HypertensionNCT01145391

Reducing Clinical Inertia in Hypertension Treatment: A Pragmatic Trial

A study testing Active Outreach to Patients and Providers in people with Hypertension, run by University of Colorado, Denver at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 79 years
Conditions the study is for: Hypertension
What is being tested?: Active Outreach to Patients and Providers
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 591 participants
Where: 1 siteUnited States
Study dates: Nov 2009to Oct 2010
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 79 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Colorado Denver
Aurora, Colorado, 80045

Other trials in United States

About this study

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

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.

Conditions: Hypertension
Being tested: Active Outreach to Patients and Providers
Keywords: hypertension, blood pressure, primary care, patient centered medical home, health information technology, clinical inertia
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Active Outreach to Patients and ProvidersOther
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.

Study groups in NCT01145391
Study group	Role	What they receive
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. Receives: Other: Active Outreach to Patients and Providers

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline, 9 months

Secondary outcomes (1)

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.
Measured: Baseline, 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2009Oct 2010

First posted16 Jun 2010 (estimated)
Study startNov 2009
Primary completionOct 2010
Study completionOct 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HypertensionStudies of the same condition, open and under way.
More trials run by University of Colorado, DenverThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 591 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01145391
Sponsor's protocol ID: 09-0646
Status last verified: Aug 2018
First submitted: 15 Jun 2010
Last updated: 15 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 22533659

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Health Promotion Outreach To Overcome Clinical Inertia In The Treatment Of Patients With Poorly-Controlled Hypertension
ClinicalTrials.gov ID: NCT01145391
Acronym / sponsor ID: 09-0646
Conditions: Hypertension
Keywords: hypertension, blood pressure, primary care, patient centered medical home, health information technology, clinical inertia
Study type: Interventional
Recruitment status: Completed
Enrolment: 591 participants (actual)
Lead sponsor: University of Colorado, DenverUniversity, hospital or other
Collaborators: Novartis Pharmaceuticals
Study start: Nov 2009
Primary completion: Oct 2010 (actual)
Study completion: Oct 2010 (actual)
First posted: 16 Jun 2010 (estimated)
Results: Posted 25 Oct 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Control	No intervention	–Patients receive usual care.
Intervention	Active comparator	Other: Active Outreach to Patients and ProvidersAn 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.

Who may qualify

Ages: 18 to 79 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Active Outreach to Patients and ProvidersAn 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	Intervention

Primary outcome

Blood Pressure
Time frame: 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.

1 secondary outcome

Clinical Inertia
Time frame: Baseline, 9 months

Results and safety

Results posted to the registry on 25 Oct 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control	293	293
Intervention	298	298

Primary outcome: Blood Pressure

Time frame: Baseline, 9 months. Mean (95% Confidence Interval). Unit: mm Hg

Measure	Intervention n = 298	Usual Care n = 293
Value	-10.1 (NA)	-9.1 (NA)

Intervention vs Usual Care: p = 0.50, Mixed Models Analysis

Population analysed: 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.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control	0 of 293 (0%)	0 of 293 (0%)	Not reported
Intervention	0 of 298 (0%)	0 of 298 (0%)	Not reported

Limitations and caveats (from the sponsor): Adherence measures were not included. Patients with and without a formal diagnosis of hypertension were enrolled, but might require different intervention strategies.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 22533659Huebschmann 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.

Related trials for Hypertension

Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Amy Huebschmann, M.D. principal investigator

University of Colorado, Denver

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Active Outreach to Patients and Providers in people with Hypertension, run by University of Colorado, Denver at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood Pressure (time frame: Baseline, 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01145391, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2018.