Guideline Adherence for Heart Health

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.

Conditions

• Cardiovascular Diseases
• Hypercholesterolemia
• Hypertension

Interventions

BEHAVIORAL

Palm-Pilot Intervention

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.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  lead NIH

Principal Investigators

• David C Goff, Jr, MD, PhD · Wake Forest University Health Sciences

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

21 Years

Max Age

84 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2002-07-31

Primary Completion

2007-09-30

Completion

2008-08-31