This was a prospective, cluster-randomized controlled trial in six community-based family medicine residency programs in Davenport, Des Moines (2 offices), Mason City, Sioux City and Waterloo, Iowa, randomized to either control (n=3) or intervention (n=3) group using a table of random numbers. Preliminary data were collected at baseline including clinic characteristics and an audit of medical records for the most recent BP from a random sample of patients with hypertension. Educational lectures, published national guidelines,19
and clinical trial evidence20
were provided to physicians in all six clinics before the study.
The study was approved by the University of Iowa Institutional Review Board (IRB) and the local IRBs for the six clinics. The recruitment process was identical in control and intervention offices. A research nurse employed by each office reviewed lists and clinic schedules for patients with diagnostic codes for hypertension and approached patients to participate. The research nurse either telephoned patients who met the study criteria or approached them during a regular clinic visit.
Patients in the active study groups provided written informed consent. Males or females over 21 years of age with a diagnosis of essential hypertension taking 0–3 antihypertensives were eligible if they did not have diabetes and their SBP was between 140–179 mm Hg or DBP 90–109 mm Hg. Patients with diabetes with a SBP between 130–179 mm Hg SBP or DBP 80–109 mm Hg were eligible. Exclusion criteria included: BP medication or dose change within four weeks of the baseline visit, BP values ≥ 180/110 mm Hg, evidence of hypertensive urgency or emergency, myocardial infarction or stroke (6 months prior to screening), New York Heart Association Class III or IV heart failure, unstable angina, serious renal or hepatic disease, pregnancy, poor prognosis (life expectancy less than 3 years), dementia or cognitive impairment.
We also performed a medical record audit of hypertensive patients from intervention clinics who met the same inclusion criteria but who did not receive the intervention, termed the passive observation group. The goal of evaluating this group was to determine if BP improved throughout the entire practice.
The primary aim was to evaluate if guideline adherence improved more in the intervention group than the control group, using a tool validated for this study.21–23
Once the patient completed the trial, the research nurses performed a structured medical record abstraction process for all patients that included all clinic progress notes, laboratory values, medications and records from hospitalizations or emergency department visits. For patients in the passive observation group, an index date was selected and data were abstracted for six months before and six months after the index date. An investigator visited each clinic and evaluated a sample of the case abstracts against the medical record to ensure that data were being completely abstracted by each research nurse. Guideline adherence was determined by the percent of 22 eligible criteria met by each patient using a computerized algorithm developed by the investigators.21–23
The research nurses were trained to measure BP using standardized guidelines and certified to properly measure BP at baseline and then once yearly.24, 25
BP was measured three times with an automated Omron HEM 907-XL device. The second and third values were averaged and used as the study BP. At the end of the baseline visit, the research nurse placed a 24-hour monitor set to measure BP every 20 minutes during the day and every 30 minutes during sleep (SpaceLabs 90217-A, SpaceLabs Medical, Redmond, Washington).26
These baseline 24-hour results were not made available to the physician or clinical pharmacist until the patient completed the trial. Finally, patients in both groups were given written information on hypertension from NHLBI.
The following data were collected at the baseline visit: patient age, height, weight, gender, race, educational degree, insurance status, household income, marital status, smoking status, alcohol intake and history of co-existing conditions. Race and ethnicity was self-declared by the patient. The nurse personally administered a validated self-reported questionnaire of medication adherence27, 28
and a questionnaire developed for another study on symptoms that might indicate adverse reactions (potential range from 0–188).8, 29
Patients returned at 3 and 6 months for repeat BP measurements. At the 6-month visit, the nurses performed all of the same procedures as performed at the baseline visit including adverse reaction and medication adherence surveys. Patients received $100 if they completed both 24-hour BP measurements to reimburse them for the inconvenience of wearing the monitors. Patients were telephoned prior to clinic visits to encourage adherence with study visits.
The intervention was modeled after our other studies.6, 8
Intervention physicians and pharmacists underwent teambuilding exercises conducted by two investigators using previous described strategies.8, 30
All six offices employed clinical pharmacists who had been at the office for at least 8 years. The clinical pharmacists had all received a doctor of pharmacy (PharmD) degree and completed a clinical pharmacy residency in primary care. In 5/6 sites the clinical pharmacists were funded 50% by the medical office (to provide family medicine physician resident education and patient care) and 50% from the College of Pharmacy (for pharmacy student teaching). In one control site, the clinical pharmacist was funded entirely by the medical office’s health system. The majority of the pharmacists’ time was spent on pharmacy student, medical resident and staff physician education on drug therapy with a minority of their time devoted to direct patient management prior to the study. All of the pharmacists were well versed in hypertension treatment. However, two initial 90-minute training sessions were provided to the intervention pharmacists by one investigator to ensure that a consistent intervention was provided.
All study visits with intervention pharmacists occurred in the medical office and pharmacists were encouraged to assess medications and BP at baseline, one month plus over the telephone at 3 months and more frequently if necessary. The pharmacists made recommendations consistent with national guidelines.18, 19
BP control was defined as an office BP <130/80 mm Hg for patients with diabetes or chronic kidney disease and <140/90 mm Hg for all other patients.18
Physicians and pharmacists in the intervention offices decided how to best implement the intervention and they were not required to perform the suggested intervention visits for this pragmatic trial. The pharmacists almost always provided face-to-face recommendations to the patient’s physician. The pharmacist provided physician education, if necessary, and all therapy changes were approved by the physician.
Clinical pharmacists in control sites abstained from providing care for study patients but continued to answer general treatment questions from physicians. Patients in the control group also received BP measurements at baseline, 3 and 6 months. The primary care physician determined when office visits for routine care or BP should occur.