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Addressing Antihypertensive Medication Adherence Through EHR-enabled Teamlets in Primary Care

Sponsor
NYU Langone Health (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05349422
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
4,400
Enrollment
1
Location
2
Arms
38
Anticipated Duration (Months)
115.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study team will conduct a cluster randomized control trial in up to 22 NYU primary care practices to assess the effectiveness and implementation of the multicomponent intervention on medication adherence and blood pressure control for patients who are non-adherent to antihypertensive medications.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Electronic Health Record (EHR) Enabled Teamlets
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
4400 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The study trial will utilize a practice-level cluster-randomized design, with 1:1 randomization of up to 22 clinics.The study trial will utilize a practice-level cluster-randomized design, with 1:1 randomization of up to 22 clinics.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Addressing Antihypertensive Medication Adherence Through EHR-enabled Teamlets in Primary Care
Anticipated Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
Jun 30, 2024
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention Group

Behavioral: Electronic Health Record (EHR) Enabled Teamlets
The intervention consist of four components: 1) patients with hypertension will be automatically screened for low medication adherence using linked EHR-pharmacy data at the time of a PCP encounter; 2) MAs will deliver a validated, rapid, survey of common causes of non-adherence; 3) MAs and/or RNs will address barriers to adherence tailored to survey response, including delivery of brief health coaching based on motivational interviewing; and 4) PCPs will address specific barriers to adherence based on survey response.
No Intervention: Usual Care Group

Usual Care Clinical Decision Support (CDS) Tools

Outcome Measures

Primary Outcome Measures

  1. Average Number of Days Covered (PDC) as a Measure of Medication Adherence [Month 12]

    The proportion of days covered (PDC) is used to estimate medication adherence by looking at the proportion of days in which a person has access to the medication, over a given period of interest

Secondary Outcome Measures

  1. Average Number of Days Covered (PDC) as a Measure of Medication Adherence [Month 18]

    The proportion of days covered (PDC) is used to estimate medication adherence by looking at the proportion of days in which a person has access to the medication, over a given period of interest

  2. Mean Systolic Blood Pressure [Month 12]

  3. Mean Systolic Blood Pressure [Month 18]

  4. Mean Diastolic Blood Pressure [Month 12]

  5. Mean Diastolic Blood Pressure [Month 18]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
Individuals:

  1. Age>18 years

  2. Presence of Hypertension as defined by either:

  3. Blood pressure ≥140/90

  4. Hypertension diagnosis

  5. Prescription for at least one antihypertensive medication

  6. Outpatient clinic visit in the NYULH between 06/1/2022 and 12/31/2025

MAs, PCPs, LPNs, and RNs:
  1. A clinician from an NYULH ambulatory practice location.
  1. Eligible clinicians include physicians, medical assistants, licensed practical nurses, and registered nurses.

  1. Adult patients during appointments with eligible clinicians

  2. Age > 18 years

Exclusion Criteria:

  1. Patients who decline to be observed.

  2. The study team has no specific exclusion criteria for patients in chart review.

Contacts and Locations

Locations

Site City State Country Postal Code
1 NYU Langone Health New York New York United States 10016

Sponsors and Collaborators

  • NYU Langone Health
  • National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Saul Blecker, MD, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
NYU Langone Health
ClinicalTrials.gov Identifier:
NCT05349422
Other Study ID Numbers:
  • 21-00133
  • R01HL156355
First Posted:
Apr 27, 2022
Last Update Posted:
Jun 9, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jun 9, 2022