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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

Tracking Information
First Submitted Date  ICMJE October 17, 2018
First Posted Date  ICMJE October 19, 2018
Last Update Posted Date July 9, 2019
Estimated Study Start Date  ICMJE September 1, 2019
Estimated Primary Completion Date June 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 5, 2019)
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
Original Primary Outcome Measures  ICMJE
 (submitted: October 17, 2018)
Measure of Adherence to the program protocol to the program protoco [ 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
Change History Complete list of historical versions of study NCT03713515 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Hypertension
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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
    Intervention: Behavioral: Helping Hypertensive Latinos Improve Medication Adherance (ALMA)
  • Active Comparator: Group B-Supported
    Will be supported by a practice facilitator
    Intervention: Behavioral: Helping Hypertensive Latinos Improve Medication Adherance (ALMA)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: October 17, 2018)
650
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2023
Estimated Primary Completion Date June 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Adebayo Ogunlade 212 263 4205 Adebayo.Ogunlade@nyumc.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03713515
Other Study ID Numbers  ICMJE 18-01290
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: 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
Responsible Party NYU Langone Health
Study Sponsor  ICMJE NYU Langone Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Antoinette Schoenthaler NYUMC Langone
PRS Account NYU Langone Health
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP