NCT04168996

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2019

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 13, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 19, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2020

Completed
Last Updated

August 4, 2020

Status Verified

July 1, 2020

Enrollment Period

2.1 years

First QC Date

November 13, 2019

Last Update Submit

July 31, 2020

Conditions

Rib Fractures

Outcome Measures

Primary Outcomes (3)

  • 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.

    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

    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).

    Change during the hospitalization, after a week, and after 6 months follow up

Secondary Outcomes (3)

  • Blaylock Risk Assessment Screening Score (BRASS)

    Change during the hospitalization, after a week, and after 6 months follow up

  • Early Screen for Discharge Planning (ESDP)

    Change during the hospitalization, after a week, and after 6 months follow up

  • Newcastle Satisfaction with Nursing Scales (NSNS)

    Change during the hospitalization, after a week, and after 6 months follow up

Study Arms (2)

rib fracture patients group

EXPERIMENTAL

Individualized discharge planning in rib fracture patients with different severity of lung injury

Behavioral: Individualized discharge planning

Control group

NO INTERVENTION

Patients included in control group received standard conservative treatment during hospitalization

Interventions

Individualized discharge planningBEHAVIORAL

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.

rib fracture patients group

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Health Sciences. University of Granada.

Granada, Andalusia, 18071, Spain

Location

Related Publications (1)

  • 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.

    PMID: 34092117DERIVED

MeSH Terms

Conditions

Rib Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesThoracic Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 13, 2019

First Posted

November 19, 2019

Study Start

October 10, 2017

Primary Completion

November 11, 2019

Study Completion

February 25, 2020

Last Updated

August 4, 2020

Record last verified: 2020-07

Locations

ES(1)