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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00517686
Acronym
FIT
Enrollment
16584
Registered
2007-08-17
Start date
2008-07-31
Completion date
2009-09-30
Last updated
2012-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease (CVD) Risk Factors

Keywords

Poor risk factor control, Treatment intensification, Medication adherence, Cardiovascular disease (CVD)

Brief 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.

Detailed 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.

Interventions

OTHERInformation 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).

Sponsors

Agency for Healthcare Research and Quality (AHRQ)
CollaboratorFED
Kaiser Permanente
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
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

Secondary

MeasureTime frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026