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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02839382
Other study ID # AHRQ 1R8HS023908-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2015
Est. completion date May 1, 2018

Study information

Verified date September 2019
Source Kaiser Permanente
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

The Northwest Coalition for Primary Care Practice Support will provide a comprehensive and robust external practice support infrastructure for small and medium primary care practices across Washington (WA), Oregon (OR) and Idaho (ID) to build their internal quality improvement (QI) capacity and improve performance on the heart health indicators of aspirin use, blood pressure and cholesterol control and smoking cessation (ABCS indicators) by disseminating and supporting the implementation of relevant Patient Centered Outcomes Research findings. This coalition of partners has a remarkable track record of collaboration and improving primary care practice: the MacColl Center for Health Care Innovation and the Center for Community Health Evaluation at Group Health Research Institute; Qualis Health, the Health IT Regional Extension Center (REC) and designated Quality Improvement Organization (QIO) for WA and ID; and the Oregon Rural Practice-based Research Network (ORPRN), along with state-level partners who are membership organizations for clinicians in small practice settings. Recruitment will leverage existing small practice relationships between Qualis Health as the health information technology (IT) REC for WA and ID and ORPRN's existing network of small practices with a goal of enrolling 320 small practices out of an estimated 1,479 with stage 1 meaningful use of their electronic health record across the three states. In addition to providing health IT support for the Physician Quality Reporting System (PQRS) to measure the ABCS indicators in all practices, our comprehensive approach to building QI capacity and improving the ABCS measures consists of: 1) practice facilitation as a unifying strategy, 2) academic detailing/outreach to support implementation of PCOR findings, and 3) shared learning collaboratives. We will employ an innovative study and evaluation design by providing two levels of support for each of the latter three practice support components. By randomly assigning practices to one of eight possible combinations of practice support, we will "…develop new evidence about the contribution of various components of the comprehensive approach and the effect of the intensity of the approach on outcomes." Our rigorous mixed-method evaluation is based on the RE-AIM framework and will employ multi-level models and interrupted time series regression. Data will be collected from a control group of practices to examine secular trends. Our Specific Aims are to: 1) Identify, recruit and conduct baseline assessments in 320 small to medium size primary care practices across the geographically contiguous region of WA, OR and ID; 2) Provide comprehensive external practice support to build QI capacity within these practices; 3) Disseminate and support the adoption of PCOR findings relevant to the ABCS quality measures; 4) Conduct a rigorous evaluation of the effectiveness of providing external practice support to implement PCOR findings and improve ABCS measures; and 5) Assess the sustainability of changes made in QI capacity and ABCS improvements and develop a model of dissemination and primary care practice support infrastructure.


Recruitment information / eligibility

Status Completed
Enrollment 209
Est. completion date May 1, 2018
Est. primary completion date May 1, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- No EHR

Study Design


Intervention

Other:
Coaching
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
Educational Outreach
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
Site Visits
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.

Locations

Country Name City State
United States GroupHealthCoop Seattle Washington

Sponsors (4)

Lead Sponsor Collaborator
Kaiser Permanente Oregon Health and Science University, Qualis Health, University of Washington

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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 × 2 randomized factorial trial to build quality improvement capacity in primary care. Implement Sci. 2016 Oct 13;11(1):138. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Hypertension NQF 0018 Controlling hypertension Every 3 months with 12 month look-back
Primary Smoking NQF 0027 Smoking and Tobacco Use Cessation, Medical Assistance Every 3 months with 12 month look-back
Secondary Change Process Capacity The change process capacity questionnaire Baseline, 15 months, 21 months
Secondary Quality Improvement Capacity Assessment Practice-level consensus agreement on QI capacity Baseline and 12 months
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