the Effects of a Nursing Trauma Care Bundle

NCT ID: NCT04077541

Last Updated: 2022-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-15

Study Completion Date

2022-01-25

Brief Summary

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To examine the effects of evidence-based care bundles combined with the internet platform in patients with extremity injuries. A longitudinal and two group experimental design will be used. Outcome measures for the trauma care bundles will use the Barthel's Index, the Posttraumatic Diagnostic Scale, and the World Health Organization Quality of Life questionnaire. The results may influence health policy and clinical practice, and a wide range of injured patient outcomes.

Detailed Description

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Background: Over 50% of injuries are accompanied by musculoskeletal injuries that are life-threatening, require amputation or lead to major extremity dysfunctions. Some barriers exist to deliver evidence-based care in the trauma group. Based on recent research findings, this project will be an evidence-based project and evaluation of care bundles combined with e health care to establish and refine evidence-based care guidelines for patients with extremity injuries in Taiwan.

Aims: To examine the effects of evidence-based care bundles combined with the internet platform in patients with extremity injuries.

Methods: A longitudinal and two group experimental design will be used. The trauma care bundles combined with internet platform will be implemented over 24-hour admission and ended in 10-14 days after hospital discharge. Participants will be patients with extremity injuries that meet the criteria. The experimental group and the control group will be given the same routine care except for the trauma care bundles. Both groups will be followed up at 3 and 6 months after hospital discharge. Fifty-eight participants for each group will be expected. The generalized estimating equations will be used to analyze the data. Outcome measures for the trauma care bundles will use the Barthel's Index, the Posttraumatic Diagnostic Scale, and the World Health Organization Quality of Life questionnaire.

Expected outcomes: This is an innovation project as it combines a comprehensive trauma care bundles with internet platform, and applied in the biggest injury population in Taiwan. It may be the pioneer study to integrate care bundle and e-health care in trauma care. The results may influence health policy and clinical practice, and a wide range of injured patient outcomes. The internet platform established by the research team may be an important template for domestic e-health in hospital-based settings and long-term care facilities.

Conditions

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Patient Portals

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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The experimental group

The trauma care bundles combined with the internet platform.

Group Type EXPERIMENTAL

internet platform

Intervention Type BEHAVIORAL

The trauma care bundles combined with the internet platform.

The control group

Only trauma care bundles.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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internet platform

The trauma care bundles combined with the internet platform.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* ISS (Injury Severe Score)\>9
* Agree to participate in this examination for 6 months after discharge
* Accidental extremity injuries
* Have a smart phone and access to the Internet

Exclusion Criteria

* Discharged within 24 hours
* Cognitive dysfunction and unable to provide formal consent
* Severe brain damage
* Burned patient
* Severe psychosis
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bih-O Lee, PHD

Role: PRINCIPAL_INVESTIGATOR

Kaohsiung Medical University

Locations

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Kaohsiung Medical University

Kaohsiung City, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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KMUHIRB-E(I)-20190203

Identifier Type: -

Identifier Source: org_study_id

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