Back to resultsEnhanced Quality in Primary Care for Elders With Diabetes and Dementia (EQUIPED-ADRD)
Primary Purpose
Diabetes, Dementia, Alzheimer Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EQUIPED-ADRD Intervention
Control (CON)
Sponsored by
About this trial
This is an interventional supportive care trial for Diabetes
Eligibility Criteria
Inclusion Criteria:
- Patient must receive care at participating NYU FGP clinics.
- Patient must be English or Spanish speaking.
- Patient must have DM diagnosis.
- Patient must have documented cognitive impairment or an ADRD diagnosis.
- Patient must have someone who is identified as a family or friend who provides caregiving assistance.
Caregiver:
- Caregiver must have adequate knowledge of identified patient and/or participate in that member's healthcare decisions.
- Caregiver must be English or Spanish speaking.
- Caregiver must demonstrate capacity to consent to research participation.
- Caregiver must be at least 21 years old.
Exclusion Criteria:
Patient:
- Patient does not receive care at participating NYU FGP clinics.
- Patient is not 65 years and older.
- Patient is not English or Spanish speaking.
- Patient does not have DM diagnosis.
- Patient does not have documented Cognitive impairment or an ADRD diagnosis.
- Patient has severe dementia, other terminal illness with <6 months to live, and/or is hospice eligible.
- Patient does not have a caregiver.
Caregiver:
- Caregiver does not have adequate knowledge of identified patient and/or does not participate in that member's healthcare decisions.
- Caregiver is not English or Spanish speaking.
- Caregiver lacks capacity to consent to research.
- Caregiver is under 21 years old.
Sites / Locations
- NYU Langone Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention (INT)
Control (CON)
Arm Description
(10 clinic sites and ~500 patients) which includes practice guidelines for clinicians, provider education, electronic health record support for quality DM-ADRD care, information about community/clinical resources, ongoing targeted provider feedback, and a panel manager (PM)
During training the CON providers will be encouraged to do cognitive screening as well as follow the guidelines in general.
Outcomes
Primary Outcome Measures
Proportion of Intervention patients reaching consensus target HbA1c
Proportion of Control patients reaching consensus target HbA1c
Secondary Outcome Measures
Full Information
NCT ID
NCT03723707
First Posted
October 22, 2018
Last Updated
February 8, 2023
Sponsor
NYU Langone Health
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT03723707
Brief Title
Enhanced Quality in Primary Care for Elders With Diabetes and Dementia
Acronym
EQUIPED-ADRD
Official Title
Enhanced Quality in Primary Care for Elders With Diabetes and Dementia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
December 3, 2018 (Actual)
Primary Completion Date
October 20, 2022 (Actual)
Study Completion Date
October 20, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Institute on Aging (NIA)
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 this study is to develop and test a care quality improvement intervention featuring use of consensus decisional guidance for the medical management of diabetes (DM) in patients with Alzheimer's disease and related dementia (ADRD) in primary care, provider (PCP) workflow enhancements supported by a panel manager(PM) for workflow support, electronic health record (EHR) decision support and feedback, and PCP collaborative learning.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Dementia, Alzheimer Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
355 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention (INT)
Arm Type
Experimental
Arm Description
(10 clinic sites and ~500 patients) which includes practice guidelines for clinicians, provider education, electronic health record support for quality DM-ADRD care, information about community/clinical resources, ongoing targeted provider feedback, and a panel manager (PM)
Arm Title
Control (CON)
Arm Type
Placebo Comparator
Arm Description
During training the CON providers will be encouraged to do cognitive screening as well as follow the guidelines in general.
Intervention Type
Behavioral
Intervention Name(s)
EQUIPED-ADRD Intervention
Intervention Description
(10 clinic sites and ~500 patients) which includes practice guidelines for clinicians, provider education, electronic health record support for quality DM-ADRD care, information about community/clinical resources, ongoing targeted provider feedback, and a panel manager (PM)
Intervention Type
Behavioral
Intervention Name(s)
Control (CON)
Intervention Description
Will use current guidelines for primary care treatment with Diabetes and Dementia
Primary Outcome Measure Information:
Title
Proportion of Intervention patients reaching consensus target HbA1c
Time Frame
30 Months
Title
Proportion of Control patients reaching consensus target HbA1c
Time Frame
30 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient must receive care at participating NYU FGP clinics.
Patient must be English or Spanish speaking.
Patient must have DM diagnosis.
Patient must have documented cognitive impairment or an ADRD diagnosis.
Patient must have someone who is identified as a family or friend who provides caregiving assistance.
Caregiver:
Caregiver must have adequate knowledge of identified patient and/or participate in that member's healthcare decisions.
Caregiver must be English or Spanish speaking.
Caregiver must demonstrate capacity to consent to research participation.
Caregiver must be at least 21 years old.
Exclusion Criteria:
Patient:
Patient does not receive care at participating NYU FGP clinics.
Patient is not 65 years and older.
Patient is not English or Spanish speaking.
Patient does not have DM diagnosis.
Patient does not have documented Cognitive impairment or an ADRD diagnosis.
Patient has severe dementia, other terminal illness with <6 months to live, and/or is hospice eligible.
Patient does not have a caregiver.
Caregiver:
Caregiver does not have adequate knowledge of identified patient and/or does not participate in that member's healthcare decisions.
Caregiver is not English or Spanish speaking.
Caregiver lacks capacity to consent to research.
Caregiver is under 21 years old.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua Chodosh, MD, MSHS, FACP
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All of the individual participant data collected during the trial, after deidentification and publication.
IPD Sharing Time Frame
Beginning 9 months and ending 5 years following article publication.
IPD Sharing Access Criteria
Researchers who provide a methodologically sound proposal.
Learn more about this trial
Enhanced Quality in Primary Care for Elders With Diabetes and Dementia
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