Clinical trial NCT06155591: Case Management of Complex Pluripathology in Primary Care
Official title: Effectiveness of the Community Nurse Case Manager in Primary Care for Complex and Pluripathological Chronic Dependent Patients: Study Protocol
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Complex and Chronic Pluripathology
Keywords: Multimorbidity
Functional Dependence
Case Management
Primary Health Care
Nursing
Lead sponsor: University of Salamanca
Sponsor class: OTHER
Collaborators: name: Consejo General de Colegios Oficiales de Enfermería de España
name: Instituto Español de Investigación Enfermera
name: Gerencia Regional de Salud de Castilla y Leon
First posted: 2023-12-04
Enrollment: 212
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Activities of daily living
timeFrame: 0,1,3,6,12 months
measure: Cognitive performance
timeFrame: 0,3,6,12 months
measure: Health-related quality of life
timeFrame: 0,3,6,12 months
Secondary outcomes:
measure: Frailty
timeFrame: 0,1,3,6,12 months
measure: Primary caregiver overload
timeFrame: 0,3,6,12 months
measure: Therapeutic adherence
timeFrame: 1,3,6,12 months
measure: User satisfaction
timeFrame: 1,3,6,12 months
measure: Degree of dyspnoea
timeFrame: 0,1,3,6,12 months
measure: Symptoms attributable to heart disease
timeFrame: 0,1,3,6,12 months
measure: Number of hospital admissions
timeFrame: 1,3,6,12 months
measure: Number of drugs chronically prescribed
timeFrame: 0,1,3,6,12 months
measure: Weight
timeFrame: 0 months
measure: Height
timeFrame: 0 months
measure: Body mass index
timeFrame: 0 months
measure: Blood pressure systolic and diastolic
timeFrame: 0,1,3,6,12 months
measure: Oxygen saturation
timeFrame: 0,1,3,6,12 months
measure: Heart rate
timeFrame: 0,1,3,6,12 months
measure: Capillary blood glucose
timeFrame: 0,1,3,6,12 months
measure: Capillary glycosylated haemoglobin
timeFrame: 0,3,6,12 months
Other outcomes:
Locations:
Study officials:
References: