Case Management of Complex Pluripathology in Primary Care
NCT ID: NCT06155591
Last Updated: 2023-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
212 participants
INTERVENTIONAL
2024-01-31
2025-07-31
Brief Summary
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To assess the effect of the implementation of the Community Nurse Case Manager (CNCM) in the care of complex and pluripathological chronic patients (CPCP) with dependence, from Primary Care, on functional capacity, cognitive performance, quality of life, consumption of health resources, clinical parameters, overload of the main caregiver, and satisfaction of the user and/or caregiver.
Design
Pre- and post-intervention quasi-experimental study in CPCP.
Methods
212 subjects will be recruited from two urban health centers in Salamanca (Spain) with complex and chronic pluripathology (CCP) associated to cardiac, respiratory pathology and/or diabetes mellitus, who are dependent and have a planned hospital discharge.
An initial evaluation will be performed after hospital discharge in both groups, including: anamnesis (prescribed drugs and symptoms attributable to the underlying pathology), physical examination (blood pressure, heart rate and oxygen saturation), determination of capillary HbA1c, and assessment of functional capacity (Barthel), cognitive performance (MoCA), quality of life (COOP-WONCA), therapeutic adherence and overload of the main caregiver (Zarit). There will be another evaluation at 3,6 and 12 months, when these same variables will be collected, in addition to the number of readmissions in each period and the satisfaction of the user and/or caregiver (Satisfad 14). The nurse from the Primary Care team will provide both groups with the usual care contemplated for this type of patient in the Portfolio of Services of the Health Service of Castilla y León. Additionally, in the experimental group there will be telephone follow-up and the caregiver will be trained on the signs of decompensation and the care required.
Conclusion
The deployment of the NCM (Nurse Care Manager) in Primary Care will provide comprehensive and individualized care to the CPCP and the main caregiver with proactive monitoring. In addition, it will reinforce the involvement of the caregiver and the patient to improve their self-care and will detect early signs and symptoms of decompensation to avoid hospital readmissions.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Control Group
Usual care of complex and pluripathological chronic patients (CPCP)
No interventions assigned to this group
Experimental Group
Usual care of CPCP + Community Nurse Case Manager (CNCM) standardized protocol
Community Nurse Case Manager (CNCM)
Their action protocol has been designed and sequenced according to the circumstances in which the Complex and Pluripathological Chronic Patient finds themself:
* Pre-hospital discharge. The hospital Nurse Case Manager (HNCM) will contact the CNCM to inform of the imminent hospital discharge.
* Hospital discharge: A comprehensive nursing assessment of the CPCP based on Marjory Gordon's functional patterns will be carried out.
* Planned visits: An infographic will be provided to identify signs and symptoms of decompensation/exacerbation and a direct dial telephone number.
* Proactive telephone follow-up: The CNCM will make comfort calls every week for the first month, every 15 days until the 3-months visit and every month until the 6- and 12-months visits.
* Exacerbations/decompensations: An appointment will be arranged with their Primary Care physician.
* Hospital readmission: The CNCM will be kept informed of the process through the HNCM and CPCP's digital clinical history.
Interventions
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Community Nurse Case Manager (CNCM)
Their action protocol has been designed and sequenced according to the circumstances in which the Complex and Pluripathological Chronic Patient finds themself:
* Pre-hospital discharge. The hospital Nurse Case Manager (HNCM) will contact the CNCM to inform of the imminent hospital discharge.
* Hospital discharge: A comprehensive nursing assessment of the CPCP based on Marjory Gordon's functional patterns will be carried out.
* Planned visits: An infographic will be provided to identify signs and symptoms of decompensation/exacerbation and a direct dial telephone number.
* Proactive telephone follow-up: The CNCM will make comfort calls every week for the first month, every 15 days until the 3-months visit and every month until the 6- and 12-months visits.
* Exacerbations/decompensations: An appointment will be arranged with their Primary Care physician.
* Hospital readmission: The CNCM will be kept informed of the process through the HNCM and CPCP's digital clinical history.
Eligibility Criteria
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Inclusion Criteria
* Frail ≥1 point
* Require a main caregiver to perform basic activities of daily living (ABVD)
* Barthel ≤60 points and/or grade II or III dependency recognised by Social Services
* Are immobilised at home and/or require social resource management
* Agree to sign (themselves or their legal guardians) the informed consent for participation in the study
Exclusion Criteria
* With non-habitual caregivers
* Barthel ≥60 points or grade I dependency recognised by Social Services
* Who reside outside the area assigned to the Garrido Sur and Miguel Armijo health centres despite being assigned to them
ALL
No
Sponsors
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Consejo General de Colegios Oficiales de Enfermería de España
UNKNOWN
Instituto Español de Investigación Enfermera
UNKNOWN
Gerencia Regional de Salud de Castilla y Leon
OTHER
José Ignacio Recio Rodriguez
OTHER
Responsible Party
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José Ignacio Recio Rodriguez
Full Professor at the University. PhD
Central Contacts
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References
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Iglesias-Sierra V, Sanchez-Aguadero N, Recio-Rodriguez JI, Sanchez-Salgado B, Garcia-Ortiz L, Alonso-Dominguez R. Effectiveness of the Community Nurse Case Manager in Primary Care for Complex, Pluripathological, Chronic, Dependent Patients: A Study Protocol. Nurs Rep. 2025 May 29;15(6):191. doi: 10.3390/nursrep15060191.
Other Identifiers
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GRS 2490/B/22
Identifier Type: -
Identifier Source: org_study_id