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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:
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.
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.
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:
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:
Teach-back, to assess an individual's understanding of newly acquired information;
Motivational Interviewing, a counseling approach that facilitates collaborative dialogues to elicit the individual's intrinsic reasons for change, commitment.
Sharing Evidence Routine for a Person-centred Plan for Action (SHERPA model), a structured shared decision-making approach;
Family interviews according to the Calgary Family Assessment and Intervention Models, designed to support families as a unit, strengthening resilience and self-care.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Other | Single arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proactive Intervention | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite Outcome - access to the emergency department or hospitalization | The number of patients with at least one event between:
| 6 and 12 months pre-post |
| 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. |
| 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 |
Inclusion Criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Casa della Comunità di Lonigo | Lonigo | Vicenza | Italy |
Only IPD used in the results publication
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| ID | Term |
|---|---|
| D002908 | Chronic Disease |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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The intervention will involve family and community nurses proactively caring for patients with chronic conditions cared for at the Community Health Home located in a rural district in northern Italy.
This proactive approach 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.
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|
| 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 |
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 |