NCT03777241

Brief Summary

The purpose of the proposed study is to evaluate the impact of a behavioral intervention team (BIT) on 2 adult units: a general medical (8N); a cardiac/medical stepdown (8S) at Vanderbilt University Medical Center (VUMC) with a higher proportion of patients with behavioral health comorbidities.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,800

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 17, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 9, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 11, 2020

Completed
Last Updated

September 9, 2020

Status Verified

September 1, 2020

Enrollment Period

12 months

First QC Date

December 14, 2018

Last Update Submit

September 7, 2020

Conditions

Outcome Measures

Primary Outcomes (3)

  • Percent of violence control measures utilized

    By extracting medications, restraints, and sitters ordered from the electronic health records

    6 months

  • Percent of patient injurious behaviors reported

    By extracting reports of biting, kicking, throwing, etc. from the electronic medical record

    6 months

  • Percent change in nurse comfort and confidence in their ability to manage patients exhibiting disruptive, threatening or acting out behavior

    By administering surveys to participants

    1 year

Secondary Outcomes (2)

  • Rate of unit nursing staff retention

    1 year

  • Patient length of stay

    6 months

Study Arms (2)

Behavioral Intervention Team

ACTIVE COMPARATOR

The participants in this arm will receive the Behavioral Intervention Team.

Behavioral: Behavioral Intervention Team

Standard of Care

ACTIVE COMPARATOR

The participants in this arm will receive the standard of care.

Behavioral: Standard of care

Interventions

Multidisciplinary team to assist with actively identifying and managing mental illness and substance abuse disorders at their earliest possible time during hospitalization.

Behavioral Intervention Team

Participants in this group will receive standard of care.

Standard of Care

Eligibility Criteria

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

You may qualify if:

  • All patients admitted to two adult medical surgical units (8N/8S) at Vanderbilt University Medical Center during the study period.
  • All clinical nurses and staff on 8N/8S employed during the study period.

You may not qualify if:

  • Patients admitted to the floor before the BIT team has begun the crossover period on the unit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Related Publications (2)

  • Hasselblad M, Morrison J, Kleinpell R, Buie R, Ariosto D, Hardiman E, Osborn SW, Nwosu SK, Lindsell C. Promoting patient and nurse safety: testing a behavioural health intervention in a learning healthcare system: results of the DEMEANOR pragmatic, cluster, cross-over trial. BMJ Open Qual. 2022 Feb;11(1):e001315. doi: 10.1136/bmjoq-2020-001315.

  • Morrison J, Hasselblad M, Kleinpell R, Buie R, Ariosto D, Hardiman E, Osborn SW, Lindsell CJ; Vanderbilt Learning Healthcare System Investigators, Vanderbilt University. The Disruptive bEhavior manageMEnt ANd prevention in hospitalized patients using a behaviORal intervention team (DEMEANOR) study protocol: a pragmatic, cluster, crossover trial. Trials. 2020 May 24;21(1):417. doi: 10.1186/s13063-020-04278-2.

MeSH Terms

Conditions

Problem Behavior

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorChild Behavior

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Ruth Kleinpell, PhD, RN

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 14, 2018

First Posted

December 17, 2018

Study Start

March 1, 2019

Primary Completion

February 9, 2020

Study Completion

May 11, 2020

Last Updated

September 9, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will share

Individual participant data be available (including data dictionaries) will be shared, particularly individual participant data that underlie the results reported after deidentification.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
Immediately following publication. No end date.
Access Criteria
Proposals should be directed to the PI via the Learning Healthcare System platform secondary data use application
More information

Locations