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Care Management for Low-Risk Patients with Heart Failure: A Randomized, Controlled Trial

Robert Frank DeBusk, MD; Nancy Houston Miller, RN, BSN; Kathleen Marie Parker, RN, MSN; Albert Bandura, PhD; Helena Chmura Kraemer, PhD; Daniel Joseph Cher, MD; Jeffrey Alan West, MD; Michael Bruce Fowler, MD; and George Greenwald, MD
[+] Article, Author, and Disclosure Information

From Stanford University School of Medicine, Stanford, California, and Kaiser Permanente Medical Care Program of Northern California, Oakland, California.

Acknowledgments: The authors thank Lynda Fisher for her meticulous collection and management of study data and Lisa Schultz for her careful preparation of the manuscript. They also thank the following research nurses for their excellent clinical contributions to the study: Linda Balanesi, RN; Louise Barrier, RN; Susan Boyce, RN; Polly Chiang-McDonald; Catherine Burger, RN; Danielle Jennings, RN, MSN; Yeuen Kim, MD; Sarah Lamb, RN, MS; Jacqueline McGrath, RN; Patricia Pearson-LeVeau, RN; Bridget Pinson, RN; and Alice Sabalvaro, RN, BSN.

Grant Support: By the National Heart, Lung, and Blood Institute, Bethesda, Maryland, grant HL56950 (“Efficacy of a Heart Failure Management System”).

Potential Financial Conflicts of Interest: None disclosed.

Requests for Single Reprints: Robert F. DeBusk, MD, Stanford University School of Medicine, 780 Welch Road, #106, Stanford, CA 94304-5735; e-mail, debusk@stanford.edu.

Current Author Addresses: Drs. DeBusk, Cher, and West, Ms. Houston Miller, and Ms. Parker: Stanford University School of Medicine, 780 Welch Road, #106, Stanford, CA 94304-5735.

Dr. Bandura: Stanford University, Psychology Building 420, Room 134, Stanford, CA 94305.

Dr. Chmura Kraemer: PBS building #C305, Stanford, CA 94305.

Dr. Fowler: Stanford University Hospital, CVRB Sec Floor South, Stanford, CA 94305.

Dr. Greenwald: 555 Castro Street, Mountain View, CA 94041.

Ann Intern Med. 2004;141(8):606-613. doi:10.7326/0003-4819-141-8-200410190-00008
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We screened 2786 patients from 5 northern California hospitals between May 1998 and October 2000. Of these, 70% (1951 patients) were excluded for 1 of the following reasons: 1) clinically significant comorbid condition complicating the interpretation of symptoms of heart failure during nurses' periodic telephone contacts, 2) psychosocial disorders limiting patients' participation in treatment, or 3) logistic limitations precluding patients' participation in a telephone-mediated intervention. The Appendix Table contains further details on study exclusions. Among the 835 medically eligible patients, 55% (462 patients) were randomly assigned to either usual care or nurse-based case management. Thus, we randomly assigned 16.6% of screened patients: 228 patients to the treatment group and 234 patients to the usual care group (Figure 1).

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Figure 1.
Patient flow.

*Four patients declined to participate and 4 dropped out for medical reasons. †Eight patients declined to participate and 7 dropped out for medical reasons.

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Figure 2.
Proportion of patients free from rehospitalization for heart failure or for any cause by treatment group.
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Figure 3.
Proportion of patients free from the combined end point of death, rehospitalization, or emergency department visit for cardiac causes or for any cause by treatment group.
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CHF Disease Management
Posted on November 18, 2004
Ariel Linden
Linden Consulting Group
Conflict of Interest: None Declared

Contrary to popular belief, the random controlled trial (RCT) is not bias free and the paper by DeBusk et al. highlights a potential threat to validity, the "Hawthorne effect," that is not recognized by the authors. The medical staff at the five Kaiser hospitals was informed of the study protocol. Considering that Kaiser is a "closed system" of care, we do not know if those physicians behaved differently as a result of being aware that they would be indirectly scrutinized for the care they provide One assessment that could provide insight as to whether this was an issue would be to indicate the CHF population-wide change in ACE-I and beta- blocker usage in addition to just the experimental and control groups. As it stands now, the reader is left to wonder if the Hawthorne effect in the reference group negated the potential positive effects of disease management (DM) services in the intervention group.

