Clinical trial NCT04077541: the Effects of a Nursing Trauma Care Bundle
Official title: The Effects of a Nursing Trauma Care Bundle Combined With the Internet Platform in Patients With Extremity Injuries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Portals
Keywords: trauma care bundles
internet platform
patients with extremity injuries
experimental design
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2019-09-04
Enrollment: 83
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: the Numeric Pain Rating Scale
timeFrame: at 1 day before hospital discharge
measure: the Numeric Pain Rating Scale
timeFrame: at 10 to 14 days after hospital discharge
measure: the Barthel's Index
timeFrame: at 1 day before hospital discharge
measure: the Barthel's Index
timeFrame: at 10 to 14 days after hospital discharge
measure: the Barthel's Index
timeFrame: at 3 months after hospital discharge
measure: the Barthel's Index
timeFrame: at 6 months after hospital discharge
measure: the Posttraumatic Diagnostic Scale
timeFrame: at 3 months after hospital discharge
measure: the Posttraumatic Diagnostic Scale
timeFrame: at 6 months after hospital discharge
measure: the WHOQOL-BREF
timeFrame: at 3 months after hospital discharge
measure: the WHOQOL-BREF
timeFrame: at 6 months after hospital discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Medical University
Study officials:
affiliation: Kaohsiung Medical University
name: Bih-O Lee, PHD
role: PRINCIPAL_INVESTIGATOR
References: