Behavioral ProblemDEMEANORNCT03777241
Disruptive bEhavior manageMEnt ANd Prevention in Hospitalized Patients Using a behaviORal Intervention Team
A study testing Behavioral Intervention Team in people with Behavioral Problem, run by Vanderbilt University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Behavioral Problem
- What is being tested?
- Behavioral Intervention Team
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,800 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2019to 11 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients admitted to the floor before the BIT team has begun the crossover period on the unit.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
About this study
Official title: 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.
Read the 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
- Conditions
- Behavioral Problem
- Being tested
- Behavioral Intervention Team, Standard of care
- Medical subject headings
- Problem Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Intervention TeamBehavioural
Multidisciplinary team to assist with actively identifying and managing mental illness and substance abuse disorders at their earliest possible time during hospitalization.
Standard of careBehavioural
Participants in this group will receive standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Intervention Team | Active comparator | The participants in this arm will receive the Behavioral Intervention Team. Receives: Behavioral: Behavioral Intervention Team |
| Standard of Care | Active comparator | The participants in this arm will receive the standard of care. Receives: Behavioral: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of violence control measures utilized
By extracting medications, restraints, and sitters ordered from the electronic health records
Measured: 6 months
Percent of patient injurious behaviors reported
By extracting reports of biting, kicking, throwing, etc. from the electronic medical record
Measured: 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
Measured: 1 year
Secondary outcomes (2)
Rate of unit nursing staff retention
By extracting rates from internal human resources records
Measured: 1 year
Patient length of stay
By extracting data from the electronic health record
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2018
- Study start1 Mar 2019
- Primary completion9 Feb 2020
- Study completion11 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Behavioral ProblemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- Vanderbilt University Medical Center
- Responsible party
- Principal investigator, Ruth Kleinpell, Vanderbilt University
- Investigators
- Ruth Kleinpell, PhD, RN, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03777241
- Sponsor's protocol ID
- 182229
- Acronym
- DEMEANOR
- Status last verified
- Sep 2020
- First submitted
- 14 Dec 2018
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data be available (including data dictionaries) will be shared, particularly individual participant data that underlie the results reported after deidentification.
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.
PubMed 35131740Morrison 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.
PubMed 32448331
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study 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
- ClinicalTrials.gov ID
- NCT03777241
- Acronym / sponsor ID
- DEMEANOR / 182229
- Conditions
- Behavioral Problem
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,800 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- Vanderbilt University Medical Center
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 9 Feb 2020 (actual)
- Study completion
- 11 May 2020 (actual)
- First posted
- 17 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral Intervention Team | Active comparator | Behavioral: Behavioral Intervention TeamThe participants in this arm will receive the Behavioral Intervention Team. |
| Standard of Care | Active comparator | Behavioral: Standard of careThe participants in this arm will receive the standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients admitted to the floor before the BIT team has begun the crossover period on the unit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral Intervention TeamMultidisciplinary team to assist with actively identifying and managing mental illness and substance abuse disorders at their earliest possible time during hospitalization. | Behavioural | Behavioral Intervention Team |
| Standard of careParticipants in this group will receive standard of care. | Behavioural | Standard of Care |
Primary outcome
Percent of violence control measures utilized
Time frame: 6 months
By extracting medications, restraints, and sitters ordered from the electronic health records
Percent of patient injurious behaviors reported
Time frame: 6 months
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
Time frame: 1 year
By administering surveys to participants
2 secondary outcomes
Rate of unit nursing staff retention
Time frame: 1 year
Patient length of stay
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Derived from this study: PubMed 35131740Hasselblad 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.
- Derived from this study: PubMed 32448331Morrison 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.
- Individual participant dataSharing planned: Yes. Individual participant data be available (including data dictionaries) will be shared, particularly individual participant data that underlie the results reported after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruth Kleinpell, PhD, RN principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Intervention Team in people with Behavioral Problem, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of violence control measures utilized (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03777241, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2020.