Enhanced Quality in Primary Care for Elders With Diabetes and Dementia

Study Overview
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Brief Summary
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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.

Official Title
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Enhanced Quality in Primary Care for Elders With Diabetes and Dementia

Conditions
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Diabetes, Dementia, Alzheimer Disease

Intervention / Treatment
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* Behavioral: EQUIPED-ADRD Intervention
* Behavioral: Control (CON)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |