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Evaluating System Change to Advance Learning and Take Evidence to Scale (ESCALATES) (ESCALATES)

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: NCT02560428
Recruitment Status : Active, not recruiting
First Posted : September 25, 2015
Last Update Posted : September 28, 2021
Sponsor:
Collaborators:
University of Texas
Rutgers University
HealthPartners Institute
University of Michigan
Case Western Reserve University
Information provided by (Responsible Party):
Deborah Cohen, Oregon Health and Science University

Study Description
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Brief Summary:
The purpose of this study is to evaluate approximately eight grants that will test interventions to improve cardiovascular disease prevention. The investigators will collect and analyze qualitative data to identify the most effective combinations of intervention strategies. The investigators will observe grantees and selected practices to understand why and how those combinations are effective. The investigators will also gather data from the grantees to assess how effective the interventions are.

Condition or disease Intervention/treatment
Program Evaluation Behavioral: ESCALATES

Detailed Description:

The purpose of this study is to evaluate approximately eight different R18 grants that will test practice change interventions to improve cardiovascular disease (CVD) prevention screening. The investigators will collect and analyze quantitative data (context, process, and outcomes) to identify the most effective combinations of intervention strategies for various practice types in relation to practice structure, context, and organizational characteristics associated with change in outcomes. The investigators will collect qualitative data (observation, interviews, online diaries) from grantees and selected practices to understand why and how those combinations are effective. The investigators will also gather documents and de-identified quantitative data from grantees.

Evidence clearly shows that many people do not receive guideline-concordant health care; this is true even for low cost treatments such as Aspirin prescribing, Blood pressure and Cholesterol control and Smoking cessation (the ABCS) known to prevent cardiovascular disease (CVD). In hospitals and integrated care systems with substantial resources, large quality improvement campaigns have been shown to increase adherence to guidelines by creating communities of learning that change behavior on a large scale. Agency for Healthcare Research and Quality (AHRQ) and the Patient Centered Outcomes Research Institute (PCORI) are partnering to launch a campaign to promote the improvement of guideline-based CVD preventive care in small primary care practices with limited resources and experience with quality improvement ("Implementation" RFA-HS-14-008). The practices for each of these R18 grants will be in a contiguous geographic region. This study will evaluate each of these R18 implementation grants.

The investigators' strategy is to conduct a prospective observational analysis to evaluate the effectiveness of the R18s ABCS quality improvement initiatives. To do this, the investigators will collect and analyze qualitative data to identify the most effective combinations of intervention strategies for various practice types, contexts, and organizational characteristics, and to understand why and how those combinations are effective. The investigators will also gather de-identified quantitative data that the R18s collected.

Study Design
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Study Type : Observational
Actual Enrollment : 7 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Evaluating System Change to Advance Learning and Take Evidence to Scale (ESCALATES)
Study Start Date : April 2015
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022
Groups and Cohorts
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Intervention Details:
  • Behavioral: ESCALATES
    The investigators collect and analyze qualitative data to identify the most effective combinations of intervention strategies for various practice types, contexts, and organizational characteristics, and to understand why and how those combinations are effective. The investigators also gather de-identified quantitative data that the R18s collected.
    Other Name: EvidenceNOW

Outcome Measures
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Primary Outcome Measures :
  1. Percentage of participants with AMI, coronary artery bypass graft, PCI or IVD, and who had documentation of used of aspirin or another antithrombotic during the measurement period. [ Time Frame: Quarterly for 4 years ]
    Acute myocardial infarction (AMI), ischemic vascular disease (IVD), percutaneous coronary interventions (PCI)

  2. Percentage of participants with diagnosis of hypertension and whose blood pressure was adequately controlled (<140/90 mmHg) during the measurement period. [ Time Frame: Quarterly for 4 years ]
  3. Percentage of participants considered at high risk of cardiovascular events who were prescribed or were on a statin therapy during the measurement period. [ Time Frame: Quarterly for 4 years ]
  4. Percentage of participants who were screened for tobacco use and received cessation counseling intervention if identified as a tobacco user. [ Time Frame: Quarterly for 4 years ]

Secondary Outcome Measures :
  1. Practice capacity for change measured by adaptive reserve (AR) [ Time Frame: Baseline, immediately after intervention, 6 months post-intervention (4 years maximum) ]
  2. Practice capacity for quality improvement measured by CPCQ [ Time Frame: Baseline, immediately after intervention, 6 months post-intervention (4 years maximum) ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study will include all R18 grantees
Criteria

Inclusion Criteria:

  • All R18 grant awardees are included in the study.

Exclusion Criteria:

  • N/A
Contacts and Locations
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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): NCT02560428


Sponsors and Collaborators
Oregon Health and Science University
University of Texas
Rutgers University
HealthPartners Institute
University of Michigan
Case Western Reserve University
Investigators
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Principal Investigator: Debbie Cohen, PhD OHSU, Department of Family Medicine
More Information
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Additional Information:

Publications of Results:

Other Publications:
Reck J. Primary care provider burnout: implications for states & strategies for mitigation. National Academy for State Health Policy. 2017 Jan.

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Responsible Party: Deborah Cohen, Associate Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT02560428    
Other Study ID Numbers: 11482
First Posted: September 25, 2015    Key Record Dates
Last Update Posted: September 28, 2021
Last Verified: September 2021
Keywords provided by Deborah Cohen, Oregon Health and Science University:
Mixed Methods
Cardiovascular Health
Implementation Evaluation
Cardiovascular Prevention Screening