Published online before print May 28, 2008, doi: 10.1161/CIRCHEARTFAILURE.107.744870
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Original Articles |
Long-Term Prospective, Randomized, Controlled Study Using Repetitive Education at Six-Month Intervals and Monitoring for Adherence in Heart Failure Outpatients
The REMADHE Trial
From the Heart Institute (InCor) do Hospital das Clínicas da Faculdade de Medicina da University of São Paulo, São Paulo, Brazil.
Correspondence to Dr Edimar Alcides Bocchi, Rua Oscar Freire 2077, apto 161, São Paulo, Brazil, CEP 05409-011. E-mail dcledimar{at}incor.usp.br
Received October 8, 2007; accepted May 13, 2008.
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Abstract |
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Background— The effectiveness of heart failure disease management programs in patients under cardiologists’ care over long-term follow-up is not established.
Methods and Results— We investigated the effects of a disease management program with repetitive education and telephone monitoring on primary (combined death or unplanned first hospitalization and quality-of-life changes) and secondary end points (hospitalization, death, and adherence). The REMADHE [Repetitive Education and Monitoring for ADherence for Heart Failure] trial is a long-term randomized, prospective, parallel trial designed to compare intervention with control. One hundred seventeen patients were randomized to usual care, and 233 to additional intervention. The mean follow-up was 2.47±1.75 years, with 54% adherence to the program. In the intervention group, the primary end point composite of death or unplanned hospitalization was reduced (hazard ratio, 0.64; confidence interval, 0.43 to 0.88; P=0.008), driven by reduction in hospitalization. The quality-of-life questionnaire score improved only in the intervention group (P<0.003). Mortality was similar in both groups. Number of hospitalizations (1.3±1.7 versus 0.8±1.3, P<0.0001), total hospital days during the follow-up (19.9±51 versus 11.1±24 days, P<0.0001), and the need for emergency visits (4.5±10.6 versus 1.6±2.4, P<0.0001) were lower in the intervention group. Beneficial effects were homogeneous for sex, race, diabetes and no diabetes, age, functional class, and etiology.
Conclusions— For a longer follow-up period than in previous studies, this heart failure disease management program model of patients under the supervision of a cardiologist is associated with a reduction in unplanned hospitalization, a reduction of total hospital days, and a reduced need for emergency care, as well as improved quality of life, despite modest program adherence over time.
Key Words: heart failure • education • disease program management • case management • controlled clinical trials • quality of life • patient compliance
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Introduction |
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Recent disease management program (DMP) meta-analyses have reported reductions in mortality and hospitalizations of heart failure (HF) patients.1–4 However, important issues in DMP for HF remain to be resolved. For example, few investigations include non-high-risk HF for early hospitalization managed by cardiologists or report long-term results.3–6 No studies have reported the long-term effects of a repetitive-cyclic reeducation program.3,4,7,8 Most DMPs have been tested in high-risk HF patients that have been discharged from the hospital, and it has been suggested that DMPs are less effective when patients are already being treated by an HF specialist.1,3,7,9,10 Improved survival is associated with cardiologist care and with multidisciplinary teams providing specialized follow-up.4,8 Whether both together could benefit HF is not well defined.
Clinical Perspective p 124
We tested whether a DMP consisting of a long-term repetitive multidisciplinary education program and telephone monitoring could benefit HF outpatients in usual ambulatory care already under the care of a cardiologist with experience in HF.
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Methods |
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Study Design
The REMADHE [Repetitive Education and Monitoring for ADherence for Heart Failure] trial is a prospective, randomized, single-center open parallel trial controlled by nonintervention simple randomization and designed to compare intervention with control (Figure 1).
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The first patient was randomized on October 5, 1999, and the last on January 18, 2005, in the Heart Institute of the São Paulo University Medical School. At least an 18-month follow-up from inclusion of the last patient was planned to initiate the trial analysis. Referred patients, with no exclusion criteria, were randomized in a 2:1 ratio between the intervention and control parallel groups, respectively. A computer-generated randomization list was drawn up by the statistician. The randomization 2:1 was used based on the previously published benefit of DMP in HF. The 2:1 randomization sequence was developed in blocks of 3, including 2 interventions and 1 control. The order of interventions and control within each block was also randomly assigned. To avoid deduction of the next treatment allocation and for arrangement of education classes, researchers were blinded for block size; each randomization included a number of patients in multiples of 3, with at least 15 eligible participants, except for the last group. The order of subjects in each group was randomized using a computer program. For allocation concealment, sequential, numbered, opaque, and sealed envelopes were used. Investigators ensured that the envelopes were opened sequentially only after the participants’ names were written on the appropriate envelopes. The nurse involved in the education/monitoring enrolled the patients and assigned participants to their groups. The participants, the nurse, and multidisciplinary team were not blinded as to group assignment. Those assessing the outcomes were blinded as to group assignment and end points (except for quality of life and adherence) that were determined by unanimous decision.
The research staff did not participate in intervention decisions. Hospitalizations, deaths, modes of death, need for emergency treatment, procedures, and events were obtained from patient self-reported data at medical visits, in telephone calls, and in a review of hospital records. At the time of enrollment and at 6-month intervals, scripted questionnaires were administered addressing heart-failure quality of life (The Minnesota Living with Heart Failure Questionnaire) and adherence score.
Standard follow-up medical visits for the intervention and control groups were performed during the study period by the same ambulatory cardiology team, which was not informed of the randomization. The scheduled interval between routine ambulatory evaluations was 3 to 4 months. Also, the ambulatory team did not participate in any step of the study. The ambulatory cardiology team was oriented to follow Brazilian Guidelines and standard treatment of the Heart Failure Clinics in the management of patients. Complementary follow-up visits were carried out, depending on each patient’s needs and on the decision of the attending cardiologist. When nurses detected noncompliance or worsening of the clinical condition, an unscheduled visit to the patient’s attending cardiologist could be proposed. Telemanagement by cardiologists or in-home technology, such as electronic blood pressure monitoring, ECG, or finger pulse oximeter, was not permitted.
Study Population Selection
Patients under the care of a cardiologist with experience in HF were consecutively recruited from a tertiary referral center. The study was carried out in the Heart Failure Clinics. Eligible ambulatory care patients were aged 18 years or older with irreversible chronic HF of at least 6 months’ duration.
Exclusion criteria included a patient’s inability to attend educational sessions and the researcher’s inability to monitor the patient because of the patient’s lack of transportation, living too far away, or social or communication barriers; myocardial infarction or unstable angina within 6 months before randomization; cardiac surgery or angioplasty within 6 months of randomization; hospitalized patients or patients recently discharged from the hospital; severe renal/hepatic/neurological/pulmonary or any systemic disease that could confuse the interpretation of results and impair expected survival; planned surgical procedure or other procedure that could influence follow-up; and pregnant women or women of childbearing potential.
Disease Program Management
This disease program management protocol was designed to have the following characteristics: inclusion of outpatients; intervention through education for patients and caregivers; medication management with optimized therapy based on guidelines and remote monitoring; delivery personnel with nurses, cardiologists, pharmacists, social workers, dietitians, dentists, and psychologists; face-to-face individual/group communication; and telephone in-person communication. The intensity/complexity was long-term follow-up with repetitive education at 6-month intervals. The environment was hospital outpatient; the outcomes measured were clinical, quality of life, and adherence.11 A daily (except on weekends) telephone number was provided to patients for emergencies or questions about HF management (Figure 1; Table 1).
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Evaluation of Adherence
Adherence was monitored during follow-up by using a self-reporting specific questionnaire (Data Supplement Appendix).
Objectives
The prespecified primary end points were as follows: (1) combined death secondary to any cause or unplanned first hospitalization; (2) quality-of-life changes. The prespecified secondary end points were as follows: (1) feasibility of this repetitive DMP based on the percentage of referred patients who were excluded and on the percentage of patients randomized for intervention who did not attend more than 1 educational session; (2) death from any cause; (3) unplanned total hospitalizations; (4) unexpected death at home or death during hospitalization; (5) need for unplanned emergency care; (6) total days of hospitalization; (7) number of days of each hospitalization; (8) adherence after DMP; and (9) subgroup analysis. The study protocol was submitted initially to the Heart Institute Ethical Committee in 1999 and received the number 827/99. The local ethical committees approved the study. All patients gave informed consent for participation in the study. The study was registered at http://clinicaltrials.gov (Identifier NCT 00505050).
Statistical Analysis
Descriptive statistical analysis was composed of simple distribution of frequencies, calculation of proportions, means, and their respective standard deviations (SDs) or standard errors (SEs). Continuous variables were expressed as mean±SD or ±SE, and categorical variables were expressed as percentages. For effects of group comparison, the t test was used for normal distribution. The Mann-Whitney test was used to compare variables without normal distribution. For analysis of quality of life and adherence, we used a 2-way analysis of variance with repeated measures on time (follow-up) (2 factors: group—intervention and control; and time—T0, T1, Tn). For categorical variables, the 
2 test or the Fisher exact test was applied. Patient survival, hospitalization, and the event rate were described using Kaplan-Meier estimates and survival graphs. Differences between the curves were tested for significance by log-rank statistics using a Cox proportional-hazards regression model and Breslow test. We analyzed all major outcomes by time to first event. Statistical analysis was performed according to the intention-to-treat principle for combined end points, death, and all data. The analysis was follow-up driven instead of event driven. In the analysis, data on patients were censored at the time of cardiac transplantation. Differences between treatment groups in postrandomization measures or events were evaluated by analysis of variance and with the 2 test. The planned sample size of 350 patients was designed to provide around 90% power, and 5% significance to detect a 20% relative reduction in the primary outcome combined death secondary to any cause or unplanned first hospitalization, assuming an annual event rate of 30%. Proportions of patients responding were compared between treatment subgroups (sex, race, age, functional class I/II and III/IV, diabetics/nondiabetics, and ischemic/nonischemic etiology) with the Mantel-Haenszel 2 test, adjusted for the stratification variable, intervention procedure. Also, participant characteristics (prognostic variables) were adjusted for by using Cox multiple regression analysis. All analyses and graphs were performed with SPSS statistical software version 11.5 and Graphpad Prism software version 4.02.
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Results |
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Population Baseline Demographic Data and Feasibility of DMP
From October 5, 1999, to February 8, 2005, 529 outpatients were referred for treatment (Table 2; Figure 2). The control and intervention groups were similar in all baseline characteristics (Table 2). The mean follow-up was 2.47±1.75 years for all patients, 2.44±1.7 years for the control group, and 2.48±1.79 years for the intervention group (P=ns). Five patients (4.3%) from the control group and 4 (1.7%) patients from the intervention group were lost to follow-up. The intervals from the result analysis to first randomization and last randomization were 2543 days and 611 days, respectively. The number of monitoring calls was 15±10 per patient, with intervals of 74±30 days between them. In 25% of calls, the need for modification of water and sodium restriction was observed; and in 2%, the need for additional cardiologist evaluation was evident. A total of 95% of additional visits to cardiologists resulted in changes in medication. During telephone follow-ups, the doses of diuretics were changed for 5% of patients.
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Prespecified Primary End Points
In the intention-to-treat analysis, the intervention group had a statistically significant risk reduction in the estimated combined end point first hospitalization or mortality (P=0.008; hazard ratio, 0.64; CI, 0.43 to 0.88) in comparison with controls (Figure 3). In the intervention group, the cumulative proportion event-free estimates (SE) at 1-, 3-, and 5-year follow-up were 71% (6), 53% (7), and 37% (9), respectively, whereas in the control group they were 60% (9), 32% (9), and 21% (11), respectively. At 2
-year follow-up, the DMP intervention resulted in a reduction of 17% in the absolute risk of the combined event and 27% reduction in the relative risk (Figure 4).
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The intervention group had smaller sequential Minnesota Quality of Life Questionnaire scores compared with control group scores during the follow-up (Figure 4). The mean scores in the intervention group from baseline to follow-up reduced –25±20, whereas in the intervention group, the means scores reduced –2.2±24 (P=0.000, intervention versus control). The initial reduction in the intervention group remained during the follow-up. The sequential questionnaire values (SD) in the intervention group at 1, 3, and 5 years were 29±20, 26±19, and 32±19. In the control group, the scores (SD) were 39±22, 29±18, and 48±32.
Secondary End Points
The feasibility of our HF DMP study was 54%. In the intention-to-treat analysis, no difference occurred in estimated total mortality between intervention and control groups (P=ns; hazard ratio, 0.80; 95% CI, 0.55 to 1.13; Figure 5). Also, no statistical differences between the groups were verified for death during hospitalization (P=ns; hazard ratio, 0.86; 95% CI, 0.53 to 1.41) and unexpected death at home (P=ns; hazard ratio, 0.83; 95% CI, 0.47 to 1.46; Table 3). The number of unplanned hospitalizations from any cause, the total number of days of hospitalization, and the need for emergency care were smaller in the intervention group than in the control group (Table 3).
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The sequential HF adherence index values were higher in the intervention group compared with those in the control group (Figure 6). The initial increment in the intervention group remained during follow-up. The mean adherence scores at baseline and during follow-up in the control group were 36.4±9.95 and 39.9±7.9 (P=ns), whereas in the intervention group they were 30.8±11 and 51.8±5.8 (P<0.0001). The sequential score values in the intervention group at 1, 3, and 5 years were 52±8, 52±6, and 51±7, respectively, whereas in the control group, the scores were 42±10, 39±11, and 40±8, respectively.
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Subgroup Analysis
The beneficial effects on the composite outcome were consistently observed among predefined subgroups: women and men; white and African Brazilian descendents; diabetics and nondiabetics; age <52 years and
52 years; New York Heart Association functional class II/II and III/IV; ischemic and nonischemic etiology. On Cox multiple regression analysis, the functional class was identified as the unique independent predictor of combined outcome (P<0.0001; corrected relative risk 0.51; CI, 0.38 to 0.68; Figure 7).
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Discussion |
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To our knowledge, our HF DMP trial is unique in the long-term repetitive use of high intensive education through interviewers and education classes of HF outpatients. Also, the study provides new sequential long-term data using an adherence index to improve the knowledge of mechanisms explaining DMP benefits.
Our HF DMP consisting of repetitive education at 6-month intervals and monitoring improved outpatient status in long-term follow-up in patients already being treated by cardiologists. The beneficial effects of the combined end point on subgroup analysis were homogeneous for sex, race, diabetics and nondiabetics, age, functional class, and etiology. Particularly noteworthy was the effectiveness in younger patients, no ischemic causes, and in patients with less severe disease in New York functional class I-II. The calculated number of HF patients who needed this DMP intervention to prevent one combined event (hospitalization or death) until 2 years of follow-up was 6 patients.
