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Health E Heart Study (South Texas Veterans Health Care System Heart Failure Disease Management Program/Study)

This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00141856
First received: August 30, 2005
Last updated: June 19, 2008
Last verified: June 2008
  Purpose

The primary objective of this telephonic heart failure specific patient education study is to assess the incremental clinical, psycho-social, and functional lifestyle benefits of the Health E Heart Study (South Texas Veterans Health Care System Heart Failure Disease Management Program/Study) when added to standard care among veteran beneficiaries with a heart failure diagnosis. A secondary objective is to assess the impact of the Health E Heart Study on total system utilization costs.


Condition Intervention Phase
Heart Failure, Congestive
Behavioral: Telephone care
Phase 4

Study Type: Interventional
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)

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.

Enrollment: 420
Study Start Date: June 2005
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 Behavioral: Telephone care

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Inclusion criteria are designed to enroll a population of VA patients with moderate-severe heart failure who are expected to be reasonably representative of and generalizable to potential candidates for the Health E Heart Disease Management Program intervention. To be eligible for the study, veteran beneficiaries must:

  • Be 18 years of age
  • Have a diagnosis of heart failure
  • Have received care in urgent care or have been hospitalized, or have more than 12 outpatient visits in the last twelve months.
  • Speak either English or Spanish.

Exclusion Criteria:

Exclusion criteria are designed to exclude persons who are unable to participate in the intervention, whose mortality or health care utilization are driven by co-morbid conditions, or who are enrolled in other research.

  • End-stage renal disease on chronic dialysis
  • Prior heart transplant
  • End-stage or terminal illness in addition to heart failure, such as metastatic malignancy or AIDS with anticipated life expectancy less than 6 months.
  • Residence in a nursing home
  • Currently participating in another research or care management program.
  • No access to a telephone
  • Severe dementia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00141856

Locations
United States, Texas
VA South Texas Health Care System
San Antonio, Texas, United States, 78229-5700
Sponsors and Collaborators
Investigators
Principal Investigator: Richard L Bauer, MD MSc BA VA South Texas Health Care System
  More Information

Publications:
Responsible Party: Bauer, Richard - Principal Investigator, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00141856     History of Changes
Other Study ID Numbers: 045-0023-313, Bauer0004
Study First Received: August 30, 2005
Last Updated: June 19, 2008
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Dis Management
Heart Decompensation
Hearts
Veteran (M01.930)

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 27, 2014