Rib FracturesNCT04168996
Individualized Discharge Planning in Patients With Rib Fracture
A study testing Individualized discharge planning in people with Rib Fractures, run by Universidad de Granada at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Rib Fractures
- What is being tested?
- Individualized discharge planning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteSpain
- Study dates
- 10 Oct 2017to 25 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The inclusion criteria were to be patients hospitalized due to fractures ribs due to falls, traffic accidents, and aggression.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Faculty of Health Sciences. University of Granada.
Granada, Andalusia, 18071
About this study
Official title: 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.
- Conditions
- Rib Fractures
- Being tested
- Individualized discharge planning
- Medical subject headings
- Rib Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized discharge planningBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| rib fracture patients group | Experimental | Individualized discharge planning in rib fracture patients with different severity of lung injury Receives: Behavioral: Individualized discharge planning |
| Control group | No intervention | Patients included in control group received standard conservative treatment during hospitalization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change during the hospitalization, after a week, and after 6 months follow up
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
Measured: Change during the hospitalization, after a week, and after 6 months follow up
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).
Measured: Change during the hospitalization, after a week, and after 6 months follow up
Secondary outcomes (3)
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.
Measured: Change during the hospitalization, after a week, and after 6 months follow up
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
Measured: Change during the hospitalization, after a week, and after 6 months follow up
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).
Measured: Change during the hospitalization, after a week, and after 6 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start10 Oct 2017
- Primary completion11 Nov 2019
- Study completion25 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rib FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie Carmen Valenza, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04168996
- Sponsor's protocol ID
- DF0086UG
- Status last verified
- Jul 2020
- First submitted
- 13 Nov 2019
- Last updated
- 4 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34092117
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Individualized Discharge Planning on, Functionality and Quality of Life in Different Severity Rib Fracture Patients
- ClinicalTrials.gov ID
- NCT04168996
- Acronym / sponsor ID
- DF0086UG
- Conditions
- Rib Fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 10 Oct 2017 (actual)
- Primary completion
- 11 Nov 2019 (actual)
- Study completion
- 25 Feb 2020 (actual)
- First posted
- 19 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rib fracture patients group | Experimental | Behavioral: Individualized discharge planningIndividualized discharge planning in rib fracture patients with different severity of lung injury |
| Control group | No intervention | –Patients included in control group received standard conservative treatment during hospitalization |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The inclusion criteria were to be patients hospitalized due to fractures ribs due to falls, traffic accidents, and aggression.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized discharge planningDischarge 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. | Behavioural | rib fracture patients group |
Primary outcome
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.
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
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).
3 secondary outcomes
Blaylock Risk Assessment Screening Score (BRASS)
Time frame: 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
Newcastle Satisfaction with Nursing Scales (NSNS)
Time frame: Change during the hospitalization, after a week, and after 6 months follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2020.
- Derived from this study: PubMed 34092117Granados 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized discharge planning in people with Rib Fractures, run by Universidad de Granada at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung Injury Score (LIS). (time frame: Change during the hospitalization, after a week, and after 6 months follow up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04168996, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2020.