Evaluation of Behavioral Health-Virtual Patient Navigation Team (BH-VPN)

• Sponsor: Wake Forest University Health Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT03204643
• Collaborator: (none)
• Enrollment: 637
• Locations: 6
• Arms: 2
• Actual Duration (Months): 9.6
• Patients Per Site: 106.2
• Patients Per Site Per Month: 11.1

Study Details

Study Description

Brief Summary

Patients who present to one of the participating EDs with a telepsychiatric consult performed will be treated and followed per the behavioral health virtual patient navigation pathway (BH-VPN) or usual care. The BH-VPN is inclusive of several components which will all be consistently applied to patients randomized to the intervention, as well as having access to behavioral health trained patient navigators. These key components are often deployed inconsistently as a part of usual care, but per the intervention, will be completed in totality for subjects who are assigned to and participate in the BH-VPN plan.

This study includes a qualitative sub-study to measure perceptions of the impact of the BH-VPN on readmission rates and patient outcomes, experiences with the services provided by the BH-VPN, and provider and clinician ideas for how to improve the services provided by the BH-VPN.

Condition or Disease	Intervention/Treatment	Phase
Mental Health	Behavioral: BH-VPN	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 637 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: An Evaluation of ED to Admission Conversion Among Patients With a Telepsychiatric Consult Who Are Followed by a Behavioral Health - Virtual Patient Navigation Team
• Actual Study Start Date: Jun 12, 2017
• Actual Primary Completion Date: Feb 14, 2018
• Actual Study Completion Date: Mar 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BH-VPN A bundle of usual care components applied consistently and completely, plus access to mental health trained patient navigators and navigation services.	Behavioral: BH-VPN; A bundle of usual care components, applied consistently and completely, along with access to behavioral health specific patient navigators and navigation services.
No Intervention: Usual Care The standard intervention (Control - Usual Care) is given in this population. May contain some of the BH-VPN components.

Outcome Measures

Primary Outcome Measures

1. Emergency Department to Inpatient Conversion Rate [5 days]

   admission from the Emergency Department with behavioral health consult completed, to an inpatient or observation setting.

Secondary Outcome Measures

1. Quality, Comfort, and Care (QCC) Defined Readmission Rate [30 days]

   readmission within 30 days to the same facility

2. Patient-centric (Protocol Defined) Readmission Rate [30 days]

   readmission within 30 days to any facility which Carolinas Healthcare System have access to the data

3. Utilization of Healthcare Services Post-discharge From Emergency Department [45 days]

   Number of Emergency Department, inpatient, observation encounters

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Present at a participating ED

• Completed telepsychiatric consult as captured in the EMR

• Completed telepsychiatric consult Monday - Friday during Navigator's potential hours of operation.

Exclusion Criteria:

• None per the protocol

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Carolinas Medical Center Mercy	Charlotte	North Carolina	United States	28207
2	Carolinas Healthcare System - Pineville	Charlotte	North Carolina	United States	28210
3	Carolinas Healthcare System University	Charlotte	North Carolina	United States	28262
4	Carolinas Healthcare System Steele Creek	Charlotte	North Carolina	United States	28278
5	Carolinas Healthcare System Huntersville	Huntersville	North Carolina	United States	28078
6	Carolinas Healthcare System - Union	Monroe	North Carolina	United States	28112

Sponsors and Collaborators

• Wake Forest University Health Sciences

Investigators

• Principal Investigator: Wayne Sparks, MD, Wake Forest University Health Sciences
• Study Director: Jason Roberge, PhD, Wake Forest University Health Sciences

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 1, 2017

More Information

Publications

None provided.

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT03204643
• Other Study ID Numbers: 00021808
• First Posted: Jul 2, 2017
• Last Update Posted: Apr 21, 2022
• Last Verified: Jan 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

Participant Flow

Arm/Group Title	BH-VPN	Usual Care
Arm/Group Description	A bundle of usual care components applied consistently and completely, plus access to mental health trained patient navigators and navigation services. BH-VPN: A bundle of usual care components, applied consistently and completely, along with access to behavioral health specific patient navigators and navigation services.	The standard intervention (Control - Usual Care) is given in this population. May contain some of the BH-VPN components.
Period Title: Overall Study
STARTED	323	314
COMPLETED	323	314
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	BH-VPN	Usual Care	Total
Arm/Group Description	A bundle of usual care components applied consistently and completely, plus access to mental health trained patient navigators and navigation services. BH-VPN: A bundle of usual care components, applied consistently and completely, along with access to behavioral health specific patient navigators and navigation services.	The standard intervention (Control - Usual Care) is given in this population. May contain some of the BH-VPN components.	Total of all reporting groups
Overall Participants	323	314	637
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	39.5 (16.8)	39.8 (16.3)	39.7 (16.5)
Sex: Female, Male (Count of Participants)
Female	140 43.3%	139 44.3%	279 43.8%
Male	183 56.7%	175 55.7%	358 56.2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	3 0.9%	1 0.3%	4 0.6%
Asian	4 1.2%	3 1%	7 1.1%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	105 32.5%	90 28.7%	195 30.6%
White	170 52.6%	182 58%	352 55.3%
More than one race	2 0.6%	1 0.3%	3 0.5%
Unknown or Not Reported	39 12.1%	37 11.8%	76 11.9%
Region of Enrollment (participants) [Number]
United States	323 100%	314 100%	637 100%

