Guideline Adherence for Heart Health

NCT00224848 | Completed Phase 2

• 2 other identifiers: 314R01HL070742
• Study Type: interventional
• Target: 61
• Locations: 0 countries
• Sites: N/A

Brief 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. 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. 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. 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. 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. 5.In addition, we will estimate the marginal cost effectiveness of the intervention for the primary endpoint.
6. 6.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).
7. 7.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).
8. 8.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).
9. 9.In addition, we will estimate the marginal cost effectiveness of the intervention for the primary endpoint.

Conditions

Cardiovascular Diseases; Hypercholesterolemia; Hypertension

Outcome Measures

Primary Outcomes (2)

• Proportion of patients treated appropriately with respect to lipid-lowering therapy within four months after lipid testing

  Measured at 2 years

• Rate of appropriate treatment among patients with high blood pressure

  Measured at 2 years

Study Arms (2)

ATP III

EXPERIMENTAL

A novel practice-based intervention, based on the ATP III Clinical Practice Guideline, which includes the use of a personal digital assistant (PDA) based decision support tool.

Behavioral: Palm-Pilot Intervention

JNC 7

ACTIVE COMPARATOR

A novel practice-based intervention, based on the JNC-7 blood pressure Clinical Practice Guideline, which includes the use of am automated blood pressure measurement device.

Behavioral: Palm-Pilot Intervention

Interventions

Palm-Pilot Intervention BEHAVIORAL

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.

ATP III; JNC 7

Eligibility Criteria

• Age: 21 Years - 84 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Potentially eligible patients for the chart abstraction sample will be adults, ages 21 through 84 years, seen in the participating primary care practices during the baseline (July 1, 2001 - June 30, 2003) or follow-up (March 1, 2004 - February 28, 2006) periods. We are examining two-year periods to increase the proportion of patients that has been screened. We can include "year 0" (July 1, 2001 - June 30, 2002), because ATPIII was published in May 2001. Although the guidelines do not exclude persons older than 84 years, at present we propose to restrict the evaluation sample to the aforementioned age group, due to acknowledged controversies regarding the appropriate preventive strategies in the very old.
• Primary Care Practices (Internal Medicine or Family Medicine) Within 3-hour driving radius of WFUSM At least 50% of practice's providers willing to participate in study Willingness to accept randomization assignment Willingness to participate in chart audit Have a computer suitable for connectivity with the PDAs for installation of software upgrades and for printing of patient-specific reports for medical record documentation purposes
• Academic practices
• Practicing healthcare provider affiliated with a primary care practice participating in GLAD Heart.
• Willingness to participate
• None
• Potentially eligible patients for the chart abstraction sample will be adults, ages 21 through 84 years, seen in the participating primary care practices during the baseline (July 1, 2001 - June 30, 2003) or follow-up (March 1, 2004 - February 28, 2006) periods. We are examining two-year periods to increase the proportion of patients that has been screened. We can include "year 0" (July 1, 2001 - June 30, 2002), because ATPIII was published in May 2001. Although the guidelines do not exclude persons older than 84 years, at present we propose to restrict the evaluation sample to the aforementioned age group, due to acknowledged controversies regarding the appropriate preventive strategies in the very old.

Sponsors & Collaborators

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

Related Publications (3)

• Ellis SD, Bertoni AG, Bonds DE, Clinch CR, Balasubramanyam A, Blackwell C, Chen H, Lischke M, Goff DC Jr. Value of recruitment strategies used in a primary care practice-based trial. Contemp Clin Trials. 2007 May;28(3):258-67. doi: 10.1016/j.cct.2006.08.009. Epub 2006 Sep 1.

  PMID: 17030154 RESULT

• Bertoni AG, Bonds DE, Steffes S, Jackson E, Crago L, Balasubramanyam A, Chen H, Goff DC Jr. Quality of cholesterol screening and management with respect to the National Cholesterol Education's Third Adult Treatment Panel (ATPIII) guideline in primary care practices in North Carolina. Am Heart J. 2006 Oct;152(4):785-92. doi: 10.1016/j.ahj.2006.04.017.

  PMID: 16996859 RESULT

• Bertoni AG, Bonds DE, Chen H, Hogan P, Crago L, Rosenberger E, Barham AH, Clinch CR, Goff DC Jr. Impact of a multifaceted intervention on cholesterol management in primary care practices: guideline adherence for heart health randomized trial. Arch Intern Med. 2009 Apr 13;169(7):678-86. doi: 10.1001/archinternmed.2009.44.

  PMID: 19364997 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Hypercholesterolemia; Hypertension

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Vascular Diseases

Study Officials

• David C Goff, Jr, MD, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 21, 2005
• First Posted: September 23, 2005
• Study Start: July 1, 2002
• Primary Completion: September 1, 2007
• Study Completion: August 1, 2008
• Last Updated: November 7, 2016

Record last verified: 2008-08