Chronic Diseases in Primary Care (PACUP)

A Nurse-led Intervention in General Practice to Manage People With Chronic Conditions: a Pre-post Study

This quasi-experimental study aims to assess if a nurse-led proactive intervention can enhance self-care and reduce hospitalizations or accesses to emergency department visits in chronically ill adults over 65 years old.

The questions that it seeks to answer are the following:

1. Can a structured, proactive nurse-led intervention reduce hospitalizations and access to emergency departments?
2. Can this intervention improve self-care, medication adherence, and the overall quality of life?

To assess its effectiveness, researchers will evaluate health outcomes before and after carrying out the intervention.

Participants will receive an initial assessment to identify specific educational needs. To enhance self-care and symptom management, patients will participate in at least three scheduled follow-up sessions (via phone call or face-to-face) during the following six months. They will also complete questionnaires assessing lifestyle quality, medication adherence, and self-care abilities.

Study Overview

• Status: Enrolling by invitation
• Conditions: Chronic Disease
• Intervention / Treatment: Other: Proactive Intervention

Detailed Description

The study aims to evaluate the effectiveness of managing people with chronic diseases through structured patient education, proactive healthcare, and prevention programs in primary care.

The intervention will be carried out in the outpatient setting and delivered by family and community nurses working in a Community Health Home, located in a rural district in northern Italy.

The quasi-experimental study takes place from September 2023 to September 2025.

• Population - All patients meeting the following inclusion criteria will be included: a) diagnosed with at least one non-oncological chronic condition, b) aged over 65 years, and c) assigned to general practitioners in the district of reference of the Community Health Home. Potential participants will be referred by general practitioners, social workers, or other professionals from home care, community, and transitional care services to family and community nurses (hereafter, nurses). Nurses will collect the informed written consent to participate in the study. Patients will be recruited through a consecutive sampling. It wasn't possible to perform an a priori power analysis because there are no available data on the chosen primary endpoint.
• Educational Intervention - The intervention will involve nurses proactively caring for patients with chronic conditions based on the Chronic Care Model approach and the Middle Range Theory of self-care in chronic disease, focusing on behavior change, engagement and empowerment, self-care and symptom perception, and health promotion planning strategies.

This process will be initiated through a phone call, during which the service will be introduced, and an appointment will be scheduled for either an outpatient or home nursing visit, depending on the patient's ability to access the Community Health Home. Following the initial structured assessment interview, patients will receive structured follow-up care with at least three contacts over six months. The frequency of these contacts will be increased at the nurse's discretion in cases of poor self-care ability or multiple educational needs identified during the initial interview. The follow-up will consist of in-person visits alternated with telephone follow-ups, focusing on self-care skill development and clinical monitoring.

Nurses will be trained on the study by a researcher in three meetings of two hours to ensure that all nurses carry out the intervention uniformly and reliably.

-Therapeutic education-

To assess educational needs, on the first interview, nurses will collect:

i) Socio-demographic data, as age, sex, informal caregiver(s) of reference, and cohabitation status; ii) Priority needs of the patients and informal caregivers through open-ended questions.

iii) Data from clinical conditions, as weight, height, vital signs, diseases, medications, blood tests, and medical exams, and civil disability status.

At the end, nurses will perform a structured assessment of social and educational needs in terms of:

• lifestyle (level of physical activity, alcohol consumption, sleeping quality, smoking habit);
• self-care skills (Patient Activation Measure questionnaire);
• risk of clinical-social frailty (Sunfrail questionnaire).

If any concerns or issues emerge, other questionnaires will be used for specific problems. All questionnaires will be used in their validated Italian versions and compiled into a pre-filled Excel file for each patient, created by the researchers.

These elements will be pre-filled based on data inputted by nurses and finalized manually. All information will be incorporated into an educational plan, which will be provided to the patient in written form.

Throughout all interviews, four communication approaches will be implemented:

1. Teach-back, to assess an individual's understanding of newly acquired information;
2. Motivational Interviewing, a counseling approach that facilitates collaborative dialogues to elicit the individual's intrinsic reasons for change, commitment.
3. Sharing Evidence Routine for a Person-centred Plan for Action (SHERPA model), a structured shared decision-making approach;

4. Family interviews according to the Calgary Family Assessment and Intervention Models, designed to support families as a unit, strengthening resilience and self-care.

   • Outcomes - The primary clinical outcome will be a composite outcome, assessed at 6 and 12 months: access to the emergency department and/or hospitalization.

