- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05588466
Practice Facilitation to Scale up a CDS for Hypertension Management
December 28, 2023 updated by: New York City Department of Health and Mental Hygiene
Assessing the Use of Practice Facilitation to Optimize Scale up of CDS for Hypertension
Hypertension (HTN) is the most prevalent modifiable risk factor for cardiovascular disease among U.S. adults.
Despite a long history of established guidelines to support clinical management, only half of U.S. adults diagnosed with HTN have poorly controlled blood pressure (BP) and medication adherence to proven effective treatment remains suboptimal.
Clinical decision support (CDS) has the potential to overcome barriers to delivering guideline-recommended care and improve HTN management.
Practice facilitation is a well-demonstrated implementation strategy to support process changes and has the potential to facilitate CDS implementation.
Our objective is to rigorously evaluate whether practice facilitation provided in concert with a HTN-focused CDS that incorporates medication adherence results is an effective strategy for scaling and implementing CDS.
The investigators will update an existing CDS to incorporate alerts and tools to address medication adherence then randomize 40 small independent primary care practices in New York City to receive either practice facilitation in addition to the CDS or the CDS alone.
After a twelve-month intervention period, The investigators will examine the differences in blood pressure control achieved by practices in the CDS plus practice facilitation group versus practices that received the CDS alone
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Hypertension (HTN) is the most prevalent modifiable risk factor for cardiovascular disease among U.S. adults.
Despite a long history of established guidelines to support clinical management, only half of U.S. adults diagnosed with HTN have poorly controlled blood pressure (BP) and medication adherence to proven effective treatment remains suboptimal.
Clinical decision support (CDS) has the potential to overcome barriers to delivering guideline-recommended care and improve HTN management.
However, optimal strategies for scaling CDS have not been well established, particularly in small independent primary care practices which often lack the resources to effectively change practice routines in order to effectively utilize CDS.
Further, CDS is used in relatively few components of the medication management process, despite indications that CDS alerts are likely to impact patient care.
Practice facilitation is a well-demonstrated implementation strategy to support process changes and has the potential to facilitate CDS implementation.
Our objective is to rigorously evaluate whether practice facilitation provided in concert with a HTN-focused CDS that incorporates medication adherence results is an effective strategy for scaling and implementing CDS.
The investigators will initially update and incorporate an evidence-based hypertension-focused CDS shown to be effective in Federally Qualified Health Centers (FQHCs) into an existing commercial electronic health record (EHR) system used by a large network of independent primary care practices.
This CDS will employ several features shown to be effective in the FQHCs, including passive alerts, order sets, documentation templates, standardized medication adherence questionnaires, and clinical reminders.
Additionally, the CDS will incorporate a new feature, a medication adherence alert based on prescription claims data.
The investigators will then randomize 40 small independent primary care practices in New York City to receive either practice facilitation in addition to the CDS or the CDS alone.
The PF intervention will include an initial training in the CDS and review of current guidelines along with follow-up in-person and remote meetings for coaching and supporting integration into the workflow.
After a twelve-month intervention period, The investigators will examine the differences in blood pressure control achieved by practices in the CDS plus practice facilitation group versus practices that received the CDS alone.
The investigators will also assess the implementation process for scaling the CDS using the RE-AIM framework.
The results of this study will inform future efforts to implement and scale CDS into small primary care practices, where much of care delivery occurs in the U.S.
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Queens, New York, United States, 11101
- NYC Department of Health and Mental Hygiene
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 83 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 18-85 years old
- an outpatient clinic visit with an HTN diagnosis based on the ICD-10 code in the prior 12 months
- must have received care at the clinic for at least 12 months
Exclusion Criteria:
- not pregnant
- not have end-stage kidney disease as defined by an ICD-10 code for dialysis or transplantation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: CDS alone
This arm will only receive the CDS.
|
The practices in the 'CDS alone' arm will receive an updated CDS for HTN management.
|
Active Comparator: CDS plus practice facilitation
This arm will receive the CDS and practice facilitation.
|
The practices in the 'CDS plus practice facilitation' arm will receive an updated CDS for HTN management plus practice facilitation to support the adoption of the CDS.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of patients who had a diagnosis of hypertension (HTN) and whose blood pressure (BP) was adequately controlled using BP documented in the electronic health record
Time Frame: 12-months
|
The primary outcome will be a measure of clinical effectiveness, or the percentage of patients who have achieved BP control, defined as BP <140/90 mmHg in the mean of the last two EHR-recorded measurements during each of the pre-intervention and post-intervention study periods.
|
12-months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in average systolic and diastolic blood pressure (mmHg) of patients who had a diagnosis of hypertension (HTN) using BP documented in the electronic health record
Time Frame: 12-months
|
A secondary measure will be the average change in systolic and diastolic BP (mmHg) of patients who had a diagnosis of HTN between the pre- and post-intervention period.
|
12-months
|
Percentage of patients who had a diagnosis of hypertension (HTN) and a documented blood pressure (BP)-lowering medication and whose calculated medication adherence rate is considered adherent using pharmacy claims data
Time Frame: 12-months
|
A secondary outcome will be percentage of patients who had a diagnosis of HTN and a documented BP-lowering medication and whose calculated medication adherence rate is considered adherent pre- and post-intervention period.
Adherence is measured as proportion of days covered (PDC) where a PDC >80% is considered adherent.
PDC is calculated using prescription fill data from pharmacy claims.
|
12-months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Duncan Maru, NYC DOHMH
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 9, 2021
Primary Completion (Estimated)
August 30, 2024
Study Completion (Estimated)
September 30, 2024
Study Registration Dates
First Submitted
April 7, 2022
First Submitted That Met QC Criteria
October 18, 2022
First Posted (Actual)
October 20, 2022
Study Record Updates
Last Update Posted (Actual)
December 29, 2023
Last Update Submitted That Met QC Criteria
December 28, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21-020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
There is a plan to share individual participant data with our collaborating investigators at NYU School of Medicine on this study.
There is a data sharing agreement between NYC DOHMH and NYU School of Medicine that specifies that the co-Principal Investigators on this study and the other investigators listed in the IRB application.
Information will be shared with our collaborators at NYU School of Medicine using the secure mechanism/ software, BisCom.
Data will be stored in secured folders with access restricted to investigators listed on this IRB, at NYU School of Medicine, in accordance with privacy and security protocols of NYU School of Medicine and NYC Department of Health and Mental Hygiene.
IPD Sharing Time Frame
The data will be available from 4/1/2022 through 10/1/2026.
IPD Sharing Access Criteria
The investigators will have access to all data sets obtained and data collected for the purposes of this study, including de-identified patient-level EHR data (i.e., demographics, encounter date, encounter information such as medication and lab orders, blood pressure and clinical decision support usage metrics [acknowledgement of alerts, and use of order sets]); Salesforce data on practice demographics, practice facilitation and clinical decision support implementation as needed to deploy surveys, conduct interviews and collaborate with DOHMH investigators on analyses.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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