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

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
      • 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.

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

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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