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      Implementation of a complex intervention to improve hospital discharge: process evaluation of a cluster randomised controlled trial

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          Abstract

          Objectives

          To study the implementation of a cluster randomised controlled effectiveness-implementation hybrid trial testing the effectiveness of a medication review at hospital discharge combined with a communication stimulus between hospital physicians (HPs) and general practitioners (GPs) on rehospitalisation of multimorbid older patients.

          Design

          Extension of Grant’s mixed method process evaluation framework to trials with multilevel clustering.

          Setting

          General internal medicine wards in Swiss hospitals.

          Participants

          Convenience samples of 15 chief physicians (of 21 hospitals participating in the effectiveness trial), 60 (74) senior HPs, 65 (164) junior HPs and 187 (411) GPs.

          Implementation strategy

          Two-hour teaching sessions for senior HPs on a patient-centred, checklist-guided discharge routine.

          Process evaluation components

          Data collection on recruitment, delivery and response from chief physicians (semistructured interviews), senior HPs, junior HPs, GPs (surveys) and patients (via HPs). Quantitative data were summarised using descriptive statistics, and interviews analysed using thematic analysis.

          Outcome measures

          Intervention dose (quantitative), implementation fidelity (qualitative), feasibility and acceptability, facilitators and barriers, implementation support strategies.

          Results

          Recruitment of hospitals was laborious but successful, with 21 hospitals recruited. Minimal workload and a perceived benefit for the clinic were crucial factors for participation. Intervention dose was high (95% of checklist activities carried out), but intervention fidelity was limited (discharge letters) or unknown (medication review). Recruitment and retention of patients was challenging, partly due to patient characteristics (old, frail) and the COVID-19 pandemic: Only 612 of the anticipated 2100 patients were recruited, and 31% were lost to follow-up within the first month after discharge. The intervention was deemed feasible and helpful by HPs, and the relevance of the topic appreciated by both HPs and GPs.

          Conclusions

          The results from this evaluation will support interpretation of the findings of the effectiveness study and may inform researchers and policy makers who aim at improving hospital discharge.

          Trial registration number

          ISRCTN18427377.

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          Most cited references40

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          Developing and evaluating complex interventions: the new Medical Research Council guidance

          Evaluating complex interventions is complicated. The Medical Research Council's evaluation framework (2000) brought welcome clarity to the task. Now the council has updated its guidance
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            Process evaluation of complex interventions: Medical Research Council guidance

            Process evaluation is an essential part of designing and testing complex interventions. New MRC guidance provides a framework for conducting and reporting process evaluation studies
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              Is Open Access

              A conceptual framework for implementation fidelity

              Background Implementation fidelity refers to the degree to which an intervention or programme is delivered as intended. Only by understanding and measuring whether an intervention has been implemented with fidelity can researchers and practitioners gain a better understanding of how and why an intervention works, and the extent to which outcomes can be improved. Discussion The authors undertook a critical review of existing conceptualisations of implementation fidelity and developed a new conceptual framework for understanding and measuring the process. The resulting theoretical framework requires testing by empirical research. Summary Implementation fidelity is an important source of variation affecting the credibility and utility of research. The conceptual framework presented here offers a means for measuring this variable and understanding its place in the process of intervention implementation.
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                Author and article information

                Journal
                BMJ Open
                BMJ Open
                bmjopen
                bmjopen
                BMJ Open
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2044-6055
                2021
                27 May 2021
                : 11
                : 5
                : e049872
                Affiliations
                [1] departmentInstitute of Primary Care , University of Zurich and University Hospital Zurich , Zurich, Switzerland
                Author notes
                [Correspondence to ] Ms Yael Rachamin; yael.rachamin@ 123456usz.ch
                Author information
                http://orcid.org/0000-0002-1484-6934
                http://orcid.org/0000-0002-1564-5296
                http://orcid.org/0000-0002-6260-8148
                Article
                bmjopen-2021-049872
                10.1136/bmjopen-2021-049872
                8162085
                34045217
                c3a45be7-5009-4563-be4f-542d2854e188
                © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

                This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:  http://creativecommons.org/licenses/by-nc/4.0/.

                History
                : 04 February 2021
                : 31 March 2021
                : 23 April 2021
                Funding
                Funded by: Swiss National Science Foundation;
                Award ID: 407440_167193
                Categories
                Geriatric Medicine
                1506
                1698
                Original research
                Custom metadata
                unlocked

                Medicine
                general medicine (see internal medicine),quality in health care,public health,qualitative research

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