Disruptive bEhavior manageMEnt ANd Prevention in Hospitalized Patients Using a behaviORal Intervention Team (DEMEANOR)

Disruptive bEhavior manageMEnt ANd Prevention in Hospitalized Patients Using a behaviORal Intervention Team: Study Protocol for a Pragmatic, Cluster, Cross-over Design

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.

Study Overview

• Status: Completed
• Conditions: Behavioral Problem
• Intervention / Treatment: Behavioral: Behavioral Intervention Team; Behavioral: Standard of care

Detailed Description

The BIT will provide a proactive psychiatric team that will screen all patients on admission, provide consultation to those meeting established criteria, and recommend interventions to the primary care team for consideration. BIT will also serve to model therapeutics tactics in communication and goal setting to the clinical staff.

Research Questions for the proposed study:

Considering that behavioral health co-morbidity is common among hospitalized medical inpatients and is associated with higher costs of care and staff dissatisfaction, we will ascertain whether the addition of dedicated, trained behavioral intervention team, compared to nursing staff training on trauma informed care and de-escalation techniques provides:

1. meaningful, measureable improvement in the prevention and management of disruptive behavior in the healthcare setting at VUMC, and
2. Improvement in staff perceptions of their ability to manage patients exhibiting disruptive, threatening or acting out behavior

Specifically, using a pragmatic, cluster cross-over trial design where the BIT crosses between 8N and 8S, we will test the hypothesis that presence of the BIT results in:

1. Improvement in the prevention and management of patients exhibiting disruptive, threatening or acting out behavior
2. Improvement in staff perceptions of their ability to manage patients exhibiting disruptive, threatening or acting out behavior

• Study Type: Interventional
• Enrollment (Actual): 3800
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37212
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Behavioral Intervention Team; The participants in this arm will receive the Behavioral Intervention Team.	Behavioral: Behavioral Intervention Team; Multidisciplinary team to assist with actively identifying and managing mental illness and substance abuse disorders at their earliest possible time during hospitalization.
Active Comparator: Standard of Care; The participants in this arm will receive the standard of care.	Behavioral: Standard of care; Participants in this group will receive standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of unit nursing staff retention	By extracting rates from internal human resources records	1 year
Patient length of stay	By extracting data from the electronic health record	6 months

Collaborators and Investigators

• Sponsor: Vanderbilt University
• Collaborators: Vanderbilt University Medical Center
• Investigators: Principal Investigator: Ruth Kleinpell, PhD, RN, Vanderbilt University Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): February 9, 2020
• Study Completion (Actual): May 11, 2020

Study Registration Dates

• First Submitted: December 14, 2018
• First Submitted That Met QC Criteria: December 14, 2018
• First Posted (Actual): December 17, 2018

Study Record Updates

• Last Update Posted (Actual): September 9, 2020
• Last Update Submitted That Met QC Criteria: September 7, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Problem Behavior
• Other Study ID Numbers: 182229

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data be available (including data dictionaries) will be shared, particularly individual participant data that underlie the results reported after deidentification.
• IPD Sharing Time Frame: Immediately following publication. No end date.
• IPD Sharing Access Criteria: Proposals should be directed to the PI via the Learning Healthcare System platform secondary data use application
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

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