Multi-Method Health System Quality Improvement Intervention to Reduce Hypertension Disparities
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|ClinicalTrials.gov Identifier: NCT01566864|
Recruitment Status : Completed
First Posted : March 29, 2012
Last Update Posted : January 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|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||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||66570 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multi-Method Health System QI Intervention to Reduce Hypertension Disparities|
|Actual Study Start Date :||April 2011|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||April 2015|
|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.
- 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.
- 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
- 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
- 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.
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01566864
|United States, Maryland|
|Johns Hopkins Community Physicians|
|Baltimore, Maryland, United States, 21211|
|Principal Investigator:||Lisa A Cooper, MD, MPH||Johns Hopkins School of Medicine|