Practice Facilitation to Scale up a CDS for Hypertension Management

NCT05588466 | Completed

• 1 other identifier: 21-020
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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

Conditions

Hypertension

Keywords

Clinical Decision Support System; Practice Facilitation; Small Independent Practices

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  12-months

Study Arms (2)

CDS alone

ACTIVE COMPARATOR

This arm will only receive the CDS.

Other: CDS Alone

CDS plus practice facilitation

ACTIVE COMPARATOR

This arm will receive the CDS and practice facilitation.

Other: CDS plus practice facilitation

Interventions

CDS Alone OTHER

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

CDS alone

CDS plus practice facilitation 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.

CDS plus practice facilitation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• not pregnant
• not have end-stage kidney disease as defined by an ICD-10 code for dialysis or transplantation

Sponsors & Collaborators

• New York City Department of Health and Mental Hygiene: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator
• NYU: collaborator

Study Sites (1)

NYC Department of Health and Mental Hygiene

Queens, New York, 11101, United States

Location

Related Publications (1)

• 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.

  PMID: 37037392 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Compact Disks

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Videodisc Recording; Optical Storage Devices; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television

Study Officials

• Duncan Maru

  NYC DOHMH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2022
• First Posted: October 20, 2022
• Study Start: June 9, 2021
• Primary Completion: August 30, 2024
• Study Completion: September 30, 2024
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will be available from 4/1/2022 through 10/1/2026.
• 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.

Locations

US (1)