Feedback of Treatment Intensification Data to Reduce Cardiovascular Disease Risk (FIT) - Full Text View

Purpose

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.

Condition	Intervention
Cardiovascular Disease (CVD) Risk Factors	Other: Information feedback intervention

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Other, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study

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

Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	9200
Study Start Date:	July 2008
Estimated Study Completion Date:	September 2009
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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).
2: No Intervention 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.

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:

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00517686

Contacts


Contact: Julie A Schmittdiel, PhD	(510)891-3872	Julie.A.Schmittdiel@kp.org

Contact: Marcia M Ewing	(510) 891-3726	Marcia.M.Ewing@kp.org

Locations


United States, California
	Kaiser Permanente - Division of Research	Not yet recruiting
	Oakland, California, United States, 94612
	Sub-Investigator: Julie A Schmittdiel, PhD
	Sub-Investigator: John Hsu, MD, MBA
	Sub-Investigator: Bruce Fireman, MA
	Sub-Investigator: Marc Jaffe, MD
	Sub-Investigator: Eve Kerr, MD
	Sub-Investigator: Gregory Pawlson, MD, MPH

Sponsors and Collaborators

Kaiser Permanente

Agency for Healthcare Research and Quality (AHRQ)

Investigators


Principal Investigator:	Joe V Selby, MD, MPH	Kaiser Permenante, Division of Research

More Information

Responsible Party:	Kaiser Permanente Division of Research ( Joe Selby, MD Principal Investigator )
Study ID Numbers:	RFA-HS-07-002
First Received:	August 15, 2007
Last Updated:	February 27, 2008
ClinicalTrials.gov Identifier:	NCT00517686
Health Authority:	United States: Institutional Review Board

Keywords provided by Kaiser Permanente:

Poor risk factor control

Treatment intensification

Medication adherence

Cardiovascular disease (CVD)

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 07, 2008

Sponsors and Collaborators:	Kaiser Permanente Agency for Healthcare Research and Quality (AHRQ)
Information provided by:	Kaiser Permanente
ClinicalTrials.gov Identifier:	NCT00517686