Multi-Method Health System Quality Improvement Intervention to Reduce Hypertension Disparities

January 3, 2018 updated by: Johns Hopkins University

Multi-Method Health System QI Intervention to Reduce Hypertension Disparities

The investigators have designed a three-part quality improvement intervention to 1) improve the clinic-based measurement of blood pressure, 2) introduce a care management system to promote self-management behaviors and rapidly titrate medications by algorithms developed in accord with guidelines and 3) introduce an interactive, needs-based, longitudinal-provider education system that promotes patient-centered care and provides practical examples of patient-provider communication strategies. The intervention will occur at six clinics within the metropolitan area of Baltimore, Maryland. The investigators will also describe clinic and health system characteristics and measure their association with implementation (uptake), success (improvements in blood pressure control and reductions in racial disparities), and sustainability of the three-part intervention over 12 -24 months.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Hypertension is common in the US. From efficacy and observational studies, we know that achieving blood pressure control can reduce morbidity and mortality. However, less than one-third of persons with hypertension achieve control as defined by national guidelines. Furthermore, racial disparities in hypertension have been clearly documented with African American patients being less likely than Caucasians to achieve adequate control. The objective of this study is to study the implementation of a multi-method quality improvement intervention in a pragmatic clinical trial. Six clinic sites within the Johns Hopkins Community Physicians (JHCP) healthcare system have been selected for participation in this study. The sites are located within the metropolitan ara of Baltimore, Maryland, yet differ greatly. We will define the context and local characteristics of each study site and determine which characteristics are associated with blood pressure control and racial disparity at the clinic (micro-system) and health system (macro-system)level. We will deploy a three-part quality improvement intervention to 1) improve the clinic-based measurement of blood pressure, 2) introduce a care management system to promote patients' self-management behaviors and rapidly titrate medications by algorithms developed in accord with guidelines and 3) introduce an interactive, needs-based, longitudinal-provider education system that promotes patient-centered care and provides practical examples of patient-provider communication strategies. Using statistical process control charting, we will determine the stability of blood pressure control in the system prior to intervention and after the introduction of each intervention. We will vary the order of the interventions among the six clinical sites to determine if each intervention is independently effective in each local context and if the effect is repeatable in other contextual situations within the same macro-system. In addition, we will study the organizational characteristics and features of the local context that are associated with implementation, uptake of the interventions and success of each intervention in achieving blood pressure control and reducing racial disparities in blood pressure control at the clinic level .

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
66570

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21211
        • Johns Hopkins Community Physicians

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria: patients with an ICD9 diagnosis of hypertension or a BP >=120/>=80 who have not been seen in the last 12 months and any patient with their most recent BP >=140/>=90 or >=130/>=80 if they have diabetes mellitus or chronic kidney disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Behavioral: Improve clinic based measurement of blood pressur
Behavioral: Improve clinic based measurement of blood pressure
This intervention seeks to improve BP control and reduce disparities through an organizational change and new skills development. To improve the reliability of BP measurement in clinics, new automated BP machines (Omron HEM-907XL) will be provided for each PCP. Medical assistants will be trained and certified in the proper use of the Omron machine by a master trainer. The will be trained to measure the arm circumference, choose the appropriate cuff and place it properly on the arm. They will be recertified yearly. Once activated, the Omron HEM-907XL will lead measurement for 5 minutes then perform a series of 3 BP measurements spaced by 30 seconds and present the man of these 3 measurements. The mean will be record in the electronic medical records.
Experimental: Behavioral: Provider education system to promote patient-cent
Behavioral: Provider education system to promote patient-centered care
The provider education intervention will address blood pressure control and disparities through audit and feedback. The intervention includes a hypertension dashboard and a linked provider-tailored education intervention. The latter aims to enhance provider communication skills during clinical encounters with hypertension patients, via teaching specific verbal behaviors with practice implications related to elicitation of hypertension treatment and adherence concerns. The dashboard is a web based tool linked to the electronic medical records that imports clinic measurements of BP and offers PCPs a quick assessment of the percentage of those achieving blood pressure control and receiving guideline-concordant care in their panel, clinic, and system overall and by patient race/ethnicity.
Experimental: Behavioral: Introduce care management system in clinics
Behavioral: Introduce care management system in clinics
The care management (CM) intervention will address blood pressure management and disparities through patient education, promotion of self-management, and the introduction of an organizational change through the addition of new team members. The CM team will contact patients with a BP of ≥140/≥90 (≥130/≥80 for patients with diabetes mellitus or chronic kidney disease) as identified through the electronic medical records for enrollment in care management services. Patients with a BP in these ranges will be referred to a CM program that emphasizes four key self-management behaviors: diet, physical activity, medication adherence, and self-monitoring. The self-management promotion program will consist of 3 one-on-one sessions either with a Pharm D. or R.D. over the course of 3 months.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percent of clinic patients with controlled blood pressure and the racial disparity in controlled BP at each clinic.
Time Frame: 24 weeks
The percent of clinic patients each week with SBP < 140 and DBP < 90, or if patient is diabetic or has CKD then SBP <130 and DBP < 80. If no BP measure, patient does not meet JNC-7 guidelines. Note: If multiple BP measures are recorded, the lowest will be used. The racial disparity is defined as the percent difference in blood pressure control between white patients and ethnic minority patients (separated into categories of African-American patients and other race patients). These outcomes will be assessed weekly for 24 weeks prior to and after roll out of each of the interventions.
24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Terminal digit preference
Time Frame: 24 weeks
The percent of BP measurements at each clinic that end in zero( or an even number) each week before, during, and after implementation of the BP measurement intervention. The measure will serve as an indicator of the uptake of the OMRON automated BP measurement device. It will be obtained weekly for 24 weeks prior to and after roll out of the BP measurement intervention
24 weeks
Repeat BP measures
Time Frame: 24 weeks
the percent of patient visits at each clinic each week where a second BP measure was done. This measure will be considered an indicator of the provider's trust of the medical assistant's initial BP recording. The measures will be obtained weekly for 24 weeks prior to and after roll-out of the BP measurement intervention
24 weeks
Patient enrollment in care management
Time Frame: 24 weeks
The percent of eligible patients who are enrolled in care management with a registered dietitian/pharmacist team. This measurement will be obtained weekly for 24 weeks before and after implementation of the care management intervention.
24 weeks
Completion of care management program
Time Frame: 24 weeks
Among patients who enroll in care management, the percent of patients who complete 3 intervention contacts with the care management team, The measure will be obtained weekly for 24 weeks before and after implementation of the care management intervention.
24 weeks
Dashboard review/communication skills training completion
Time Frame: 12 months
The number of dashboard reviews and communication skills training modules completed in each quarter, both divided by the number of providers in each site. This measure will be obtained quarterly for 12 months following the baseline response
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johns Hopkins University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Heart, Lung, and Blood Institute (NHLBI)
Johns Hopkins Community Physicians

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lisa A Cooper, MD, MPH, Johns Hopkins School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 22, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 29, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 5, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NA_00037622
  • 5P50HL105187-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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