Feedback of Treatment Intensification Data to Reduce Cardiovascular Disease Risk (FIT) (FIT)
|ClinicalTrials.gov Identifier: NCT00517686|
Recruitment Status : Completed
First Posted : August 17, 2007
Last Update Posted : August 3, 2012
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Disease (CVD) Risk Factors||Other: Information feedback intervention||Not Applicable|
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.
- 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.
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16584 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Feedback of Treatment Intensification Data to Reduce Cardiovascular Disease Risk (FIT)|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||September 2009|
The study will use automated databases and PHASE information systems to identify patients and incorporate feedback on a monthly basis into the ongoing reports used by program staff at facilities randomized to this intervention arm (n=4).
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).
No Intervention: 2
Usual care facilities (n=4) will continue to use current PHASE reports that include information on recent risk factor levels and current use of selected medications but no treatment intensification information, and no information on medication adherence.
- 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. [ Time Frame: 3 months; 1 year ]
- 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. [ Time Frame: 3 months; 1 year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00517686
|United States, California|
|Kaiser Permanente - Division of Research|
|Oakland, California, United States, 94612|
|Principal Investigator:||Joe V Selby, MD, MPH||Kaiser Permenante, Division of Research|