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The Northwest Coalition for Primary Care Practice Support (H2N)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02839382
Recruitment Status : Completed
First Posted : July 21, 2016
Last Update Posted : September 16, 2019
Sponsor:
Collaborators:
University of Washington
Oregon Health and Science University
Qualis Health
Information provided by (Responsible Party):
Kaiser Permanente

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Essential Hypertension Nicotine Dependence Hyperlipidemia Other: Coaching Other: Educational Outreach Other: Site Visits Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 209 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: The Northwest Coalition for Primary Care Practice Support
Actual Study Start Date : May 1, 2015
Actual Primary Completion Date : May 1, 2018
Actual Study Completion Date : May 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Coaching
External facilitation by a practice coach for 15 months
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
Other Name: Practice Facilitation

Active Comparator: Educational Outreach
Academic detailing phone calls to support implementation of a cardiovascular risk calculator/estimator in each clinic
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
Other Name: Practice Facilitation

Other: 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
Other Name: Academic Detailing

Active Comparator: Site Visit
Site visits made by practices to 'exemplar" practices to learn innovative approaches to quality improvement
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
Other Name: Practice Facilitation

Other: 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.
Other Name: Peer-to-peer learning

Active Comparator: Educational Outreach and Site Visit
In this arm of the study, practices will be offered both educational outreach and an opportunity for a site visit
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
Other Name: Practice Facilitation

Other: 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
Other Name: Academic Detailing

Other: 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.
Other Name: Peer-to-peer learning




Primary Outcome Measures :
  1. Appropriate use of Aspirin [ Time Frame: Every 3 months with 12 month look-back ]
    National Quality Forum (NQF) 0068 Ischemic Vascular Disease (IVD): Use of Aspirin or another Antithrombotic

  2. Hypertension [ Time Frame: Every 3 months with 12 month look-back ]
    NQF 0018 Controlling hypertension

  3. Smoking [ Time Frame: Every 3 months with 12 month look-back ]
    NQF 0027 Smoking and Tobacco Use Cessation, Medical Assistance


Secondary Outcome Measures :
  1. Change Process Capacity [ Time Frame: Baseline, 15 months, 21 months ]
    The change process capacity questionnaire

  2. Quality Improvement Capacity Assessment [ Time Frame: Baseline and 12 months ]
    Practice-level consensus agreement on QI capacity



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02839382


Locations
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United States, Washington
GroupHealthCoop
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Kaiser Permanente
University of Washington
Oregon Health and Science University
Qualis Health
Investigators
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Principal Investigator: Michael L Parchman, MD Kaiser Permanente
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT02839382    
Other Study ID Numbers: AHRQ 1R8HS023908-01
First Posted: July 21, 2016    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Essential Hypertension
Hyperlipidemias
Tobacco Use Disorder
Cardiovascular Diseases
Hypertension
Vascular Diseases
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders