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

• ClinicalTrials.gov Identifier: NCT03777241
• Recruitment Status: Completed
• First Posted: December 17, 2018
• Last Update Posted: September 9, 2020
• Sponsor: Vanderbilt University
• Collaborator: Vanderbilt University Medical Center
• Information provided by (Responsible Party): Ruth Kleinpell, Vanderbilt University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Behavioral Problem	Behavioral: Behavioral Intervention Team; Behavioral: Standard of care	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 3800 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Disruptive bEhavior manageMEnt ANd Prevention in Hospitalized Patients Using a behaviORal Intervention Team: Study Protocol for a Pragmatic, Cluster, Cross-over Design
• Actual Study Start Date: March 1, 2019
• Actual Primary Completion Date: February 9, 2020
• Actual Study Completion Date: May 11, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Percent of violence control measures utilized [ Time Frame: 6 months ]
   By extracting medications, restraints, and sitters ordered from the electronic health records
2. Percent of patient injurious behaviors reported [ Time Frame: 6 months ]
   By extracting reports of biting, kicking, throwing, etc. from the electronic medical record
3. Percent change in nurse comfort and confidence in their ability to manage patients exhibiting disruptive, threatening or acting out behavior [ Time Frame: 1 year ]
   By administering surveys to participants

Secondary Outcome Measures :

1. Rate of unit nursing staff retention [ Time Frame: 1 year ]
   By extracting rates from internal human resources records
2. Patient length of stay [ Time Frame: 6 months ]
   By extracting data from the electronic health record

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

United States, Tennessee

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37212

Sponsors and Collaborators

Vanderbilt University

Vanderbilt University Medical Center

Investigators

• Principal Investigator: Ruth Kleinpell, PhD, RN; Vanderbilt University Medical Center

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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). pii: 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.

• Responsible Party: Ruth Kleinpell, Professor, Vanderbilt University
• ClinicalTrials.gov Identifier: NCT03777241
• Other Study ID Numbers: 182229
• First Posted: December 17, 2018
• Last Update Posted: September 9, 2020
• Last Verified: September 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Individual participant data be available (including data dictionaries) will be shared, particularly individual participant data that underlie the results reported after deidentification.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (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
• URL: https://redcap.vanderbilt.edu/surveys/?s=CR8TNYXKWX

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Problem Behavior; Behavioral Symptoms