Background: The sectorization of health-care systems leads to inefficient treatment, especially for elderly people with cognitive impairment. The transition from hospital care to primary care is insufficiently coordinated, and communication between health-care providers is often lacking. Consequences include a further deterioration of health, higher rates of hospital readmissions, and institutionalization. Models of collaborative care have shown their efficacy in primary care by improving patient-related outcomes. The main goal of this trial is to compare the effectiveness of a collaborative care model with usual care for people with cognitive impairment who have been admitted to a hospital for treatment due to a somatic illness. The aim of the intervention is to improve the continuity of treatment and care across the transition between the in-hospital and adjoining primary care sectors. Methods/design: The trial is a longitudinal multisite randomized controlled trial with two arms (care as usual and intersectoral care management). Inclusion criteria at the time of hospital admission due to a somatic illness are age 70+ years, cognitive impairment (Mini Mental State Examination, MMSE ≤26), living at home, and written informed consent. Each participant will have a baseline assessment at the hospital and two follow-up assessments at home (3 and 12 months after discharge). The estimated sample size is n = 398 people with cognitive inmpairement plus their respective informal caregivers (where available). In the intersectoral care management group, specialized care managers will develop, implement, and monitor individualized treatment and care based on comprehensive assessments of the unmet needs of the patients and their informal caregivers. These assessments will occur at the hospital and in participants' homes. Primary outcomes are (1) activities of daily living, (2) readmission to the hospital, and (3) institutionalization. Secondary outcomes include (a) frailty, (b) delirium, (c) quality of life, (d) cognitive status, (e) behavioral and psychological symptoms of dementia, (f) utilization of services, and (g) informal caregiver burden.

Background In the healthcare system in Germany, different institutions and actors play specific roles in the discharge and transition of patients from hospitals into primary care (Sachverständigenrat zur Begutachtung der Entwicklung im Gesundheitswesen, Wettbewerb an der Schnittstelle zwischen ambulanter und stationärer Gesundheitsversorgung, 2012). However, there are shortcomings in these intersectoral transitions. Especially in older people with cognitive impairment (PCI), discharge management often lacks coordination and cooperation between healthcare providers. This frequently results in higher rates of unscheduled readmission. The project intersec-CM is a randomised controlled trial (RCT) that aims to explore up to what extent an intersectoral care management (ICM) can improve this transition. This ICM is delivered by nurses with special training in care management. The objective of this paper is to describe a mixed-methods process evaluation of the intersectoral care management intervention and the factors that facilitate and inhibit its implementation. Methods Different study designs for process evaluations from previous literature were collected and analysed according to the dimension implementation fidelity, satisfaction with the intervention, feasible transfer into routine care, optimum point of time, frequency and execution of the intervention, and context factors. Results The actor-network theory was chosen as the theoretic framework for the process evaluation. Based on this theory, a mixed-methods design was developed to combine and integrate qualitative and quantitative evaluation methods. The qualitative part includes semi-structured interviews using topic guides (phase 1) and later in-depth interviews with narrative portions (phase 3), which will be analysed by using the qualitative content analysis according to Kuckartz. The quantitative survey (phase 2) is conducted with standardised questionnaires. Discussion Challenges in data collection include the development of interview guidelines, which require different terminologies depending on every specific actor targeted in the intervention. Conducting the interviews, there is a risk of misunderstanding the older PCI by the interviewer and vice versa. However, the combination of qualitative and quantitative approaches as different techniques of process evaluation may help to capture, integrate and analyse data on different dimensions of the intervention. Conclusions The results of our process evaluation may serve as an implementation guideline for intersectoral care management in the German healthcare system. Furthermore, the approach to evaluate the process of a complex intervention in health care for older PCI may serve as a stimulus to broaden the evidence base also of other complex intervention studies to improve health care for this vulnerable group. The study was ethically approved by the Ethics Committee of the Ernst-Moritz-Arndt University of Greifswald. The study has been registered at the U.S. National Library of Medicine. Trial registration ClinicalTrials.gov NCT03359408. Registered on 2 December 2017. The approximate date when recruitment to the process evaluation of the study will be completed is 31 May 2021.

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