP, multimorbidity patterns, polypharmacy and the presence of ADRs in older patients admitted for exacerbation of chronic diseases. The MoPIM (morbidity, potentially inappropriate medication) study is a multicentre prospective cohort study of an estimated sample of 800 older (≥65 years) patients admitted to five general hospitals in Spain due to an exacerbation of a chronic disease. Patients referred to home hospitalisation, admitted due to an acute process or with a fatal outcome expected at the time of admission are excluded. Sociodemographic data, chronic morbidities and geriatric syndromes, number of chronic prescribed medications, PIP at admission to hospital and on discharge, according to the newest screening tool of older screening tool of older person's potentially inappropriate prescriptions/screening tool to alert doctors to right treatment criteria, and ADRs during hospitalisation are being collected. Multimorbidity patterns will be identified using cluster analyses techniques, and the frequency of polypharmacy, PIP and ADRs will be calculated. Finally, the possible relationship between those indicators will be identified through bivariate and multivariate analyses. The project has been approved by the clinical research ethics committees of each centre: Comité Ético de investigación Clínica del Parc Taulí, Comitè Ètic d'Investigació Clínica Osona per a la Recerca i Educació Sanitàries (FORES), Comité de Ètica de la Investigación con Medicamentos (CEIm)-Parc de Salut MAR, Comité Ético de Investigación Clínica de Euskadi, Comité de Ética de Investigación del Hospital Universitario de Canarias. The results will be actively and mainly disseminated through publication in peer-reviewed journals and communications in scientific conferences. NCT02830425.

Baré M ，Herranz S ，Jordana R ，Gorgas MQ ，Ortonobes S ，Sevilla D ，De Jaime E ，Ibarra O ，Martín C ，MoPIM study group ... -  《BMJ Open》