Process evaluation of the randomized trial-"Care management for older people with cognitive impairment during and...

Effective care of people with cognitive impairment and their families depends, among other things, on the cooperation of the professionals involved in their care. An effective dementia care management support model for people with dementia and their families for the outpatient sector has been further developed for ambulatory and hospital settings. The intersec-CM randomized controlled trial (RCT) implemented this intersectoral care management (iCM) model into routine care in three hospitals in Bielefeld and Greifswald (Germany). Care managers (CMs) trained in advance for the study used a computer-based information management system (IMS) to assess patients' health and care needs and to develop individualized care plans. The iCM aimed to improve hospital-to-primary-care transitions and ensure cross-sectoral care. This was accompanied by a process evaluation to complement the data collected in the RCT. The aim was to understand how the complex intervention works in the selected real-world setting. This paper presents the results of this process evaluation.

For the process evaluation, a mixed-method design was chosen and applied. The evaluation was based on the guidelines of the British Medical Research Council for the implementation and process evaluation of complex interventions (MRC framework). A method triangulation was conducted consisting of several successive phases (t1: qualitative, t2: quantitative, t3: qualitative).

The sample (t1: individual interviews n = 30, t2: survey n = 177, t3: individual interviews n = 33) consisted of patients and their relatives, clinical physicians, social workers, carers, general practitioners, care managers (CMs), and project management. The process evaluation showed that intersectoral iCM could be implemented in the hospitals. The CMs were partially successful in assessing needs, developing individual treatment plans, and coordinating and monitoring the needs of people with cognitive impairment and their families. They found it difficult to work with the different actors in the healthcare system because of the rigid daily routines and lack of time in the clinics. Overall, the results show that (1) people with cognitive impairment and their families can benefit from the intervention and (2) iCM can help with the flow of information between health professionals.

The present process evaluation underlines the necessity and meaningfulness of process evaluations to understand the functionality and procedural feasibility of an RCT. Through the study, significant insights into the "black box" of the implementation of the iCM intervention could be gained.

ClinicalTrials.gov NCT03359408. The trial was registered on December 2, 2017.