Hypertension
Conditions
Keywords
hypertension, blood pressure, primary care, patient centered medical home, health information technology, clinical inertia
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.
Interventions
OTHERActive 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.
Sponsors
Novartis Pharmaceuticals
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure | Baseline, 9 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Clinical Inertia | Baseline, 9 months | 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. |
Countries
United States
Participant flow
Recruitment details
Dates of the recruitment period: September 2009 - January 2010. Types of locations: University of Colorado Hospital primary care clinics
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Control Patients receive usual care. | 293 |
| 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. | 298 |
| Total | 591 |
Baseline characteristics
| Characteristic | Control | Intervention | Total |
|---|---|---|---|
| Age, Continuous Age, 45-54 years | 49.7 years STANDARD_DEVIATION 2.8 | 49.9 years STANDARD_DEVIATION 2.9 | 49.8 years STANDARD_DEVIATION 2.8 |
| Age, Continuous Age, <45 years | 34.6 years STANDARD_DEVIATION 6.4 | 35.5 years STANDARD_DEVIATION 5.3 | 35.1 years STANDARD_DEVIATION 5.8 |
| Age, Continuous Age, 55-64 years | 58.9 years STANDARD_DEVIATION 3 | 59.6 years STANDARD_DEVIATION 2.6 | 59.2 years STANDARD_DEVIATION 2.8 |
| Age, Continuous Age, 65-79 years | 69.8 years STANDARD_DEVIATION 3.9 | 69.6 years STANDARD_DEVIATION 3.7 | 69.7 years STANDARD_DEVIATION 3.8 |
| Region of Enrollment United States | 293 participants | 298 participants | 591 participants |
| Sex: Female, Male Female | 153 Participants | 170 Participants | 323 Participants |
| Sex: Female, Male Male | 140 Participants | 128 Participants | 268 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 293 | 0 / 298 |
| serious Total, serious adverse events | 0 / 293 | 0 / 298 |
Outcome results
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.
Time frame: Baseline, 9 months
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Blood Pressure | -10.1 mm Hg |
| Usual Care | Blood Pressure | -9.1 mm Hg |
p-value: 0.5Mixed Models Analysis
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.
Time frame: Baseline, 9 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention | Clinical Inertia | -10.7 % visits with inertia present |
| Usual Care | Clinical Inertia | -29.3 % visits with inertia present |