Case Management of Complex Pluripathology in Primary Care (ENGESCC)

Effectiveness of the Community Nurse Case Manager in Primary Care for Complex and Pluripathological Chronic Dependent Patients: Study Protocol

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Complex and Chronic Pluripathology
• Intervention / Treatment: Other: Community Nurse Case Manager (CNCM)

• Study Type: Interventional
• Enrollment (Estimated): 212
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Virginia Iglesias Sierra; Phone Number: 630098762; Email: viglesiass@saludcastillayleon.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; Usual care of complex and pluripathological chronic patients (CPCP)
Experimental: Experimental Group; Usual care of CPCP + Community Nurse Case Manager (CNCM) standardized protocol	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frailty	Evaluated by FRAIL questionnaire. This consists of 5 simple questions on fatigue, endurance, ambulation, comorbidity and weight loss. Persons scoring 1 point or more are considered frail	0,1,3,6,12 months
Primary caregiver overload	Evaluated by the Zarit scale. Score (22 - 110). A score ≥47 points being considered overburden	0,3,6,12 months
User satisfaction	Evaluated by Satisfad Questionnaire 14. Score (0-42). Each item is assessed through a 4-level Likert scale. A higher score means a higher level of satisfaction	1,3,6,12 months
Degree of dyspnoea	Evaluated by modified Medical Research Council Scale. This consists of 5 levels. The higher the level, the lower the tolerance to activity due to dyspnoea	0,1,3,6,12 months
Symptoms attributable to heart disease	Evaluated by the New York Heart Association Functional Classification. This consists of 4 Class. Class I patients have no symptoms, while those in classes II, III and IV have mild, moderate and severe symptoms, respectively	0,1,3,6,12 months
Number of hospital admissions	Collected from the patient's medical history	1,3,6,12 months
Number of drugs chronically prescribed	Collected from the patient's medical history	0,1,3,6,12 months
Weight	Collected from the patient's medical history	0 months
Height	Collected from the patient's medical history	0 months
Body mass index	Collected from the patient's medical history	0 months
Oxygen saturation	Measured in %	0,1,3,6,12 months
Heart rate	Measured in bpm	0,1,3,6,12 months
Capillary blood glucose	Measured in mg/dl	0,1,3,6,12 months
Capillary glycosylated haemoglobin	Measured in %	0,3,6,12 months
Therapeutic adherence	Evaluated by a scale to assess the patient's skills and knowledge of the prescribed treatment, adapted from the DRUGS and Med-Take scales. A score > 75%, the patient is adherence to treatment.	1,3,6,12 months
Blood pressure systolic and diastolic	Measured in mmHg	0,1,3,6,12 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: November 24, 2023
• First Submitted That Met QC Criteria: December 1, 2023
• First Posted (Actual): December 4, 2023

Study Record Updates

• Last Update Posted (Estimated): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 2, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Primary Health Care; Nursing; Case Management; Multimorbidity; Functional Dependence
• Other Study ID Numbers: GRS 2490/B/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No