NCT02839382

Brief Summary

The purpose of this project is to build capacity for quality improvement (QI) in small primary care practices across Washington, Oregon and Idaho by improving risk factors for heart attacks such as blood pressure, cholesterol and smoking. The Northwest Coalition for Primary Care Practice Support will assist practices by providing them with a QI coach, creating group learning opportunities, and conducting educational outreach activities. An innovative study design will be used to determine what levels and types of support are most helpful and effective.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
209

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2015

Typical duration for not_applicable

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

Study Start

First participant enrolled

May 1, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 18, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 21, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

September 16, 2019

Status Verified

September 1, 2019

Enrollment Period

3 years

First QC Date

July 18, 2016

Last Update Submit

September 12, 2019

Conditions

Outcome Measures

Primary Outcomes (3)

  • Appropriate use of Aspirin

    National Quality Forum (NQF) 0068 Ischemic Vascular Disease (IVD): Use of Aspirin or another Antithrombotic

    Every 3 months with 12 month look-back

  • Hypertension

    NQF 0018 Controlling hypertension

    Every 3 months with 12 month look-back

  • Smoking

    NQF 0027 Smoking and Tobacco Use Cessation, Medical Assistance

    Every 3 months with 12 month look-back

Secondary Outcomes (2)

  • Change Process Capacity

    Baseline, 15 months, 21 months

  • Quality Improvement Capacity Assessment

    Baseline and 12 months

Study Arms (4)

Coaching

ACTIVE COMPARATOR

External facilitation by a practice coach for 15 months

Other: Coaching

Educational Outreach

ACTIVE COMPARATOR

Academic detailing phone calls to support implementation of a cardiovascular risk calculator/estimator in each clinic

Other: CoachingOther: Educational Outreach

Site Visit

ACTIVE COMPARATOR

Site visits made by practices to 'exemplar" practices to learn innovative approaches to quality improvement

Other: CoachingOther: Site Visits

Educational Outreach and Site Visit

ACTIVE COMPARATOR

In this arm of the study, practices will be offered both educational outreach and an opportunity for a site visit

Other: CoachingOther: Educational OutreachOther: Site Visits

Interventions

An external facilitator or coach is assigned 15-20 primary care clinics and will make face-to-face site visits and monthly phone calls for 15 months to support building QI capacity in each assigned practcie

Also known as: Practice Facilitation
CoachingEducational OutreachEducational Outreach and Site VisitSite Visit

Practices randomized to this arm of the study will receive an educational outreach phone call by an academic expert on implementation strategies for use of a cardiovascular risk calculator within their daily work flow and clinic setting

Also known as: Academic Detailing
Educational OutreachEducational Outreach and Site Visit

Practices randomized to this arm of the study will be given an opportunity to make a site visit to an "exemplar" practice to learn about innovative approaches to conducting quality improvement activities.

Also known as: Peer-to-peer learning
Educational Outreach and Site VisitSite Visit

Eligibility Criteria

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

You may qualify if:

  • Primary care practice with 10 or fewer providers and an Electronic Health Record (EHR) that meets Stage 1 meaningful use criteria

You may not qualify if:

  • No EHR

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GroupHealthCoop

Seattle, Washington, 98101, United States

Location

Related Publications (6)

  • Parchman ML, Fagnan LJ, Dorr DA, Evans P, Cook AJ, Penfold RB, Hsu C, Cheadle A, Baldwin LM, Tuzzio L. Study protocol for "Healthy Hearts Northwest": a 2 x 2 randomized factorial trial to build quality improvement capacity in primary care. Implement Sci. 2016 Oct 13;11(1):138. doi: 10.1186/s13012-016-0502-7.

    PMID: 27737719BACKGROUND
  • Fagnan LJ, Walunas TL, Parchman ML, Dickinson CL, Murphy KM, Howell R, Jackson KL, Madden MB, Ciesla JR, Mazurek KD, Kho AN, Solberg LI. Engaging Primary Care Practices in Studies of Improvement: Did You Budget Enough for Practice Recruitment? Ann Fam Med. 2018 Apr;16(Suppl 1):S72-S79. doi: 10.1370/afm.2199.

    PMID: 29632229BACKGROUND
  • Baldwin LM, Fischer MA, Powell J, Holden E, Tuzzio L, Fagnan LJ, Hummel J, Parchman ML. Virtual Educational Outreach Intervention in Primary Care Based on the Principles of Academic Detailing. J Contin Educ Health Prof. 2018 Fall;38(4):269-275. doi: 10.1097/CEH.0000000000000224. No abstract available.

    PMID: 30346338BACKGROUND
  • Tuzzio L, O'Meara ES, Holden E, Parchman ML, Ralston JD, Powell JA, Baldwin LM. Barriers to Implementing Cardiovascular Risk Calculation in Primary Care: Alignment With the Consolidated Framework for Implementation Research. Am J Prev Med. 2021 Feb;60(2):250-257. doi: 10.1016/j.amepre.2020.07.027. Epub 2020 Dec 3.

  • Parchman ML, Anderson ML, Penfold RB, Kuo E, Dorr DA. The Ability of Practices to Report Clinical Quality Measures: More Evidence of the Size Paradox? J Am Board Fam Med. 2020 Jul-Aug;33(4):620-625. doi: 10.3122/jabfm.2020.04.190369.

  • Parchman ML, Anderson ML, Coleman K, Michaels LA, Schuttner L, Conway C, Hsu C, Fagnan LJ. Assessing quality improvement capacity in primary care practices. BMC Fam Pract. 2019 Jul 25;20(1):103. doi: 10.1186/s12875-019-1000-1.

MeSH Terms

Conditions

Cardiovascular DiseasesEssential HypertensionTobacco Use DisorderHyperlipidemias

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesSubstance-Related DisordersChemically-Induced DisordersMental DisordersDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Michael L Parchman, MD

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2016

First Posted

July 21, 2016

Study Start

May 1, 2015

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

September 16, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will share

Locations