Feedback of Treatment Intensification Data to Reduce Cardiovascular Disease Risk (FIT)

Cardiovascular Disease (CVD) Risk Factors Clinical Trial

— FIT  

Official title:

Feedback of Treatment Intensification Data to Reduce Cardiovascular Disease Risk (FIT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00517686
• Other study ID #: RFA-HS-07-002
• Status: Completed
• Phase: N/A
• First received: August 15, 2007
• Last updated: August 1, 2012
• Start date: July 2008
• Est. completion date: September 2009

Study information

• Verified date: August 2012
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The primary research question of this study is to determine whether measuring, reporting and feeding back information to primary care teams on the need for treatment intensification in patients at high risk for cardiovascular disease (CVD) can improve rates of treatment intensification and reduce levels of poorly controlled systolic blood pressure, LDL-c, and A1c.

Description:

Project Description: We propose a cluster randomized trial intervention involving eight or more medical facilities of Kaiser Permanente Northern California (KP) and more than 65,000 patients at high risk for CVD. At intervention facilities, patient-level information obtained from KP's electronic health record on the need for treatment intensification (for systolic blood pressure, LDL-c, and A1c) and on recent medication adherence are added to a population management database and fed back through software currently used by staff working with primary care providers. Staff at control facilities continue to use the same population management database and software but only receive information on risk factor levels and selected medications.

Specific Aims:

1. Evaluate the effectiveness of measurement and feedback of treatment intensification information in patients at high risk of CVD for improving rates of treatment intensification and for reducing levels of poorly controlled systolic blood pressure, LDL-c, and A1c.

2. Evaluate the impact of the intervention, compared with current practice, on total numbers of patient contacts, outpatient visits, and costs of care in relation to improvements in risk factor control.

3. Evaluate the effect of this innovation on physician and staff perceptions of the value (effectiveness and efficiency) of the population management program for high-risk patients.

Relevance: If this translational study shows that feedback of information on treatment intensification leads to higher rates of intensification and improved risk factor control, this finding will have shown a population-level use of health information technology for improving clinical quality and will also have validated treatment intensification as a metric of clinical quality.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16584
• Est. completion date: September 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Among the randomized medical facilities, we will study a population that is drawn from the PHASE registry and includes patients with at least one of the following:

• Diabetes, coronary artery disease; congestive heart failure; stroke/tia; peripheral artery disease; chronic kidney disease; hypertension; or hyperlipidemia

• PHASE patients must be in poor control for at least one CVD risk factor and meet study criteria for needing treatment intensification at some point during the 6-month period.

Exclusion Criteria:

• All patients eligible for the study will be included in the analyses

• There will be no exclusions based on clinical or other criteria.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Cardiovascular Disease (CVD) Risk Factors
• Cardiovascular Diseases

Intervention

Other:
• Information feedback intervention
This study will evaluate an information feedback intervention: measuring, reporting and feeding back information to primary care teams on the need for treatment intensification in patients at high risk for cardiovascular disease (CVD).

Locations

Country	Name	City	State
United States	Kaiser Permanente - Division of Research	Oakland	California

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tightly-linked processes (i.e., was treatment intensified more frequently) measured in the 3 months after initial reporting of need for intensification; and mean levels of intermediate outcomes (SBP, LDL-c, and A1c), measured for all study population.		3 months; 1 year	No
Secondary	Proportions in control for each risk factor; treatment intensification and risk factor improvements in subgroups; and efficiency in terms of patient contacts, visits and costs per unit improvement in risk factor control.		3 months; 1 year	No