Clinical trial NCT01566864: Multi-Method Health System Quality Improvement Intervention to Reduce Hypertension Disparities
Official title: Multi-Method Health System QI Intervention to Reduce Hypertension Disparities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: hypertension
disparities
care management
provider education
audit and feedback
Omron
African Americans
organizational change
implementation research
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Johns Hopkins Community Physicians
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2012-03-29
Enrollment: 66570
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Percent of clinic patients with controlled blood pressure and the racial disparity in controlled BP at each clinic.
timeFrame: 24 weeks
Secondary outcomes:
measure: Terminal digit preference
timeFrame: 24 weeks
measure: Repeat BP measures
timeFrame: 24 weeks
measure: Patient enrollment in care management
timeFrame: 24 weeks
measure: Completion of care management program
timeFrame: 24 weeks
measure: Dashboard review/communication skills training completion
timeFrame: 12 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Community Physicians
state: Maryland
Study officials:
affiliation: Johns Hopkins School of Medicine
name: Lisa A Cooper, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.