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Clinical Trials/NCT03723707
NCT03723707
Completed
Not Applicable

Enhanced Quality in Primary Care for Elders With Diabetes and Dementia

NYU Langone Health1 site in 1 country355 target enrollmentStarted: December 3, 2018Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
355
Locations
1
Primary Endpoint
Percent of Patients Who Reach Consensus Target HBA1c

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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 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 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 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.

Outcomes

Primary Outcomes

Percent of Patients Who Reach Consensus Target HBA1c

Time Frame: 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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