Cardiovascular DiseaseH2NNCT02839382
The Northwest Coalition for Primary Care Practice Support
A study testing Coaching, Educational Outreach and Site Visits in people with Cardiovascular Disease and Essential Hypertension, run by Kaiser Permanente at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Disease, Essential Hypertension, Nicotine Dependence
- What is being tested?
- Coaching, Educational Outreach and Site Visits
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 209 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2015to 1 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Primary care practice with 10 or fewer providers and an Electronic Health Record (EHR) that meets Stage 1 meaningful use criteria
Who cannot join
- No EHR
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Coaching, Educational Outreach, Site Visits
- Medical subject headings
- Cardiovascular Diseases, Essential Hypertension, Tobacco Use Disorder, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoachingOther
Also called Practice Facilitation
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 OutreachOther
Also called Academic Detailing
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 VisitsOther
Also called Peer-to-peer learning
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.
| Study group | Role | What they receive |
|---|---|---|
| Coaching | Active comparator | External facilitation by a practice coach for 15 months Receives: Other: Coaching |
| Educational Outreach | Active comparator | Academic detailing phone calls to support implementation of a cardiovascular risk calculator/estimator in each clinic Receives: Other: Coaching; Other: Educational Outreach |
| Site Visit | Active comparator | Site visits made by practices to 'exemplar" practices to learn innovative approaches to quality improvement Receives: Other: Coaching; Other: 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 Receives: Other: Coaching; Other: Educational Outreach; Other: Site Visits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appropriate use of Aspirin
National Quality Forum (NQF) 0068 Ischemic Vascular Disease (IVD): Use of Aspirin or another Antithrombotic
Measured: Every 3 months with 12 month look-back
Hypertension
NQF 0018 Controlling hypertension
Measured: Every 3 months with 12 month look-back
Smoking
NQF 0027 Smoking and Tobacco Use Cessation, Medical Assistance
Measured: Every 3 months with 12 month look-back
Secondary outcomes (2)
Change Process Capacity
The change process capacity questionnaire
Measured: Baseline, 15 months, 21 months
Quality Improvement Capacity Assessment
Practice-level consensus agreement on QI capacity
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study start1 May 2015
- Primary completion1 May 2018
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington, Oregon Health and Science University, Qualis Health
- Responsible party
- Sponsor
- Investigators
- Michael L Parchman, MD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02839382
- Sponsor's protocol ID
- AHRQ 1R8HS023908-01
- Acronym
- H2N
- Status last verified
- Sep 2019
- First submitted
- 18 Jul 2016
- Last updated
- 16 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 27737719Fagnan 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.
PubMed 29632229Baldwin 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.
PubMed 30346338Tuzzio 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.
PubMed 33279368Parchman 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.
PubMed 32675274Parchman 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.
PubMed 31345167
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Northwest Coalition for Primary Care Practice Support
- ClinicalTrials.gov ID
- NCT02839382
- Acronym / sponsor ID
- H2N / AHRQ 1R8HS023908-01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- University of Washington, Oregon Health and Science University, Qualis Health
- Study start
- 1 May 2015 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 21 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Coaching | Active comparator | Other: CoachingExternal facilitation by a practice coach for 15 months |
| Educational Outreach | Active comparator | Other: Coaching, Other: Educational OutreachAcademic detailing phone calls to support implementation of a cardiovascular risk calculator/estimator in each clinic |
| Site Visit | Active comparator | Other: Coaching, Other: Site VisitsSite visits made by practices to 'exemplar" practices to learn innovative approaches to quality improvement |
| Educational Outreach and Site Visit | Active comparator | Other: Coaching, Other: Educational Outreach, Other: Site VisitsIn this arm of the study, practices will be offered both educational outreach and an opportunity for a site visit |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Primary care practice with 10 or fewer providers and an Electronic Health Record (EHR) that meets Stage 1 meaningful use criteria
Key exclusion criteria (1 listed)
- No EHR
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CoachingAlso: Practice FacilitationAn 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 | Coaching, Educational Outreach, Educational Outreach and Site Visit, Site Visit |
| Educational OutreachAlso: Academic DetailingPractices 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 | Educational Outreach, Educational Outreach and Site Visit |
| Site VisitsAlso: Peer-to-peer learningPractices 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 | Educational Outreach and Site Visit, Site Visit |
Primary outcome
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
Hypertension
Time frame: Every 3 months with 12 month look-back
NQF 0018 Controlling hypertension
Smoking
Time frame: Every 3 months with 12 month look-back
NQF 0027 Smoking and Tobacco Use Cessation, Medical Assistance
2 secondary outcomes
Change Process Capacity
Time frame: Baseline, 15 months, 21 months
Quality Improvement Capacity Assessment
Time frame: Baseline and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2019.
- Background: PubMed 27737719Parchman 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.
- Background: PubMed 29632229Fagnan 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.
- Background: PubMed 30346338Baldwin 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.
- Derived from this study: PubMed 33279368Tuzzio 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.
- Derived from this study: PubMed 32675274Parchman 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.
- Derived from this study: PubMed 31345167Parchman 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael L Parchman, MD principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coaching, Educational Outreach and Site Visits in people with Cardiovascular Disease and Essential Hypertension, run by Kaiser Permanente at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Appropriate use of Aspirin (time frame: Every 3 months with 12 month look-back). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02839382, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2019.