The Importance of Testing Interventions in Real-World Settings

BACKGROUND:
Even in high-performing healthcare systems, some patients with diabetes have poor blood pressure (BP) control due to poor medication adherence and lack of medication intensification. Using the best evidence from efficacy trials to improve BP control among patients with diabetes and persistent hypertension, investigators in this study designed a pharmacist-led care management program — the Adherence and Intensification of Medications (AIM) intervention. To evaluate the implementation of the AIM intervention in real-life clinic settings, investigators then conducted a multi-site randomized trial in two high-performing integrated healthcare systems: Kaiser Permanente and VA. This study focused on 16 primary care teams at five medical centers (3 VAMCs and 2 Kaiser Permanente), comparing 1,797 intervention to 2,303 control patients from 6 months preceding to 6 months following the 14-month intervention period (8/08 through 9/09). Patients in the control arm of the study received usual care — standard care through their primary care provider. Patients in the AIM intervention group received consultation from pharmacists at their clinic or by phone at three-month intervals. The primary outcome measure was relative change in systolic BP (SBP) at six months following the intervention period; secondary analyses examined short-term SBP changes at 3-month intervals throughout the study period.

FINDINGS:

• In examining three-month intervals, the AIM program lowered systolic BP among patients more rapidly than usual care did for patients in the control group. However, usual care patients achieved equally low SBP levels by six months after the intervention, decreasing 9.0 mm Hg vs. 8.9 mm Hg in the intervention group. Thus, by six months and throughout the remainder of follow-up, control team patients' mean SBP were indistinguishible from those of the intervention group participants.
• There were no differences in health services utilization between eligible intervention and control patients during the 14-month intervention period.
• Patients in the AIM intervention group were more likely than patients in the control group to undergo medication changes during the 6-month period following their start date, although both groups had high rates of medication changes.
• Authors note that these findings emphasize the importance of evaluating programs that are found to be effective in efficacy trials in real-life clinical settings before urging widespread adoption.

LIMITATIONS:

• Other existing programs may have contributed to BP lowering among patients in the control group (i.e., performance measures, perfomance bonuses).
• In the intervention group, only 53% of study participants had a pharmcist encounter. Higher rates of participation might have led to a more substantial initial improvement and longer term effects.

AUTHOR/FUNDING INFORMATION:
This study was partly funded through VA/HSR&D's Quality Enhancement Research Initiative (QUERI; SDP 06-128). Drs. Heisler, Hofer, Klamerus, and Kerr are part of HSR&D's Center for Clinical Management Research, Ann Arbor, MI. Dr. Kerr also is Director of Diabetes-QUERI.

Heisler M, Hofer T, Schmittdiel J, Selby J, Klamerus M, Bosworth H, Bermann M, and Kerr E. Improving Blood Pressure Control through a Clinical Pharmacist Outreach Program in Diabetes Patients in Two High-Performing Health Systems: The Adherence and Intensification of Medications (AIM) Cluster Randomized Controlled Pragmatic Trial. Circulation May 8, 2012;e-pub ahead of print.