Trial Outcomes & Findings for Reducing Clinical Inertia in Hypertension Treatment: A Pragmatic Trial (NCT NCT01145391)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

591 participants

Primary outcome timeframe

Baseline, 9 months

Results posted on

2018-08-15

Participant Flow

Dates of the recruitment period: September 2009 - January 2010. Types of locations: University of Colorado Hospital primary care clinics

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.

Participant milestones

Participant milestones
Measure	Control Patients receive usual care.	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.
Overall Study STARTED	293	298
Overall Study 9 Months Post-randomization	293	298
Overall Study COMPLETED	293	298
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Reducing Clinical Inertia in Hypertension Treatment: A Pragmatic Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control n=293 Participants Patients receive usual care.	Intervention n=298 Participants An outreach coordinator raised patient and provider awareness of unmet BP goals, arranged BP-focused clinic visits, and furnished providers with treatment decision support.	Total n=591 Participants Total of all reporting groups
Age, Continuous Age, <45 years	34.6 years STANDARD_DEVIATION 6.4 • n=93 Participants	35.5 years STANDARD_DEVIATION 5.3 • n=4 Participants	35.1 years STANDARD_DEVIATION 5.8 • n=27 Participants
Age, Continuous Age, 45-54 years	49.7 years STANDARD_DEVIATION 2.8 • n=93 Participants	49.9 years STANDARD_DEVIATION 2.9 • n=4 Participants	49.8 years STANDARD_DEVIATION 2.8 • n=27 Participants
Age, Continuous Age, 55-64 years	58.9 years STANDARD_DEVIATION 3.0 • n=93 Participants	59.6 years STANDARD_DEVIATION 2.6 • n=4 Participants	59.2 years STANDARD_DEVIATION 2.8 • n=27 Participants
Age, Continuous Age, 65-79 years	69.8 years STANDARD_DEVIATION 3.9 • n=93 Participants	69.6 years STANDARD_DEVIATION 3.7 • n=4 Participants	69.7 years STANDARD_DEVIATION 3.8 • n=27 Participants
Sex: Female, Male Female	153 Participants n=93 Participants	170 Participants n=4 Participants	323 Participants n=27 Participants
Sex: Female, Male Male	140 Participants n=93 Participants	128 Participants n=4 Participants	268 Participants n=27 Participants
Region of Enrollment United States	293 participants n=93 Participants	298 participants n=4 Participants	591 participants n=27 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Intervention n=298 Participants An outreach coordinator raised patient and provider awareness of unmet BP goals, arranged BP-focused clinic visits, and furnished providers with treatment decision support.	Usual Care n=293 Participants Usual care
Blood Pressure	-10.1 mm Hg 95% Confidence Interval NA • Interval -12.2 to -8.0	-9.1 mm Hg 95% Confidence Interval NA • Interval -11.3 to -6.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention n=298 Participants An outreach coordinator raised patient and provider awareness of unmet BP goals, arranged BP-focused clinic visits, and furnished providers with treatment decision support.	Usual Care n=293 Participants Usual care
Clinical Inertia	-10.7 % visits with inertia present Interval -18.8 to -2.6	-29.3 % visits with inertia present Interval -36.9 to -21.6

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Amy Huebschmann

University of Colorado Denver School of Medicine

Phone: 303-724-2268

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER