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A Randomized Controlled Trial of Geriatric Emergency Department Innovations

Primary Purpose

Frailty

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Frailty

Eligibility Criteria

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

Inclusion Criteria:

Northwestern Emergency Department patients who are:

  • 65 years or older
  • living independently or with friends, family, or caregivers in the community
  • Clinical Frailty Scale (CFS) score of 4 or greater

Exclusion Criteria:

Patients will be excluded if they:

  • Tested positive for COVID-19
  • Are unable to complete the assessments in English
  • Are unable to provide informed consent or complete follow-up participation
  • Have an Emergency Severity Index (ESI) score of 1 (critical) or 5 (non-urgent)
  • Are held in the ED involuntarily as a prisoner or patient with a psychiatric complaint
  • Are enrolled in another study to avoid patient fatigue and confounding
  • Received a GEDI, Social Work, Pharmacy, or Physical Therapy consult outside of this trial during the current ED visit
  • Leave the ED against medical advice or without being seen by a physician
  • Are admitted to the ICU
  • Are too medically unstable to participate in the assessment

Sites / Locations

  • Northwestern University Department of Emergency MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Other

Arm Label

Control

Intervention

Arm Description

Standard emergency department care

Standard emergency department are plus GEDI consult

Outcomes

Primary Outcome Measures

Number of patients with hospital admission or death
A composite measure of any hospitalizations or death during the index ED visit or within the follow up time frame

Secondary Outcome Measures

PROMIS-Preference
The Patient-Reported Outcomes Measurement Information System (PROMIS)-Preference (PROPr) score summarizes multiple domains into a single score anchored at 0 (as bad as dead) and 1 (perfect or ideal health). This score quantifies the value that individuals place on different states of health. Preference-based scores can be used in cost-utility analyses and to estimate quality-adjusted life years (QALYs). PROPr is calculated from the scores for the 7 PROMIS domains: Cognition, Depression, Fatigue, Pain Interference, Physical Function, Sleep Disturbance, and Ability to Participate in Social Roles and Activities. Preference-based scores PROMIS domain scores can be calculated using the HealthMeasures Scoring Service. The HealthMeasures Scoring Service export includes PROMIS theta values used to calculate PROPr using Multi-Attribute Utility Theory (MAUT) which is available at https://github.com/janelhanmer/PROPr
PROMIS-Preference
The Patient-Reported Outcomes Measurement Information System (PROMIS)-Preference (PROPr) score summarizes multiple domains into a single score anchored at 0 (as bad as dead) and 1 (perfect or ideal health). This score quantifies the value that individuals place on different states of health. Preference-based scores can be used in cost-utility analyses and to estimate quality-adjusted life years (QALYs). PROPr is calculated from the scores for the 7 PROMIS domains: Cognition, Depression, Fatigue, Pain Interference, Physical Function, Sleep Disturbance, and Ability to Participate in Social Roles and Activities. Preference-based scores PROMIS domain scores can be calculated using the HealthMeasures Scoring Service. The HealthMeasures Scoring Service export includes PROMIS theta values used to calculate PROPr using Multi-Attribute Utility Theory (MAUT) which is available at https://github.com/janelhanmer/PROPr
Return Emergency Department Visits
Any Emergency Department Visits which occurs after the ED encounter in which the patient was enrolled in the study.
Return Emergency Department Visits
Any Emergency Department Visits which occurs after the ED encounter in which the patient was enrolled in the study.
Death
All cause death
Death
All cause death
PROMIS Item Bank v2.0 - Physical Function (Adaptive)
The Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Item Bank uses Computer Adaptive Testing (CAT) in which participant responses guide the system's choice of subsequent items from the full item bank (165 items in total in adult bank). Although items differ across respondents taking CAT, scores are comparable across participants. Measure Description: PROMIS subscale for physical function assesses the extent to which patients' perceived capability rather than actual performance of physical activities using a 5-point Likert scale. PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. T-scores range from 20 to 80. A higher PROMIS T-score represents more of the concept being measured.
PROMIS Item Bank v2.0 - Physical Function (Adaptive)
The Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Item Bank uses Computer Adaptive Testing (CAT) in which participant responses guide the system's choice of subsequent items from the full item bank (165 items in total in adult bank). Although items differ across respondents taking CAT, scores are comparable across participants. Measure Description: PROMIS subscale for physical function assesses the extent to which patients' perceived capability rather than actual performance of physical activities using a 5-point Likert scale. PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. T-scores range from 20 to 80. A higher PROMIS T-score represents more of the concept being measured.
PROMIS Item Bank v2.0 - Ability to Participate Social Roles and Activities (Adaptive)
The Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities Item Bank uses Computer Adaptive Testing (CAT) in which participant responses guide the system's choice of subsequent items from the full item bank (35 items in total). Although items differ across respondents taking CAT, scores are comparable across participants. Measure Description: PROMIS item bank for ability to participate in social roles and activities assesses the extent to which patients' perceived ability to perform one's usual social roles and activities using a 5-point Likert scale. PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. T-scores range from 20 to 80. A higher PROMIS T-score represents more of the concept being measured.
PROMIS Item Bank v2.0 - Ability to Participate Social (Adaptive)
The Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities Item Bank uses Computer Adaptive Testing (CAT) in which participant responses guide the system's choice of subsequent items from the full item bank (35 items in total). Although items differ across respondents taking CAT, scores are comparable across participants. Measure Description: PROMIS item bank for ability to participate in social roles and activities assesses the extent to which patients' perceived ability to perform one's usual social roles and activities using a 5-point Likert scale. PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. T-scores range from 20 to 80. A higher PROMIS T-score represents more of the concept being measured.
PROMIS Item Bank v. 1.0 - Emotional Distress - Anxiety (Adaptive)
The Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Item Bank uses Computer Adaptive Testing (CAT) in which participant responses guide the system's choice of subsequent items from the full item bank (29 items in total). Although items differ across respondents taking CAT, scores are comparable across participants. Measure Description: PROMIS item bank for anxiety assesses the extent to which patients experience anxiety symptoms over the past 7 days using a 5-point Likert scale. PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. T-scores range from 20 to 80. A higher PROMIS T-score represents more of the concept being measured.
PROMIS Item Bank v. 1.0 - Emotional Distress - Anxiety (Adaptive)
The Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Item Bank uses Computer Adaptive Testing (CAT) in which participant responses guide the system's choice of subsequent items from the full item bank (29 items in total). Although items differ across respondents taking CAT, scores are comparable across participants. Measure Description: PROMIS item bank for anxiety assesses the extent to which patients experience anxiety symptoms over the past 7 days using a 5-point Likert scale. PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. T-scores range from 20 to 80. A higher PROMIS T-score represents more of the concept being measured.
PROMIS Item Bank v. 1.0 - Emotional Distress - Depression (Adaptive)
The Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Item Bank uses Computer Adaptive Testing (CAT) in which participant responses guide the system's choice of subsequent items from the full item bank (28 items in total). Although items differ across respondents taking CAT, scores are comparable across participants. Measure Description: PROMIS item bank for depression assesses the extent to which patients experience depressive symptoms over the past 7 days using a 5-point Likert scale. PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. T-scores range from 20 to 80. A higher PROMIS T-score represents more of the concept being measured.
PROMIS Item Bank v. 1.0 - Emotional Distress - Depression (Adaptive)
The Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Item Bank uses Computer Adaptive Testing (CAT) in which participant responses guide the system's choice of subsequent items from the full item bank (28 items in total). Although items differ across respondents taking CAT, scores are comparable across participants. Measure Description: PROMIS item bank for depression assesses the extent to which patients experience depressive symptoms over the past 7 days using a 5-point Likert scale. PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. T-scores range from 20 to 80. A higher PROMIS T-score represents more of the concept being measured.
Number of patients admitted
A patient who is admitted to inpatient status during the emergency department visit in which they are enrolled in the study
Number of patients admitted
A patient who is admitted to inpatient status during the emergency department visit in which they are enrolled in the study or within the follow up time frame
Number of patients admitted
A patient who is admitted to inpatient status during the emergency department visit in which they are enrolled in the study or within the follow up time frame
Number of patients with hospital admission or death
A composite measure of any hospitalizations or death during the index ED visit or within the follow up time frame

Full Information

First Posted
September 30, 2019
Last Updated
March 17, 2023
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT04115371
Brief Title
A Randomized Controlled Trial of Geriatric Emergency Department Innovations
Official Title
A Randomized Controlled Trial of Geriatric Emergency Department Innovations
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 7, 2019 (Actual)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
April 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

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

5. Study Description

Brief Summary
This study evaluates the Geriatric Emergency Department Innovations (GEDI) program at Northwestern Memorial Hospital to care for older adults in the emergency department. Half of the patients will be cared for by a standard ED team plus the GEDI team, while half of the patients will receive usual ED care.
Detailed Description
Hospitalization is common for older adults in the Emergency Department (ED) but it carries significant risks including the development of delirium, falls, and nosocomial infections. The Geriatric Emergency Department Innovations (GEDI) program at Northwestern Memorial Hospital attempts to identify and address health related risks for older adults without exposing them to the risks of hospitalization,. GEDI is a unique program consisting of a multidisciplinary team of Transitional Care Nurses (TCN), social workers, pharmacists, occupational therapists and physical therapists who perform ED-based geriatric assessment and care coordination. To determine the impact of GEDI on health services use and Health Related Quality-of-Life (HRQoL) we will conduct a randomized controlled trial comparing GEDI compared to usual ED care(which often involves hospitalization).

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
840 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard emergency department care
Arm Title
Intervention
Arm Type
Other
Arm Description
Standard emergency department are plus GEDI consult
Intervention Type
Behavioral
Intervention Name(s)
Intervention
Intervention Description
Geriatric assessment and care coordination provided by a multidisciplinary team in the emergency department including transitional care nurses, social workers, pharmacists, occupational therapists, and physical therapists.
Primary Outcome Measure Information:
Title
Number of patients with hospital admission or death
Description
A composite measure of any hospitalizations or death during the index ED visit or within the follow up time frame
Time Frame
30 days
Secondary Outcome Measure Information:
Title
PROMIS-Preference
Description
The Patient-Reported Outcomes Measurement Information System (PROMIS)-Preference (PROPr) score summarizes multiple domains into a single score anchored at 0 (as bad as dead) and 1 (perfect or ideal health). This score quantifies the value that individuals place on different states of health. Preference-based scores can be used in cost-utility analyses and to estimate quality-adjusted life years (QALYs). PROPr is calculated from the scores for the 7 PROMIS domains: Cognition, Depression, Fatigue, Pain Interference, Physical Function, Sleep Disturbance, and Ability to Participate in Social Roles and Activities. Preference-based scores PROMIS domain scores can be calculated using the HealthMeasures Scoring Service. The HealthMeasures Scoring Service export includes PROMIS theta values used to calculate PROPr using Multi-Attribute Utility Theory (MAUT) which is available at https://github.com/janelhanmer/PROPr
Time Frame
9 days
Title
PROMIS-Preference
Description
The Patient-Reported Outcomes Measurement Information System (PROMIS)-Preference (PROPr) score summarizes multiple domains into a single score anchored at 0 (as bad as dead) and 1 (perfect or ideal health). This score quantifies the value that individuals place on different states of health. Preference-based scores can be used in cost-utility analyses and to estimate quality-adjusted life years (QALYs). PROPr is calculated from the scores for the 7 PROMIS domains: Cognition, Depression, Fatigue, Pain Interference, Physical Function, Sleep Disturbance, and Ability to Participate in Social Roles and Activities. Preference-based scores PROMIS domain scores can be calculated using the HealthMeasures Scoring Service. The HealthMeasures Scoring Service export includes PROMIS theta values used to calculate PROPr using Multi-Attribute Utility Theory (MAUT) which is available at https://github.com/janelhanmer/PROPr
Time Frame
30 days
Title
Return Emergency Department Visits
Description
Any Emergency Department Visits which occurs after the ED encounter in which the patient was enrolled in the study.
Time Frame
9 days
Title
Return Emergency Department Visits
Description
Any Emergency Department Visits which occurs after the ED encounter in which the patient was enrolled in the study.
Time Frame
30 days
Title
Death
Description
All cause death
Time Frame
9 days
Title
Death
Description
All cause death
Time Frame
30 days
Title
PROMIS Item Bank v2.0 - Physical Function (Adaptive)
Description
The Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Item Bank uses Computer Adaptive Testing (CAT) in which participant responses guide the system's choice of subsequent items from the full item bank (165 items in total in adult bank). Although items differ across respondents taking CAT, scores are comparable across participants. Measure Description: PROMIS subscale for physical function assesses the extent to which patients' perceived capability rather than actual performance of physical activities using a 5-point Likert scale. PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. T-scores range from 20 to 80. A higher PROMIS T-score represents more of the concept being measured.
Time Frame
9 days
Title
PROMIS Item Bank v2.0 - Physical Function (Adaptive)
Description
The Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Item Bank uses Computer Adaptive Testing (CAT) in which participant responses guide the system's choice of subsequent items from the full item bank (165 items in total in adult bank). Although items differ across respondents taking CAT, scores are comparable across participants. Measure Description: PROMIS subscale for physical function assesses the extent to which patients' perceived capability rather than actual performance of physical activities using a 5-point Likert scale. PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. T-scores range from 20 to 80. A higher PROMIS T-score represents more of the concept being measured.
Time Frame
30 days
Title
PROMIS Item Bank v2.0 - Ability to Participate Social Roles and Activities (Adaptive)
Description
The Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities Item Bank uses Computer Adaptive Testing (CAT) in which participant responses guide the system's choice of subsequent items from the full item bank (35 items in total). Although items differ across respondents taking CAT, scores are comparable across participants. Measure Description: PROMIS item bank for ability to participate in social roles and activities assesses the extent to which patients' perceived ability to perform one's usual social roles and activities using a 5-point Likert scale. PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. T-scores range from 20 to 80. A higher PROMIS T-score represents more of the concept being measured.
Time Frame
9 days
Title
PROMIS Item Bank v2.0 - Ability to Participate Social (Adaptive)
Description
The Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities Item Bank uses Computer Adaptive Testing (CAT) in which participant responses guide the system's choice of subsequent items from the full item bank (35 items in total). Although items differ across respondents taking CAT, scores are comparable across participants. Measure Description: PROMIS item bank for ability to participate in social roles and activities assesses the extent to which patients' perceived ability to perform one's usual social roles and activities using a 5-point Likert scale. PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. T-scores range from 20 to 80. A higher PROMIS T-score represents more of the concept being measured.
Time Frame
30 days
Title
PROMIS Item Bank v. 1.0 - Emotional Distress - Anxiety (Adaptive)
Description
The Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Item Bank uses Computer Adaptive Testing (CAT) in which participant responses guide the system's choice of subsequent items from the full item bank (29 items in total). Although items differ across respondents taking CAT, scores are comparable across participants. Measure Description: PROMIS item bank for anxiety assesses the extent to which patients experience anxiety symptoms over the past 7 days using a 5-point Likert scale. PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. T-scores range from 20 to 80. A higher PROMIS T-score represents more of the concept being measured.
Time Frame
9 days
Title
PROMIS Item Bank v. 1.0 - Emotional Distress - Anxiety (Adaptive)
Description
The Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Item Bank uses Computer Adaptive Testing (CAT) in which participant responses guide the system's choice of subsequent items from the full item bank (29 items in total). Although items differ across respondents taking CAT, scores are comparable across participants. Measure Description: PROMIS item bank for anxiety assesses the extent to which patients experience anxiety symptoms over the past 7 days using a 5-point Likert scale. PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. T-scores range from 20 to 80. A higher PROMIS T-score represents more of the concept being measured.
Time Frame
30 days
Title
PROMIS Item Bank v. 1.0 - Emotional Distress - Depression (Adaptive)
Description
The Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Item Bank uses Computer Adaptive Testing (CAT) in which participant responses guide the system's choice of subsequent items from the full item bank (28 items in total). Although items differ across respondents taking CAT, scores are comparable across participants. Measure Description: PROMIS item bank for depression assesses the extent to which patients experience depressive symptoms over the past 7 days using a 5-point Likert scale. PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. T-scores range from 20 to 80. A higher PROMIS T-score represents more of the concept being measured.
Time Frame
9 days
Title
PROMIS Item Bank v. 1.0 - Emotional Distress - Depression (Adaptive)
Description
The Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Item Bank uses Computer Adaptive Testing (CAT) in which participant responses guide the system's choice of subsequent items from the full item bank (28 items in total). Although items differ across respondents taking CAT, scores are comparable across participants. Measure Description: PROMIS item bank for depression assesses the extent to which patients experience depressive symptoms over the past 7 days using a 5-point Likert scale. PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. T-scores range from 20 to 80. A higher PROMIS T-score represents more of the concept being measured.
Time Frame
30 days
Title
Number of patients admitted
Description
A patient who is admitted to inpatient status during the emergency department visit in which they are enrolled in the study
Time Frame
24 hours
Title
Number of patients admitted
Description
A patient who is admitted to inpatient status during the emergency department visit in which they are enrolled in the study or within the follow up time frame
Time Frame
9 days
Title
Number of patients admitted
Description
A patient who is admitted to inpatient status during the emergency department visit in which they are enrolled in the study or within the follow up time frame
Time Frame
30 days
Title
Number of patients with hospital admission or death
Description
A composite measure of any hospitalizations or death during the index ED visit or within the follow up time frame
Time Frame
9 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Northwestern Emergency Department patients who are: 65 years or older living independently or with friends, family, or caregivers in the community Clinical Frailty Scale (CFS) score of 4 or greater Exclusion Criteria: Patients will be excluded if they: Tested positive for COVID-19 Are unable to complete the assessments in English Are unable to provide informed consent with no Legally Authorized Representative Present or are unable to complete follow-up participation Are held in the ED involuntarily as a prisoner or patient with a psychiatric complaint Are enrolled in another study to avoid patient fatigue and confounding Received a GEDI, Social Work, Pharmacy, or Physical Therapy consult outside of this trial during the current ED visit Leave the ED against medical advice or without being seen by a physician Are admitted to the ICU Are too medically unstable to participate in the assessment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Scott Dresden, MD MS
Phone
312-926-6494
Email
s-dresden@northwestern.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Katherine Piserchia
Phone
312-926-9760
Email
k-piserchia@northwestern.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott M Dresden, MD, MS
Organizational Affiliation
Northwestern University Department of Emergency Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University Department of Emergency Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katherine Piserchia
Phone
312-926-9760
Email
k-piserchia@northwestern.edu
First Name & Middle Initial & Last Name & Degree
Scott M Dresden, MD, MS

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The Galter Library at Northwestern University has implemented a DigitalHub to facilitate the storage and sharing of research products, including data sets, presentations, documentation, brochures, etc. The DigitalHub also provides digital object identifier so that these resources can be appropriately cited and tracked. Where feasible we will curate and make available structured data both as de-identified and limited datasets as defined under HIPAA. Interested collaborators will complete an online collaborative research request survey.
IPD Sharing Time Frame
The data will be made available at the completion of the study and will be available for at least 5 years.
IPD Sharing Access Criteria
Access will be determined by the DigitalHub requirements.
IPD Sharing URL
https://digitalhub.northwestern.edu/
Citations:
PubMed Identifier
32858227
Citation
Dresden SM, Lo AX, Lindquist LA, Kocherginsky M, Post LA, French DD, Gray E, Heinemann AW. The impact of Geriatric Emergency Department Innovations (GEDI) on health services use, health related quality of life, and costs: Protocol for a randomized controlled trial. Contemp Clin Trials. 2020 Oct;97:106125. doi: 10.1016/j.cct.2020.106125. Epub 2020 Aug 26.
Results Reference
derived

Learn more about this trial

A Randomized Controlled Trial of Geriatric Emergency Department Innovations

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