- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04168996
Individualized Discharge Planning in Patients With Rib Fracture
July 31, 2020 updated by: Marie Carmen Valenza, Universidad de Granada
Effectiveness of an Individualized Discharge Planning on, Functionality and Quality of Life in Different Severity Rib Fracture Patients
Patients with rib fractures may develop pneumonia and even respiratory failure requiring critical care, ventilator management, and hospitalization.
Discharge planning is a broad range of time-limited services designed to ensure healthcare continuity, avoid preventable poor outcomes among at-risk populations, and promote the safe and timely transfer of patients care.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
81
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Andalucia
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Granada, Andalucia, Spain, 18071
- Faculty of Health Sciences. University of Granada.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- The inclusion criteria were to be patients hospitalized due to fractures ribs due to falls, traffic accidents, and aggression.
Exclusion Criteria:
- Exclusion criteria were an inability to provide informed consent, the presence of psychiatric or cognitive disorders, progressive neurological disorders, or inability to cooperate. Patients who had experienced hospitalization in the Intense Care Unit were also excluded.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: rib fracture patients group
Individualized discharge planning in rib fracture patients with different severity of lung injury
|
Discharge planning is designed to ensure healthcare continuity, avoid preventable poor outcomes among at-risk populations, and promote the safe and timely transfer of patient care.
The individualized discharge planning is characterized to take into account the preferences, interests and clinical profile of each patient.
|
|
No Intervention: Control group
Patients included in control group received standard conservative treatment during hospitalization
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lung Injury Score (LIS).
Time Frame: Change during the hospitalization, after a week, and after 6 months follow up
|
This score was assessed the progression of the lung injury and the development of acute respiratory distress syndrome.
The final value was obtained by dividing the sum of the variables used: no injury (LIS=0), mild to moderate (LIS≥0.1),
severe (LIS>2.5).
We were allocated with a cutoff in the score of LIS.
|
Change during the hospitalization, after a week, and after 6 months follow up
|
|
EuroQol-5D (EQ-5D)
Time Frame: Change during the hospitalization, after a week, and after 6 months follow up
|
This measure contains two sections, a descriptive questionnaire about health impairment and a numerical scale about health status perception.
The descriptive section includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Each dimension is categorized into three levels of functioning for each of the five dimensions.
The numerical scale ranges from 0 (defined as the worst imaginable health state) to 100 (defined as the best imaginable health state
|
Change during the hospitalization, after a week, and after 6 months follow up
|
|
Barthel Index
Time Frame: Change during the hospitalization, after a week, and after 6 months follow up
|
The Barthel Index assesses the level of dependence required by patient to perform the activities.
The item scores are totaled which may vary from 0 (total dependence) to 100 (fully independent).
|
Change during the hospitalization, after a week, and after 6 months follow up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blaylock Risk Assessment Screening Score (BRASS)
Time Frame: Change during the hospitalization, after a week, and after 6 months follow up
|
It comprises a 10-item scale with a score between 0 and 40, with a higher score correlating with a greater likelihood of discharge complications and length of stay. A score of 0-10 identifies patients at low risk for complications, 11-20 identifies those requiring discharge planning, and scores above 20 indicate patients who require extensive discharge planning. |
Change during the hospitalization, after a week, and after 6 months follow up
|
|
Early Screen for Discharge Planning (ESDP)
Time Frame: Change during the hospitalization, after a week, and after 6 months follow up
|
The question screening tool was composed for several items (age, living status, disability, and self-reported walking limitation).
The score was between 0 and 23.
A positive score (≥ 10) was found to indicate the need for automatic referral for complex discharge planning
|
Change during the hospitalization, after a week, and after 6 months follow up
|
|
Newcastle Satisfaction with Nursing Scales (NSNS)
Time Frame: Change during the hospitalization, after a week, and after 6 months follow up
|
This measure contains two scales, the experiences of nursing care scale (cognitive evaluation), and the satisfaction with nursing care scale (emotional evaluation).
Item scores for each of the scales are summed so that the two scale with scores range from 0 (the best care and full satisfaction) to 100 (the worse care and no satisfaction).
|
Change during the hospitalization, after a week, and after 6 months follow up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 10, 2017
Primary Completion (Actual)
November 11, 2019
Study Completion (Actual)
February 25, 2020
Study Registration Dates
First Submitted
November 13, 2019
First Submitted That Met QC Criteria
November 15, 2019
First Posted (Actual)
November 19, 2019
Study Record Updates
Last Update Posted (Actual)
August 4, 2020
Last Update Submitted That Met QC Criteria
July 31, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DF0086UG
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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