The Northwest Coalition for Primary Care Practice Support (H2N)
Primary Purpose
Cardiovascular Disease, Essential Hypertension, Nicotine Dependence
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Coaching
Educational Outreach
Site Visits
Sponsored by
About this trial
This is an interventional health services research trial for Cardiovascular Disease
Eligibility 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
Sites / Locations
- GroupHealthCoop
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Coaching
Educational Outreach
Site Visit
Educational Outreach and Site Visit
Arm Description
External facilitation by a practice coach for 15 months
Academic detailing phone calls to support implementation of a cardiovascular risk calculator/estimator in each clinic
Site visits made by practices to 'exemplar" practices to learn innovative approaches to quality improvement
In this arm of the study, practices will be offered both educational outreach and an opportunity for a site visit
Outcomes
Primary Outcome Measures
Appropriate use of Aspirin
National Quality Forum (NQF) 0068 Ischemic Vascular Disease (IVD): Use of Aspirin or another Antithrombotic
Hypertension
NQF 0018 Controlling hypertension
Smoking
NQF 0027 Smoking and Tobacco Use Cessation, Medical Assistance
Secondary Outcome Measures
Change Process Capacity
The change process capacity questionnaire
Quality Improvement Capacity Assessment
Practice-level consensus agreement on QI capacity
Full Information
NCT ID
NCT02839382
First Posted
July 18, 2016
Last Updated
September 12, 2019
Sponsor
Kaiser Permanente
Collaborators
University of Washington, Oregon Health and Science University, Qualis Health
1. Study Identification
Unique Protocol Identification Number
NCT02839382
Brief Title
The Northwest Coalition for Primary Care Practice Support
Acronym
H2N
Official Title
The Northwest Coalition for Primary Care Practice Support
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
May 1, 2015 (Actual)
Primary Completion Date
May 1, 2018 (Actual)
Study Completion Date
May 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
Collaborators
University of Washington, Oregon Health and Science University, Qualis Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Disease, Essential Hypertension, Nicotine Dependence, Hyperlipidemia
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
209 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Coaching
Arm Type
Active Comparator
Arm Description
External facilitation by a practice coach for 15 months
Arm Title
Educational Outreach
Arm Type
Active Comparator
Arm Description
Academic detailing phone calls to support implementation of a cardiovascular risk calculator/estimator in each clinic
Arm Title
Site Visit
Arm Type
Active Comparator
Arm Description
Site visits made by practices to 'exemplar" practices to learn innovative approaches to quality improvement
Arm Title
Educational Outreach and Site Visit
Arm Type
Active Comparator
Arm Description
In this arm of the study, practices will be offered both educational outreach and an opportunity for a site visit
Intervention Type
Other
Intervention Name(s)
Coaching
Other Intervention Name(s)
Practice Facilitation
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Educational Outreach
Other Intervention Name(s)
Academic Detailing
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Site Visits
Other Intervention Name(s)
Peer-to-peer learning
Intervention Description
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.
Primary Outcome Measure Information:
Title
Appropriate use of Aspirin
Description
National Quality Forum (NQF) 0068 Ischemic Vascular Disease (IVD): Use of Aspirin or another Antithrombotic
Time Frame
Every 3 months with 12 month look-back
Title
Hypertension
Description
NQF 0018 Controlling hypertension
Time Frame
Every 3 months with 12 month look-back
Title
Smoking
Description
NQF 0027 Smoking and Tobacco Use Cessation, Medical Assistance
Time Frame
Every 3 months with 12 month look-back
Secondary Outcome Measure Information:
Title
Change Process Capacity
Description
The change process capacity questionnaire
Time Frame
Baseline, 15 months, 21 months
Title
Quality Improvement Capacity Assessment
Description
Practice-level consensus agreement on QI capacity
Time Frame
Baseline and 12 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael L Parchman, MD
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
Facility Information:
Facility Name
GroupHealthCoop
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
27737719
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 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.
Results Reference
background
PubMed Identifier
29632229
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.
Results Reference
background
PubMed Identifier
30346338
Citation
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.
Results Reference
background
PubMed Identifier
33279368
Citation
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.
Results Reference
derived
PubMed Identifier
32675274
Citation
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.
Results Reference
derived
PubMed Identifier
31345167
Citation
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.
Results Reference
derived
Learn more about this trial
The Northwest Coalition for Primary Care Practice Support
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