the Effects of a Nursing Trauma Care Bundle

NCT04077541 | Completed

• 1 other identifier: KMUHIRB-E(I)-20190203
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

Patient Portals

Keywords

trauma care bundles; internet platform; patients with extremity injuries; experimental design

Outcome Measures

Primary Outcomes (10)

• the Numeric Pain Rating Scale

  The NPRS is a one-dimensional measure of pain intensity in adults. A NPRS has similar anchors at the extremes but offers numbers from 0 through 10. It is well known and broadly used scale in clinical settings. It also used to be applied in post injury pain

  at 1 day before hospital discharge

• the Numeric Pain Rating Scale

  The NPRS is a one-dimensional measure of pain intensity in adults. A NPRS has similar anchors at the extremes but offers numbers from 0 through 10. It is well known and broadly used scale in clinical settings. It also used to be applied in post injury pain

  at 10 to 14 days after hospital discharge

• the Barthel's Index

  The BI will be used to measure functional disabilities patients with extremity injury. The BI, organically developed by Mahoney and Barthel (1965), assesses BADL in terms of respondent abilities related to feeding, bathing, grooming, dressing, bowel and bladder control, toilet use, transfer, mobility, and stair use. The BI has 30 items with scores range from 0 to 100, with higher scores representing higher independence in performing BADLs. A total BI score of 0 to 20 correlates with total dependence, 21 to 60 correlates with severe dependence, 61 to 90 correlates with moderate dependence, 91 to 99 correlates with slight dependence, and 100 correlates with total independence. The Chinese version was applied in older populations, with Cronbach's alpha ranging from 0.79 to .085 (Shyu, Tang, Tsai, Liang, \& Chen, 2006). The Cronbach's alpha for this current project will be retested using the injury group.

  at 1 day before hospital discharge

• the Barthel's Index

  The BI will be used to measure functional disabilities patients with extremity injury. The BI, organically developed by Mahoney and Barthel (1965), assesses BADL in terms of respondent abilities related to feeding, bathing, grooming, dressing, bowel and bladder control, toilet use, transfer, mobility, and stair use. The BI has 30 items with scores range from 0 to 100, with higher scores representing higher independence in performing BADLs. A total BI score of 0 to 20 correlates with total dependence, 21 to 60 correlates with severe dependence, 61 to 90 correlates with moderate dependence, 91 to 99 correlates with slight dependence, and 100 correlates with total independence. The Chinese version was applied in older populations, with Cronbach's alpha ranging from 0.79 to .085 (Shyu, Tang, Tsai, Liang, \& Chen, 2006). The Cronbach's alpha for this current project will be retested using the injury group.

  at 10 to 14 days after hospital discharge

• the Barthel's Index

  The BI will be used to measure functional disabilities patients with extremity injury. The BI, organically developed by Mahoney and Barthel (1965), assesses BADL in terms of respondent abilities related to feeding, bathing, grooming, dressing, bowel and bladder control, toilet use, transfer, mobility, and stair use. The BI has 30 items with scores range from 0 to 100, with higher scores representing higher independence in performing BADLs. A total BI score of 0 to 20 correlates with total dependence, 21 to 60 correlates with severe dependence, 61 to 90 correlates with moderate dependence, 91 to 99 correlates with slight dependence, and 100 correlates with total independence. The Chinese version was applied in older populations, with Cronbach's alpha ranging from 0.79 to .085 (Shyu, Tang, Tsai, Liang, \& Chen, 2006). The Cronbach's alpha for this current project will be retested using the injury group.

  at 3 months after hospital discharge

• the Barthel's Index

  The BI will be used to measure functional disabilities patients with extremity injury. The BI, organically developed by Mahoney and Barthel (1965), assesses BADL in terms of respondent abilities related to feeding, bathing, grooming, dressing, bowel and bladder control, toilet use, transfer, mobility, and stair use. The BI has 30 items with scores range from 0 to 100, with higher scores representing higher independence in performing BADLs. A total BI score of 0 to 20 correlates with total dependence, 21 to 60 correlates with severe dependence, 61 to 90 correlates with moderate dependence, 91 to 99 correlates with slight dependence, and 100 correlates with total independence. The Chinese version was applied in older populations, with Cronbach's alpha ranging from 0.79 to .085 (Shyu, Tang, Tsai, Liang, \& Chen, 2006). The Cronbach's alpha for this current project will be retested using the injury group.

