Enhanced person profiles: a cluster randomised trial protocol for Swiss long-term care facilities

Family participation and teamwork are widely recommended as crucial components of person-centred dementia care in long-term care facilities, yet in everyday practice they often remain ad hoc and dependent on individual staff members rather than embedded in reproducible whole-team models. Robust evidence on such models and their impact on the quality of life of people with dementia is limited. A team of Swiss researchers led by Frank Spichiger and Andrea Koppitz of the LORE Long-Term Care Research Group at the HES-SO School of Health Sciences Fribourg has now published a study protocol in BMC Geriatrics describing a cluster randomised crossover trial designed to close this evidence gap. The trial will evaluate the enhanced person profile, a complex intervention that incorporates clinical tools for routine family participation and psychological safety methods that strengthen teamwork, ultimately aiming to improve the quality of life of people with dementia living in long-term care facilities.

The enhanced person profile builds directly on the original person profile, a complex intervention that has already been tested under randomised controlled trial conditions. In that earlier work, family participation and teamwork were identified as weak areas of the intervention. Rather than treating these elements as incidental by-products of good care, the researchers developed a programme that makes them explicit clinical targets. The enhanced version incorporates clinical tools designed to bring family members into the care process on a routine basis, and it adds psychological safety methods intended to enhance how care teams work together. Psychological safety, a concept from organisational research, describes a climate in which team members feel able to speak up, share concerns, and admit uncertainty without fear of embarrassment or reprisal, a condition that implementation scientists increasingly view as a prerequisite for reliable interprofessional collaboration in healthcare settings.

The trial itself is methodologically ambitious. The researchers will conduct a two-period, two-sequence cluster randomised crossover trial in 20 long-term care facilities in German-speaking Switzerland, involving 260 people with dementia. In a cluster randomised design, entire facilities rather than individual residents are randomised, which prevents contamination between intervention and control conditions within the same ward. Each period will last 7 months, separated by a 1-month washout, and clusters will follow one of two sequences: intervention followed by usual care, or usual care followed by intervention. The crossover structure is statistically efficient because each facility serves as its own comparison over time, and the washout period is intended to limit carryover effects between the two conditions. Assessments are planned at baseline (T0), at the crossover point after 7 months (T1), and at follow-up after 15 months (T2).

The primary outcome of the trial is proxy-rated quality of life measured with QUALIDEM, an instrument developed specifically for people with dementia whose self-report capacity is limited. Because many residents in long-term care facilities cannot reliably complete questionnaires themselves, proxy ratings by care staff who know the residents well are the standard approach in this field, and QUALIDEM covers domains such as care relationship, mood, and social engagement that are directly relevant to person-centred practice. Secondary outcomes will comprise symptoms and concerns measured with the Integrated Palliative Care Outcome Scale for People with Dementia (IPOS-Dem), person-centred care assessed with the Person-Centred Practice Inventory Staff Short Form (PCPI-S SF), perceived family participation captured with the Family Involvement Congruence Total Score (FICS-T), and teamwork evaluated with the Team Climate Inventory (TCI) at the unit level.

The choice of secondary outcomes reflects the intervention’s theory of change. If the enhanced person profile works as intended, the clinical tools for family participation should raise the congruence between how families and staff perceive family involvement, while the psychological safety methods should improve the team climate on the participating units. Changes in these mechanisms are then expected to translate into better quality of life and fewer unresolved symptoms and concerns for residents. By measuring person-centred practice from the staff perspective alongside family participation and teamwork, the trial can test whether these intermediate variables move in the predicted direction, providing evidence not only about whether the intervention works but also about how it works.

Statistically, the analyses will be carried out using linear mixed-effects models under the intention-to-treat principle, accounting for clustering and repeated measures. Mixed-effects models are the appropriate tool for this design because they handle the hierarchical structure of the data, with residents nested within facilities and repeated measurements nested within residents, and they can estimate the intracluster correlation coefficient, which quantifies how similar residents within the same facility are. The intention-to-treat principle means that all randomised clusters will be analysed according to their assigned sequence regardless of adherence, preserving the benefits of randomisation. The researchers also plan for the possibility of missing data, an unavoidable challenge in longitudinal studies with people whose dementia progresses over the 15-month study period, and the protocol acknowledges approaches for data that are missing not at random.

