Design, rationale, and baseline characteristics of a cluster randomized controlled trial of pay for performance for hypertension treatment: study protocol

Abstract

Background: Despite compelling evidence of the benefits of treatment and well-accepted guidelines for treatment, hypertension is controlled in less than one-half of United States citizens.

Methods/design: This randomized controlled trial tests whether explicit financial incentives promote the translation of guideline-recommended care for hypertension into clinical practice and improve blood pressure (BP) control in the primary care setting. Using constrained randomization, we assigned 12 Veterans Affairs hospital outpatient clinics to four study arms: physician-level incentive; group-level incentive; combination of physician and group incentives; and no incentives (control). All participants at the hospital (cluster) were assigned to the same study arm. We enrolled 83 full-time primary care physicians and 42 non-physician personnel. The intervention consisted of an educational session about guideline-recommended care for hypertension, five audit and feedback reports, and five disbursements of incentive payments. Incentive payments rewarded participants for chart-documented use of guideline-recommended antihypertensive medications, BP control, and appropriate responses to uncontrolled BP during a prior four-month performance period over the 20-month intervention. To identify potential unintended consequences of the incentives, the study team interviewed study participants, as well as non-participant primary care personnel and leadership at study sites. Chart reviews included data collection on quality measures not related to hypertension. To evaluate the persistence of the effect of the incentives, the study design includes a washout period.

Discussion: We briefly describe the rationale for the interventions being studied, as well as the major design choices. Rigorous research designs such as the one described here are necessary to determine whether performance-based payment arrangements such as financial incentives result in meaningful quality improvements.

Trial registration: http://www.clinicaltrials.govNCT00302718.

Figures

Figure 1

Randomization schematic. ALLHAT = Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial; VA = Veterans Administration. *Enrolled up to seven primary care physicians at each study site. †Enrolled up to 15 non-physician participants (e.g., nurses and pharmacists) at each study site.

Figure 2

Feedback report #3 for a physician participant in the individual and group incentives study arm. BP = blood pressure.

Figure 3

Study outcomes assessed to determine incentive payment. JNC 7 = Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. *Blood pressure control for patients without co-existing diabetes defined as < 140/90 mm Hg; with co-existing diabetes < 130/80 mm Hg. †Defined as either adding new or increasing current antihypertensive medication, prescribing lifestyle modifications, or rechecking the patient's blood pressure within six weeks to determine if blood pressure controlled; if not controlled, responding with at least one of above actions.

Figure 4

Study timeline.