Case Management of Complex Pluripathology in Primary Care

NCT06155591 | Unknown

• 1 other identifier: GRS 2490/B/22
• Study Type: interventional
• Target: 212
• Locations: 0 countries
• Sites: N/A

Brief Summary

Aims 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.

Conditions

Complex and Chronic Pluripathology

Keywords

Multimorbidity; Functional Dependence; Case Management; Primary Health Care; Nursing

Outcome Measures

Primary Outcomes (3)

• Activities of daily living

  Evaluated by Barthel index. Score (0-100). A person is considered totally dependent if it is ˂20 points; severely dependent if it is between 25-60 points; moderately dependent if it is between 65-90 points; and mildly dependent if it is equal to 95 points

  0,1,3,6,12 months

• Cognitive performance

  Evaluated by Montreal Cognitive Assessment (MoCA). Score (0-30). A score of 26 or higher is considered normal

  0,3,6,12 months

• Health-related quality of life

  Evaluated by Health-related quality of life (COOP-WONCA test). This consists of a drawing representing a level of functioning on seven areas with a 5-level Likert scale. Higher scores express worse levels of functioning/well-being.

  0,3,6,12 months

Secondary Outcomes (16)

• Frailty

  0,1,3,6,12 months

• Primary caregiver overload

  0,3,6,12 months

• Therapeutic adherence

  1,3,6,12 months

• User satisfaction

  1,3,6,12 months

• Degree of dyspnoea

  0,1,3,6,12 months

Study Arms (2)

Control Group

NO INTERVENTION

Usual care of complex and pluripathological chronic patients (CPCP)

Experimental Group

EXPERIMENTAL

Usual care of CPCP + Community Nurse Case Manager (CNCM) standardized protocol

Other: Community Nurse Case Manager (CNCM)

Interventions

Community Nurse Case Manager (CNCM) OTHER

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.

Experimental Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Dependent complex and pluripathological chronic patients (CPCP) with associated cardiac and/or respiratory pathologies and/or diabetes mellitus
• 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

You may not qualify if:

• Patients with other pathologies associated with complex pluripathology
• 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

Sponsors & Collaborators

• José Ignacio Recio Rodriguez: lead
• Consejo General de Colegios Oficiales de Enfermería de España: collaborator
• Instituto Español de Investigación Enfermera: collaborator
• Gerencia Regional de Salud de Castilla y Leon: collaborator

Related Publications (1)

• 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.

  PMID: 40559482 DERIVED

Central Study Contacts

Virginia Iglesias Sierra

CONTACT

630098762; viglesiass@saludcastillayleon.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Full Professor at the University. PhD

Study Record Dates

• First Submitted: November 24, 2023
• First Posted: December 4, 2023
• Study Start: January 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: July 1, 2025
• Last Updated: December 8, 2023

Record last verified: 2023-12