NCT02585557

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
245

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2015

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 23, 2015

Completed
9 days until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

February 6, 2020

Status Verified

February 1, 2020

Enrollment Period

4.2 years

First QC Date

October 21, 2015

Last Update Submit

February 4, 2020

Conditions

Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

  • Measurable reduction in arteriosclerotic cardiovascular disease (ASCVD) risk

    By comparing EHR data at baseline and post-intervention, determine whether practice support resulted in discernible reduction in CVD risk.

    18 months

Study Arms (5)

Cluster A

EXPERIMENTAL

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.

Other: Primary Care Practice Support

Cluster B

EXPERIMENTAL

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.

Other: Primary Care Practice Support

Cluster C

EXPERIMENTAL

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.

Other: Primary Care Practice Support

Cluster D

EXPERIMENTAL

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.

Other: Primary Care Practice Support

Cluster E

EXPERIMENTAL

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.

Other: Primary Care Practice Support

Interventions

Primary Care Practice SupportOTHER

The intervention consists of practice facilitation, academic detailing, and regional learning collaboratives.

Cluster ACluster BCluster CCluster DCluster E

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 26577091DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Sam Cykert, MD

    UNC Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2015

First Posted

October 23, 2015

Study Start

November 1, 2015

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

February 6, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Will share data on practice improvement. Practices receive data relevant to reducing their patients cardiovascular risk. The practice then receives advice on practice redesign and population management to improve, standard, clinical, chronic care measures. There is no experimental, direct patient intervention.