Secondary outcomes include quality of care and medication adherence, and self-care abilities. These will be assessed with Patient-Reported Experience Measures (PREMs), questionnaires, and other indicators related to the process (number of visits, number of prescriptions, number of activated services).

-Data Collection- Nurses' charts (Excel files) and hospital and pharmaceutical databases will be used by authorised members to extract data.

- Statistical Analysis- Descriptive statistics will be employed by researchers to summarize socio-demographic characteristics. The Wilcoxon signed-rank test and McNemar's test will be used to compare pre-post-intervention outcomes.

Primary and secondary outcomes will be analyzed according to the intention-to-treat principle at the level of individual participants. Changes in repeated measures over time will be evaluated, with adjustments for baseline confounders. To further increase the transparency of results, researchers will evaluate to perform a sensitivity analysis. Cost analysis will be considered, taking into account human resources involved, materials, technologies, and savings from avoided hospitalizations and emergency care.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Vicenza
    • Lonigo, Vicenza, Italy
      • Casa della Comunità di Lonigo

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Diagnosed with at least one non-oncological chronic condition;
• Aged over 65 years;
• Assigned to general practitioners in the district of reference of the Community Health Home.

Exclusion criteria:

• Life expectancy of less than 12 months, as assessed by the general practitioner;
• Having more than one home access a week of intensive home care.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Intervention; Single arm

Other: Proactive Intervention; The educational program will be carried out as a structured intervention, aiming to actively involve patients in their own healthcare pathway, promoting changes in behavior and self-care. The first act will consist of a double-level assessment, first having nurses collect data to assess the educational needs, then delving into a structured assessment of social and educational needs from lifestyle, self-care, medication adherence, and frailty risk. After that, four communication approaches will be implemented to enhance educational effectiveness: teach-back, motivational interviewing, the SHERPA model, and Calgary Family Interviews.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite Outcome - access to the emergency department or hospitalization	The number of patients with at least one event between: access to the emergency department for pathological causes related to the chronic disease;; hospitalization for related pathological causes. Data will be collected from hospital integrated databases (Atlante, HR suite) from authorized employed healthcare professionals.	6 and 12 months pre-post

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Result endpoint: Medication adherence.	Within the reference period, each patient medication adherence will be calculated for each chronic drug therapy by comparing the theoretical days of prescription coverage with the effective period (in days) elapsed between drug prescriptions. % of medication adherence = [(n. of pills inside the box * drug dosage)/ daily dose] / days elapsing between the prescriptions.	6 and 12 months after the intervention
Result endpoint: Self-care ability	The outcome will be assessed through the Patient Activation Measure (PAM), a survey validated also initalian (local language).	6 and 12 months after the intervention
Result endpoint: Quality of received care	The quality of recived care will be assessed via a Patient Reported Experience Measures (PREMsT), already adopted from the local health authority (ULSS 8 Berica). Questions will be asking patients opinions about the visit experience (relationship with the healthcare professional, waiting times) and about community healthcare assistance (management of health and care), giving also the chance to leave comments and suggestions.	6 and 12 months after the intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Process evaluations: periodic use of nursing service	Number of users with at least 3 nursing visits within the reference period.	12 months after the intervention
Process evaluation: service utilization for each user	Number of nursing visits received for each user within the reference period	12 months after the intervention
Process evaluations: GP visits	Number of medical visits by the general practitioner for each user, within the reference period.	12 months after the intervention
Process evaluations: prescriptions of aids and devices	Rate of users with new prescriptions of aids or devices requested within the reference period.	12 months after the intervention
Process evaluations: family assessment	Number of users that recived structured assessment interviews for families within the reference period.	12 months after the interventions
Process evaluations: nurse visits at home	Number of users that recieved at least one nuse visit at home within the reference period.	12 months after the intervention
Process evaluations: activation of healthcare services	Number of services activated per person: physiotherapist, palliative care, social worker, etc.	12 months after the intervention
Process evaluations: relapses of desease	Rate of users reported to the general practitioner for suspected exacerbation of chronic pathology within 12 months after the intervention.	12 months after the intervention

Collaborators and Investigators

• Sponsor: Universita di Verona

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Actual): January 31, 2025
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: January 16, 2025
• First Submitted That Met QC Criteria: March 12, 2026
• First Posted (Actual): March 18, 2026

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: primary care; patient education; community nursing; chronic deseases
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Chronic Disease
• Other Study ID Numbers: Prog. 334CET

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Only IPD used in the results publication

Drug and device information, study documents

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