Beyond the outcome evaluation, the trial will employ a mixed-methods process evaluation to examine implementation, mechanisms, and context. Process evaluations are increasingly recognised as essential companions to randomised trials of complex interventions, because complex interventions contain multiple interacting components whose effects depend heavily on the setting in which they are delivered. The researchers will use the Consolidated Framework for Implementation Research (CFIR), a widely applied taxonomy of implementation determinants, to structure their analysis of contextual factors. The intervention will be described using the Template for Intervention Description and Replication (TIDieR), which supports reproducibility, and implementation targets will be specified with the Action, Actor, Context, Target, Time (AACTT) framework. Qualitative follow-up will explore sustainability, addressing the question of whether facilities can maintain the enhanced person profile after the trial ends, which is critical for large-scale adoption.

The trial is embedded in routine long-term care, which strengthens the ecological validity of the findings but also demands careful attention to feasibility for participating facilities. The study will be conducted in accordance with the European Medicines Agency Good Clinical Practice guidelines and the principles of the Declaration of Helsinki. All participants will provide informed consent and sign a consent form before any study procedures or data collection. The protocol and study documents, including the consent forms, educational materials, and electronic case report forms, were reviewed and approved by the Berne Cantonal Ethics Committee as the lead committee on 16 September 2026 under BASEC-ID 2026-00761, and the trial was registered in the German Clinical Trials Register under DRKS00041653. Data collection will be managed with Research Electronic Data Capture (REDCap), and dementia severity will be characterised with the Clinical Dementia Rating (CDR).

The study is funded by the VELUX Foundation and involves collaborators from the University of Lausanne, HES-SO School of Engineering and Management Vaud, the University of Vienna, Osnabrück University of Applied Sciences, Lausanne University Hospital, the University of Geneva, Bern University of Applied Sciences, and the Psychiatric University Hospital Zurich, reflecting the interdisciplinary nature of dementia care research that spans nursing science, geriatric psychiatry, palliative care, and implementation science. The authors declare no competing interests, and the protocol is published open access under a Creative Commons Attribution 4.0 International License.

The stakes of this research are considerable. Populations are ageing rapidly across Europe, and long-term care facilities care for a growing number of residents living with dementia, a condition that erodes memory, communication, and the ability to participate in decisions about one’s own life. Person-centred care, endorsed by the World Health Organization as a cornerstone of quality long-term care, aims to preserve dignity and individuality even as the disease advances, and family members often remain the people who know a resident’s history, preferences, and values best. Whether structured, whole-team models for family participation and psychologically safe teamwork can measurably improve the quality of life of people with dementia is precisely the question this trial is designed to answer. If the enhanced person profile proves effective and implementable, the researchers intend for the trial to determine its mechanisms of action and the implementation requirements for large-scale adoption, offering long-term care facilities a reproducible alternative to ad hoc, staff-dependent practice.

Subject of Research: Enhanced person profiles: a cluster randomised trial protocol for Swiss long-term care facilities

Article Title: Enhanced person profiles: a cluster randomised trial protocol for Swiss long-term care facilities

Article References: Spichiger, F., Koppitz, A., Kipfer, S., Zahner, S., Müller-Kägi, E., von Gunten, A., Bosisio, F., Nagl-Cupal, M., Büscher, A., Gamondi, C., Pautex, S., Meichtry, A., & Riese, F. (2026). Enhanced person profiles: a cluster randomised trial protocol for Swiss long-term care facilities. BMC Geriatrics. https://doi.org/10.1186/s12877-026-08507-2

Image Credits: AI Generated

DOI: 10.1186/s12877-026-08507-2

Keywords: dementia, long-term care, person-centred care, family participation, teamwork, cluster randomised trial, quality of life, Switzerland, geriatrics, nursing homes, Enhanced, person