HypertensionPhase 4NCT03713515
Bridging the Evidence-to-practice Gap
A Phase 4 study testing ALTA in people with Hypertension, run by NYU Langone Health at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hypertension
- What is being tested?
- ALTA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 652 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2020to 30 Sep 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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.
- Conditions
- Hypertension
- Being tested
- ALTA
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALTABehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Practice Faciliation | Experimental | Will be supported by a practice facilitator Receives: Behavioral: ALTA |
| Usual Care | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implementation Fidelity - Adherence: Screening
Defined as the percentage of eligible participants who were screened.
Measured: Up to Month 12
Implementation Fidelity - Adherence: Referrals
Defined as the percentage of screened participants who were referred.
Measured: Up to Month 12
Implementation Fidelity - Adherence: Enrollment
Defined as the percentage of referred participants who were enrolled.
Measured: Up to Month 12
Secondary outcomes (2)
Change in Blood Pressure (BP) Control
Assessed as the change in percentage of participants with blood pressure (BP) control, defined as systolic BP (SBP) <140 and diastolyic BP (DBP) <90 mmHg.
Measured: Baseline, Post Intervention (Months 24-36)
Change in Medication Adherence
Assessed via pharmacy refills obtained from prescription orders in the clinic EHR using the proportion of days covered (PDC) metric; medication adherence defined as PDC ≥ 80; this outcome will be measured as the change in percentage of participants who meet medication adherence.
Measured: Baseline, Post Intervention (Months 24-36)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start1 Dec 2020
- Primary completion30 May 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Stepped Wedge
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 652 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoinette Schoenthaler, EdD, Principal investigator, NYUMC Langone
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03713515
- Sponsor's protocol ID
- 18-01290
- Status last verified
- Jun 2026
- First submitted
- 17 Oct 2018
- Last updated
- 10 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Schoenthaler A, De La Calle F, D'aguilar N, De Leon E, Nay J, Collela D, Dapkins I, Mandal S, Rosal MC. Bridging evidence and practice: multi-method evaluation of implementation fidelity of a multilevel hypertension intervention in a federally qualified health center. Front Health Serv. 2026 Jul 17;6:1856884. doi: 10.3389/frhs.2026.1856884. eCollection 2026.
PubMed 42539511De Leon E, De La Calle F, Mandal S, Rosal MC, Nay J, Colella D, Dapkins I, Schoenthaler A. Understanding Implementation of a Technology-Facilitated Hypertension Model in Federally Qualified Health Centers: A Realist Evaluation of Staff Experiences. J Gen Intern Med. 2026 Jun 1. doi: 10.1007/s11606-026-10505-4. Online ahead of print.
PubMed 42223807Chervonski E, Pelegri E, De La Calle F, Mandal S, Graves CA, Colella D, Elmaleh-Sachs A, Nay J, Dapkins I, Schoenthaler A. Cardiovascular Health Markers With Remote Team-Based Hypertension Management in a Safety-Net Population. Am J Prev Med. 2025 Nov;69(5):108031. doi: 10.1016/j.amepre.2025.108031. Epub 2025 Aug 5.
PubMed 40763829Schoenthaler A, De La Calle F, De Leon E, Garcia M, Colella D, Nay J, Dapkins I. Application of the FRAME-IS to a multifaceted implementation strategy. BMC Health Serv Res. 2024 Jun 1;24(1):695. doi: 10.1186/s12913-024-11139-0.
PubMed 38822342Gago C, De Leon E, Mandal S, de la Calle F, Garcia M, Colella D, Dapkins I, Schoenthaler A. "Hypertension is such a difficult disease to manage": federally qualified health center staff- and leadership-perceived readiness to implement a technology-facilitated team-based hypertension model. Implement Sci Commun. 2024 May 2;5(1):49. doi: 10.1186/s43058-024-00587-8.
PubMed 38698497Schoenthaler A, De La Calle F, Leon E, Garcia M, Colella D, Nay J, Dapkins I. Application of the FRAME-IS to a Multifaceted Implementation Strategy. Res Sq [Preprint]. 2024 Feb 12:rs.3.rs-3931349. doi: 10.21203/rs.3.rs-3931349/v1.
