Enhanced Quality in Primary Care for Elders With Diabetes and Dementia

Not Applicable

Completed

• Conditions: Alzheimer Disease; Dementia; Diabetes
• Interventions: Behavioral: EQUIPED-ADRD Intervention; Behavioral: Control (CON)

• Registration Number: NCT03723707
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-22
• Study First Submitted QC: 2018-10-25
• Study First Posted: 2018-10-29
• Study Start: 2018-12-03
• Primary Completion: 2022-10-20
• Study Completion: 2022-10-20
• Results First Submitted: 2023-10-17
• Status Verified: 2023-11
• Results First Submitted QC: 2023-11-08
• Last Update Submitted: 2023-11-08
• Results First Posted: 2023-11-09
• Last Update Posted: 2023-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 355

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention (INT)	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)
Control (CON)	Control (CON)	During training the CON providers will be encouraged to do cognitive screening as well as follow the guidelines in general.

Primary Outcome Measures

Name	Time	Method
Percent of Patients Who Reach Consensus Target HBA1c	Up to Month 24	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.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States