The American Journal of Managed Care March 2010
An Intervention for VA Patients With Congestive Heart Failure
An intervention of variable intensity for congestive heart failure showed some improvements but no survival effect, suggesting a tradeoff between intervention cost and intensity and survival benefit.
Objective: To assess the effect of a telephone intervention to improve quality of life among patients with congestive heart failure (CHF).
Study Design: Prospective randomized study.
Methods: Single-site recruitment of 458 patients using Veterans Health Administration care into a randomized controlled trial with a 1-year preintervention data collection period and a 1-year intervention and follow-up period. To compensate for imbalanced study groups, propensity scores were included in adjusted models of quality of life, satisfaction with care, inpatient utilization, survival, and costs of care.
Results: Patients aged 45 to 95 years participated in the study; 22% were of Hispanic race/ethnicity, and 7% were African American. All but 5 were male, consistent with the older population among veterans. At baseline, 40% were in Goldman Specific Activity Scale class I, 42% were in class III, 6% were in class II or IV, and 12% were unclassified. Patients scored a mean (SD) of 14 (1.5) points below the norm on the physical component score. After the yearlong intervention, no differences in clinical outcomes were noted between the intervention group and the control group. The CHF-related costs were higher for the intervention group, as were overall costs that included the cost of the intervention. Intervention group patients reported better compliance with weight monitoring and exercise recommendations.
Conclusions: A risk-stratified intervention for patients with CHF resulted in potential behavioral improvements but no survival benefit. A high-cost high-intensity intervention may be required to improve survival for patients with CHF. Inclusion of the costs of interventions is recommended for future researchers.
(Am J Manag Care. 2010;16(3):158-165)
In future investigations, the cost of interventions for congestive heart failure (CHF) should be included in cost analyses to provide clinical and policy decision makers with a clear picture of the economic implications of novel interventions.
- This study showed evidence of positive effects of an intervention of variable intensity for CHF on healthcare utilization, self-care behaviors, and possibly quality of life.
- This study found no survival benefits of the intervention; future research should attempt to determine what components and level of intensity are required to affect survival.
- Healthcare systems may need to balance intervention cost increases against multiple benefits to patients.
In a randomized controlled trial among 458 VA patients with CHF, we tested a telemedicine intervention designed to improve patients’ health-related quality of life and clinical outcomes with minimal effect on costs of care among VA patients with CHF. We hypothesized that, compared with control group patients receiving usual care, patients receiving the intervention would have (1) improved physical and mental health-related quality of life and (2) equivalent costs of care. As secondary objectives, we examined the effects of the intervention on survival over a 1-year period and on compliance and satisfaction with care.
Patients receiving care at a large southwestern medical center in the VA were recruited into a trial of an intervention to improve outcomes and quality of life among patients with CHF. Approval of the study was granted by the institutional review board before study initiation. Subjects participated in the informed consent process and granted consent in writing.
Eligibility criteria included the following: age at least 18 years, diagnosis of CHF (International Classification of Diseases, Ninth Revision, Clinical Modification [ICD-9-CM] codes 425 and 428), receipt of inpatient care or urgent care or more than 12 outpatient visits in the past 12 months, and speaker of English or Spanish.
Of 539 patients identified, 81 (15%) were ineligible. Reasons for ineligibility included the following: (1) end-stage renal disease or congestive dialysis, (2) prior heart transplant, (3) end-stage or terminal illness in addition to CHF (such as metastatic malignant neoplasm or AIDS) with anticipated life expectancy less than 6 months, (4) residence in a nursing home, (5) participation in another research or care management program, (6) refusal to participate in the study, (7) relocation out of the area, and (8) severe dementia.
The study used a prospective randomized controlled design, with a 1-year intervention and data collection period. Retrospectively, 1-year preintervention data were collected to provide baseline assessments. In June 2005, the intervention team began contacting identified patients with CHF for enrollment in a 1-year home-based telephone disease management CHF program. Recruited patients were assigned to treatment or control status based on the last digit of their social security number (odd vs even). Enrollment occurred over a 6-month period from mid-June through December 1, 2005. All veterans enrolled in this telephone disease management program continued to receive comprehensive CHF care from the VA. Registered nurses conducted a telephone survey at intake, with reassessments at 6 and 12 months querying participants’ knowledge, behavior, and health status. The study was registered at clinicaltrials.gov (identifier NCT00141856). A CONSORT (Consolidated Standards of Reporting Trials) flowchart in the Figure shows the sample development.