Our beneficial effects in outpatients indicate that the spectrum of patients who would have a long-term benefit from DMP is quite broad, including patients with nonadvanced HF or those under ambulatory care. In fact, most patients in a community setting of HF in a β-blocker era are in functional class I and II and could become a target for DMP application.12,13 The DMP indication for nonadvanced HF under ambulatory care might prevent deterioration to a stage that requires hospitalization.14,15 Our results differ from those of previous trials that included nonadvanced HF and were different in design, DMP intensity and complexity, time of follow-up, and sociodemographic characteristics.15,16 Our findings are in accordance with the first report of DMP success in high-risk HF patients for early hospitalization and with the DIAL [Randomized Trial of Telephone Intervention in Chronic Heart Failure] trial that had shorter follow-up.5,17
Our results support the role of our DMP design of long-term follow-up with high-intensity repetitive education and monitoring for the management of nonadvanced HF outpatients who are already being treated by a cardiologist. Our results disagree with the idea that DMP of medium-duration (3 to 6 months) follow-up is more consistently associated with success compared with long-duration programs.1,18–20 Also, our results do not support the concept that long-term, intensive postdischarge follow-up is unnecessary, especially in patients with nonadvanced HF who are under ambulatory care, providing that the patient has immediate access to specialist service in the event of suspected deterioration.21,22 However, our results are in accordance with the long-term benefit of DMP reported recently regarding heart failure clinics and home-based intervention for HF patients after hospital discharge.23–26
REMADHE is a unique study with sequential quality-of-life results on long-term follow-up in nonadvanced HF outpatients. The repetitive education could be a factor contributing to persistence of the early benefit. Persistent effects on quality of life can have important clinical implications, because the conventional step-up medication approach in HF may have a positive impact on survival or morbidity, but not on quality of life.27 HF DMP effects on quality of life are controversial, and the beneficial effects have not been sustained.1,3,28 In general, trials that include quality-of-life assessment had short follow-up, and the evaluation was at the end of the study.3,5,20,29,30 Our results agree with results from a previous trial developed in South America in different clinical settings that resulted in improved end-study quality of life.5 However, our results do not agree with long-term quality-of-life results after hospital discharge in older patients or a reported unsustained effect.18,28 Also, our quality-of-life improvement was higher than that reported in a meta-regression analysis.29
Our understanding of the potential underlying mechanisms for improving outcomes with DMP remains limited.23,31–37 On the basis of the persistent initial improvement in sequential adherence results, reported for the first time in our study, a role for adherence improvement in mechanisms determining long-term HF DMP success may be suggested. The hypothesis that adherence would be monitored in long-term follow-up as an additional mechanism to prevent the reduction in late positive effects is attractive.38 Also, the intervention has no underlying psychosocial theory but was designed with methods of support that have worked well in these medical settings.
Prespecified Subgroup Analysis
Our investigation is the first to suggest that HF DMP can have long-term effects in white Brazilians and in African Brazilians. As a consequence, this HF DMP can be proposed for use in black populations as it is for the general population. It is attractive to test this DMP design also in African-Americans because they are at a higher risk of HF, and the age of onset is significantly younger in comparison with whites.39 However, the functional class was an independent predictor of combined outcome.
Limitations
Inherent main limitations of the protocol include the open design and the absence of blinding to the treatment assignment. The unblinded design could allow a certain degree of cointervention by nurses or doctors to compensate for patients not being in the DMP group or to optimize the situation of the intervened subjects to better illustrate the effectiveness of the DMP. Also, control patients could learn about the intervention. However, the researchers provided different schedules for control and intervention groups concerning ambulatory care to avoid any contamination. Despite the cardiology team not being informed of patient allocations, blind care is not completely warranted. However, all nonpharmacological trials have these limitations.40 Furthermore, the REMADHE study can be accepted as being of very high quality according to the Checklist to Evaluate a Report of a Nonpharmacological Trial (CLEAR NPT).40 Perception of quality of life may be better because patients in the intervention group have the comfort of knowing that they have a knowledgeable healthcare professional that they will talk to frequently; however, this comfort is an essential component of the intervention. The included population was composed of relatively fewer older patients in comparison with reported data.41 However, younger patients may represent a significant absolute number of HF hospitalized patients, in general, not included in DMP trials.41 There are limitations in obtaining self-report data and hospital records because of unreliable answers and hospitalizations in nonaccessible distant hospitals. However, all deaths, all hospitalizations, and the need for emergency treatment were confirmed by documentation. One additional limitation of our HF DMP trial is the initial low feasibility of the intervention influenced by social conditions; however, its long-term indication for selected patients seems to be a realistic objective.
Conclusions and Clinical Implications
For a longer follow-up period than in previous studies, this HF DMP model in patients already cared for by a cardiologist is associated with a reduction in unplanned hospitalization, total hospital days, and the need for emergency care, as well as improved quality of life, despite modest program adherence over time.
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Acknowledgments |
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Disclosures
None.
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Footnotes |
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The online-only Data Supplement is available with this article at http://circheartfailure.ahajournals.org/cgi/content/full/CIRCHEARTFAILURE.107.744870/DC1.
Clinical trial registration information—URL: http://www.clinicaltrials.gov. Unique indentifier: NCT 00505050.
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