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OpenTrials
Completed

NCT Number: NCT01145391

Reducing Clinical Inertia in Hypertension Treatment: A Pragmatic Trial

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Denver

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Blood Pressure

    Time frame: Baseline, 9 months

    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.

Secondary outcomes

  1. Clinical Inertia

    Time frame: Baseline, 9 months

    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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Novartis Pharmaceuticals

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 16, 2010
Registry last updated
Aug 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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