Clinical trial NCT02585557: Heart Health NOW (Previously Known as FAST PACE NC)
Official title: Heart Health NOW (Previously Known as Facilitation, Spread, and Translation of Patient-Centered Evidence in North Carolina Practices)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2015-10-23
Enrollment: 245
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The objective of this study is to determine if primary care practice support accelerates the dissemination and implementation of patient-centered outcome results (PCOR) findings to improve heart health and increases primary care practices' capacity to incorporate other PCOR findings in the future.

Detailed description: The burden of cardiovascular disease in North Carolina remains large. The latest data available show an annual cardiovascular death rate of 263 per 100,000 explaining almost one-third of deaths in the state. Disease progression is largely determined by several risk factors including elevated blood pressure or cholesterol, not using aspirin for prevention, and tobacco use. Primary care practices as currently organized have been unable to get more than half these patients to achieve recommended targets for risk factor reduction. Small independent practices, in particular, lack resources for enhanced practice support to improve cardiovascular care.

This study will enroll 300 primary care practices to evaluate the effect of primary care support on evidence-based cardiovascular disease (CVD) prevention and organizational change process measures. Each practice will start the trial as a control, receive the intervention at a randomized time point, and then enter a maintenance period 12 months after starting the intervention. All practices will receive 12 months of the intense intervention including onsite quality improvement (QI) facilitation, academic detailing, electronic health record (EHR) support, and, through the North Carolina Health Information Exchange (HIE), a shared statewide utility providing whole population analytics, care gap identification, benchmarking, and an external reporting mechanism which otherwise would not be available to independent practices.

A successful intervention would prove that practice facilitation supported by effective informatics tools is an effective method of translating PCOR findings into practice. Discernible reductions in cardiovascular risk in 300 practices covering over an estimated 900,000 adult patients would likely lead to prevention of thousands of cardiovascular events within 10 years.

Eligibility criteria: Inclusion Criteria:

* Primary care practice in North Carolina with 10 or fewer providers in a single location
* must have implemented an EHR and either be connected to or have agreed to connect to the HIE.

Exclusion Criteria:

* practices with more than 10 providers in a single location
* practices receiving practice facilitation services beyond the usual support provided by Area Health Education Centers (AHEC) or the Community Care of North Carolina (CCNC) program through their parent organization.
* practices without an EHR
* practices where the central practice organization either bars the practice from our program or provides onsite facilitation services equal to or greater than the 4-6 hour standard contact with a QI coach

Primary outcomes:
measure: Measurable reduction in arteriosclerotic cardiovascular disease (ASCVD) risk
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: UNC Chapel Hill
name: Sam Cykert, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weiner BJ, Pignone MP, DuBard CA, Lefebvre A, Suttie JL, Freburger JK, Cykert S. Advancing heart health in North Carolina primary care: the Heart Health NOW study protocol. Implement Sci. 2015 Nov 14;10:160. doi: 10.1186/s13012-015-0348-4.