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Expanded nursing competencies to improve person-centred care for nursing home residents with complex health needs (Expand-Care): exploratory cluster-randomized trial

Expanded nursing competencies to improve person-centred care for nursing home residents with complex health needs (Expand-Care): exploratory cluster-randomized trial - Expand-Care

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
DRKS
Registry ID
DRKS00028708
Enrollment
165
Registered
2022-05-25
Start date
2022-07-26
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complex care needs of residents in long-term care facilities

Interventions

Group 1: The intervention consists of the implementation of a role profile for nurses with expanded competencies in person-centred care in long-term care. Intervention components will be resident-rela

Sponsors

Universität zu Lübeck, Institut für Sozialmedizin und Epidemiologie, Sektion für Forschung und Lehre in der Pflege
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (High level of care dependency: German grade 3) OR ((medium level of care dependency: German grade 2) AND ((multimorbidity: three or more chronic illnesses) OR (at least one unplanned emergency service use: out-of-hour, emergency transport, emergency room or hospitalisation in the previous 8 weeks)))

Exclusion criteria

Exclusion criteria: (Life expectancy less than six months) OR (resident or legal guardian unable to understand study information in german language)

Design outcomes

Primary

MeasureTime frame
Hospital stays of nursing home residents (number, kind of admissions (elective versus unplanned), length of stay in days, reason for admission, initiation by whom, discharge diagnosis) will be copied from the digital resident record of nursing homes retrospectively at three time points (t0: Baseline and randomisation, t1: t0 +3 months, t2: t0 + 6 months).

Secondary

MeasureTime frame
All outcomes extracted from residents’ digital records will be measured at three timepoints (t0: baseline and randomisation, t1: t0 +3 months, t2: t0 + 6 months) for three months retrospectively. Outcomes measured questionnaire-based with residents (or by proxy) will be collected at t0 and t2, according to the time-frame defined by the respective instrument. Distal outcomes will be: Out-of-hour physician contacts (number and kind of contact (e.g. visits, telephone calls), reasons for initiation and initiator); emergency service use (number and kinds of services used, initiator, reason for contact), as documented in the residents’ record; health related quality of life (EuroQol 5-dimension 5-level (EQ-5D-5L)), as self-reported by resident or proxy assessment by nursing staff. Proximal outcomes will be: Symptom burden (Four-dimensional symptom questionnaire (4DSQ), Self-care in chronic diseases (LTCQ-8-G), and Person-Centred Climate Questionnaire Patients (German version, PCQ-P-G) as reported by resident (no proxy assessment); Falls and fall-related injuries, pressure ulcer category 2 or higher, incontinence associated dermatitis, potentially inappropriate medication (using PRISCUS criteria), contacts with general practitioners (kind of contact, e.g. telephone, fax, visit; reason, initiator, planned versus unplanned), all extracted from residents’ digital record. Further outcomes (safety, harms) will be: all-cause mortality (date, reasons, t1 and t2 only), current level of care based on nursing care insurance act, extracted from residents’ digital record. Further outcomes on resource use will be: Other health care utilisation data (based on FIMA Questionnaire), extracted from residents’ digital record. A process evaluation will address implementation, change mechanisms and contextual factors of the intervention using predominantly qualitative methods (interviews, focus groups, observations) with nurses, residents and family if applicable.

Countries

Germany

Contacts

Public ContactKatharina Silies

Universität zu Lübeck, Institut für Sozialmedizin und Epidemiologie, Sektion für Forschung und Lehre in der Pflege

katharina.silies@uksh.de004945150051261

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 9, 2026