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BACKGROUND/RATIONALE:
There are 65 million Americans and over 8.5 million veterans who have been diagnosed with hypertension; yet only 31% of all hypertensive patients have their blood pressure (BP) under effective control (<140/90 mm/Hg). Uncontrolled hypertension greatly increases the risk of cerebral vascular accidents, coronary artery disease, myocardial infarction, renal failure, congestive heart failure, and mortality. Despite the damaging impact of hypertension and the availability of well-defined therapies and widely accepted target values for BP, interventions to improve BP control have had limited success.
OBJECTIVE(S):
The study is one of the first to compare three interventions designed to improve BP control: a behavioral educational intervention, an evidence-based medication management intervention, and combined intervention for patients with poor BP control defined by home BP monitoring. The primary hypotheses are: 1) Patients who receive only the behavioral intervention will show improved rates of BP control as compared to the control group over 18 months of follow-up; 2) Patients who receive only the hypertension medication management intervention will show improved rates of BP control as compared to the control group over 18 months of follow-up; and, 3) Patients who receive the combined intervention will show higher rates of BP control as compared to all other patients over the 18 months of follow-up.
METHODS:
A three-year randomized controlled trial among veterans with poor BP control testing three interventions in three VA primary care clinics is proposed to improve BP control. We will test these interventions using home BP monitoring in a four group design administered via the telephone: 1) control group - a group of hypertensive patients who receive usual care; 2) Nurse-administered tailored behavioral intervention previously tested (HSR&D grant IIR 20-034); 3) Nurse-administered medication management according to a hypertension decision support system that uses the VA's Computerized Medical Record System (VA HSR&D grant CPI 99275); 4) combination of the tailored behavioral and medication management interventions.
A random sample of hypertensive patients with poor BP control at baseline (n=609) were consented and randomly allocated to one of four arms. The interventions will activate only when home BP monitoring indicates inadequate BP control. Patients assigned to the behavioral intervention will receive a tailored self-management intervention to promote adherence with medication, information on the risks of hypertension and health behaviors at periodic telephone contacts. Patients will receive feedback about their recent BP values, continuous patient education, and will be monitored and supported to enhance treatment adherence. Patients randomized to the medication management arm will have their hypertension regimen changed by a nurse using a hypertension decision support system developed and validated in the VA. Medication recommendations generated are based on JNC 7 and the VA's hypertension treatment guidelines and are also individualized to patients' comorbid illnesses, laboratory values, and other elements of patients' clinical status. Medication management will be based on home BP monitoring and delivered by telephone. The nurse is part of an extended primary care team and communicates changes to the patients' primary care providers via a study physician.
The primary outcome will be a dichotomous measure representing whether or not the patient's BP is in control: >140/90 mm/Hg (non-diabetic) and >130/80 mm/Hg (diabetics). Measures will be made at six-month intervals over 18 months (4 total measurements). We will model the outcome measures and evaluate the interventions using a mixed effects model for dichotomous outcomes.
FINDINGS/RESULTS:
Among 20 individuals, we pilot tested the feasibility of the telemedicine devices and the reliability of the blood pressure readings (October 2005). Results suggested that patients were able to use the equipment and the devices were reliable.
We enrolled 589 participants to the primary study and randomized 147 to usual care, 148 to behavioral intervention, 148 to a medication management intervention, and 146 to a combined behavioral medication management intervention. Nearly 50% of the participants are minorities and 41% of had a diagnosis of Diabetes at baseline. The average age of the sample was 63.5 years (30 -89 years of age). Eighty-six percent had a high school diploma or greater and 62% scored greater than a 9th grade equivalent on the REALM health literacy questionnaire. At the commencement of the study, the overall average blood pressure was 129.2/77.5.
Each of the participants randomized to the intervention were issued a blood pressure monitor and a telemedicine device. During the twenty-four months since enrollment started, the nurses have resolved 287 triggered safety alerts for 72 patients and 1686 triggered interventions alerts for 386 patients. The research assistants have resolved 1732 triggered technical alerts for 381 patients. Among the technical alerts triggered only 59 were patient initiated.
IMPACT:
The proposed trial will be one of the first to evaluate the use of non-clinic based blood pressure readings and telecommunications to activate an intervention and monitor its effects. Added benefits of this study will include monitoring and treatment algorithms that can be translated into VA primary care clinics should they prove to be effective. The views expressed by some of the patients (77) who have completed the study identify that daily monitoring, nurse interaction and Study Physician were important to their understanding of hypertension. Some of the comments from patients were "I would like to see everyone with diagnosis of hypertension involved in this study and would like to see the study last longer than 18 months. Felt the study was very helpful", "Very good, and very educational. Directions and instructions during enrollment were such that I could understand them". "Study and care were outstanding. Enjoyed having someone (nurse) call me, especially praise calls, they were really good", "Actually appreciated the study; medication changes are working better than prior medication changes. Liked this medicine better", "Excellent program - need to get more veterans involved", "I think it was very beneficial to me. Two areas helpful to me were diet (I lost 20 lbs) and exercising (4 times a week). Nurse phone calls were a good reminder for me" "It was a really good program. It was good to have a list of resources to call if I had a problem. Also was good to get the telephone reminders. Another thing was the validation that my BP was being controlled despite the elevate numbers received in the clinic".
PUBLICATIONS:
None at this time.
DRA:
Chronic Diseases, Health Services and Systems
DRE:
Treatment, Quality of Care, Communication and Decision Making
Keywords:
Behavior (patient), Telemedicine, Hypertension
MeSH Terms:
none
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