Patient-Reported Outcomes and Care Experience in Chronic Patients Enrolled in a Family and Community Nurse Follow-Up Programme: Pre-Post Analysis of the "SENECA" Study (ASL Alessandria)

Abstract

INTRODUCTION
Chronic obstructive pulmonary disease (COPD) and heart failure (HF) are leading causes of hospitalisation and reduced quality of life in elderly populations. In Italy, the progressive implementation of the National Chronic Disease Plan and the emerging role of the Family and Community Nurse (IFeC),call for evidence on nurse-led care models’ impact on patient-centred outcomes. The “Evaluation of the effectiveneSs of a new managEmeNt modEl for patients with Chronic obstructive pulmonary disease and/or heArt failure” (SENECA) study evaluate a new IFeC-based care model at ASL Alessandria, incorporating systematic collection of Patient-Reported Outcome Measures (PROMs) and Patient-Reported Experience Measures (PREMs) at enrolment and at six-month follow-up.
OBJECTIVES
The study aims to assess pre-post changes in health-related quality of life, care experience and therapeutic adherence after six months of IFeC-led follow-up; secondary, to explore the presence of socio-demographic and clinical predictors of change in patient-reported outcomes.
METHODS
SENECA is a prospective observational study enrolling patients discharged with diagnosis of COPD, HF or both from hospitals of Casale Monferrato, Acqui Terme, Novi Ligure, Tortona, and from Community Health Center of Moncalvo.
Quality of life, patient-reported outcomes and medication adherence were assessed at baseline (T0) and at six-month follow-up (T1)using the SF-12 Standard Version 1, IC-PREM-I, and the 8-item Morisky Medication Adherence Scale (MMAS-8).Normality of score changes was assessed using Shapiro-Wilk test to guide the choice between parametric and non-parametric methods; changes between T0 and T1 were evaluated using the Wilcoxon signed-rank test for continuous outcomes, while changes in dichotomised medication adherence categories were assessed using McNemar’s test  Independent predictors of change in the SF-12 physical (ΔPCS) and mental (ΔMCS) component scores were estimated via robust multiple linear regression, with baseline scores included as covariates. Analyses were performed in Stata v17.
RESULTS
A total of 237 patients (median age 81 years;50.2% female)were enrolled: 47.3% with diagnoses of COPD, 26.6% with heart failure, 26.1% with both.
The PREM score increased significantly from T0 to T1 across all sites (mean 12.62 vs 13.36;Wilcoxon z=-6.02,p<0.001), reflecting greater satisfaction with the care experience. Therapeutic adherence increased significantly(McNemar p=0.014;OR = 3.0,95% CI:1.14–9.23).
Both SF-12 components improved significantly at follow-up (PCS:p<0.001;MCS:p=0.001);43% of patients reached the minimum clinically important difference (Minimal Clinically Important Difference-MCID≥3 points) for the physical component. Diagnosis-stratified analyses showed significant SF-12 improvements in both the COPD and HF subgroups; in the comorbidity group, improvement reached significance only for the mental component. Regression models identified female sex(β =−3.97 for ΔPCS; p<0.004),comorbidity diagnosis(β =−4.91 for ΔPCS; p<0.002)and baseline adherence(medium:β=+7.50,p<0.001;high:β=+4.72, p=0.018,for ΔMCS)as independent predictors of PROMs change.
CONCLUSIONS
The IFeC-based care model evaluated in the SENECA study is associated with clinically and statistically significant improvements in PROMs and PREMs in an elderly chronic patient population, although the reduced score variability observed for PREM at follow-up may indicate a ceiling effect warranting further investigation. Baseline therapeutic adherence emerged as a key predictor of mental health gain, supporting the need for adherence-stratified interventions. The Seneca study, initiated concurrently with the launch of this care model, represents a first step toward future larger-scale studies aimed at identifying the factors most strongly associated with overall patient satisfaction, encompassing physical health, psychological well-being, and quality of life.