Practice Facilitation to Scale up a CDS for Hypertension Management
Primary Purpose
Hypertension
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CDS Alone
CDS plus practice facilitation
Sponsored by

About this trial
This is an interventional prevention trial for Hypertension focused on measuring Clinical Decision Support System, Practice Facilitation, Small Independent Practices
Eligibility Criteria
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
Sites / Locations
- NYC Department of Health and Mental Hygiene
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
CDS alone
CDS plus practice facilitation
Arm Description
This arm will only receive the CDS.
This arm will receive the CDS and practice facilitation.
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
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
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.
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
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.
Full Information
NCT ID
NCT05588466
First Posted
April 7, 2022
Last Updated
October 25, 2022
Sponsor
New York City Department of Health and Mental Hygiene
Collaborators
Agency for Healthcare Research and Quality (AHRQ), NYU
1. Study Identification
Unique Protocol Identification Number
NCT05588466
Brief Title
Practice Facilitation to Scale up a CDS for Hypertension Management
Official Title
Assessing the Use of Practice Facilitation to Optimize Scale up of CDS for Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 9, 2021 (Actual)
Primary Completion Date
August 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York City Department of Health and Mental Hygiene
Collaborators
Agency for Healthcare Research and Quality (AHRQ), NYU
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
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Clinical Decision Support System, Practice Facilitation, Small Independent Practices
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CDS alone
Arm Type
Active Comparator
Arm Description
This arm will only receive the CDS.
Arm Title
CDS plus practice facilitation
Arm Type
Active Comparator
Arm Description
This arm will receive the CDS and practice facilitation.
Intervention Type
Other
Intervention Name(s)
CDS Alone
Intervention Description
The practices in the 'CDS alone' arm will receive an updated CDS for HTN management.
Intervention Type
Other
Intervention Name(s)
CDS plus practice facilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
12-months
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
12-months
Title
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
Description
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.
Time Frame
12-months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Duncan Maru
Organizational Affiliation
NYC DOHMH
Official's Role
Study Director
Facility Information:
Facility Name
NYC Department of Health and Mental Hygiene
City
Queens
State/Province
New York
ZIP/Postal Code
11101
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Practice Facilitation to Scale up a CDS for Hypertension Management
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