Case Management of Complex Pluripathology in Primary Care
- Conditions
- Complex and Chronic Pluripathology
- Interventions
- Other: Community Nurse Case Manager (CNCM)
- Registration Number
- NCT06155591
- Lead Sponsor
- José Ignacio Recio Rodriguez
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 212
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental Group Community Nurse Case Manager (CNCM) Usual care of CPCP + Community Nurse Case Manager (CNCM) standardized protocol
- Primary Outcome Measures
Name Time Method Activities of daily living 0,1,3,6,12 months 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
Cognitive performance 0,3,6,12 months Evaluated by Montreal Cognitive Assessment (MoCA). Score (0-30). A score of 26 or higher is considered normal
Health-related quality of life 0,3,6,12 months 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.
- Secondary Outcome Measures
Name Time Method Primary caregiver overload 0,3,6,12 months Evaluated by the Zarit scale. Score (22 - 110). A score ≥47 points being considered overburden
Therapeutic adherence 1,3,6,12 months 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.
User satisfaction 1,3,6,12 months 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
Degree of dyspnoea 0,1,3,6,12 months 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
Symptoms attributable to heart disease 0,1,3,6,12 months 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
Number of drugs chronically prescribed 0,1,3,6,12 months Collected from the patient's medical history
Frailty 0,1,3,6,12 months 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
Number of hospital admissions 1,3,6,12 months Collected from the patient's medical history
Weight 0 months Collected from the patient's medical history
Height 0 months Collected from the patient's medical history
Body mass index 0 months Collected from the patient's medical history
Blood pressure systolic and diastolic 0,1,3,6,12 months Measured in mmHg
Heart rate 0,1,3,6,12 months Measured in bpm
Oxygen saturation 0,1,3,6,12 months Measured in %
Capillary blood glucose 0,1,3,6,12 months Measured in mg/dl
Capillary glycosylated haemoglobin 0,3,6,12 months Measured in %