NCT02515578

Brief Summary

Heart disease and strokes cause one in three deaths reported each year in the United States. Primary care practices need to implement new research findings that help decrease patients' risk for heart disease and stroke. This project will help to build primary care practice capacity for quality improvement and change management in small and medium size primary care practices in Colorado and New Mexico. This project will also help practices implement patient-centered outcomes research findings.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5,508

participants targeted

Target at P75+ for not_applicable cardiovascular-diseases

Timeline
Completed

Started Oct 2015

Typical duration for not_applicable cardiovascular-diseases

Geographic Reach
1 country

1 active site

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

July 15, 2015

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 5, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2018

Completed
Last Updated

January 25, 2021

Status Verified

January 1, 2021

Enrollment Period

2.8 years

First QC Date

July 15, 2015

Last Update Submit

January 22, 2021

Conditions

Keywords

Primary Health CareCardiovascular DiseasesQuality Improvement

Outcome Measures

Primary Outcomes (6)

  • Change of documentation of aspirin therapy in patients with ischemic vascular disease.

    The percent of patients aged 18 years and older with Ischemic Vascular Disease (IVD) with documented use of aspirin or other antithrombotic. This is a practice-level indicator of documentation of care processes for cardiovascular disease.

    Baseline, 3, 6, 9, 12, and 15 months from baseline

  • Change of documentation of blood pressure in patients with a diagnosis of hypertension.

    The percent of patients aged 18 - 85 who had a diagnosis of hypertension (HTN) and whose blood pressure (BP) was adequately controlled (\<140/90) during the measurement year. This is a practice-level indicator of documentation of care processes for cardiovascular disease.

    Baseline, 3, 6, 9, 12, and 15 months from baseline

  • Change of documentation of blood pressure in patients with adequately controlled blood pressure.

    The percent of patients aged 18 - 85 who had a diagnosis of hypertension (HTN) and whose blood pressure (BP) was adequately controlled (age 18-59 and/or people with diabetes or chronic kidney disease \<140/90; age 60-85 \<150/90) during the measurement year. This is a practice-level indicator of documentation of care processes for cardiovascular disease.

    Baseline, 3, 6, 9, 12, and 15 months from baseline

  • Change of documentation of fasting LDL in patients with a fasting LDL at or below the LDL goal.

    The percent of patients aged 20 - 79 who had a fasting LDL test performed and whose risk-stratified fasting LDL is at or below the recommended LDL goal. This is a practice-level indicator of documentation of care processes for cardiovascular disease.

    Baseline, 3, 6, 9, 12, and 15 months from baseline

  • Change of documentation of patients who had a fasting LDL test performed and prescribed a statin based on risk.

    The percent of patients aged 20 - 79 who had a fasting LDL test performed and who are prescribed a recommended dose of statin based on risk status if indicated. This is a practice-level indicator of documentation of care processes for cardiovascular disease.

    Baseline, 3, 6, 9, 12, and 15 months from baseline

  • Change of documentation of patients screened about tobacco use.

    The percent of patients aged 18 years or older screened about tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user. This is a practice-level indicator of documentation of care processes for cardiovascular disease.

    Baseline, 3, 6, 9, 12, and 15 months from baseline

Secondary Outcomes (1)

  • Change of the documentation in primary care practice's.

    Baseline, 9 and 15 months from baseline

Study Arms (2)

Standard practice transformation support

ACTIVE COMPARATOR

Primary care practices will receive a cardiovascular care toolkit, practice facilitation, practice assessment with feedback, health information technology assistance, academic detailing, and periodic collaborative learning sessions

Other: Standard practice transformation support

Enhanced practice transformation support

EXPERIMENTAL

Primary care practices will receive practice facilitation, practice assessment with feedback, health information technology assistance, academic detailing, and periodic collaborative learning sessions PLUS patient advisory council support and a modified cardiovascular care toolkit based on combined practice and patient input regarding the local context.

Other: Enhanced practice transformation support

Interventions

Enhanced practice transformation support
Standard practice transformation support

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must be staff or clinicians (including physicians, nurse practitioners, and physician assistants) in an enrolled primary care practice
  • Primary care practices must be family medicine or general internal medicine practices with a maximum of ten lead clinicians
  • Primary care practices must be either independent or, if part of a larger organization, demonstrate on careful screening that they do not receive significant quality improvement support from the larger organization

You may not qualify if:

  • Primary care practices with more than 10 lead clinicians
  • Non-independent primary care practices that receive significant quality improvement support from their system or organization
  • Clinicians and staff who do not speak or read English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado, Denver

Denver, Colorado, United States

Location

Related Publications (3)

  • Zittleman L, Westfall JM, Callen D, Herrick AM, Nkouaga C, Simpson M, Dickinson LM, Fernald D, Kaufman A, English AF, Dickinson WP, Nease DE Jr. Does engagement matter? The impact of patient and community engagement on implementation of cardiovascular health materials in primary care settings. BMC Prim Care. 2024 Apr 25;25(1):135. doi: 10.1186/s12875-024-02365-w.

  • Fernald DH, Mullen R, Hall T, Bienstock A, Kirchner S, Knierim K, de la Cerda D, Callan D, Rhyne RL, Dickinson LM, Dickinson WP. Exemplary Practices in Cardiovascular Care: Results on Clinical Quality Measures from the EvidenceNOW Southwest Cooperative. J Gen Intern Med. 2020 Nov;35(11):3197-3204. doi: 10.1007/s11606-020-06094-5. Epub 2020 Aug 17.

  • English AF, Dickinson LM, Zittleman L, Nease DE Jr, Herrick A, Westfall JM, Simpson MJ, Fernald DH, Rhyne RL, Dickinson WP. A Community Engagement Method to Design Patient Engagement Materials for Cardiovascular Health. Ann Fam Med. 2018 Apr;16(Suppl 1):S58-S64. doi: 10.1370/afm.2173.

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • W. Perry Dickinson, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 15, 2015

First Posted

August 5, 2015

Study Start

October 1, 2015

Primary Completion

July 31, 2018

Study Completion

July 31, 2018

Last Updated

January 25, 2021

Record last verified: 2021-01

Locations