Reducing Clinical Inertia in Hypertension Treatment: A Pragmatic Trial

Health Promotion Outreach To Overcome Clinical Inertia In The Treatment Of Patients With Poorly-Controlled Hypertension

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Other: Active Outreach to Patients and Providers

• Study Type: Interventional
• Enrollment (Actual): 591
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Patients receive usual care.
Active Comparator: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Inertia	Definition of clinical inertia: failure of a primary care physician to initiate/intensify anti-hypertensive medications AND the failure to provide behavioral counseling to lower blood pressure during a clinic visit where blood pressure is elevated above 140/90 mm Hg. The clinical inertia measure is the percentage of clinic visits with clinical inertia present divided by the total number of clinic visits. We report a change in group mean levels of clinical inertia from baseline to 9 months post-randomization. Negative values for clinical inertia represent a decrease in the percentage of clinic visits where clinical inertia was present. Pre-randomization clinical inertia was assessed in the last 2 clinic visits prior to randomization, and post-randomization inertia was assessed in the first 2 post-randomization visits. Hypothesis: clinical inertia will be significantly greater in the usual care compared with intervention group in the post-randomization period.	Baseline, 9 months

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Novartis Pharmaceuticals
• Investigators: Principal Investigator: Amy Huebschmann, M.D., University of Colorado, Denver

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: June 15, 2010
• First Submitted That Met QC Criteria: June 15, 2010
• First Posted (Estimate): June 16, 2010

Study Record Updates

• Last Update Posted (Actual): August 15, 2018
• Last Update Submitted That Met QC Criteria: August 13, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: hypertension; primary care; blood pressure; patient centered medical home; health information technology; clinical inertia
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 09-0646

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No