NCT01566864

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66,570

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
Completed

Started Apr 2011

Longer than P75 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 29, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

January 5, 2018

Status Verified

January 1, 2018

Enrollment Period

4 years

First QC Date

March 22, 2012

Last Update Submit

January 3, 2018

Conditions

Keywords

hypertensiondisparitiescare managementprovider educationaudit and feedbackOmronAfrican Americansorganizational changeimplementation research

Outcome Measures

Primary Outcomes (1)

  • Percent of clinic patients with controlled blood pressure and the racial disparity in controlled BP at each clinic.

    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 Outcomes (5)

  • Terminal digit preference

    24 weeks

  • Repeat BP measures

    24 weeks

  • Patient enrollment in care management

    24 weeks

  • Completion of care management program

    24 weeks

  • Dashboard review/communication skills training completion

    12 months

Study Arms (3)

Behavioral: Improve clinic based measurement of blood pressur

EXPERIMENTAL
Behavioral: Improve clinic based measurement of blood pressure

Behavioral: Provider education system to promote patient-cent

EXPERIMENTAL
Behavioral: Provider education system to promote patient-centered care

Behavioral: Introduce care management system in clinics

EXPERIMENTAL
Behavioral: Introduce care management system in clinics

Interventions

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.

Behavioral: Improve clinic based measurement of blood pressur

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.

Behavioral: Provider education system to promote patient-cent

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.

Behavioral: Introduce care management system in clinics

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Community Physicians

Baltimore, Maryland, 21211, United States

Location

Related Publications (3)

  • Block L, Flynn SJ, Cooper LA, Lentz C, Hull T, Dietz KB, Boonyasai RT. Promoting sustainability in quality improvement: an evaluation of a web-based continuing education program in blood pressure measurement. BMC Fam Pract. 2018 Jan 10;19(1):13. doi: 10.1186/s12875-017-0682-5.

  • Boonyasai RT, Carson KA, Marsteller JA, Dietz KB, Noronha GJ, Hsu YJ, Flynn SJ, Charleston JM, Prokopowicz GP, Miller ER 3rd, Cooper LA. A bundled quality improvement program to standardize clinical blood pressure measurement in primary care. J Clin Hypertens (Greenwich). 2018 Feb;20(2):324-333. doi: 10.1111/jch.13166. Epub 2017 Dec 21.

  • Cooper LA, Marsteller JA, Noronha GJ, Flynn SJ, Carson KA, Boonyasai RT, Anderson CA, Aboumatar HJ, Roter DL, Dietz KB, Miller ER 3rd, Prokopowicz GP, Dalcin AT, Charleston JB, Simmons M, Huizinga MM. A multi-level system quality improvement intervention to reduce racial disparities in hypertension care and control: study protocol. Implement Sci. 2013 Jun 4;8:60. doi: 10.1186/1748-5908-8-60.

Related Links

MeSH Terms

Conditions

Hypertension

Interventions

Ambulatory Care Facilities

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Health FacilitiesHealth Care Facilities Workforce and Services

Study Officials

  • Lisa A Cooper, MD, MPH

    Johns Hopkins School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2012

First Posted

March 29, 2012

Study Start

April 1, 2011

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

January 5, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations