Stroke QUERI Project - Take Control of Your Blood Pressure (TCYB) Study

Project Number R01 HL070713-01 funded by NHLBI.
June 1, 2003 - May 31, 2008

Only approximately 25% of all hypertensive patients have their blood pressure (BP) under effective control (<140/90 mm Hg). Abundant evidence shows that effective BP control lowers the risk of CVD.

We propose a five-year trial to evaluate both a nurse-case manager administered behavioral intervention and blood pressure self-monitoring interventions to improve BP patient control. This trial will occur in a primary care setting among diagnosed hypertensive patients and will improve patient BP control. We will examine the effect of each of these interventions separately and in combination, and we will test the following hypotheses: The proportion of patients with adequate BP control who receive BOTH the home blood pressure monitors AND the nurse-case manager intervention will be increased by 25% as compared to usual care over 2 years of follow-up. The proportion of patients with adequate BP control who receive only the home blood pressure monitors OR the nurse-case manager intervention will be increased by 10% as compared to usual care over 2 years of follow-up.

This is a 2 by 2 randomized controlled trial. We will obtain consent from 570 hypertensive patients from 3 large Primary Care Clinics and randomly assign them to receive the nurse intervention alone, home monitoring alone, both interventions, or usual care. Based on baseline needs assessment, patients randomized to the nurse administered, tailored intervention will receive a telephone intervention to promote adherence with medication, including support and reminders, information on the risks of hypertension, health behaviors, patient/provider communication, literacy, and side effects at periodic telephone contacts. Patients will receive continuous patient education and will be monitored and supported to enhance adherence. Patients assigned to the home BP monitors will record their BP bi-weekly and provide this information to their provider. The primary outcome will represent whether or not the patient’s BP is >140/90 mm/Hg (non-diabetic) and >130/85 mm/Hg (diabetics) at baseline and subsequent 6-month intervals for 24 months.

We are in the first year of our five-year study and have completed the development of the nurse intervention and recruited all appropriate staff. All staff have been trained to perform BP measurements using a random zero sphygmomanometer. We are in the process of piloting the interventions and have obtained local IRB approval. We will begin recruiting in the next three months.

Project work is ongoing.

One of the national health objectives for the year 2010 is to increase the proportion of patients with controlled BP to at least 50%, and this study will provide important information that will help meet these goals. The proposed interventions will be easily implemented across other sites once their effectiveness has been determined. The product of our research will be recommendations for health services interventions that will allow primary care clinic managers to achieve an improved rate of BP control for their patients with hypertension. Translation of our findings into practice will be enhanced by the pragmatic design of each intervention.