PReventing and Approaching Crises for frail community-dwelling patients Through Innovative Care (PRACTIC): protocol for an effectiveness cluster randomised controlled trial.

BACKGROUND: Demographic changes, with an increasing number and proportion of older people with multimorbidity and frailty, will put more pressure on home care services in municipalities. Frail multimorbid people receiving home care services are at high risk of developing crises, defined as critical challenges and symptoms, which demand immediate and new actions. The crises often result in adverse events, coercive measures, and acute institutionalisation. There is a lack of evidence-based interventions to prevent and resolve crises in community settings. METHODS: This is a participatory action research design (PAR) in a 6-month cluster randomised controlled trial (RCT). The trial will be conducted in 30 municipalities, including 150 frail community-dwelling participants receiving home care services judged by the services to be at risk of developing crisis. Each municipality (cluster) will be randomised to receive either the locally adapted TIME intervention (the intervention group) or care as usual (the control group). The Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropsychiatric Symptoms (TIME) is a manual-based, multicomponent programme that includes a rigorous assessment of the crisis, one or more interdisciplinary case conferences, and the testing and evaluation of customised treatment measures. PAR in combination with an RCT will enhance adaptations of the intervention to the local context and needs. The primary outcome is as follows: difference in change between the intervention and control groups in individual goal achievement to resolve or reduce the challenges of the crises between baseline and 3 months using the PRACTIC Goal Setting Interview (PGSI). Among the secondary outcomes are the difference in change in the PGSI scale at 6 months and in neuropsychiatric symptoms (NPSs), quality of life, distress perceived by professional carers and next of kin, and institutionalisation at 3 and 6 months. DISCUSSION: Through customised interventions that involve patients, the next of kin, the social context, and health care services, crises may be prevented and resolved. The PReventing and Approaching Crises for frail community-dwelling patients Through Innovative Care (PRACTIC) study will enhance innovation for health professionals, management, and users in the development of new knowledge and a new adapted approach towards crises. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT05651659. Registered 15.12.22.

Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropsychiatric Symptoms (TIME) in home care services: a cluster randomized feasibility trial.

BACKGROUND: Behavioral and psychological symptoms of dementia (BPSD) occur frequently in people with dementia and can contribute to an increased need for help and a reduced quality of life, but also predict early institutionalization. The Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropsychiatric Symptoms (TIME) might be a useful personalized approach to BPSD in people with dementia. The main objective of this feasibility trial was to explore the trial design and methods along with the patients' and the home care staff's acceptance of the TIME intervention before developing a definitive trial. Additionally, we wanted to explore whether TIME could be appropriate for staff in home care services in their approach towards people with dementia with anxiety and depression. METHODS: This was a 18-month feasibility trial using a parallel cluster randomized controlled design. Nine municipalities from the eastern part of Norway (clusters) - 40 people with dementia and 37 of their next of kin- were randomized to the TIME intervention or to treatment as usual. In addition, qualitative data as field notes were collected and summarized. RESULTS: The staff in home care services experienced TIME as an appropriate method; in particular, the systematic approach to the patient's BPSD was experienced as useful. However, the completion of the assessment phase was considered exhaustive and time-consuming, and some of the staff found it challenging to find time for the case conferences. CONCLUSIONS: We consider that TIME, with some adjustments, could be useful for staff in home care services in cases where they face challenges in providing care and support to people with dementia. This feasibility trial indicates that we can move forward with a future definitive randomized controlled trial (RCT) to test the effect of TIME in people with dementia receiving home care services. TRIAL REGISTRATION: ClinicalTrial.gov identifier: SI0303150608.