Enhanced Quality in Primary Care for Elders With Diabetes and Dementia

NCT03723707 | Completed Results

• 2 other identifiers: s18-011661R21AG057291-01
• Study Type: interventional
• Target: 355
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Dementia; Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Intervention (INT)

EXPERIMENTAL

(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

Control (CON)

PLACEBO COMPARATOR

During training the CON providers will be encouraged to do cognitive screening as well as follow the guidelines in general.

Behavioral: Control (CON)

Interventions

EQUIPED-ADRD Intervention BEHAVIORAL

(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 (INT)

Control (CON) BEHAVIORAL

Will use current guidelines for primary care treatment with Diabetes and Dementia

Control (CON)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

Related Publications (1)

• Adeyemi O, Christina W, Arcila-Mesa M, Dickson VV, Ferris R, Tarpey T, Fletcher J, Blaum C, Chodosh J. Enhanced quality in primary care for elders with diabetes and dementia: Protocol for a multisite randomized controlled trial. Contemp Clin Trials. 2026 Jan;160:108165. doi: 10.1016/j.cct.2025.108165. Epub 2025 Nov 24.

  PMID: 41297852 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Dementia; Alzheimer Disease

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Mauricio Arcila-Mesa
• Organization: NYU Langone Health

Mauricio.arcila-mesa@nyulangone.org

646-501-4660

Study Officials

• Joshua Chodosh, MD, MSHS, FACP

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2018
• First Posted: October 29, 2018
• Study Start: December 3, 2018
• Primary Completion: October 20, 2022
• Study Completion: October 20, 2022
• Last Updated: November 9, 2023
• Results First Posted: November 9, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 5 years following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

US (1)