  at 6 months after hospital discharge

• the Posttraumatic Diagnostic Scale

  The PTDS is a self-report instrument for post traumatic syndrome that is simple to administer and has demonstrated good psychometric properties. The PTSD will not use to diagnose if injured patients have psychological illnesses. It will be applied in measuring how and what post traumatic symptoms that patients will have after injuries. The scale is a structured interview for assessing PTSD diagnostic status and symptom. The degree of severity is rated on a five-point scale scoring with zero: not at all, one: once per week or less / a little, two: 2 to 3 times per week / somewhat, three: 4 to 5 times per week / a lot, and four: 6 or more times a week / severe (Pynoos et al., 1993). This instrument was not only broadly used in patients with mental illnesses, but also used in patients with vehicle accidents domestically (Wang, 2013). The Cronbach's alpha for the current study will be retested using the injury group.

  at 3 months after hospital discharge

• the Posttraumatic Diagnostic Scale

  The PTDS is a self-report instrument for post traumatic syndrome that is simple to administer and has demonstrated good psychometric properties. The PTSD will not use to diagnose if injured patients have psychological illnesses. It will be applied in measuring how and what post traumatic symptoms that patients will have after injuries. The scale is a structured interview for assessing PTSD diagnostic status and symptom. The degree of severity is rated on a five-point scale scoring with zero: not at all, one: once per week or less / a little, two: 2 to 3 times per week / somewhat, three: 4 to 5 times per week / a lot, and four: 6 or more times a week / severe (Pynoos et al., 1993). This instrument was not only broadly used in patients with mental illnesses, but also used in patients with vehicle accidents domestically (Wang, 2013). The Cronbach's alpha for the current study will be retested using the injury group.

  at 6 months after hospital discharge

• the WHOQOL-BREF

  The World Health Organization Quality of Life questionnaire (WHOQOL-BREF) will be used to measure HRQOL. Six popular generic instruments of HRQOL are commonly used as disability outcome measures, some of them were developed later were tested trans-culturally in extensive research programs such as the WHOQOL-BREF (Yao, 2000). The WHOQOL-BREF is a 28-tem scale that is measure along with 4 domains including physical, psychological, social relationship and environment. Scores range from 1 to 5 with higher scores indicating higher quality of life (The WHOQOL Taiwan Group, 2000). The reliability and validity of the Chinese WHOQOL-BREF have been tested in various clinical settings.

  at 3 months after hospital discharge

• the WHOQOL-BREF

  The World Health Organization Quality of Life questionnaire (WHOQOL-BREF) will be used to measure HRQOL. Six popular generic instruments of HRQOL are commonly used as disability outcome measures, some of them were developed later were tested trans-culturally in extensive research programs such as the WHOQOL-BREF (Yao, 2000). The WHOQOL-BREF is a 28-tem scale that is measure along with 4 domains including physical, psychological, social relationship and environment. Scores range from 1 to 5 with higher scores indicating higher quality of life (The WHOQOL Taiwan Group, 2000). The reliability and validity of the Chinese WHOQOL-BREF have been tested in various clinical settings.

  at 6 months after hospital discharge

Study Arms (2)

The experimental group

EXPERIMENTAL

The trauma care bundles combined with the internet platform.

Behavioral: internet platform

The control group

NO INTERVENTION

Only trauma care bundles.

Interventions

internet platform BEHAVIORAL

The trauma care bundles combined with the internet platform.

The experimental group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Discharged within 24 hours
• Cognitive dysfunction and unable to provide formal consent
• Severe brain damage
• Burned patient
• Severe psychosis

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (1)

Kaohsiung Medical University

Kaohsiung City, Taiwan

Location

Study Officials

• Bih-O Lee, PHD

  Kaohsiung Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2019
• First Posted: September 4, 2019
• Study Start: October 15, 2019
• Primary Completion: June 18, 2021
• Study Completion: January 25, 2022
• Last Updated: March 31, 2022

Record last verified: 2022-03

Locations

TW (1)