NCT05583487

Brief Summary

The purpose of this research study is to decide if using a nurse-led mobility protocol affects teamwork perceptions, when mobilizing ventilated neurosurgery patients. Participants will mobilize ventilated neurosurgery patients according to either facility standard procedures or a piloted nurse-led mobility protocol. Each selected patient will be mobilized once during his/her hospitalization for the purposes of this study. Patient mobility may take up to 1 hour. Following this, participating staff will be asked to complete a survey used to measure teamwork perceptions. Participants will be given up to 30 minutes to complete the survey. Total study duration is 3 months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 17, 2022

Completed
15 days until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2023

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

February 6, 2023

Status Verified

February 1, 2023

Enrollment Period

3 months

First QC Date

October 10, 2022

Last Update Submit

February 2, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Teamwork perceptions

    Will be measured using the reliable and valid Nursing Teamwork Survey (NTS) established by Beatrice Kalisch, PhD. The NTS is composed of items with Likert-type scale ranging from 1-5. Higher scores indicate more positive perceptions of teamwork, while lower scores indicate more negative perceptions of teamwork. This scale has been tested and has good psychometric properties including adequate validity and reliability. The minimum total score is 33, while the highest possible score is 165 per participant.

    Will take each participant no more than 30 minutes to complete. Each participant will take this once following each patient mobility instance.

Study Arms (2)

Control/non-experimental group

ACTIVE COMPARATOR

The control/nonexperimental group will consist of multidisciplinary teams, who will not be given the nurse-led protocol and will be asked to mobilize the assigned ventilated neurosurgery patient according the facility's standard mobility procedures.

Other: Standard of Care

Experimental/interventional group

EXPERIMENTAL

The experimental/interventional group will consist of multidisciplinary teams who will use a given nurse-led protocol (intervention) to mobilize the assigned patient.

Other: Nurse-led progressive mobility protocol

Interventions

The nurse-led mobility progression protocol incorporates a checklist for four primary team members belonging to each discipline to follow before, during, and after providing mobility for each patient. It outlines steps to progress patient mobility from in-bed mobility activities to out-of-bed activities as tolerated. This protocol intervention was created and designed based upon a review of previously conducted studies' interventions and findings, as well as expert guidelines established in the literature. Furthermore, multidisciplinary experts at the medical center who work with ventilated neurosurgery patients were consulted to form the protocol to further establish hemodynamic, neurological, respiratory, and physiological patient safety parameters. This intervention has not been implemented in previous studies and will be piloted for this study.

Also known as: nurse-led protocol
Experimental/interventional group

For the purposes of the current study, the control group of multidisciplinary teams requested to mobilize the ventilated neurosurgery patient, may also consist of the primary nurse, RT, PT, and PCT. They will be asked to progressively mobilize the patient to the best of their ability according to standard of care procedures, incorporating any resources the medical center provides including, but not limited to, written information, equipment, ThinkLift, etc.

Control/non-experimental group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult (18 years of age or older)
  • male or female registered nurses or licensed vocational nurses, patient care technicians, respiratory therapists, and physical therapists
  • currently employed by the medical center
  • currently care for neurosurgery patients in a part time or full-time capacity
  • may work during day shift and/or night shift hours.

You may not qualify if:

  • staff members employed by an agency outside of the medical center
  • staff not routinely assigned to care for neurosurgery patients on the neurosurgical ICU (float pool staff)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75088, United States

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Adrianna Lall

    University of Texas at Arlington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
All teams will be asked to progressively mobilize the ventilated neurosurgery patient they are assigned to during the shift. Each team will be blinded to whether or not they will be utilizing the nurse-led mobility protocol or standard mobility procedures until arrival at the patient's room during the assigned mobility time.
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: This study will consist of a quasi-experimental research design to examine causality between two or more variables by comparing groups following an intervention. Although the intervention itself will be randomly assigned/administered to each of the multidisciplinary groups for this proposed research study, true randomization of participants cannot be achieved. This is primarily due to each patient having a pre-assigned multidisciplinary care team for each shift. Changing this patient assignment would compromise patient safety while interfering with continuity of care and workflow, which hospital units strive to achieve. By applying the purpose and elements of a quasi-experimental approach to this proposed research study, researchers can determine if an intervention/active independent variable consisting of a nurse-led mobility protocol, has an effect on the outcome measure of teamwork perceptions , which will serve as dependent variables.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 10, 2022

First Posted

October 17, 2022

Study Start

November 1, 2022

Primary Completion

January 24, 2023

Study Completion

February 1, 2023

Last Updated

February 6, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations