Enhanced Quality in Primary Care for Elders With Diabetes and Dementia

NCT ID: NCT03723707

Last Updated: 2023-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 355 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-03
• Study Completion Date: 2022-10-20

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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)

Group Type: EXPERIMENTAL

EQUIPED-ADRD Intervention

Intervention Type: 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)

Control (CON)

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

Group Type: PLACEBO_COMPARATOR

Control (CON)

Intervention Type: BEHAVIORAL

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

Interventions

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)

Intervention Type: BEHAVIORAL

Control (CON)

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joshua Chodosh, MD, MSHS, FACP

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

NYU Langone Health

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1R21AG057291-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

s18-01166

Identifier Type: -

Identifier Source: org_study_id