Quality Improvement Intervention to Promote Early Mobilization in Trauma ICU

NCT04203953 | Completed

• 1 other identifier: 201910048RINB
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Despite the fact that many lines of evidence point to the safety and feasibility of early mobilization in medical or surgical ICUs, there remains limited evidence regarding the efficacy or outcome of mobilizing patients in trauma ICU. Given the lack of published literature or routine protocol for mobilizing this population in our institution, the investigators developed a formal protocol and quality improvement project. Objective: To determine the flexibility and effects of an early mobilization project in a trauma ICU. Design: Observational, pre-post design. Setting: A eight-bed trauma ICU in a medical center in Taipei. Patients: Critically ill adults admitted to the trauma ICU. Intervention: This project will involve a routine care baseline phase to promote early mobilization of critically ill patients. The bedside physical therapist (PT) will assess the appropriateness of the activity level throughout the day. The PT will provide guidelines for appropriate activities, with the option to perform more advanced activities using equipment. Early mobilization will be provided once daily 5 days/week during the 30-minute family visiting time. Outcome: The primary outcome measures will be as follows: (1) the proportion of patients with occupational therapist (OT) and/or PT consultations per ICU days 3, 7 and 14; (2) the time and types of mobilization activities performed at the day of ICU admission, the day of ICU discharge and the day of hospital discharge, including passive and active activities; (3) the Perme intensive care unit mobility score at the day of ICU admission, the day of ICU discharge and the day of hospital discharge; Secondary outcome measures will include the following: (1) the number of times and reasons for suspended activities; (2) mobilization-related adverse events. Statistical Analysis: Unadjusted comparisons before and after implementation of the project will be performed using chi-square analysis, Fisher exact test, or the Wilcoxon signed rank test, as appropriate. A two-sided p-value less than 0.05 will be used to determine statistical significance.

Conditions

Patients Admitted to the ICU More Than 3 Days Post-onset

Outcome Measures

Primary Outcomes (4)

• the proportion of patients with OT and/or PT consultations by ICU

  on days 3, 7 and 14 after onset

  up to 1 year

• the time mobilization activities performed in the ICU

  on the day of ICU admission, the day of ICU discharge and the day of hospital discharge

  up to 1 year

• the types of mobilization activities performed in the ICU

  on the day of ICU admission, the day of ICU discharge and the day of hospital discharge. The activities including passive and active activities.

  up to 1 year

• the Perme intensive care unit mobility score

  on the day of ICU admission, the day of ICU discharge and the day of hospital discharge. The Perme ICU Mobility Score ranges from 0 to 32. The score is derived from 15 items grouped in 7 categories: mental status, potential mobility barriers, functional strength, bed mobility, transfers, gait, and endurance. The score uses a maximum range of 2 to 4 points for each of the 15 items, and it provides a total score that reflects the patient's mobility status at one particular moment in time. A high score indicates few potential mobility barriers and decreased assistance whereas a low score indicates more potential barriers to mobility and more assistance needed for mobility.

  up to 1 year

Secondary Outcomes (3)

• the number of times that activities were stopped

  up to 1 year

• the reasons that activities were stopped

  up to 1 year

• mobilization-related adverse events

  up to 1 year

Interventions

Early mobilization program OTHER

Early mobilization will be defined as any active exercise where the patients could assist with the activity using their own muscle strength and control that occurred within the first 7 days of trauma ICU admission and will be intended to maintain or restore overall function as well as being scored using the ICU mobility scale.15 The ICU mobility scale includes rolling, bridging, sitting, standing and walking, and upper and lower limb flexion and extension. In-bed therapies will include active or active-assist range of motion, bridge exercise, quadriceps setting, straight leg raising, rolling exercises and facilitation.

Eligibility Criteria

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

Study Population

100 patients

You may qualify if:

• patients \>20 years of age admitted to the trauma ICU (more than 3 days)
• who were alive more than 7 days after ICU admission

You may not qualify if:

• patients \< 20 years old who required trauma ICU admission for less than three days
• died after ICU admission
• Glasgow Coma Scale (GCS) \< 6
• raised intracranial pressure\>20mmHg
• with cardiopulmonary arrest
• with acute myocardial infarction
• with rapidly developing neuromuscular disease
• with pregnancy
• with ruptured or leaking aortic aneurysm
• ICU admission for palliative care or medical orders specifying alternate activities.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2019
• First Posted: December 18, 2019
• Study Start: December 3, 2019
• Primary Completion: July 30, 2021
• Study Completion: August 21, 2021
• Last Updated: November 3, 2021

Record last verified: 2021-11

Locations

TW (1)