Outcome Measures

1. Primary Outcome

Title	Emergency Department to Inpatient Conversion Rate
Description	admission from the Emergency Department with behavioral health consult completed, to an inpatient or observation setting.
Time Frame	5 days

Outcome Measure Data

Analysis Population Description

The number of patients that were admitted

Arm/Group Title	BH-VPN	Usual Care
Arm/Group Description	A bundle of usual care components applied consistently and completely, plus access to mental health trained patient navigators and navigation services. BH-VPN: A bundle of usual care components, applied consistently and completely, along with access to behavioral health specific patient navigators and navigation services.	The standard intervention (Control - Usual Care) is given in this population. May contain some of the BH-VPN components.
Measure Participants	323	314
Number [participants]	178 55.1%	198 63.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	BH-VPN, Usual Care
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.06
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.74
	Confidence Interval	(2-Sided) 95%; 0.54 to 1.02
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Quality, Comfort, and Care (QCC) Defined Readmission Rate
Description	readmission within 30 days to the same facility
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BH-VPN	Usual Care
Arm/Group Description	A bundle of usual care components applied consistently and completely, plus access to mental health trained patient navigators and navigation services. BH-VPN: A bundle of usual care components, applied consistently and completely, along with access to behavioral health specific patient navigators and navigation services.	The standard intervention (Control - Usual Care) is given in this population. May contain some of the BH-VPN components.
Measure Participants	323	314
Count of Participants [Participants]	7 2.2%	2 0.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	BH-VPN, Usual Care
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.76
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.07
	Confidence Interval	(2-Sided) 95%; 0.70 to 1.64
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Patient-centric (Protocol Defined) Readmission Rate
Description	readmission within 30 days to any facility which Carolinas Healthcare System have access to the data
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BH-VPN	Usual Care
Arm/Group Description	A bundle of usual care components applied consistently and completely, plus access to mental health trained patient navigators and navigation services. BH-VPN: A bundle of usual care components, applied consistently and completely, along with access to behavioral health specific patient navigators and navigation services.	The standard intervention (Control - Usual Care) is given in this population. May contain some of the BH-VPN components.
Measure Participants	323	314
Count of Participants [Participants]	28 8.7%	23 7.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	BH-VPN, Usual Care
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.62
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.16
	Confidence Interval	(2-Sided) 95%; 0.65 to 2.08
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Utilization of Healthcare Services Post-discharge From Emergency Department
Description	Number of Emergency Department, inpatient, observation encounters
Time Frame	45 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BH-VPN	Usual Care
Arm/Group Description	A bundle of usual care components applied consistently and completely, plus access to mental health trained patient navigators and navigation services. BH-VPN: A bundle of usual care components, applied consistently and completely, along with access to behavioral health specific patient navigators and navigation services.	The standard intervention (Control - Usual Care) is given in this population. May contain some of the BH-VPN components.
Measure Participants	323	314
Count of Participants [Participants]	112 34.7%	89 28.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	BH-VPN, Usual Care
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.08
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.35
	Confidence Interval	(2-Sided) 0.96%; 0.96 to 1.90
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	We followed each patient for 45 days after the ED discharge and then followed the patient for an additional 60 days for utilization outcomes.
Arm/Group Title	BH-VPN		Usual Care
Arm/Group Description	A bundle of usual care components applied consistently and completely, plus access to mental health trained patient navigators and navigation services. BH-VPN: A bundle of usual care components, applied consistently and completely, along with access to behavioral health specific patient navigators and navigation services.		The standard intervention (Control - Usual Care) is given in this population. May contain some of the BH-VPN components.
All Cause Mortality
	BH-VPN		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/323 (0%)		4/314 (1.3%)
Serious Adverse Events
	BH-VPN		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/323 (0%)		0/314 (0%)
Other (Not Including Serious) Adverse Events
	BH-VPN		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/323 (0%)		0/314 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.