Clinical trial NCT03777241: Disruptive bEhavior manageMEnt ANd Prevention in Hospitalized Patients Using a behaviORal Intervention Team
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
Overall status: COMPLETED
Phase: NA
Conditions: Behavioral Problem
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
Collaborators: name: Vanderbilt University Medical Center
First posted: 2018-12-17
Enrollment: 3800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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:

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

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.

Primary outcomes:
measure: Percent of violence control measures utilized
timeFrame: 6 months
measure: Percent of patient injurious behaviors reported
timeFrame: 6 months
measure: Percent change in nurse comfort and confidence in their ability to manage patients exhibiting disruptive, threatening or acting out behavior
timeFrame: 1 year
Secondary outcomes:
measure: Rate of unit nursing staff retention
timeFrame: 1 year
measure: Patient length of stay
timeFrame: 6 months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Ruth Kleinpell, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.