NCT06702150

Brief Summary

The goal of this quasi-experimental study is to analyze the effect of organizing nursing care according to the primary nursing model on therapeutic self-care and satisfaction with nursing care for elderly people with multimorbidity in hospital. Participants were patients of both sexes aged over 65 years with at least two chronic diseases admitted to an acute hospital ward. The main questions it aims to answer are:

  • Does the use of the primary nursing model increase participants' perceived ability for therapeutic self-care?
  • Does the use of the primary care model increase participants' satisfaction with nursing care? The researchers are comparing whether implementing the primary nursing model with the usual care model increases patients' capacity for therapeutic self-care. Participants:
  • Complete a self-care skills questionnaire on admission to the inpatient unit;
  • Complete the same self-care questionnaire on discharge from hospital;
  • Complete the same self-care questionnaire by telephone one month after discharge from hospital
  • Complete a nursing care satisfaction questionnaire on discharge from hospital;

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
206

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 18, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 12, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 22, 2024

Completed
Last Updated

November 22, 2024

Status Verified

November 1, 2024

Enrollment Period

1.4 years

First QC Date

November 12, 2024

Last Update Submit

November 20, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Average global self-care score at discharge from inpatient unit

    Evaluated by the difference in response to the Therapeutic Self-Care Scale on admission and discharge from the unit. It is a 12-question Likert scale with a minimum score of zero (0) and a maximum score of five (5), with higher scores corresponding to better results. Average response scores are used.

    On the day of discharge from the inpatient unit, assessment up to 24 hours later.

  • Average global self-care score at follow-up

    Evaluated by the difference between the response to the Therapeutic Self-Care Scale at discharge and at follow-up. Also assessed by the difference between the response to the Therapeutic Self-Care Scale at admission and at follow-up. Therapeutic Self-Care Scale is a 12-question Likert scale with a minimum score of zero (0) and a maximum score of five (5), with higher scores corresponding to better results. Average response scores are used.

    At the follow-up 30 days after hospital discharge

Secondary Outcomes (1)

  • Average score for satisfaction with nursing care at discharge from inpatient unit

    On the day of discharge from the inpatient unit, assessment up to 24 hours later.

Study Arms (2)

Changing the nursing care model to the primary nursing model

EXPERIMENTAL

Inpatient unit where the primary nursing model has been implemented.

Behavioral: Changing the nursing care model to the primary nursing model

Standard of care

NO INTERVENTION

In this unit there was no change in the model of nursing care; the model used was the individualized care model. In this model, each nurse is responsible for the whole care of a group of patients on one working day and may or may not be given responsibility for the same patients on subsequent days. The patients who agreed to participate in the study completed the same questionnaires and at the same frequency as the patients in the intervention unit.

Interventions

The nurses received training in primary nursing care before the start of the intervention. The model was tested and implemented in early April 2022. Since then, all patients admitted to the unit have been assigned to a primary nurse within the first 48 hours. This nurse is responsible for developing and monitoring the patient's care plan, assessing care needs, implementing the care plan and evaluating the outcomes. This nurse is also responsible for coordinating care needs and discharge planning with other healthcare professionals. When the primary nurse is not working, another nurse from his or her team continues the care plan that he or she has defined. All patients admitted to the unit who met the selection criteria were informed about the study and, if they agreed to take part, completed a self-care competence questionnaire at admission (baseline), at discharge and one month after discharge. They also completed a questionnaire on satisfaction with nursing care at discharge.

Changing the nursing care model to the primary nursing model

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Have at least two chronic diseases
  • Have at least one disease classified in the International Classification of Diseases, Ninth Revision (ICD9) and belonging to one of the following groups: cardiovascular disease, cancer, chronic obstructive pulmonary disease and diabetes;
  • Expect to be hospitalised for more than 48 hours;
  • Have the cognitive ability to read, write and understand the information provided;
  • Speak, read and write Portuguese.

You may not qualify if:

  • Transfer to other levels of care within the organisation
  • Discharged to other care units outside the organisation
  • Episodes of readmission within 30 days of leaving hospital, as this made the last moment of data collection impossible.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital da LUz

Lisbon, 2745-849, Portugal

Location

Related Publications (1)

  • Goncalves I, Almeida S, Jesus E, Nunes E. Effect of the Primary Nursing Model on Self-Care Skills of Hospitalized Older Patients with Multimorbidity: A Quasi-Experimental Study. Healthcare (Basel). 2025 Sep 27;13(19):2457. doi: 10.3390/healthcare13192457.

Study Officials

  • Elvio Jesus, Professor

    Universidade Católica Portuguesa

    STUDY DIRECTOR
  • Elisabete Nunes, Professor

    Nursing School of Lisbon

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: In the hospital where the study was carried out, each nurse is responsible for the whole care of a group of people on one working day and may or may not be given responsibility for the same people on subsequent days (individualized care model). An intervention was proposed in an inpatient unit consisting of implementing the model of organizing care by primary nursing in which a nurse is responsible for the care plan for a group of people from admission to discharge from the unit.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of nursing

Study Record Dates

First Submitted

November 12, 2024

First Posted

November 22, 2024

Study Start

April 18, 2022

Primary Completion

August 31, 2023

Study Completion

August 31, 2023

Last Updated

November 22, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share

Only IPD used in the results publication

Shared Documents
SAP

Locations