Enhanced Quality in Primary Care for Elders With Diabetes and Dementia

Diabetes Clinical Trial

— EQUIPED-ADRD  

Official title:

Enhanced Quality in Primary Care for Elders With Diabetes and Dementia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03723707
• Other study ID #: s18-01166
• Secondary ID: 1R21AG057291-01
• Status: Completed
• Phase: N/A
• Start date: December 3, 2018
• Est. completion date: October 20, 2022

Study information

• Verified date: November 2023
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 355
• Est. completion date: October 20, 2022
• Est. primary completion date: October 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia
• Diabetes
• Diabetes Mellitus

Intervention

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)
• Control (CON)
Will use current guidelines for primary care treatment with Diabetes and Dementia

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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