Secondly, and potentially more importantly, telephonic-based DM is intended to guide participants toward improving control of their condition by bringing the individual and their physician in line with evidence-based practice guidelines. If in fact most individuals already adhered to self- management behaviors -- as seems evident here -- there is little gain to be expected from a DM program.

For these two reasons, the "external validity" and generalizability of this study is unknown. Thus, the conclusion drawn by the authors that the benefits of disease management may not valuable to low-risk patients elsewhere is overreaching. An equally valid conclusion, with stronger "internal validity" would be: "A telephonic-based disease management strategy does not appear to work in tightly-controlled, well-managed, low risk CHF patient population."

Conflict of Interest:

None declared

Care Management for Heart Failure
Posted on December 17, 2004
Robert F. DeBusk
Stanford University
Conflict of Interest: None Declared

Dr. Linden notes that physicians' awareness of the study may have influenced the care provided to study participants. However, any such effect was substantially mitigated by the fact that our study was conducted by an "outside" group of Stanford-based investigators without the incentive or means to provide feedback to Kaiser physicians or administrators on the quality of care provided to patients during the study. Given the nature of excluded patients, Linden's suggestion of an analysis of changes in medication prescription rates among these subjects would be difficult to interpret. As Linden suggests, the evidence-based "baseline" care provided by Kaiser physicians for these low-risk heart failure patients might not have been amenable to improvement. However, our group has conducted a series of multi-center randomized trials in Kaiser Permanente Hospitals in which care management produced superior outcomes. (1-4) These trials focused on behaviors (exercise, smoking, diet, drug adherence) that were under the direct control of patients. As we noted in our present paper, rehospitalization is only partly influenced by patients' adherence to medication regiments for heart failure. Indeed, most rehospitalizations in the present study were not for heart failure, but for coronary artery disease and other medical conditions. This underscores the need to address the multiple comorbidities associated with chronic diseases (5). We agree with Linden that our study was not designed to evaluate the generalizability of our findings to non-HMO settings. Regarding the value of disease management in low-risk patients treated elsewhere, our conclusions speak for themselves: "Although nurse care management did not statistically significantly reduce the rate of rehospitalization compared to the Kaiser Permanente HMO-treated group, its potential value in non-HMO settings should not be diminished."

Dr. Linden raises an interesting methodologic problem with evaluating nurse care management: such studies rely on physicians' willingness to collaborate closely with the nurse care managers. It is our impression that physicians practicing in HMO settings are more willing to do so than those practicing in other settings. A future challenge is how to organize and conduct rigorous studies of care management for various chronic conditions outside of environments such as HMOs whose physicians place a high value on collaboration.

Robert F. DeBusk, MD Daniel J. Cher, MD Helena C. Kraemer, PhD

References 1. Taylor CB, Houston-Miller N, Killen JD, DeBusk RF: Smoking cessation after acute myocardial infarction: effects of a nurse-managed intervention. Ann Int Med 113: 118-123, 1990. 2. DeBusk RF, Miller NH, Superko HR, Dennis CA, Thomas RJ, Lew HT, Berger III WE, Heller RS, Rompf J, Gee D, Kraemer HC, Bandura A, Ghandour G, Clark M, Fisher L, Taylor CB: A case management system for coronary risk factor modification following acute myocardial infarction. Annals Int Med; 120:721-729, 1994. 3. Taylor CB, Miller NH, Herman S, Smith PM, Sobel D, Fisher L, DeBusk RF. A nurse-managed smoking cessation program for hospitalized smokers. AJPH; 86:1557-1560, 1996. 4. Miller NH, Smith PM, DeBusk RF, Sobel DS, Taylor CB: Smoking cessation and hospitalized patients: results of a randomized trial. Arch Int Med 157; 409-415, 1997. 5. DeBusk RF, West JA, Miller NH, Taylor CB. Chronic Disease Management. Treating the patient with disease(s) vs treating disease(s) in the patient. Arch Intern Med 1999; 2739-2742.

Stanford University School of Medicine Stanford University

Conflict of Interest:

None declared

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Summary for Patients

Nurse Care Management for Low-Risk Patients with Heart Failure

The summary below is from the full report titled “Care Management for Low-Risk Patients with Heart Failure. A Randomized, Controlled Trial.” It is in the 19 October 2004 issue of Annals of Internal Medicine (volume 141, pages 606-613). The authors are R.F. DeBusk, N. Houston Miller, K.M. Parker, A. Bandura, H. Chmura Kraemer, D.J. Cher, J.A. West, M.B. Fowler, and G. Greenwald.


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