Health E Heart Study (South Texas Veterans Health Care System Heart Failure Disease Management Program/Study)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
|Official Title:||Health E Heart Study (South Texas Veterans Health Care System Heart Failure Disease Management Program/Study)|
- Cardiovascular death/re-hospitalization within 6 to12 months from enrollment; 6 to 12 month all-cause mortality/re-hospitalization treatment failure; 6-month heart failure mortality/re-hospitalization; interim analyses [ Time Frame: At 6 months and at 12 months ] [ Designated as safety issue: No ]
- all measures at 6-month intervals
- Secondary outcomes include alternative definitions of clinical impact through chart review at study start; functional status and resource utilization and costs at study start, at 6 months, and at twelve months.
|Study Start Date:||June 2005|
|Study Completion Date:||June 2008|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
CHF is one of the most common diagnoses for Department of Veterans Affairs (VA) patients. Cost of care, particularly inpatient hospitalization, is high dollar expenditure in the budget.
Study subjects, recruited from the enrolled patient population of the STVHCS, are identified by a diagnosis of CHF in VA clinical databases. Administrative and clinical inclusion and exclusion criteria will be applied by review of medical records. Subjects who appear to meet inclusion criteria will be mailed a pre-enrollment letter containing an Information Sheet describing the program. A follow-up phone call by an RN will go over the program in detail, review the Information Sheet, and initiate enrollment if the subject wishes to participate. As a less than minimal risk study, verbal consent or refusal will be documented in the respective subject's computerized medical record. Assenting subjects will be randomized by the last digit of the social security (odd and even) in a 1:1 ratio to the control group (standard care at STVHCS) or the intervention group (receiving the telephonic disease management services in addition to standard care). The intervention group will receive a telephonic intervention for one year that consists of formal scheduled nurse telephone education sessions, 24-hour access to a nurse counseling and symptom advice telephone line, printed action plans, workbooks, and individualized assessment letters, medication compliance reminders, vaccination reminders, and physician alerts about signs and symptoms of decompensation. Once enrolled, the RN conducts a telephonic assessment at intake, 6, and 12 months to assess each participant's knowledge, behavior, and health status related to the HF condition.
All subjects enrolled in the study will continue to receive comprehensive heart failure care from the STVHCS with those subjects randomized to the program receiving the additional telephonic intervention. Risk stratification is determined from a combination of review of the medical record patient admission history, and other self-reported information. Factors considered include: Goldman Specific Activity Scale, self-management practices, medical history, medical management, and psychosocial factors. The algorithm employs Boolean logic and sorts patients into one of three categories that determines the frequency of scheduled calls over the course of the year. The communications to physicians occurs through the VA CPRS system regularly, usually after each scheduled patient call. Pre-specific clinical, process, and economic outcomes will be collected on all subjects and analyzed at 6 and 12 months post-randomization.
Comparisons: The study will compare resources consumed in providing care to patients with heart failure post-randomization receiving standard care with resources consumed with standard care supplemented by the Health E Heart Disease Management Program. The study will measure direct VA medical care costs.
Study subjects will all receive comprehensive medical care for congestive heart failure from the STVHCS. Experimental subjects will receive additional telephone calls, patient education sessions, customized treatment and self-management plans, and written patient education materials. All subjects will receive telephonic assessments of health status, and functional status at 6 and 12 months after randomization.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00141856
|United States, Texas|
|VA South Texas Health Care System|
|San Antonio, Texas, United States, 78229-5700|
|Principal Investigator:||Richard L Bauer, MD MSc BA||VA South Texas Health Care System|