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OpenTrials
Completed

NCT Number: NCT03723707

Enhanced Quality in Primary Care for Elders With Diabetes and Dementia

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EQUIPED-ADRD Intervention

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)

Behavioral

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Acronym: EQUIPED-ADRD

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Oct 29, 2018
Registry last updated
Nov 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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