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Completed

NCT Number: NCT02560428

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

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.

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Key information

Conditions

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All R18 grant awardees are included in the study.

Exclusion criteria

  • N/A

Treatment and study plan

ESCALATES

Behavioral

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 names: EvidenceNOW

Primary outcomes

  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

    Patients 18years and older and 85years or younger with at least one face to face visit and active diagnosis of essential hypertension at any time before the first date of month 7 of the measurement period and who did not (i) have an active diagnosis of pregnancy at any time during the measurement period; or (ii) have evidence of end stage renal disease, dialysis, or renal transplant before or during the measurement period

  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

    Patients 21 and older with at least one face to face visit who have an active diagnosis of clinical atherosclerotic cardiovascular, LDL-C result >= 190mg/dL, aged 40 to 75years at the beginning of the measurement period with an active diagnosis of diabetes with the highest LDL-C result of 70 to 189mg/ dL and who (i) did not have adverse effect, allergy or intolerance to statin medication therapy; (ii) did not have an active diagnosis of pregnancy or breastfeeding; (iii) did not receive palliative care; (iv) did not have an active liver disease or hepatic disease of insufficiency; (v) did not have end stage renal disease; or (vi) did not have a most recent LDL-C results<70mg/dL for patients with a diabetes diagnosis who are not currently receiving statin medication therapy during the current measurement period or any time period.

  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

    Patients 18years and older as of the first day of the measurement period with at least two visits during the measurement period

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • Case Western Reserve University
  • HealthPartners Institute
  • Rutgers University
  • University of Michigan
  • University of Texas

Registry information

Acronym: ESCALATES

Important dates

Study start
2015
Primary completion
2022
Study completion
2022
First posted
Sep 25, 2015
Registry last updated
Jun 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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