PubMed 38410454Schoenthaler 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.
PubMed 33597041
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03713515
- Acronym / sponsor ID
- 18-01290
- Conditions
- Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 652 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 19 Oct 2018 (actual)
- Results
- Posted 10 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Stepped Wedge
| Arm | Type | Receives |
|---|---|---|
| Practice Faciliation | Experimental | Behavioral: ALTAWill be supported by a practice facilitator |
| Usual Care | No intervention | –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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
- Refuse to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALTAThe 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. | Behavioural | Practice Faciliation |
Primary outcome
Implementation Fidelity - Adherence: Screening
Time frame: Up to Month 12
Defined as the percentage of eligible participants who were screened.
Implementation Fidelity - Adherence: Referrals
Time frame: Up to Month 12
Defined as the percentage of screened participants who were referred.
Implementation Fidelity - Adherence: Enrollment
Time frame: Up to Month 12
Defined as the percentage of referred participants who were enrolled.
2 secondary outcomes
Change in Blood Pressure (BP) Control
Time frame: Baseline, Post Intervention (Months 24-36)
Change in Medication Adherence
Time frame: Baseline, Post Intervention (Months 24-36)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42539511Schoenthaler A, De La Calle F, D'aguilar N, De Leon E, Nay J, Collela D, Dapkins I, Mandal S, Rosal MC. Bridging evidence and practice: multi-method evaluation of implementation fidelity of a multilevel hypertension intervention in a federally qualified health center. Front Health Serv. 2026 Jul 17;6:1856884. doi: 10.3389/frhs.2026.1856884. eCollection 2026.
- Derived from this study: PubMed 42223807De Leon E, De La Calle F, Mandal S, Rosal MC, Nay J, Colella D, Dapkins I, Schoenthaler A. Understanding Implementation of a Technology-Facilitated Hypertension Model in Federally Qualified Health Centers: A Realist Evaluation of Staff Experiences. J Gen Intern Med. 2026 Jun 1. doi: 10.1007/s11606-026-10505-4. Online ahead of print.
- Derived from this study: PubMed 40763829Chervonski E, Pelegri E, De La Calle F, Mandal S, Graves CA, Colella D, Elmaleh-Sachs A, Nay J, Dapkins I, Schoenthaler A. Cardiovascular Health Markers With Remote Team-Based Hypertension Management in a Safety-Net Population. Am J Prev Med. 2025 Nov;69(5):108031. doi: 10.1016/j.amepre.2025.108031. Epub 2025 Aug 5.
- Derived from this study: PubMed 38822342Schoenthaler A, De La Calle F, De Leon E, Garcia M, Colella D, Nay J, Dapkins I. Application of the FRAME-IS to a multifaceted implementation strategy. BMC Health Serv Res. 2024 Jun 1;24(1):695. doi: 10.1186/s12913-024-11139-0.
- Derived from this study: PubMed 38698497Gago C, De Leon E, Mandal S, de la Calle F, Garcia M, Colella D, Dapkins I, Schoenthaler A. "Hypertension is such a difficult disease to manage": federally qualified health center staff- and leadership-perceived readiness to implement a technology-facilitated team-based hypertension model. Implement Sci Commun. 2024 May 2;5(1):49. doi: 10.1186/s43058-024-00587-8.
- Derived from this study: PubMed 38410454Schoenthaler A, De La Calle F, Leon E, Garcia M, Colella D, Nay J, Dapkins I. Application of the FRAME-IS to a Multifaceted Implementation Strategy. Res Sq [Preprint]. 2024 Feb 12:rs.3.rs-3931349. doi: 10.21203/rs.3.rs-3931349/v1.
- Derived from this study: PubMed 33597041Schoenthaler 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoinette Schoenthaler, EdD principal investigator
NYUMC Langone
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ALTA in people with Hypertension, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implementation Fidelity - Adherence: Screening (time frame: Up to Month 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03713515, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.