Development of a guideline for the early detection of psychosis in long-term care facilities
| ISRCTN | ISRCTN16976551 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16976551 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | University College Odisee |
| Funder | University College Odisee |
- Submission date
- 10/10/2025
- Registration date
- 16/10/2025
- Last edited
- 16/10/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
This study develops a practice-oriented clinical guideline for the care of nursing home residents with psychotic symptoms. Psychosis is frequent yet often underestimated in this population, leading to missed care and unnecessary suffering. It is characterized by delusions, hallucinations, and profound disruption of identity and reality. The study aims to map the prevalence, characteristics, and correlates of psychotic symptoms and related needs, identify organizational and experiential barriers, and develop evidence- and expert-based recommendations to improve care and quality of life.
Who can participate?
The study includes three groups of participants from participating care facilities: nursing home residents, healthcare professionals, and family members. Healthcare professionals and family members are included based on their professional or personal involvement with the residents.
What does the study involve?
Residents are assessed using standardized behavioral scales (NPI-NH, BEHAVE-AD, Cornell Depression Scale, Doloplus-2), the Montreal Cognitive Assessment (MoCA), and a structured DSM-5-based interview for psychotic symptoms, anxiety, and depression. Residents with significant psychotic symptoms undergo a multidisciplinary needs-based analysis and pharmacological review involving a geriatrician, psychiatrist, neurologist, and pharmacist. Healthcare professionals and family members participate in focus groups to capture organizational and experiential barriers in daily care.
What are the possible benefits and risks of participating?
Participants may benefit from a better understanding of their or residents’ needs, improved awareness among staff, and contributions to a guideline that may enhance future care. Risks are minimal and mainly involve the time required to complete assessments or participate in interviews and focus groups; all data are handled confidentially.
Where is the study run from?
University College Odisee (Belgium)
When is the study starting and how long is it expected to run for?
June 2025 to April 2027
Who is funding the study?
University College Odisee (Belgium)
Who is the main contact?
Hilde Lahaye, hilde.lahaye@odisee.be
Contact information
Public, Scientific, Principal investigator
Hospitaalstraat 23
Sint-Niklaas
9100
Belgium
 ORCID ID |
0009-0002-6245-5249 |
|---|---|
| Phone | +32 (0)497593546 |
| hilde.lahaye@odisee.be |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Multicentre cross-sectional study |
| Secondary study design | Cross sectional study |
| Study type | Participant information sheet |
| Scientific title | Unmet care needs among residents of long-term care facilities with moderate to severe psychotic symptoms |
| Study acronym | PHARE |
| Study objectives | Psychotic symptoms such as delusions and hallucinations affect up to one in five residents in long-term care facilities, yet they are often overlooked, normalized, or misattributed to dementia or psychiatric history. This normalization results in care gaps, as psychotic symptoms are rarely acknowledged as indicators of unmet needs requiring appropriate and tailored interventions. Instead, psychotropic medication is frequently prescribed, despite well-documented concerns regarding appropriateness, side effects, and limited effectiveness. General practitioners themselves report insufficient knowledge and uncertainty in managing these symptoms, further contributing to inadequate care. Previous research has shown that a needs-based care approach can significantly improve outcomes in residents, but psychotic symptoms have remained largely underexplored. When recognized, they reveal profound distress, fear, and existential disruption for residents and their caregivers. This study therefore aims to close a critical gap by mapping missed care, conducting medication reviews, and developing a practical guideline to improve early detection and appropriate support for residents with psychotic symptoms. |
| Ethics approval(s) |
Approved 26/05/2025, Committee of Ethics Antwerp University Hospital (Drie Eikenstraat 655, Edegem, 2650, Belgium; +32 (0)38213897; ethisch.comite@uza.be), ref: B3002025000079 |
| Health condition(s) or problem(s) studied | Older adults in nursing homes with moderate and severe psychotic symptoms |
| Intervention | This multicentre, observational study combines cross-sectional and mixed-methods approaches over 1.5 years to inform the development of a practice-oriented clinical guideline for nursing home residents with psychotic symptoms. In the preparatory phase, residents are assessed using standardized behavioral scales, including the NPI-NH, Cornell Depression Scale, and Doloplus-2, alongside the Montreal Cognitive Assessment (MoCA) and a structured clinical interview based on DSM-5 criteria for psychotic symptoms, anxiety, and depression, conducted by trained psychologists. Quality of life is evaluated using the WHOQOL-8 questionnaire and semistructured interviews. Residents with significant psychotic symptoms (NPI-NH score ≥6 on delusions and/or hallucinations) will undergo a detailed needs-based analysis to identify missed care and care priorities, as well as a multidisciplinary pharmacological review involving a geriatrician, psychiatrist, neurologist, and pharmacist to evaluate the appropriateness of treatment. Focus groups with professionals, residents, and family members will capture organizational and experiential barriers in daily care. Findings from these assessments will inform the identification of key clinical and organizational questions, guide evidence-based recommendations, and support the development of a practical guideline aimed at improving care and quality of life. |
| Intervention type | Other |
| Primary outcome measure(s) |
Prevalence and characteristics of psychotic symptoms measured using the Neuropsychiatric Inventory-Nursing Home version (NPI-NH) and a structured DSM-5-based clinical interview at baseline |
| Key secondary outcome measure(s) |
1. Quality of life measured using the WHOQOL-8 questionnaire and semi-structured interviews at baseline |
| Completion date | 30/04/2027 |
Eligibility
| Participant type(s) | Health professional, Carer, Resident |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 1500 |
| Key inclusion criteria | The study includes nursing home residents, healthcare professionals, and family members from participating care facilities. There are no specific inclusion criteria beyond residency or professional/family involvement in the care of the residents. |
| Key exclusion criteria | Does not meet the inclusion criteria |
| Date of first enrolment | 01/09/2025 |
| Date of final enrolment | 30/04/2027 |
Locations
Countries of recruitment
- Belgium
Study participating centres
Sint-Niklaas
9100
Belgium
Sint-Niklaas
9100
Belgium
Lommel
3920
Belgium
Lommel
3920
Belgium
Hoegaarden
3320
Belgium
Kluisbergen
9690
Belgium
Zwalm
9630
Belgium
Maarkedal
9680
Belgium
Herent
3020
Belgium
Beringen-Koersel
3582
Belgium
Herk-de-Stad
3540
Belgium
Montenaken
3890
Belgium
's Gravenvoeren
3798
Belgium
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Hilde Lahaye (hilde.lahaye@odisee.be). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
10/10/2025: Study's existence confirmed by the Committee of Ethics Antwerp University Hospital.
