N/A
Completed N=136
Veterans Affairs Lowering Readmission in Heart Failure
Source: ClinicalTrials.gov NCT01144182 ↗Enrolled (actual)
136
Serious AEs
11.0%
Results posted
Oct 2015
Primary outcomePrimary: General Quality of Life From the Standardized Physical Component Score — 31.6; 35.5 units on a scale — p=0.05
Summary
Heart failure (HF) greatly increases mortality and lowers quality of life (QOL). HF is the most common indication for readmission in older adults and the most frequent reason for 30-day readmission. Medications and restriction of dietary sodium constitute crucial therapy to lower HF recurrence. However, adherence to medications and dietary recommendations is low in HF patients. Nonadherence is often due to an interaction among the environment, the patient and providers. In the VALOR in Heart Failure Study, we will assess a novel quality improvement program (QIP) to improve HF care using a pretest-posttest design. This interdisciplinary theory-based prospective experimental study will target improving HF treatment using patient-based behavioral and checklist intervention, as well as provider and system-targeted checklists and treatment defaults (posttest or intervention phase); this will be compared to current best practice (CBP) evaluated in the pretest (pretest or pre-intervention) phase. It is hypothesized that the QIP, which intervenes on patient, provider and system levels, will improve QOL and lower HF recurrence compared to CBP.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY General Quality of Life From the Standardized Physical Component Score |
31.6; 35.5 | 0.05 |
| PRIMARY Heart Failure Specific Quality of Life |
42.5; 38.0 | 0.26 |
| SECONDARY Standardized Mental Component Score |
48.8; 53.2 | .56 |
| SECONDARY Physical Functioning |
37.5; 41.4 | 0.22 |
| SECONDARY Role Physical |
50.0; 53.1 | 0.05 |
| SECONDARY Pain Index |
51.0; 61.5 | 0.34 |
| SECONDARY General Health |
41.0; 57.0 | 0.008 sig |
| SECONDARY Vitality |
45.0; 50.0 | 0.30 |
| SECONDARY Social Functioning |
62.0; 75.0 | 0.15 |
| SECONDARY Role Emotional |
66.7; 75.0 | 0.55 |
| SECONDARY Mental Health |
74.0; 80.0 | 0.56 |
| SECONDARY Physical Subscale of Heart Failure Specific Quality of Life |
21.5; 19.0 | 0.15 |
| SECONDARY Emotional Subscale of Heart Failure Specific Quality of Life |
7.0; 6.0 | 0.36 |
Eligibility Criteria
Inclusion Criteria
- All patients admitted with either systolic or diastolic HF will be identified through ongoing daily prospective manual search of admission records in VA NYHHS
- Men and women ( 21 years) being discharged after a HF admission will be eligible
- They must have an available phone
Exclusion Criteria
- Patients with poor short-term survival (< 3 months)
- recent major surgery (< 1 month)
- planned discharge to a long-term-care facility
- severe dementia or other serious psychiatric illness
- temporarily in the area
- those unable to provide consent, refusal to participate
- logistic or discretionary reasons (including participation in another study) will be excluded
Data sourced from ClinicalTrials.gov (NCT01144182). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.