Reducing Clinical Inertia in Hypertension Treatment: A Pragmatic Trial

NCT ID: NCT01145391

Last Updated: 2018-08-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

591 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-10-31

Brief Summary

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The goal of this project is to use health information technology and team-based care in novel ways to support the establishment of a Patient-Centered Medical Home model of care aimed at improving the diagnosis and management of hypertension. Compared with patients who receive usual care, patients who receive intervention will have a lower average systolic blood pressure 9 months after randomization.

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Control

Patients receive usual care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

An outreach coordinator raised patient and provider awareness of unmet Blood Pressure goals, arranged Blood Pressure-focused clinic visits, and furnished providers with treatment decision support.

Group Type ACTIVE_COMPARATOR

Active Outreach to Patients and Providers

Intervention Type OTHER

An outreach coordinator raised patient and provider awareness of unmet Blood Pressure goals, arranged Blood Pressure-focused clinic visits, and furnished providers with treatment decision support.

Interventions

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Active Outreach to Patients and Providers

An outreach coordinator raised patient and provider awareness of unmet Blood Pressure goals, arranged Blood Pressure-focused clinic visits, and furnished providers with treatment decision support.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adult men and women age 18-79
* At least 2 Blood Pressure readings from separate days on record
* Average of last 3 Blood Pressure readings (or last 2 if only 2 available) with (Systolic Blood Pressure ≥140 or Diastolic Blood Pressure ≥90) and (last Systolic Blood Pressure ≥135 or last Diastolic Blood Pressure ≥85), recorded by any University of Colorado Hospital clinic within the last 18 months
* No clinic visit in the past month
* At least one Primary Care Physician visit in the past 18 months
* First Primary Care Physician visit at least 6 months in the past

Exclusion Criteria

* Serious comorbidities, including active cancer diagnosis, hospice care, nursing home residence
* Diagnosis of diabetes (these patients are enrolled in a separate study that also targets Blood Pressure control)
* End-stage renal disease / hemodialysis
* Primary Care Physician appointment pending
* Patient instructed to monitor Blood Pressure at home / documentation of white coat hypertension
* Blood Pressure managed by specialist or outside provider
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amy Huebschmann, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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University of Colorado Denver

Aurora, Colorado, United States

Site Status

Countries

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United States

References

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Huebschmann AG, Mizrahi T, Soenksen A, Beaty BL, Denberg TD. Reducing clinical inertia in hypertension treatment: a pragmatic randomized controlled trial. J Clin Hypertens (Greenwich). 2012 May;14(5):322-9. doi: 10.1111/j.1751-7176.2012.00607.x. Epub 2012 Mar 16.

Reference Type RESULT
PMID: 22533659 (View on PubMed)

Other Identifiers

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09-0646

Identifier Type: -

Identifier Source: org_study_id

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