Heart Health NOW (Previously Known as FAST PACE NC) (HHN)

University of North Carolina (UNC)

Status: Completed

Conditions: Cardiovascular Disease

Treatments: Other: Primary Care Practice Support

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02585557

15-0479

1R18HS023912-01 (U.S. AHRQ Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 245 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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245 participants in 5 patient groups

Cluster A

Experimental group

Description:

50 practices randomly assigned to start intervention at month 9. Assigned Intervention: Primary Care Practice Support. The intervention consists of practice facilitation, academic detailing, and regional learning collaboratives.

Treatment:

Other: Primary Care Practice Support

Cluster B

Experimental group

Description:

50 practices randomly assigned to start intervention at month 11. Assigned Intervention: Primary Care Practice Support. The intervention consists of practice facilitation, academic detailing, and regional learning collaboratives.

Treatment:

Other: Primary Care Practice Support

Cluster C

Experimental group

Description:

50 practices randomly assigned to start intervention at month 12. Assigned Intervention: Primary Care Practice Support. The intervention consists of practice facilitation, academic detailing, and regional learning collaboratives.

Treatment:

Other: Primary Care Practice Support

Cluster D

Experimental group

Description:

50 practices randomly assigned to start intervention at month 14. Assigned Intervention: Primary Care Practice Support. The intervention consists of practice facilitation, academic detailing, and regional learning collaboratives.

Treatment:

Other: Primary Care Practice Support

Cluster E

Experimental group

Description:

50 practices randomly assigned to start intervention at month 16. Assigned Intervention: Primary Care Practice Support. The intervention consists of practice facilitation, academic detailing, and regional learning collaboratives.

Treatment:

Other: Primary Care Practice Support