Creating change through short-term pilots and rapid cycle testing: a case of cardiovascular risk reduction

Q: What is the clinical evidence from this study?

Population: Atherosclerotic cardiovascular disease (ASCVD) risk (n=75149). Intervention: ASCVD Risk Reduction Initiative. Primary outcome: Systolic BP and LDL-C at 6 months post randomisation (for the planned effectiveness trial).

Q: What does this research mean for the field?

Combining randomized controlled trials, quality improvement, and iterative rapid cycle testing within a learning health system facilitates the development and scaling of cardiovascular risk reduction programs. Novelty: ClaimNovelty.METHODOLOGICAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

Laura Ellen Ashcraft; Katy Mahraj; Laurie A Norton; Marguerite Balasta; Kayla Clark; Karen Glanz; John Wood; Wendell Kellum; Carolina Garzon Mrad; Jordan Sigler; Yaphet Getachew; Alexander C Fanaroff; Shivan J Mehta; David A Asch; Kevin G Volpp

doi:10.1136/bmjoq-2025-004001

July 1, 2026BMJ Open QualityOpen Access

Creating change through short-term pilots and rapid cycle testing: a case of cardiovascular risk reduction

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Key result

ASCVD Risk Reduction Initiative builds a scalable cardiovascular risk program using trials and quality improvement.

n=75,149

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Why the study?

Despite effective and low-cost diagnosis and treatment options, scalable evidence-based strategies have not achieved optimal cardiovascular risk reduction.

Key Points

To describe the first three years of an academic health system initiative developing, testing, and scaling a care delivery innovation to reduce atherosclerotic cardiovascular disease risk.
Evaluated a four-phase learning health system model integrating quality improvement, iterative rapid cycle testing, human-centered design, and randomized trial methodologies.
Identified a baseline cohort of 133,070 primary care patients with elevated atherosclerotic cardiovascular disease risk and at least two elevated blood pressure measurements in the prior year.
Conducted multiple short-term parallel pilot studies testing blood pressure monitoring, statin prescribing, electronic health record workflows, and multidisciplinary staffing structures.
Interventions that increased clinician burden through visit nudges, peer comparison feedback, or default return visit schedules demonstrated lower clinician acceptability and reduced effectiveness.
Strategies providing virtual, asynchronous patient support and utilizing navigators alongside nurse practitioners proved more acceptable and effective than models relying solely on primary care physicians.
Implementation required navigating disparate electronic health record systems across sites, dual research-clinical staff documentation roles, and long-term economic reimbursement pathways.

Structured PICO

P

Population

A health system initiative involving 75,149 patients across multiple pilot studies to develop and evaluate innovative care models for atherosclerotic cardiovascular disease risk reduction.

I

Intervention

ASCVD Risk Reduction Initiative, utilizing quality improvement, rapid cycle testing, and human-centered design to develop the Penn Medicine Healthy Heart (PMHH) program (a 6-month text message-based program with remote monitoring for BP and cholesterol management).

O

Outcome

Systolic BP and LDL-C at 6 months post-randomization (for the planned PMHH effectiveness trial)surrogate

Combining traditional research methods, quality improvement, rapid cycle testing, and human-centered design can successfully develop and scale innovative cardiovascular risk reduction programs in a learning health system.

Limitations

Significant investment required in research operations, clinician socialization, and staff training
Separate EHRs between multiple sites and differences in workflows
Cross-use of staff in research and clinical tasks necessitated documenting in multiple systems
Inability to compare directly across pilot studies due to differences in eligibility, measures, and design
Challenges obtaining exit interviews with a fully representative sample of patients
Significant investment in research operations, clinician socialization, and staff training limits potential generalizability to healthcare settings without such infrastructure
Separate EHRs between multiple sites and differences in hiring, credentialing, research billing, and referral workflows
Navigators and nurse practitioners were cross-used in research and clinical tasks, necessitating documentation in multiple systems
Ability to compare directly across pilot studies was limited by differences in eligibility criteria, study measures, and intervention design
Challenges with obtaining exit interviews with a fully representative sample of patients

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Implication

Supports testing of integrated ASCVD programs; leaves open real-world effectiveness before practice adoption.

Abstract

Despite the availability of safe, effective and low-cost diagnosis and treatment options for atherosclerotic cardiovascular disease (ASCVD) and a significant decrease in death rates in the past several decades, ASCVD remains the leading cause of morbidity and mortality in the USA. Scalable, evidence-based strategies have not achieved a level of success that optimally lowers cardiovascular risk. In this case study, we describe the first three years of the ASCVD Risk Reduction Initiative at a large academic health system, an effort to develop, evaluate and scale a heart disease prevention programme for patients whose modifiable risk remains high despite having access to care. The Initiative models a learning health system, combining traditional randomised controlled trials with quality improvement projects, iterative rapid cycle testing, data analyses, incorporation of learnings from concurrent projects at other institutions and user research to test a variety of approaches to cardiovascular risk reduction. This approach could be generalised to other important population health improvement challenges. In this article, we detail our pilot study process, results to date and challenges experienced in this example of care delivery innovation in action.

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Cite This Study

Ashcraft et al. (2026) studied Atherosclerotic cardiovascular disease (ASCVD) risk (n=75,149). ASCVD Risk Reduction Initiative was evaluated on Systolic BP and LDL-C at 6 months post randomisation (for the planned effectiveness trial). The ASCVD Risk Reduction Initiative combined randomized trials, quality improvement, and rapid cycle testing to develop a scalable cardiovascular risk reduction program.

synapsesocial.com/papers/6a5b38f68167787360d24dcc https://doi.org/10.1136/bmjoq-2025-004001

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Creating change through short-term pilots and rapid cycle testing: a case of cardiovascular risk reduction

Figures

Key Points

Structured PICO

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

Creating change through short-term pilots and rapid cycle testing: a case of cardiovascular risk reduction

Figures

Key Points

Structured PICO

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

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