Multidisciplinary CommunicationNCT05583487
Multidisciplinary Teamwork Perceptions When Mobilizing Ventilated Neurosurgery Patients
A study testing Nurse-led progressive mobility protocol in people with Multidisciplinary Communication, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multidisciplinary Communication
- What is being tested?
- Nurse-led progressive mobility protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2022to 1 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center
Dallas, Texas, 75088
About this study
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.
- Conditions
- Multidisciplinary Communication
- Being tested
- Nurse-led progressive mobility protocol, Standard of Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-led progressive mobility protocolOther
Also called nurse-led protocol
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.
Standard of CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Nurse-led progressive mobility protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Will take each participant no more than 30 minutes to complete. Each participant will take this once following each patient mobility instance.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start1 Nov 2022
- Primary completion24 Jan 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multidisciplinary CommunicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adrianna Lall, University of Texas Southwestern Medical Center
- Investigators
- Adrianna Lall, Principal investigator, University of Texas at Arlington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05583487
- Sponsor's protocol ID
- STU-2022-0903
- Status last verified
- Feb 2023
- First submitted
- 10 Oct 2022
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidisciplinary Teamwork Perceptions When Mobilizing Ventilated Neurosurgery Patients
- ClinicalTrials.gov ID
- NCT05583487
- Acronym / sponsor ID
- STU-2022-0903
- Conditions
- Multidisciplinary Communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 24 Jan 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 17 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control/non-experimental group | Active comparator | Other: Standard of CareThe 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. |
| Experimental/interventional group | Experimental | Other: Nurse-led progressive mobility protocolThe experimental/interventional group will consist of multidisciplinary teams who will use a given nurse-led protocol (intervention) to mobilize the assigned patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse-led progressive mobility protocolAlso: nurse-led protocolThe 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. | Other | Experimental/interventional group |
| Standard of CareFor 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. | Other | Control/non-experimental group |
Primary outcome
Teamwork perceptions
Time frame: Will take each participant no more than 30 minutes to complete. Each participant will take this once following each patient mobility instance.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrianna Lall principal investigator
University of Texas at Arlington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-led progressive mobility protocol in people with Multidisciplinary Communication, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Teamwork perceptions (time frame: Will take each participant no more than 30 minutes to complete. Each participant will take this once following each patient mobility instance.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2023.