5E Program for Preventing Venous Thromboembolism in Patients With Spinal Cord Disorders

Effects of a Venous Thromboembolism Prevention Program on the Occurrence of Venous Thromboembolism in Patients With Spinal Cord Disorders

The goal of this quasi-experimental study is to examine the effects of a venous thromboembolism prevention program, or "5E" program, on the rates of venous thromboembolism in patients with spinal cord disorders. The main questions it aims to answer are:

• Will participants receiving the 5E program have lower rates of venous thromboembolism compared to those receiving the usual care?
• Will participants receiving the 5E program have lower scores of venous thromboembolism signs and symptoms compared to those receiving the usual care?
• Will the average thigh and calf circumferences of participants before and after receiving the 5E program be different?

Participants in the intervention group will receive the 5E program, including

• Education: health education regarding venous thromboembolism prevention
• Elevation: leg elevation of 10-20 degrees
• Exercise: ankle exercises
• Enough fluid: adequate fluid uptake
• Early application of intermittent pneumatic compression (IPC): IPC use within 48 hours after admission

Study Overview

• Status: Recruiting
• Conditions: Spinal Cord Diseases; Venous Thromboembolism; Spinal Cord Injuries; Nurse's Role
• Intervention / Treatment: Behavioral: 5E program

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wiphawadee Potisopha, Ph.D.; Phone Number: +660954291592; Email: wiphpo@kku.ac.th

Study Locations

• Thailand
  • Chaiyaphum, Thailand, 36000
    • Recruiting
    • Chaiyaphum Hospital
    • Contact: Suchada Chindamart, BNS; Phone Number: +66619411828; Email: suchada.chi@kkumail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Caprini scores of 5-8 and >8
• Able to communicate in the Thai language
• Willing to participate in this study

Exclusion Criteria:

• Alteration of consciousness
• Experiencing complications, including neurogenic shock and autonomic dysreflexia
• Being pregnant
• Having fluid restriction

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 5E Program; Participants in the 5E program group will receive 7-day nursing interventions.	Behavioral: 5E program; Participants in the 5E program group will receive 7-day nursing interventions including; Education: health education regarding venous thromboembolism prevention; Elevation: leg elevation of 10-20 degrees; Exercise: ankle exercises; Enough fluid: adequate fluid uptake; Early application of intermittent pneumatic compression (IPC): IPC use within 48 hours after admission
No Intervention: Usual Care; Participants in the control group will receive 7-day usual care interventions, including health education regarding signs and symptoms of venous thromboembolism and IPC use if the participants experienced muscle power as grade 0.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of venous thromboembolism	The diagnosis of venous thromboembolism is confirmed by a Doppler ultrasound scan of the femoral vein and popliteal vein by a physician working at the study site. The physician will record the results in the data record form.	The day before implementing the intervention and at 7 days after implementing intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Signs and symptoms of deep venous thrombosis and pulmonary embolism	The Well's Score for deep venous thrombosis (DVT) includes clinical parameters: active cancer or palliative (+1), paralysis (+1), recently bedridden for more than 3 days (+1), localized tenderness (+1), entire leg swelling (+1), calf swelling more than 3 cm compared with asymptomatic leg (+1), pitting edema (+1), previous DVT documented (+1), collateral superficial veins (non-varicose) (+1), and alternative diagnosis (-2). The Modified Well's Score for pulmonary embolism (PE) includes the following criteria: clinical signs and symptoms of DVT (3); an alternative diagnosis is less likely than PE (3); a heart rate greater than 100 (1.5); immobilization for 3 or more consecutive days (1.5); previous objectively diagnosed PE or DVT (1.5); hemoptysis (1); and malignancy (1).	The day before implementing the intervention and Day 1 - Day 7 after implementing intervention
Thigh and calf circumference	Thigh and calf circumferences will be measured in centimeters using the standardized measuring tape. The assistant researcher will record the results in the data record form.	The day before implementing the intervention and Day 1 - Day 7 after implementing intervention

Collaborators and Investigators

• Sponsor: Khon Kaen University

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2024
• Primary Completion (Estimated): May 30, 2024
• Study Completion (Estimated): October 31, 2024

Study Registration Dates

• First Submitted: January 21, 2024
• First Submitted That Met QC Criteria: March 4, 2024
• First Posted (Actual): March 8, 2024

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Embolism and Thrombosis; Trauma, Nervous System; Thromboembolism; Venous Thromboembolism; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: KhonKaenU001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No