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| Name | Class |
|---|---|
| Novartis Pharmaceuticals | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Patients receive usual care. | |
| Intervention | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amy Huebschmann, M.D. | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Denver | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22533659 | Result | 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. |
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Patients were excluded if they had serious comorbidities (e.g. active cancer diagnosis, hospice care, end-stage renal disease), diabetes mellitus, BP management by a nephrologist or other sub-specialist, a notation of white coat hypertension, or a notation that patient should monitor BP at home.
Dates of the recruitment period: September 2009 - January 2010. Types of locations: University of Colorado Hospital primary care clinics
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Patients receive usual care. |
| FG001 | Intervention | An outreach coordinator raised patient and provider awareness of unmet BP goals, arranged BP-focused clinic visits, and furnished providers with treatment decision support. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Patients receive usual care. |
| BG001 | Intervention | An outreach coordinator raised patient and provider awareness of unmet BP goals, arranged BP-focused clinic visits, and furnished providers with treatment decision support. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intention-to-treat analyses using restricted maximum likelihood (REML) for a repeated measures model with incomplete data (SAS Proc Mixed). As this assumes that the occurrence of missing follow-up data depends only on observed data (i.e., pre-randomization values), we also performed a sensitivity analysis using the method proposed by Little. | Posted | Mean | 95% Confidence Interval | mm Hg | Baseline, 9 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Patients receive usual care. |
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Adherence measures were not included. Patients with and without a formal diagnosis of hypertension were enrolled, but might require different intervention strategies.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amy Huebschmann | University of Colorado Denver School of Medicine | 303-724-2268 | amy.huebschmann@ucdenver.edu |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Baseline, 9 months |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Usual Care | Usual care |
|
|
|
| Secondary | 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. | Posted | Number | 95% Confidence Interval | % visits with inertia present | Baseline, 9 months |
|
|
|
| 0 |
| 293 |
| 0 |
| 293 |
| EG001 | Intervention | An outreach coordinator raised patient and provider awareness of unmet BP goals, arranged BP-focused clinic visits, and furnished providers with treatment decision support. | 0 | 298 | 0 | 298 |
The study funder, Novartis Pharmaceuticals Corporation, had no role in the data analysis or manuscript preparation; however, as part of the study agreement Novartis approved the investigators' study design and final manuscript.