Enhanced Quality in Primary Care for Elders With Diabetes and Dementia (EQUIPED-ADRD)

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.

Study Overview

• Status: Completed
• Conditions: Diabetes; Dementia; Alzheimer Disease
• Intervention / Treatment: Behavioral: EQUIPED-ADRD Intervention; Behavioral: Control (CON)

• Study Type: Interventional
• Enrollment (Actual): 355
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention (INT); (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)	Behavioral: EQUIPED-ADRD Intervention; (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)
Placebo Comparator: Control (CON); During training the CON providers will be encouraged to do cognitive screening as well as follow the guidelines in general.	Behavioral: Control (CON); Will use current guidelines for primary care treatment with Diabetes and Dementia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of Patients Who Reach Consensus Target HBA1c	Percentage of patients with normal HbA1c (>=7 and <=8.5) at the end of the trial after completing the 24-month Follow-up and who had reported values in their electronic health record within 6 months of study completion.	Up to Month 24

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Joshua Chodosh, MD, MSHS, FACP, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2018
• Primary Completion (Actual): October 20, 2022
• Study Completion (Actual): October 20, 2022

Study Registration Dates

• First Submitted: October 22, 2018
• First Submitted That Met QC Criteria: October 25, 2018
• First Posted (Actual): October 29, 2018

Study Record Updates

• Last Update Posted (Estimated): November 9, 2023
• Last Update Submitted That Met QC Criteria: November 8, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Endocrine System Diseases; Neurodegenerative Diseases; Tauopathies; Diabetes Mellitus; Dementia; Alzheimer Disease
• Other Study ID Numbers: s18-01166; 1R21AG057291-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No