HypertensionNCT05588466
Practice Facilitation to Scale up a CDS for Hypertension Management
A study testing CDS Alone and CDS plus practice facilitation in people with Hypertension, run by New York City Department of Health and Mental Hygiene at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- CDS Alone and CDS plus practice facilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2021to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- not pregnant
- not have end-stage kidney disease as defined by an ICD-10 code for dialysis or transplantation
Trial locations and contacts
1 site in 1 country.
United States1 site
NYC Department of Health and Mental Hygiene
Queens, New York, 11101
About this study
Official title: 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
Read the 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.
- Conditions
- Hypertension
- Being tested
- CDS Alone, CDS plus practice facilitation
- Keywords
- Clinical Decision Support System, Practice Facilitation, Small Independent Practices
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDS AloneOther
The practices in the 'CDS alone' arm will receive an updated CDS for HTN management.
CDS plus practice facilitationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| CDS alone | Active comparator | This arm will only receive the CDS. Receives: Other: CDS Alone |
| CDS plus practice facilitation | Active comparator | This arm will receive the CDS and practice facilitation. Receives: Other: CDS plus practice facilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12-months
Secondary outcomes (2)
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.
Measured: 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
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.
Measured: 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start9 Jun 2021
- Primary completion30 Aug 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York City Department of Health and Mental Hygiene
- Sponsor type
- Other government
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), NYU
- Responsible party
- Sponsor
- Investigators
- Duncan Maru, Study director, NYC DOHMH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05588466
- Sponsor's protocol ID
- 21-020
- Status last verified
- May 2025
- First submitted
- 7 Apr 2022
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Blecker S, Gannon M, De Leon S, Shelley D, Wu WY, Tabaei B, Magno J, Pham-Singer H. Practice facilitation for scale up of clinical decision support for hypertension management: study protocol for a cluster randomized control trial. Contemp Clin Trials. 2023 Jun;129:107177. doi: 10.1016/j.cct.2023.107177. Epub 2023 Apr 8.
PubMed 37037392
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Use of Practice Facilitation to Optimize Scale up of CDS for Hypertension
- ClinicalTrials.gov ID
- NCT05588466
- Acronym / sponsor ID
- 21-020
- Conditions
- Hypertension
- Keywords
- Clinical Decision Support System, Practice Facilitation, Small Independent Practices
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- New York City Department of Health and Mental HygieneOther government
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), NYU
- Study start
- 9 Jun 2021 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 20 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CDS alone | Active comparator | Other: CDS AloneThis arm will only receive the CDS. |
| CDS plus practice facilitation | Active comparator | Other: CDS plus practice facilitationThis arm will receive the CDS and practice facilitation. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- not pregnant
- not have end-stage kidney disease as defined by an ICD-10 code for dialysis or transplantation
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 |
|---|---|---|
| CDS AloneThe practices in the 'CDS alone' arm will receive an updated CDS for HTN management. | Other | CDS alone |
| CDS plus practice facilitationThe 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. | Other | CDS plus practice facilitation |
Primary outcome
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.
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Derived from this study: PubMed 37037392Blecker S, Gannon M, De Leon S, Shelley D, Wu WY, Tabaei B, Magno J, Pham-Singer H. Practice facilitation for scale up of clinical decision support for hypertension management: study protocol for a cluster randomized control trial. Contemp Clin Trials. 2023 Jun;129:107177. doi: 10.1016/j.cct.2023.107177. Epub 2023 Apr 8.
- Individual participant dataSharing planned: Yes. 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.
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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.
Duncan Maru study director
NYC DOHMH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CDS Alone and CDS plus practice facilitation in people with Hypertension, run by New York City Department of Health and Mental Hygiene 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 3 inclusion and 2 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 22 May 2025. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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). 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 NCT05588466, which also lists 1 linked publication.
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 22 May 2025.