Guideline Adherence for Heart Health
Condition: Cardiovascular Diseases; Hypercholesterolemia; Hypertension
MeSH terms: Cardiovascular Diseases; Hypercholesterolemia
Study type: Interventional
Phase: Phase 2

Summary: 
      This study addresses the challenges associated with implementation of clinical practice
      guidelines (CPG's) and is motivated by our interest in gaining insight regarding the
      following general research questions about CPG implementation:

      A. Can physician adherence to complex CPGs be promoted by use of a hand-held computerized
      decision support tool providing patient-specific recommendations, documentation, and drug
      dosing assistance? B. Will increased adherence to CPGs reduce variation in management by age,
      gender and race/ethnicity such that disparities in healthcare are reduced or eliminated? C.
      What are the cost implications of using PDA-based technology to promote CPG adherence?

      This randomized, controlled, unblinded, practice-based trial will address these research
      questions by testing the following hypotheses in a 2 year behavioral intervention period:

        1. The absolute proportion of patients that is treated appropriately with respect to
           lipid-lowering drug therapy within 4 months after testing will be increased by a net of
           at least 9% by the intervention as measured in baseline and follow-up independent
           cross-sectional samples of eligible patients (primary endpoint).

        2. The absolute proportion of patients that is treated to the appropriate low density
           lipoprotein cholesterol (LDL-C) goal during follow-up of the baseline cohort of eligible
           patients is increased by a net of at least 12% by the intervention (secondary endpoint).

        3. The proportions of eligible patients that are appropriately screened, risk-stratified,
           and counseled regarding therapeutic lifestyle changes are increased by the intervention
           (tertiary endpoints).

        4. The intervention effect in subgroups defined by disease status (CVD, diabetes or
           neither), age, gender, and race/ethnicity reduces any disparities observed at baseline
           (exploratory analyses).

        5. In addition, we will estimate the marginal cost effectiveness of the intervention for
           the primary endpoint.

      The aims were modified in Year 1 to include an attention control group to enable evaluating
      and testing the impact of strategies to improve adherence to the recently released JNC 7
      guideline by testing the following hypotheses:

        1. The absolute proportion of patients that is treated appropriately with respect to blood
           pressure lowering drug therapy will be 10% greater in intervention practices than in
           comparison practices as measured in follow-up independent cross-sectional samples of
           eligible patients (primary endpoint).

        2. The absolute proportion of patients that is treated to the appropriate blood pressure
           goal during follow-up will be 10% greater in the intervention practices (secondary
           endpoint).

        3. The intervention effect in subgroups defined by disease status (CVD, diabetes or
           neither), age, gender, and race/ethnicity reduces any disparities observed at baseline
           (exploratory analyses).

        4. In addition, we will estimate the marginal cost effectiveness of the intervention for
           the primary endpoint.
    

Detailed description: 
      BACKGROUND:

      Many investigators have identified "gaps" in the quality of care delivered in routine
      practice in the U.S. According to the Institute of Medicine (IOM) report "Crossing the
      Quality Chasm: A New Health System for the 21st Century," the "gap" between evidence and
      practice might be better termed a "chasm". High blood cholesterol was identified as one of 15
      high priority conditions for Department of Health and Human Services (DHHS) initial focus. In
      addition, the report stresses the importance of increased use of information technology to
      support clinical and administrative processes. Six major aims are spelled out in the IOM
      report "health care should be safe, effective, patient-centered, timely, efficient and
      equitable." We have developed an intervention that is grounded in this philosophy.
      Specifically, we are focusing on a guideline that promotes the timely use of safe and
      effective interventions in a patient-tailored manner. A hand-held computerized decision
      support tool will be a core component of the intervention to support consistent and efficient
      medical decision-making. Although our goal is to improve overall adherence with the chosen
      guideline, we expect that the quality improvement process will result in increased equity,
      reflected in reduced disparities with respect to appropriate treatment between patient
      subgroups defined by gender, race/ethnicity, and age.

      DESIGN NARRATIVE:

      GLAD Heart is a randomized trial. The study intervention (academic detailing on ATPIII and a
      hand-held computerized decision support tool that provides patient-specific, ATPIII-based
      risk stratification and treatment recommendations for cholesterol management) and an
      attention control intervention (academic detailing on JNC7 and automated blood pressure
      devices) will be delivered at the level of randomization which is the practice. All practices
      (N=64) will receive usual care, consisting of guideline dissemination, baseline performance
      feedback, continuing education, and patient education materials. Outcomes will be assessed
      based on patient level data from chart reviews (N 20,000) of adult patients eligible for
      cholesterol measurement. To assess ATPIII-related outcomes, we will compare changes in
      baseline and follow-up chart abstraction between the two arms. To assess JNC7-related
      outcomes, we will compare differences in follow-up chart abstraction only between the two
      arms. Appropriate analytic methods will be used to analyze these correlated data. Impact
      evaluation for both arms will be conducted via baseline and follow-up surveys of
      participating providers. Process evaluation will be conducted by tracking use of the
      PDA-based tool and monitoring appropriate use of the automated blood pressure devices. Other
      tracking information will be collected to ensure intervention and data collection success.
    

Intervention name(s): Palm-Pilot Intervention
Intervention type(s): Behavioral
Intervention description(s): Both groups received guideline dissemination, patient activation materials, continuing education (CE) and feedback based on baseline chart audit. The intervention included academic detailing (AD) and a hand-held computerized decision support tool that provided patient-specific, ATPIII-based risk stratification and treatment recommendations. CE sessions offered information relevant to ATPIII and JNC7 and focused on the evidence base. AD offerings focused on strategies to apply concepts to practice and were specific to the randomized arm. Investigators visited each practice at baseline to educate physicians about the guideline and evidence supporting prevention of CVD, and to provide training on use of the Palm tool. Visits were conducted as "lunch and learn" sessions. The tool was a modified version of NHLBI's PDA decision support program and indicates specific drug therapies and dosages needed to achieve cholesterol reduction and prints documentation. A user's manual was developed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention