Reducing Clinical Inertia in Hypertension Treatment: A Pragmatic Trial

NCT01145391 | Completed Results

• 1 other identifier: 09-0646
• Study Type: interventional
• Target: 591
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension

Keywords

hypertension; blood pressure; primary care; patient centered medical home; health information technology; clinical inertia

Outcome Measures

Primary Outcomes (1)

• Blood Pressure

  Hypothesis: compared with patients who receive usual care, patients who receive intervention will have an average systolic blood pressure that is at least 5 points lower 9 months after randomization.

  Baseline, 9 months

Secondary Outcomes (1)

• Clinical Inertia

  Baseline, 9 months

Study Arms (2)

Control

NO INTERVENTION

Patients receive usual care.

Intervention

ACTIVE COMPARATOR

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.

Other: Active Outreach to Patients and Providers

Interventions

Active Outreach to Patients and Providers 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.

Intervention

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

• 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.

  PMID: 22533659 RESULT

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

Adherence measures were not included. Patients with and without a formal diagnosis of hypertension were enrolled, but might require different intervention strategies.

Results Point of Contact

• Title: Amy Huebschmann
• Organization: University of Colorado Denver School of Medicine

amy.huebschmann@ucdenver.edu

303-724-2268

Study Officials

• Amy Huebschmann, M.D.

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2010
• First Posted: June 16, 2010
• Study Start: November 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: August 15, 2018
• Results First Posted: October 25, 2012

Record last verified: 2018-08

Locations

US (1)