Multidisciplinary group clinic appointments: the Self-Management and Care of Heart Failure (SMAC-HF) trial

Abstract

Background: This trial tested the effects of multidisciplinary group clinic appointments on the primary outcome of time to first heart failure (HF) rehospitalization or death.

Methods and results: HF patients (n=198) were randomly assigned to standard care or standard care plus multidisciplinary group clinics. The group intervention consisted of 4 weekly clinic appointments and 1 booster clinic at month 6, where multidisciplinary professionals engaged patients in HF self-management skills. Data were collected prospectively for 12 months beginning after completion of the first 4 group clinic appointments (2 months post randomization). The intervention was associated with greater adherence to recommended vasodilators (P=0.04). The primary outcome (first HF-related hospitalization or death) was experienced by 22 (24%) in the intervention group and 30 (28%) in standard care. The total HF-related hospitalizations, including repeat hospitalizations after the first time, were 28 in the intervention group and 45 among those receiving standard care. The effects of treatment on rehospitalization varied significantly over time. From 2 to 7 months post randomization, there was a significantly longer hospitalization-free time in the intervention group (Cox proportional hazard ratio=0.45 (95% confidence interval, 0.21-0.98; P=0.04). No significant difference between groups was found from month 8 to 12 (hazard ratio=1.7; 95% confidence interval, 0.7-4.1).

Conclusions: Multidisciplinary group clinic appointments were associated with greater adherence to selected HF medications and longer hospitalization-free survival during the time that the intervention was underway. Larger studies will be needed to confirm the benefits seen in this trial and identify methods to sustain these benefits.

Clinical trial registration url: http://www.clinicaltrials.gov. Unique identifier: NCT00439842.

Keywords: clinical trial; heart failure; survival analysis.

Figure 1

Flowchart of SMAC-HF enrollment, randomization and follow-up to first HF-related rehospitalization or death.

Figure 2

Kernel-smoothed hazard functions for the event HF rehospitalization or death. Zero was pre-specified as the randomization date plus 8 weeks. The hazard functions represent the probability of HF rehospitalization or death at time t conditional on survival to that point. The group hazards cross at approximately 7 months post-randomization, with the rate of rehospitalization or death in the intervention group lower than that of the control group prior to 7 months.

Figure 3

Kaplan-Meier survival estimates of time to first HF rehospitalization or death. Zero was pre-specified as the randomization date plus 8 weeks. The dashed horizontal line at month 7 (which is 30 days after the final booster group clinic appointment occurs) marks the month at which the difference in treatment group hazard functions cross, thus indicating the effect of treatment compared to standard care is different prior to and after this point. Up to month 7 (all events with t > 30 days post-booster censored), the Cox model identified a significantly longer event-free time associated with the intervention (p = 0.04) for recipients of the intervention. The effect of the intervention did not extend into the later period of follow-up (p = 0.30).