Back to resultsIndividualized Discharge Planning in Patients With Rib Fracture
Primary Purpose
Rib Fractures
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Individualized discharge planning
Sponsored by
About this trial
This is an interventional treatment trial for Rib Fractures
Eligibility Criteria
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.
Sites / Locations
- Faculty of Health Sciences. University of Granada.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
rib fracture patients group
Control group
Arm Description
Individualized discharge planning in rib fracture patients with different severity of lung injury
Patients included in control group received standard conservative treatment during hospitalization
Outcomes
Primary Outcome Measures
Lung Injury Score (LIS).
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.
EuroQol-5D (EQ-5D)
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
Barthel Index
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).
Secondary Outcome Measures
Blaylock Risk Assessment Screening Score (BRASS)
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.
Early Screen for Discharge Planning (ESDP)
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
Newcastle Satisfaction with Nursing Scales (NSNS)
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).
Full Information
NCT ID
NCT04168996
First Posted
November 13, 2019
Last Updated
July 31, 2020
Sponsor
Universidad de Granada
1. Study Identification
Unique Protocol Identification Number
NCT04168996
Brief Title
Individualized Discharge Planning in Patients With Rib Fracture
Official Title
Effectiveness of an Individualized Discharge Planning on, Functionality and Quality of Life in Different Severity Rib Fracture Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
October 10, 2017 (Actual)
Primary Completion Date
November 11, 2019 (Actual)
Study Completion Date
February 25, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rib Fractures
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Arm Title
rib fracture patients group
Arm Type
Experimental
Arm Description
Individualized discharge planning in rib fracture patients with different severity of lung injury
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients included in control group received standard conservative treatment during hospitalization
Intervention Type
Behavioral
Intervention Name(s)
Individualized discharge planning
Intervention Description
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.
Primary Outcome Measure Information:
Title
Lung Injury Score (LIS).
Description
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.
Time Frame
Change during the hospitalization, after a week, and after 6 months follow up
Title
EuroQol-5D (EQ-5D)
Description
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
Time Frame
Change during the hospitalization, after a week, and after 6 months follow up
Title
Barthel Index
Description
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).
Time Frame
Change during the hospitalization, after a week, and after 6 months follow up
Secondary Outcome Measure Information:
Title
Blaylock Risk Assessment Screening Score (BRASS)
Description
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.
Time Frame
Change during the hospitalization, after a week, and after 6 months follow up
Title
Early Screen for Discharge Planning (ESDP)
Description
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
Time Frame
Change during the hospitalization, after a week, and after 6 months follow up
Title
Newcastle Satisfaction with Nursing Scales (NSNS)
Description
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).
Time Frame
Change during the hospitalization, after a week, and after 6 months follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Faculty of Health Sciences. University of Granada.
City
Granada
State/Province
Andalucia
ZIP/Postal Code
18071
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34092117
Citation
Granados Santiago M, Valenza MC, Prados Roman E, Lopez Lopez L, Munoz Vigueras N, Cabrera Martos I, Cebria I Iranzo MA. Impacts of tailored, rehabilitation nursing care on functional ability and quality of life in hospitalized elderly patients after rib fractures. Clin Rehabil. 2021 Nov;35(11):1544-1554. doi: 10.1177/02692155211022734. Epub 2021 Jun 6.
Results Reference
derived
Learn more about this trial
Individualized Discharge Planning in Patients With Rib Fracture
We'll reach out to this number within 24 hrs