NCT00876330

Brief Summary

The purpose of this study is to evaluate the impact of electronic health record clinical decision support and automated telephone outreach on antihypertensive and lipid-lowering therapy in ambulatory care.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
6,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2009

Longer than P75 for not_applicable

Status
unknown

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

April 3, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 6, 2009

Completed
25 days until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

September 20, 2012

Status Verified

September 1, 2012

Enrollment Period

3.6 years

First QC Date

April 3, 2009

Last Update Submit

September 19, 2012

Conditions

HyperlipidemiaHypertension

Keywords

Clinical Decision Support SystemsHyperlipidemiaHypertension

Outcome Measures

Primary Outcomes (1)

  • The main outcome measure will be the proportion of patients at treatment goal.

    Baseline and 6 months

Study Arms (2)

1

EXPERIMENTAL

Receives Hypertension and Hyperlipidemia Intervention using Clinical Decision Support.

Other: Clinical Decision Support for HypertensionOther: Automated Telephone Outreach for Antihypertensive Therapy

2

EXPERIMENTAL

Receives Hypertension and Hyperlipidemia Intervention with automated telephone outreach.

Other: Clinical Decision Support for Lipid-lowering TherapyOther: Automated Telephone Outreach for Lipid-lowering Therapy

Interventions

Clinical Decision Support for HypertensionOTHER

Clinical decision support alerts for antihypertensive therapy

1
Automated Telephone Outreach for Antihypertensive TherapyOTHER

Automated Telephone Outreach to patients for antihypertensive medication therapy.

1
Clinical Decision Support for Lipid-lowering TherapyOTHER

Clinical Decision Support alerts for Lipid-lowering medication therapy.

2
Automated Telephone Outreach for Lipid-lowering TherapyOTHER

Automated telephone outreach to patients for Lipid-lowering medication therapy.

2

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • MDs, NPs, PAs, or DOs practicing in primary care or medical subspecialties and using eClinical Works EHR
  • Patients of eligible physicians who have hypertension or hyperlipidemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HyperlipidemiasHypertension

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Steven R Simon, MD, MPH

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

  • David W Bates, MD, MSc

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Site Principal Investigator

Study Record Dates

First Submitted

April 3, 2009

First Posted

April 6, 2009

Study Start

May 1, 2009

Primary Completion

December 1, 2012

Study Completion

March 1, 2013

Last Updated

September 20, 2012

Record last verified: 2012-09