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

This study is currently recruiting participants.
Verified March 2012 by Johns Hopkins University
Sponsor:
Collaborators:
Johns Hopkins Community Physicians
Information provided by (Responsible Party):
Lisa Cooper, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01566864
First received: March 22, 2012
Last updated: March 27, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Hypertension
Behavioral: Improve clinic based measurement of blood pressure
Behavioral: Provider education system to promote patient-centered care
Behavioral: Introduce care management system in clinics

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multi-Method Health System QI Intervention to Reduce Hypertension Disparities

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Percent of clinic patients with controlled blood pressure and the racial disparity in controlled BP at each clinic. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Terminal digit preference [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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

  • Repeat BP measures [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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

  • Patient enrollment in care management [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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.

  • Completion of care management program [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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.

  • Dashboard review/communication skills training completion [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 58705
Study Start Date: April 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
    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.
    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.
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 .

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01566864

Contacts
Contact: Lisa A Cooper, MD, MPH 410-614-3659 lisa.cooper@jhmi.edu
Contact: Katie Dietz, MPH 443-287-1826 kdietz4@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Community Physicians Recruiting
Baltimore, Maryland, United States, 21211
Sponsors and Collaborators
Johns Hopkins University
Johns Hopkins Community Physicians
Investigators
Principal Investigator: Lisa A Cooper, MD, MPH Johns Hopkins School of Medicine
  More Information

Additional Information:
No publications provided by Johns Hopkins University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lisa Cooper, James F. Fries Professor in Medicine, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01566864     History of Changes
Other Study ID Numbers: P50HL0105187, 5P50HL105187-02
Study First Received: March 22, 2012
Last Updated: March 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
hypertension
disparities
care management
provider education
audit and feedback
Omron
African Americans
organizational change
implementation research

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 21, 2014