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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
81

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Spain
    • Andalucia
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: rib fracture patients group
Individualized discharge planning in rib fracture patients with different severity of lung injury
Behavioral: Individualized discharge planning
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad de Granada

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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 10, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 11, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 25, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 13, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 19, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 4, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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