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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 24, 2014