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Bridging the Evidence-to-practice Gap: Evaluating Practice Facilitation as a Strategy to Accelerate Translation of a Systems-level Adherence Intervention Into Safety Net Practices

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ClinicalTrials.gov Identifier: NCT03713515
Recruitment Status : Not yet recruiting
First Posted : October 19, 2018
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:
The proposed project will address this evidence-to-practice gap by evaluating, in a cluster-randomized controlled trial, the effect of practice facilitation (PF) of the ALMA intervention versus a self-directed control on implementation fidelity (primary outcome) and clinical measures at 12 months (secondary outcomes).

Condition or disease Intervention/treatment Phase
Hypertension Behavioral: Helping Hypertensive Latinos Improve Medication Adherance (ALMA) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 650 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Bridging the Evidence-to-practice Gap: Evaluating Practice Facilitation as a Strategy to Accelerate Translation of a Systems-level Adherence Intervention Into Safety Net Practices
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group A-Self Directed Condition
This group will not receive support from a practice facilitator, who are specially trained individuals who will help implement the Helping Hypertensive Latinos Improve Medication Adherence (ALMA) intervention
Behavioral: Helping Hypertensive Latinos Improve Medication Adherance (ALMA)
intervention to help patients improve their ability to take their high blood pressure medications and control their blood pressure

Active Comparator: Group B-Supported
Will be supported by a practice facilitator
Behavioral: Helping Hypertensive Latinos Improve Medication Adherance (ALMA)
intervention to help patients improve their ability to take their high blood pressure medications and control their blood pressure




Primary Outcome Measures :
  1. Measure of Adherence to the program protocol [ Time Frame: 15 Months ]
    Will be assessed via pharmacy refills obtained from prescription orders in the clinic EHR using the proportion of days covered (PDC) metric, calculated as the total number of days covered by the medication



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Self-identify as Latino
  • Be fluent in English or Spanish
  • Be age 18 years or older
  • Receiving care at one of the 12 Family Health Centers (FHC)
  • Have uncontrolled HTN documented in the electronic health record (EHR) on at least two visits in the past year (defined as an average BP ≥ 140/90 mmHg)
  • Have been prescribed at least one anti-hypertensive medication and be non- adherent to their medications, defined as adherence <80% in the preceding 12 months, as determined by prescription orders obtained from the clinic EHR.

Clinic and nonclinical staff inclusion criteria:

  • Primary care provider (MD/DO, NP), Nurse, Medical Assistant, or administrative staff employed at the participating FHCs and (b) interacts with at least five patients with a diagnosis of hypertension.

Exclusion Criteria:

  • Being deemed unable to comply with the study protocol (either self-selected or by indicating during screening that s/he could not complete all requested tasks)
  • Participation in other hypertension-related clinical trials
  • Have significant psychiatric comorbidity or reports of substance abuse (as documented in the EHR)
  • Plan to discontinue care at the FHC within the next 12 months

Clinic and nonclinical staff exclusion criteria:

  • Refuse to participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03713515


Contacts
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Contact: Adebayo Ogunlade 212 263 4205 Adebayo.Ogunlade@nyumc.org

Locations
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United States, New York
NYUMC Langone Not yet recruiting
New York, New York, United States, 10016
Contact: Adebayo Ogunlade    212-263-4205    Adebayo.Ogunlade@nyumc.org   
Principal Investigator: Antoinette Schoenthaler, MD         
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Antoinette Schoenthaler NYUMC Langone

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03713515     History of Changes
Other Study ID Numbers: 18-01290
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). Access will be granted to Researchers who provide a methodologically sound proposal.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Beginning 3 months and ending 5 years following article publication.
Access Criteria: Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata. Information regarding submitting requests and accessing data may be found at (Link to be provided). NYU Data Catalog

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No