- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06702150
Nursing Model and Health Outcomes of Elderly People with Multimorbidity: a Quasi-experimental Study
Effect of the Primary Nursing Model on Health Outcomes of Elderly Person with Multimorbidity: a Quasi-experimental Study
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;
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The self-care skills questionnaire used was the Therapeutic Self-care Scale (TSC), translated and validated for the Portuguese population.
The questionnaire used to assess satisfaction with care was the Scale of Citizen Satisfaction with Care (ESCCE), validated for the Portuguese population.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Lisboa, Portugal, 2745-849
- Hospital da Luz
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Changing the nursing care model to the primary nursing model
Inpatient unit where the primary nursing model has been implemented.
|
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.
|
|
No Intervention: Standard of care
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Average global self-care score at discharge from inpatient unit
Time Frame: On the day of discharge from the inpatient unit, assessment up to 24 hours later.
|
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
Time Frame: At the follow-up 30 days after hospital discharge
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Average score for satisfaction with nursing care at discharge from inpatient unit
Time Frame: On the day of discharge from the inpatient unit, assessment up to 24 hours later.
|
Assessed by answering the Citizen Satisfaction with Nursing Care Scale at discharge from the unit.
This is a 47-question Likert scale with a minimum score of one (1) and a maximum of seven (7), with higher scores corresponding to better results.
Average and total response scores are used.
|
On the day of discharge from the inpatient unit, assessment up to 24 hours later.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Elvio Jesus, Professor, Universidade Católica Portuguesa
- Study Chair: Elisabete Nunes, Professor, Nursing School of Lisbon
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CES/01/2022/ME
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Aged
-
Federal University of Rio Grande do SulNot yet recruiting
-
Instituto Politécnico de BragançaUniversity of Alcala; Research Center for Active Living and WellbeingCompletedAged Healthy Volunteer | Aged 60 Years or OlderPortugal
-
Samsung ElectronicsCompletedAged | Adults | Middle Age | Aged, 80 and OverKorea, Republic of
-
Consorci Sanitari de l'Alt Penedès i GarrafCompletedAged | Patient Safety | Aged, 80 and Over | Restraint, PhysicalSpain
-
The Hong Kong Polytechnic UniversityThe University of Hong Kong; Education University of Hong KongRecruiting
-
University Hospital, ToulouseCompleted
-
Abbott NutritionCompleted
-
Gulf Medical UniversityRecruitingAged | Geriatric | Balance | Fall Risk, Fall Prevention | Aged Healthy VolunteerUnited Arab Emirates
Clinical Trials on Changing the nursing care model to the primary nursing model
-
Istanbul University - CerrahpasaCompletedNursing Care Delivery ModelTurkey (Türkiye)
-
Abant Izzet Baysal UniversityCompletedQuality of Life | Transitional Care | Nursing CareTurkey
-
Kutahya Health Sciences UniversityCompleted
-
YaNi PengCompleted
-
The Fourth Affiliated Hospital of Zhejiang University...Recruiting
-
Regina Elena Cancer InstituteRecruiting
-
University of PennsylvaniaCompletedStroke | Transient Ischemic AttackUnited States
-
The Fourth Affiliated Hospital of Zhejiang University...Not yet recruitingTotal Knee Arthroplasty
-
Gazi UniversityCompletedDementia of Alzheimer TypeTurkey (Türkiye)
-
Saglik Bilimleri UniversitesiActive, not recruiting