NCT00517686

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16,584

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 17, 2007

Completed
11 months until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

August 3, 2012

Status Verified

August 1, 2012

Enrollment Period

1 year

First QC Date

August 15, 2007

Last Update Submit

August 1, 2012

Conditions

Cardiovascular Disease (CVD) Risk Factors

Keywords

Poor risk factor controlTreatment intensificationMedication adherenceCardiovascular disease (CVD)

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (2)

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

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.

Interventions

Information feedback interventionOTHER

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).

1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente - Division of Research

Oakland, California, 94612, United States

Location

Related Publications (1)

  • 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.

    PMID: 22747998DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesMedication Adherence

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Joe V Selby, MD, MPH

    Kaiser Permenante, Division of Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2007

First Posted

August 17, 2007

Study Start

July 1, 2008

Primary Completion

July 1, 2009

Study Completion

September 1, 2009

Last Updated

August 3, 2012

Record last verified: 2012-08

Locations

US(1)