A Multicenter Randomized Controlled Evaluation of Heart Failure Disease Management Using Advanced Telecommunications Within a Diverse Provider Network: The Specialized Primary and Networked Care in HF (SPAN-CHF) III Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Congestive Heart Failure
- Sponsor
- Tufts Medical Center
- Enrollment
- 212
- Locations
- 2
- Primary Endpoint
- Number of days hospitalized for heart failure per patient-year of follow-up
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
This study will randomize participants with a diagnosis of congestive heart failure and at least one risk factor for hospitalization to either a tablet computer and web based disease management program or a telephone based disease management program. Both interventions are home based with heart failure education and symptom monitoring provided by nurse managers. The nurse managers are in close communication with both the participants and the participants' physicians . The components of the disease management program have been developed at Tufts Medical Center and the New England Quality Care Alliance with studies showing improved clinical outcomes, including reduced hospitalizations. The goal of this study is to transition this successful home monitoring and disease management program to a tablet computer and web-based implementation to both improve clinical outcomes (reducing hospitalizations and improving self-perceived health status) and improve provider-patient satisfaction. We hypothesize that the tablet computer based disease management will decrease heart failure hospitalizations.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients age ≥ 18 with a primary care provider or specialist that is participating within the Collaborative Health ACO.
- •Patient able to consent
- •A diagnosis of heart failure with at least one of the following risk factors:
- •Hospitalization for heart failure within the prior year
- •NYHA class III-IV symptoms
- •Most recent BNP ≥ 300 pg/mL (or Nt-proBNP ≥ 600 pg/mL) as long as within 90 days prior to enrollment
Exclusion Criteria
- •Acute myocardial infarction, PCI or CABG within 30 days before enrollment
- •Planned revascularization procedures, cardiac mechanical support implantation, cardiac transplantation, or other cardiac surgery within 30 days following study randomization.
- •Illness other than heart failure deemed the principal limitation to life expectancy or principal cause of disability
- •Severe angina as the principal cause of limitation
- •Uncorrected valvular disease, except where valvular regurgitation was considered to be secondary to severe left ventricular dilation, or where surgical correction is deemed excessively risky or declined by the patient.
- •Moderate to severe dementia such that unable to participate in disease management program
- •Severe visual or auditory disability such that unable to participate in disease management program
- •Hospice care
- •Listed for heart transplantation
- •No access to a working telephone
Outcomes
Primary Outcomes
Number of days hospitalized for heart failure per patient-year of follow-up
Time Frame: 90 days
Secondary Outcomes
- Cardiovascular Mortality(90 days)
- Change in health status as assessed by the SF-12(90 days)
- Number of days hospitalized for any cause(90 days)
- Number of days hospitalized for cardiovascular causes at 90 days(90 days)
- Change in self-care as assessed by the SCHFI(90 days)
- All Cause Mortality(90 days)