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

Primary Purpose

Behavioral Problem

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Intervention Team
Standard of care
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Behavioral Problem

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Behavioral Intervention Team

Standard of Care

Arm Description

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

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

Outcomes

Primary Outcome Measures

Percent of violence control measures utilized
By extracting medications, restraints, and sitters ordered from the electronic health records
Percent of patient injurious behaviors reported
By extracting reports of biting, kicking, throwing, etc. from the electronic medical record
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

Secondary Outcome Measures

Rate of unit nursing staff retention
By extracting rates from internal human resources records
Patient length of stay
By extracting data from the electronic health record

Full Information

First Posted
December 14, 2018
Last Updated
September 7, 2020
Sponsor
Vanderbilt University
Collaborators
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03777241
Brief Title
Disruptive bEhavior manageMEnt ANd Prevention in Hospitalized Patients Using a behaviORal Intervention Team
Acronym
DEMEANOR
Official Title
Disruptive bEhavior manageMEnt ANd Prevention in Hospitalized Patients Using a behaviORal Intervention Team: Study Protocol for a Pragmatic, Cluster, Cross-over Design
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
February 9, 2020 (Actual)
Study Completion Date
May 11, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University
Collaborators
Vanderbilt University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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: meaningful, measureable improvement in the prevention and management of disruptive behavior in the healthcare setting at VUMC, and 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: Improvement in the prevention and management of patients exhibiting disruptive, threatening or acting out behavior Improvement in staff perceptions of their ability to manage patients exhibiting disruptive, threatening or acting out behavior

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Behavioral Problem

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3800 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Behavioral Intervention Team
Arm Type
Active Comparator
Arm Description
The participants in this arm will receive the Behavioral Intervention Team.
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
The participants in this arm will receive the standard of care.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Intervention Team
Intervention Description
Multidisciplinary team to assist with actively identifying and managing mental illness and substance abuse disorders at their earliest possible time during hospitalization.
Intervention Type
Behavioral
Intervention Name(s)
Standard of care
Intervention Description
Participants in this group will receive standard of care.
Primary Outcome Measure Information:
Title
Percent of violence control measures utilized
Description
By extracting medications, restraints, and sitters ordered from the electronic health records
Time Frame
6 months
Title
Percent of patient injurious behaviors reported
Description
By extracting reports of biting, kicking, throwing, etc. from the electronic medical record
Time Frame
6 months
Title
Percent change in nurse comfort and confidence in their ability to manage patients exhibiting disruptive, threatening or acting out behavior
Description
By administering surveys to participants
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Rate of unit nursing staff retention
Description
By extracting rates from internal human resources records
Time Frame
1 year
Title
Patient length of stay
Description
By extracting data from the electronic health record
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruth Kleinpell, PhD, RN
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://redcap.vanderbilt.edu/surveys/?s=CR8TNYXKWX
Citations:
PubMed Identifier
35131740
Citation
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.
Results Reference
derived
PubMed Identifier
32448331
Citation
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.
Results Reference
derived

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

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