Practice Facilitation to Scale up a CDS for Hypertension Management

NCT ID: NCT05588466

Last Updated: 2025-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-09
• Study Completion Date: 2024-09-30

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

CDS alone

This arm will only receive the CDS.

Group Type: ACTIVE_COMPARATOR

CDS Alone

Intervention Type: OTHER

The practices in the 'CDS alone' arm will receive an updated CDS for HTN management.

CDS plus practice facilitation

This arm will receive the CDS and practice facilitation.

Group Type: ACTIVE_COMPARATOR

CDS plus practice facilitation

Intervention Type: OTHER

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.

Interventions

CDS Alone

The practices in the 'CDS alone' arm will receive an updated CDS for HTN management.

Intervention Type: OTHER

CDS plus 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role: collaborator

NYU

UNKNOWN

Sponsor Role: collaborator

New York City Department of Health and Mental Hygiene

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Duncan Maru

Role: STUDY_DIRECTOR

NYC DOHMH

Locations

NYC Department of Health and Mental Hygiene

Queens, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37037392 (View on PubMed)

Other Identifiers

21-020

Identifier Type: -

Identifier Source: org_study_id