Enhancing Caregiver Support for Heart Failure Patients: The CarePartner Study

Sponsor: VA
ClinicalTrials.gov Identifier: NCT00555360

Informal caregivers assisted by health information technology may help to fill the gaps in VA care management of heart failure patients by enhancing
support for patients’ treatment adherence, behavior changes, and symptom monitoring.

Heart failure (HF) is a leading cause of preventable hospitalization and death in the VA and many patients fall short of self-care goals. Numerous efficacy trials have shown that HF care management supported by health information technology (ie, HITCM) can improve patients’ outcomes, although VA care managers in “real-world” health systems are often overwhelmed by the need to provide monitoring and behavior change services. The challenge will be to identify ways to leverage assistance from informal caregivers (ICGs) who lack the resources to fill this role effectively.

Impact: This study will evaluate a model for leveraging ICGs and structuring their role in HF patients’ overall disease management. If effective, the service may provide the frequent monitoring and behavior change assistance that patients need, allowing VA to extend its impact beyond what current care management programs can realistically deliver.

Principal Investigators: John D Piette, PhD, VA Ann Arbor Healthcare System
Source: ClinicalTrials.gov

Beta-Blockers in Heart Failure: Pharmacy-level Intervention Comparison

Sponsor: VA
ClinicalTrials.gov Identifier: NCT01002456

The overall objective of the proposed pilot study is to begin evaluation of two methods for promoting adherence to guidelines for beta-blocker therapy in heart failure. The design includes site level baseline measurement, feedback, re-measurement after six months, and randomized (by site) comparison samples. The setting is VA sites, with intervention directed at the pharmacy.

Current evidence-based guidelines in VA recommend one of three beta-blockers (carvedilol, metoprolol succinate, or bisoprolol) that have been shown to reduce mortality in heart failure patients with systolic dysfunction, with recommended target doses. However, Pharmacy Benefits Management (PBM) data indicate that prescribing for beta-blockers in heart failure patients that is not in accordance with guidelines is substantial, both in terms of the agent selected and the dose. Sites will be recruited and randomized to two different intensities of intervention to promote adherence to guidelines.

Principal Investigator: Madeline McCarren, Edward Hines Jr VA Hospital
Source: ClinicalTrials.gov

Step Trial of Exercise and Self-management in Severe Cardiopulmonary Illness

Sponsor: VA
ClinicalTrials.gov Identifier: NCT00467298

The study is a randomized trial of a cardiopulmonary self-management intervention to improve functional capacity, health-related quality of life, and to reduce healthcare utilization. Two hundred (100 in each group) will be recruited from VA Puget Sound Health Care System over four years. Outcomes will be measured at three points: at entry, at the end of the six-month intervention, and 12 months after entry. Change in functional capacity at the end of the intervention program is the primary outcome.

Principal Investigator: Bonnie G Steele, PhD RN, VA Puget Sound Health Care System
Source: ClinicalTrials.gov

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