Reducing Clinical Inertia in Hypertension Treatment: A Pragmatic Trial

This study has been completed.
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01145391
First received: June 15, 2010
Last updated: October 24, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Hypertension
Other: Active Outreach to Patients and Providers

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Health Promotion Outreach To Overcome Clinical Inertia In The Treatment Of Patients With Poorly-Controlled Hypertension

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Blood Pressure [ Time Frame: Baseline, 9 months ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Clinical Inertia [ Time Frame: Baseline, 9 months ] [ Designated as safety issue: No ]

    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.



Enrollment: 591
Study Start Date: November 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01145391

Locations
United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Novartis Pharmaceuticals
Investigators
Principal Investigator: Amy Huebschmann, M.D. University of Colorado, Denver
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01145391     History of Changes
Other Study ID Numbers: 09-0646
Study First Received: June 15, 2010
Results First Received: October 10, 2011
Last Updated: October 24, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
hypertension
blood pressure
primary care
patient centered medical home
health information technology
clinical inertia

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 15, 2014