Reducing Clinical Inertia in Hypertension Treatment: A Pragmatic Trial

Study Overview
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Brief Summary
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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.

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

Conditions
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Hypertension

Intervention / Treatment
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* Other: Active Outreach to Patients and Providers


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Patients receive usual care. | |
| Active Comparator: Intervention<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypertension, blood pressure, primary care, patient centered medical home, health information technology, clinical inertia