Summary

for people ages 18-85 (full criteria)
study started
estimated completion
Mark Pletcher

Description

Summary

BP-MAP is a cluster randomized controlled trial (RCT) designed to compare the effectiveness of BP lowering from a clinic-based quality improvement program with Full Support (dedicated practice facilitation) vs. a Self-Guided version of the program. The American Medical Association (AMA) developed the framework for the interventions. The trial will be conducted within the National Patient-Centered Clinical Research Network (PCORnet) that enables distributed querying of electronic health record data in a common data model. The primary outcome will be change in clinic-level blood pressure (BP) control at 6 months. Secondary outcomes will include other blood pressure (BP) control metrics, other time points (12 and 18 months), and process measures such as BP measurement accuracy, medication intensification, and average systolic blood pressure (SBP) reduction after a medication intensification, and repeat visit within 4 weeks after a visit with elevated BP. The investigators hypothesize clinics randomized to the Full Support version will achieve a larger increase from baseline in the proportion of their hypertensive patients with controlled BP at 6 months as compared to clinics randomized to the Self-Guided version, and also as compared with usual care. The investigators will also conduct non-randomized comparisons of BP control in the Full Support and Self-Guided intervention arms to BP control in non-participating "Usual Care" institutions in PCORnet. The investigators requested certification of exemption from IRB oversight given that both arms will implement accepted guideline-based minimal risk quality improvement interventions. The protocol was submitted to the IRB and received approval with a certification letter designating the study as exempt.

Keywords

HypertensionSelf-Guided M.A.P. BP Improvement ProgramFull Support M.A.P. BP Improvement ProgramSelf-GuidedFull Support

Eligibility

For people ages 18-85

ACTIVE CLINICS

For inclusion as an Active Clinic in this study, clinics may participate must be able to identify:

  • A Site Champion who works at the clinic and who is willing to take primary responsibility for implementing the M.A.P. intervention
  • A Physician Champion who works at the clinic and who is willing to advocate actively for the M.A.P. intervention
  • A Practice Change Facilitator willing to attend a 1-day training and help guide implementation of the M.A.P intervention for Full Support sites, with the support of AMA staff (may be the Site Champion or Physician Champion, or a person with regional responsibilities who can support multiple sites)

Sites will be excluded if they:

  • Have implemented any high blood pressure quality improvement component from the M.A.P.

BP improvement program as part of Target: BP or from the AMA or Target: BP websites

  • Are currently involved in an ongoing clinical trial or grant funded project related to high blood pressure or hypertension

USUAL CARE CLINICS:

Usual Care Clinics will include PCORnet Datamarts participating in BP TRACK, a concurrently-running BP Control Registry within PCORnet that will provide quarterly datamart-level estimates of BP control and other aggregate metrics relevant to BP control.

All participating datamarts will be included, with the following exceptions:

  • Datamarts with any Active Clinics participating in BP MAP will be excluded
  • Datamarts that obscure dates via date-shifting will be excluded, as this will not allow for control of concurrent secular trends

PATIENTS

Within clinics (Active or Usual Care), patients will be eligible (and identified from the electronic health record) if they meet National Quality Forum BP Control Metric (NQF 0018) criteria:

  • Age 18-85 on the date of analysis
  • At least one outpatient encounter with a diagnosis of hypertension during the first six months of the measurement year (ending on the date of analysis)
  • No diagnosis or evidence of end-stage renal disease on or prior to the end of the measurement year
  • No pregnancy during the measurement year
  • No admission to an inpatient setting during the measurement year

Lead Scientist

  • Mark Pletcher
    As an epidemiologist and a general internal medicine physician, my research is designed to inform clinical decision-making and policy relevant to primary care and prevention.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT03818659
Study Type
Interventional
Last Updated