SPAN-CHF II: Specialized Primary and Networked Care in Heart Failure II

Linda Brookes, MSc

Disclosures

October 10, 2005

Editorial Collaboration

Medscape &

Presenter: Andrew R. Weintraub, MD (Tufts-New England Medical Center, Boston, Massachusetts)

A randomized controlled study of a disease management program in heart failure patients has shown even greater improvement in short-term clinical outcomes when an automated home monitoring (AHM) system is added to the program. The original Specialized Primary and Networked Care in Heart Failure (SPAN-CHF) disease management program was the first nurse-driven disease management program shown in a randomized clinical trial, SPAN-CHF I, to produce significant benefit in heart failure patients.[1] The SPAN-CHF II study added an interactive home monitoring system to the program.[2]

SPAN-CHF I

SPAN-CHF I enrolled 200 patients at 6 different clinical sites. All patients had been hospitalized with a primary diagnosis of heart failure and discharged within the previous 2 weeks; most were on appropriate heart failure medications. Patients were randomized to usual care or intervention with the disease management program over 90 days. During this period, compared with patients randomized to usual care, those who were randomized to the disease management program experienced 52% fewer heart failure hospitalizations (P = .027), 43% fewer cardiovascular hospitalizations (P = .043), and 36% fewer days in hospital for cardiovascular cause (P < .001). In addition, intervention patients showed a trend toward reduced all-cause hospitalizations and total hospital days. Discontinuation of the active intervention, however, resulted in loss of the initial benefit during long-term follow-up.

Disease Management Program

The intervention program used in SPAN-CHF I consisted of a home visit by an experienced nurse-manager within 3 days of randomization. During this visit, which focused on dietary and medical compliance, daily weight self-monitoring, and early reporting of changes in weight or clinical status, patients and family members were given a handbook designed by the SPAN-CHF team outlining the program. The handbook contained information about heart failure (definition), medications, low-salt diet, importance of daily weight, and clinical signs and symptoms that should prompt a call to the SPAN-CHF nurse or the patient's primary care physician. The handbook also contained the phone numbers for the patient's SPAN-CHF nurse and the 24-hour SPAN-CHF on-call nurse. At the time of the visit, the nurse also did a cardiovascular examination and a symptom assessment.

Depending on clinical status, the nurse-manager telephoned patients weekly or biweekly, focusing on identifying changes in clinical condition and education reinforcement. At each follow-up phone call, the information discussed during the home visit was reinforced. Nurse-managers were available by telephone 24 hours per day, 7 days per week.

Patients were instructed to report clinical status changes, including any change in weight > 2 pounds. Nurse-managers received 24-hour/day support and weekly management teleconferences with heart failure physician-specialists. They also communicated frequently with primary care physicians, alerting them to changes in patient condition and suggesting regimen changes advised by the heart failure physician-specialists.

SPAN-CHF II

In SPAN-CHF II, an AHM was added to the SPAN-CHF I disease management program and this combined intervention was tested at 4 centers, including 2 in Massachusetts.

A total of 188 patients (mean age 68, 65% male) who had previously been hospitalized for heart failure were enrolled in the study. All patients had undergone measurement of left ventricular (LV) function (mean 30%) within the previous 6 months. Most (95%) had New York Heart Association (NYHA) class II/III disease. The group was well treated with heart failure medications, particularly angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (81%-90%) and beta-blockers (84%-93%). These medications and doses were defined as optimized by heart failure specialists.

Patients were randomized within 2 weeks of heart failure hospitalization to an intervention arm, consisting of the SPAN-CHF I disease management program plus AHM (n = 95) or to a control arm consisting of the SPAN-CHF I disease management program only (n = 93).

Automated Home Monitoring System

The AHM consisted of an objective data component (Philips Medical Systems North America; Shelton, Connecticut) comprising an interactive standing weight scale and a blood pressure cuff to measure blood pressure and pulse, as well as a text message component (Health Hero Network, Mountain View, California) comprising an interactive device that displayed series of questions about clinical status and medication compliance. Weight, pulse, and blood pressure measurements obtained by the patient and answers to the text questions were transmitted daily by phone line via a modem to the nurse-manager, who reviewed the trends information daily. The text message answers were categorized into low, intermediate, and high risk.

Results

Hospitalizations for heart failure, the primary endpoint of the study, were significantly reduced by 72% over 90 days in the group that had disease management plus AHM compared with disease management alone (Table 1). Cardiac hospitalizations were also significantly reduced, by 63%, on the intervention arm. However, all-cause hospitalizations did not differ between the 2 arms.

Table 1. Number of Hospitalizations Per Patient-Year Alive
Control Intervention RR P Value
Heart failure 1.82 0.51 0.28 .03
Cardiac 2.20 0.81 0.37 .029
All 2.73 2.18 0.80 NS

A trend was seen toward fewer days for heart failure, cardiac, or all-cause hospitalization in the intervention group, but none of the differences reached significance (Table 2).

Table 2. Number of Hospitalization Days Per Patient-Year Alive
Control Intervention RR P Value
Heart failure 9.04 4.06 0.45 NS
Cardiac 10.62 4.61 0.43 NS
All 14.24 10.25 0.72 NS

Patients with diabetes at baseline were significantly more likely, and those who had AHM significantly less likely, to be hospitalized for heart failure (Table 3). However, no significant effects of age, gender, LV ejection fraction, NYHA class, or hypertension were seen.

Table 3. Interaction of Diabetes and AHM With Primary Endpoint
Variable Odds Ratio P Value
Diabetes 4.36 .002
AHM vs no AHM .24 .018

Four deaths occurred in the control arm and 1 in the intervention arm.

Clinical Implications

The addition of AHM to the disease management system previously validated in SPAN-CHF I produced further improvement in short-term heart failure-related clinical outcomes in patients recently hospitalized for heart failure. The nurse-managers who ran the study estimated that the addition of the AHM intervention resulted in only 15% to 20% additional time spent on interaction with patients. No reduction was seen in all-cause hospitalization with the AHM intervention, possibly because the nurse-managers may have been identifying more noncardiac reasons for hospitalization.

A number of analyses of the SPAN-CHF data are being carried out, including the interventions performed during the study period and the cost-effectiveness of the disease management program with and without ATM.

References
  1. Weintraub AJ, Kimmelstiel C, Levine D, et al. A multicenter randomized controlled comparison of telephonic disease management vs automated home monitoring in patients recently hospitalized with heart failure: SPAN-CHF II trial. Program and abstracts from the 9th Annual Scientific Meeting of the Heart Failure Society of America, September 18-21, 200, Boca Raton, Florida. Recent and late breaking clinical trials.

  2. Kimmelstiel C, Levine D, Perry K, Patel AR, et al. Randomized, controlled evaluation of short- and long-term benefits of heart failure disease management within a diverse provider network: the SPAN-CHF trial. Circulation. 2004;110:1450-1455.

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