Guideline Adherence for Heart Health — GLAD Heart  

Hypertension Clinical Trial

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Hypercholesterolemia
• Hypertension

• NCT number: NCT00224848
• Study type: Interventional
• Source: National Heart, Lung, and Blood Institute (NHLBI)
• Status: Completed
• Phase: Phase 2
• Start date: July 2002
• Completion date: August 2008