Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Trial of Low And High Intensity Strategies to Maintain Blood Pressure Control
Brief Summary: The long-range goal of this research is to advance understanding of long-term blood pressure (BP) control in patients with uncontrolled hypertension (HTN). The work builds on our experience in implementing new models of care in Veterans Affairs (VA) and non-VA settings, including three National Institute of Health (NIH) studies of pharmacist-based HTN management. The long-term effectiveness of such models, especially in veterans, is unknown. Thus, the primary goal of this study is to evaluate how to sustain long-term BP control in veterans with HTN following a 6-month intensive pharmacist intervention.

This study will enroll veterans with uncontrolled HTN into a 6-month intensive pharmacist-based intervention. Following this initial intervention, participants will be randomized to continued intervention or a one-time patient and provider education intervention. BP will be compared in the two groups over a 2-year follow-up period. The intervention to control and sustain BP will follow VA guidelines and include: 1) comprehensive medication assessment by the pharmacist; 2) an explicit plan to intensify treatment if indicated; 3) strategies to improve adherence; and 4) follow-up pharmacist visits to sustain BP control. The intervention is based on models identified in a recent Agency for Healthcare Research and Quality (AHRQ) report as being the most potent strategies to improve BP. The study will benefit from a strong research team with expertise in guideline development, implementation science, quality measurement, and behavioral science. The study will also provide important information on the degree to which BP control deteriorates after patients are referred back to usual care. The specific aims and related hypotheses of the study are to:

Aim 1:Compare BP control in patients randomized to long-term continuation of the pharmacist intervention or to a less intense one-time patient and provider education intervention.

Hypothesis 1a: Patients randomized to the continued pharmacist intervention will have higher rates of BP control 24 months after randomization.

Hypothesis 1b: Patients randomized to the continued pharmacist intervention will have lower mean BP 24 months after randomization.

Aim 2: Compare antihypertensive medication intensification in patients randomized to the continued pharmacist intervention or the less intense intervention.

Hypothesis 2: A higher proportion of patients who continued the pharmacist intervention will have medication intensification over the 24-month follow-up.

Aim 3: Compare medication adherence in the two intervention groups. Hypothesis 3a: Medication adherence will be higher in patients randomized to the continued pharmacist intervention group during the 24 month follow-up period.

Hypothesis 3b: Improvements in medication adherence will be associated with improvements in BP during each study interval.


Options:
A: Arm Label: Arm 1; Type: ACTIVE_COMPARATOR; Interventions: Other: High Intensity Intervention, Other: All- 6 month pharmacist intervention | Arm Label: Arm 2; Type: ACTIVE_COMPARATOR; Interventions: Other: Low Intensity Intervention, Other: All- 6 month pharmacist intervention | Intervention Type: OTHER; Name: High Intensity Intervention; Assigned to Arm(s): Arm 1 | Intervention Type: OTHER; Name: Low Intensity Intervention; Assigned to Arm(s): Arm 2 | Intervention Type: OTHER; Name: All- 6 month pharmacist intervention; Assigned to Arm(s): Arm 1, Arm 2
B: Arm Label: Insulin glargine; Type: OTHER; Interventions: Drug: Insulin glargine | Intervention Type: DRUG; Name: Insulin glargine; Assigned to Arm(s): Insulin glargine
C: Arm Label: Arm 1; Type: EXPERIMENTAL; Interventions: Behavioral: Intervention | Arm Label: Arm 2; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Usual care | Intervention Type: BEHAVIORAL; Name: Intervention; Assigned to Arm(s): Arm 1 | Intervention Type: BEHAVIORAL; Name: Usual care; Assigned to Arm(s): Arm 2
D: Arm Label: Usual care; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Nurse-led blood pressure clinic; Type: EXPERIMENTAL; Interventions: Other: Nurse-led blood pressure clinic | Intervention Type: OTHER; Name: Nurse-led blood pressure clinic; Assigned to Arm(s): Nurse-led blood pressure clinic

Answer: A