Back to resultsBridging the Evidence-to-practice Gap
Primary Purpose
Hypertension
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
ALTA
Sponsored by
About this trial
This is an interventional health services research trial for Hypertension
Eligibility Criteria
Inclusion Criteria:
- Self-identify as Latino
- Be fluent in English or Spanish
- Be age 18 years or older
- Receiving care in a safety-net primary care practice
- 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 practices 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 their practice within the next 12 months
Clinic and nonclinical staff exclusion criteria:
• Refuse to participate
Sites / Locations
- NYUMC LangoneRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Practice Faciliation
Usual Care
Arm Description
Will be supported by a practice facilitator
Using a stepped wedge design, all practice sites begin as part of the Usual Care (UC) control condition and will receive standard hypertension management that is part of the current clinic procedure. No practice facilitation will occur at this time.
Outcomes
Primary Outcome Measures
Level of implementation fidelity
Implementation fidelity will be defined as the degree to which ALTA was delivered, as intended. A mixed methods approach will be used to assess the five core domains of implementation fidelity: (1) adherence to the program protocol; (2) dose of the program delivered; (3) quality of program delivery; (4) participant responsiveness; and (5) program differentiation.
Secondary Outcome Measures
Blood Pressure (BP) control
First, BP control, will be defined as SBP <140 and DBP <90 mmHg.121 BP control will be assessed using the mean of the last two measurements recorded in the electronic health record (EHR) during each of the pre-intervention and post-intervention study periods (baseline and 12 months). We will also examine the proportion of patients with BP control <130/80 mmHg in exploratory analyses to provide preliminary data on BP control rates of hypertensive Latino patients when considering the new guidelines. We will also explore mean change in systolic and diastolic BP based on the mean of the last two recorded BP readings in the EHR during the pre- and post-intervention periods.
Medication adherence
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.
Full Information
NCT ID
NCT03713515
First Posted
October 17, 2018
Last Updated
September 26, 2023
Sponsor
NYU Langone Health
1. Study Identification
Unique Protocol Identification Number
NCT03713515
Brief Title
Bridging the Evidence-to-practice Gap
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The proposed project will address this evidence-to-practice gap by evaluating the effect of practice facilitation (PF) of the intervention implementation fidelity (primary outcome) and clinical measures at 12 months (secondary outcomes).
Detailed Description
Advancing Medication Adherence for Latinx with Hypertension through a Team-based Care Approach (ALTA) evaluates the effectiveness of using a quality improvement method called practice facilitation (PF) to implement our evidence-based systems-level intervention for improving medication adherence and blood pressure control.
The ALTA intervention focuses on identifying Latinx patients with uncontrolled hypertension who are non-adherent to their antihypertensive medication, referring them to health coaches, coaching patients on medication adherence and self-management, care planning, and monitoring patients to improve patient outcomes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Stepped Wedge
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
700 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Practice Faciliation
Arm Type
Experimental
Arm Description
Will be supported by a practice facilitator
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Using a stepped wedge design, all practice sites begin as part of the Usual Care (UC) control condition and will receive standard hypertension management that is part of the current clinic procedure. No practice facilitation will occur at this time.
Intervention Type
Behavioral
Intervention Name(s)
ALTA
Intervention Description
The study will involve each site starting with the usual care phase, followed by a period of 6 months during which practice facilitators will conduct the pre-implementation evaluation (e.g., workflow analysis, environmental scan), refine the practice facilitation strategies that will be used in the implementation phase, and train staff in the Advancing Medication Adherence for Latinos with Hypertension through a Team-based Care Approach (ALTA) intervention model. ALTA is an efficacious systems-level intervention designed to help patients improve their ability to take their high blood pressure medications and control their blood pressure. Practices and the Project ALTA team will work together to implement the ALTA model into routine care to improve blood pressure control and medication adherence in Latinx patients.
Primary Outcome Measure Information:
Title
Level of implementation fidelity
Description
Implementation fidelity will be defined as the degree to which ALTA was delivered, as intended. A mixed methods approach will be used to assess the five core domains of implementation fidelity: (1) adherence to the program protocol; (2) dose of the program delivered; (3) quality of program delivery; (4) participant responsiveness; and (5) program differentiation.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Blood Pressure (BP) control
Description
First, BP control, will be defined as SBP <140 and DBP <90 mmHg.121 BP control will be assessed using the mean of the last two measurements recorded in the electronic health record (EHR) during each of the pre-intervention and post-intervention study periods (baseline and 12 months). We will also examine the proportion of patients with BP control <130/80 mmHg in exploratory analyses to provide preliminary data on BP control rates of hypertensive Latino patients when considering the new guidelines. We will also explore mean change in systolic and diastolic BP based on the mean of the last two recorded BP readings in the EHR during the pre- and post-intervention periods.
Time Frame
Baseline and 12 months
Title
Medication adherence
Description
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.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Self-identify as Latino
Be fluent in English or Spanish
Be age 18 years or older
Receiving care in a safety-net primary care practice
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 practices 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 their practice within the next 12 months
Clinic and nonclinical staff exclusion criteria:
• Refuse to participate
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jocelyn Cruz, MPH
Phone
6465013474
Email
Jocelyn.Acosta@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoinette Schoenthaler, EdD
Organizational Affiliation
NYUMC Langone
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYUMC Langone
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jocelyn Cruz
Phone
646-501-3474
Email
Jocelyn.Acosta@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Antoinette Schoenthaler, EdD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
Beginning 3 months and ending 5 years following article publication.
IPD Sharing 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
Citations:
PubMed Identifier
33597041
Citation
Schoenthaler A, De La Calle F, Soto A, Barrett D, Cruz J, Payano L, Rosado M, Adhikari S, Ogedegbe G, Rosal M. Bridging the evidence-to-practice gap: a stepped-wedge cluster randomized controlled trial evaluating practice facilitation as a strategy to accelerate translation of a multi-level adherence intervention into safety net practices. Implement Sci Commun. 2021 Feb 17;2(1):21. doi: 10.1186/s43058-021-00111-2. Erratum In: Implement Sci Commun. 2021 Oct 21;2(1):122.
Results Reference
derived
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Bridging the Evidence-to-practice Gap
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