Clinical trial NCT00517686: Feedback of Treatment Intensification Data to Reduce Cardiovascular Disease Risk (FIT)
Official title: Feedback of Treatment Intensification Data to Reduce Cardiovascular Disease Risk (FIT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease (CVD) Risk Factors
Keywords: Poor risk factor control
Treatment intensification
Medication adherence
Cardiovascular disease (CVD)
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2007-08-17
Enrollment: 16584
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 3 months; 1 year
Secondary outcomes:
measure: 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.
timeFrame: 3 months; 1 year
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Kaiser Permanente - Division of Research
state: California
Study officials:
affiliation: Kaiser Permenante, Division of Research
name: Joe V Selby, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Selby JV, Schmittdiel JA, Fireman B, Jaffe M, Ransom LJ, Dyer W, Uratsu CS, Reed ME, Kerr EA, Hsu J. Improving treatment intensification to reduce cardiovascular disease risk: a cluster randomized trial. BMC Health Serv Res. 2012 Jul 2;12:183. doi: 10.1186/1472-6963-12-183.