Effect, economic and process-evaluation of a generic function focused care program for long-term care; study protocol of a multicenter cluster-randomized trial

BACKGROUND: Nurses are in a key position to stimulate older people to maximize their functional activity and independence. However, nurses still often work in a task-oriented manner and tend to take over tasks unnecessarily. It is evident to support nurses to focus on the capabilities of older people and provide care assistance only when required. Function-Focused Care (FFC) is a holistic care-philosophy aiming to support nurses to deliver care in which functioning and independence of older people is optimized. Dutch and internationally developed FFC-based interventions often lack effectiveness in changing nurses' and client's behavior. Process-evaluations have yielded lessons and implications resulting in the development of an advanced generic FFC-program: the 'SELF-program'. The SELF-program aims to improve activity stimulation behavior of nurses in long-term care services, and with that optimize levels of self-reliance in activities of daily living (ADL) in geriatric clients. The innovative character of the SELF-program lies for example in the application of extended behavior change theory, its interactive nature, and tailoring its components to setting-specific elements and needs of its participants. This paper describes the outline, content and theoretical background of the SELF-program. Subsequently, this paper describes a protocol for the assessment of the program's effect, economic and process-evaluation in a two-arm (SELF-program vs care as usual) multicenter cluster-randomized trial (CRT).

METHOD: The proposed CRT has three objectives, including getting insight into the program's: (1) effectiveness regarding activity stimulation behavior of nurses and self-reliance in ADL of geriatric clients, and (2) cost-effectiveness from a societal perspective including assessments of quality of life and health-care use. Measurements will take place prior to program implementation (baseline), directly after (T1), and in long-term (T2). Parallel to the CRT, a process evaluation will be conducted to provide insight into the program's: (3) feasibility regarding implementation, mechanisms of impact and contextual factors.

DISCUSSION: The SELF-program was developed following the Medical Research Council framework, which addresses the systematic development, feasibility testing, evaluation and implementation of complex interventions. The program has been subjected to a feasibility study before and results of studies described in this protocol are expected to be available from end 2022 onwards.

TRIAL-REGISTRATION: The study is registered in the Dutch Trial Register ( NL9189 ), as of December 22 2020.