The design of an observational study of hypertension management, adherence and pressure control in Blood Pressure Success Zone Program participants

K. A. Payne, J. J. Caro, W. L. Daley, Z. M. Khan, K. J. Ishak, K. Stark, D. Purkayastha, J. Flack, E. Velázquez, S. Nesbitt, D. Morisky, R. Califf

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Aims: The Blood Pressure Success Zone (BPSZ) Program, a nationwide initiative, provides education in addition to a complimentary trial of one of three antihypertensive medications. The BPSZ Longitudinal Observational Study of Success (BPSZ-BLISS) aims to evaluate blood pressure (BP) control, adherence, persistence and patient satisfaction in a representative subset of BPSZ Program participants. The BPSZ-BLISS study design is described here. Methods: A total of 20,000 physicians were invited to participate in the study. Using a call centre supported Interactive Voice Response System (IVRS), physicians report BP and other data at enrolment and every usual care visit up to 12 ± 2 months; subjects self-report BPs, persistence, adherence and treatment satisfaction at 3, 6 and 12 months post-BPSZ Program enrolment. In addition to BPSZ Program enrolment medications, physicians prescribe antihypertensive medications and schedule visits as per usual care. The General Electric Healthcare database will be used as an external reference. Results: After 18 months, over 700 IRB approved physicians consented and enrolled 10,067 eligible subjects (48% male; mean age 56 years; 27% newly diagnosed); 97% of physicians and 78% of subjects successfully entered IVRS enrolment data. Automated IVRS validations have maintained data quality (< 5% error on key variables). Enrolment was closed 30 April 2007; study completion is scheduled for June 2008. Conclusions: The evaluation of large-scale health education programmes requires innovative methodologies and data management and quality control processes. The BPSZ-BLISS design can provide insights into the conceptualisation and planning of similar studies.

Original languageEnglish (US)
Pages (from-to)1313-1321
Number of pages9
JournalInternational Journal of Clinical Practice
Volume62
Issue number9
DOIs
StatePublished - Sep 2008

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Observational Studies
Blood Pressure
Hypertension
Pressure
Physicians
Antihypertensive Agents
Research Ethics Committees
Patient Satisfaction
Health Education
Information Systems
Quality Control
Self Report
Longitudinal Studies
Appointments and Schedules
Databases
Delivery of Health Care
Education

ASJC Scopus subject areas

  • Medicine(all)

Cite this

The design of an observational study of hypertension management, adherence and pressure control in Blood Pressure Success Zone Program participants. / Payne, K. A.; Caro, J. J.; Daley, W. L.; Khan, Z. M.; Ishak, K. J.; Stark, K.; Purkayastha, D.; Flack, J.; Velázquez, E.; Nesbitt, S.; Morisky, D.; Califf, R.

In: International Journal of Clinical Practice, Vol. 62, No. 9, 09.2008, p. 1313-1321.

Research output: Contribution to journalArticle

Payne, KA, Caro, JJ, Daley, WL, Khan, ZM, Ishak, KJ, Stark, K, Purkayastha, D, Flack, J, Velázquez, E, Nesbitt, S, Morisky, D & Califf, R 2008, 'The design of an observational study of hypertension management, adherence and pressure control in Blood Pressure Success Zone Program participants', International Journal of Clinical Practice, vol. 62, no. 9, pp. 1313-1321. https://doi.org/10.1111/j.1742-1241.2008.01840.x
Payne, K. A. ; Caro, J. J. ; Daley, W. L. ; Khan, Z. M. ; Ishak, K. J. ; Stark, K. ; Purkayastha, D. ; Flack, J. ; Velázquez, E. ; Nesbitt, S. ; Morisky, D. ; Califf, R. / The design of an observational study of hypertension management, adherence and pressure control in Blood Pressure Success Zone Program participants. In: International Journal of Clinical Practice. 2008 ; Vol. 62, No. 9. pp. 1313-1321.
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abstract = "Aims: The Blood Pressure Success Zone (BPSZ) Program, a nationwide initiative, provides education in addition to a complimentary trial of one of three antihypertensive medications. The BPSZ Longitudinal Observational Study of Success (BPSZ-BLISS) aims to evaluate blood pressure (BP) control, adherence, persistence and patient satisfaction in a representative subset of BPSZ Program participants. The BPSZ-BLISS study design is described here. Methods: A total of 20,000 physicians were invited to participate in the study. Using a call centre supported Interactive Voice Response System (IVRS), physicians report BP and other data at enrolment and every usual care visit up to 12 ± 2 months; subjects self-report BPs, persistence, adherence and treatment satisfaction at 3, 6 and 12 months post-BPSZ Program enrolment. In addition to BPSZ Program enrolment medications, physicians prescribe antihypertensive medications and schedule visits as per usual care. The General Electric Healthcare database will be used as an external reference. Results: After 18 months, over 700 IRB approved physicians consented and enrolled 10,067 eligible subjects (48{\%} male; mean age 56 years; 27{\%} newly diagnosed); 97{\%} of physicians and 78{\%} of subjects successfully entered IVRS enrolment data. Automated IVRS validations have maintained data quality (< 5{\%} error on key variables). Enrolment was closed 30 April 2007; study completion is scheduled for June 2008. Conclusions: The evaluation of large-scale health education programmes requires innovative methodologies and data management and quality control processes. The BPSZ-BLISS design can provide insights into the conceptualisation and planning of similar studies.",
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AU - Caro, J. J.

AU - Daley, W. L.

AU - Khan, Z. M.

AU - Ishak, K. J.

AU - Stark, K.

AU - Purkayastha, D.

AU - Flack, J.

AU - Velázquez, E.

AU - Nesbitt, S.

AU - Morisky, D.

AU - Califf, R.

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