When patients agreed to enroll, the intervention team (McKesson Corporation) created a participant-specific selfmanagement plan using the primary care physician’s therapeutic plan, the intensity of which varied per a standardized risk stratification algorithm. Risk stratification was determined using a combination of review of the medical record, patient admission history, and self-report at baseline. Factors included the Goldman Specific Activity Scale,6-8 self-management practices,9 medical history and management,6,7,9-15 and psychosocial factors.7,9 The copyrighted algorithm used Boolean logic and sorted patients into 3 risk categories that determined the frequency of scheduled telephone interactions over the course of the year (low risk [2 calls], medium risk [7 calls], and high risk [16 calls]). Full details are available from the developer.
During the scheduled telephone interactions, disease management nurse interventions included education and coaching for behavior change based on guidelines established by the American Heart Association16 and using motivational interviewing principles.17 Interventions occurred more frequently in the first 6 months of the program, and high-risk participants were called on average every 3 to 4 weeks, medium-risk participants every 8 weeks, and low-risk participants every 6 months. The mean intervention length was 30 to 40 minutes and focused on the participant-specific self-management plan derived from the participant admission history and based on the program focus. The program focus was participant education and behavior change for fluid weight management, medication adherence, diet, early treatment for escalating symptoms, discussion of recent laboratory values, and vital signs monitoring.
The intervention included access to a nurse advice line for symptoms and counseling 24 hours a day 7 days per week, medication compliance reminders, vaccination reminders, and printed literature, including action plans, workbooks, and postassessment letters, in addition to the scheduled nurse education and motivational interviewing sessions. The participant’s physician was provided with faxed alerts about signs and symptoms of decompensation, as well as notification of gaps between participant-reported practice and guideline recommendations. In addition, communication to physicians occurred through the VA electronic medical record system regularly and was customary after each scheduled call, providing information on the patient’s condition. Physicians were encouraged to communicate to the disease management registered nurses through the electronic medical record system, providing their recommendations for further counseling topics or clarification of subject-reported information.
During the study, intervention nurses averaged 157 patient telephone interventions per month for the first 12 months and 121 interventions per month overall for 19 months. Altogether, 89% of interventions were completed within the first 13 months. Fewer than 75 interventions per month were completed after the first 13 months.
Sources of data included patient self-report in the structured interviews, a VA resource allocation center for cost estimates, a medical record review of the patient’s electronic medical record, and administrative extracts of the medical record. Extracts from the VA’s all-electronic medical record are transmitted nightly to a central data repository according to a nationally standardized protocol for inclusion in administrative databases, which may be accessed for research purposes. The VA databases provided demographics, vital statistics, VA priority status diagnoses, procedures and dates of care for inpatient and outpatient health services, and medication prescriptions and selected laboratory results.
Congestive heart failure was denoted by ICD-9-CM code 425 or 428. Comorbidity was measured by indicators for diagnosis of chronic obstructive pulmonary disease (COPD) (codes 490-496, 500-505, and 506.4), hypertension (codes 401-405), and diabetes (code 250). In addition, we calculated the modified Charlson-Deyo comorbidity index, a weighted score assessing 18 conditions (CHF, myocardial infarction, peripheral vascular disease, stroke, chronic lung disease, peptic ulcerative disease, rheumatologic disease, dementia, hemiplegia, diabetes, diabetes with complications, mild liver disease, moderate-to-severe liver disease, renal disease, cancer, metastatic cancer, AIDS, and human immunodeficiency virus without AIDS).18,19 These measures were assessed for both years (preintervention and postintervention).
Demographics from the medical record extracts included age at baseline, race/ethnicity (white, African American, or other or missing), sex, and marital status (married vs other status). Priority status for care in the VA is assigned by the VA during enrollment in the healthcare system based on a veteran’s military service and service-related medical conditions. Values range from 1 to 8. Priority 1 veterans have a service-connected condition that is 50% to 100% disabling. Priority status was extracted from enrollment files and was recoded as high-priority versus any lower-priority status. High-priority veterans did not have copayments for care or medications, whereas lower-priority veterans had copayments.
Additional data were collected by medical review, including baseline medications, lipid levels, blood pressure, moderate-to-severe ejection fraction, and vaccination status. Lipids included total cholesterol, high-density lipoprotein, low-density lipoprotein, and triglycerides and were averaged across all baseline-year values. Medication use assessed prescriptions each year for angiotensin-converting enzyme inhibitors, antihypertensives, β-blockers, diuretics, and cardiac glycosides. Blood pressure was the highest outpatient value recorded in the baseline year. High blood pressure was defined as exceeding 140 mm Hg systolic or 90 mm Hg diastolic for patients without diabetes and as exceeding 130 mm Hg systolic or 80 mm Hg diastolic for patients with diabetes. Moderate-tosevere ejection fraction denoted an indication of moderate or severe systolic dysfunction recorded from any of the following test results noted in the medical record: cardiac catheterization, transthoracic echocardiogram, multiple gated acquisition scan, or persantine thallium stress test.