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Reducing Clinical Inertia in Hypertension Treatment: A Pragmatic Trial

Primary Purpose

Hypertension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active Outreach to Patients and Providers
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hypertension focused on measuring hypertension, blood pressure, primary care, patient centered medical home, health information technology, clinical inertia

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Colorado Denver

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control

Intervention

Arm Description

Patients receive usual care.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
June 15, 2010
Last Updated
August 13, 2018
Sponsor
University of Colorado, Denver
Collaborators
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01145391
Brief Title
Reducing Clinical Inertia in Hypertension Treatment: A Pragmatic Trial
Official Title
Health Promotion Outreach To Overcome Clinical Inertia In The Treatment Of Patients With Poorly-Controlled Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
hypertension, blood pressure, primary care, patient centered medical home, health information technology, clinical inertia

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
591 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients receive usual care.
Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
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 Type
Other
Intervention Name(s)
Active Outreach to Patients and Providers
Intervention Description
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 Outcome Measure Information:
Title
Blood Pressure
Description
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.
Time Frame
Baseline, 9 months
Secondary Outcome Measure Information:
Title
Clinical Inertia
Description
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.
Time Frame
Baseline, 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy Huebschmann, M.D.
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22533659
Citation
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.
Results Reference
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Reducing Clinical Inertia in Hypertension Treatment: A Pragmatic Trial

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