Promoting Patient-Centered Care Through a Heart Failure Simulation Study

Study Overview
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Brief Summary
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The initial aim of this study will be to assess current methods of heart failure (HF) patient education in terms of patient satisfaction, level of preparedness for home, and care provider satisfaction. The second aim will be to design and create a living with HF at home simulation session. The third aim will test the hypothesis that hospitalized HF patients who receive education in a simulation room in addition to usual HF education will have improved qualitative and quantitative outcomes as compared to those who do not receive the additional education support.

Official Title
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Promoting Patient-Centered Care Through a Heart Failure Simulation Study

Conditions
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Heart Failure

Intervention / Treatment
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* Behavioral: Full simulation and education
* Behavioral: See simulation room, usual education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female > 18 years of age. Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures. Documentation of HF of any etiology based on clinical assessment of the Primary Investigator, using standard-of-care criteria for diagnosis. Heart failure of either preserved or reduced ventricular function. Exclusion Criteria: Patients requiring ICU monitoring LVAD candidate/recipient Cardiac transplant candidate/recipient Confusion Sepsis Terminal illness (other than HF) with expected survival of less than 1 year Enrollment or planned enrollment in another randomized clinical trial during this hospitalization Inability to comply with planned study procedures Active illicit drug use Participation in any other clinical trials involving investigational or marketed products within 30 days prior to entry in the study. Other conditions that in the opinion of the Primary Investigator may increase risk to the subject and/or compromise the quality of the clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Full simulation and education<br>Patients who will receive full simulation and education session prior to discharge. | Behavioral: Full simulation and education<br> <br> |
| Other: See simulation room, usual education<br>Patients will be shown the simulation room prior to discharge but will only receive usual education. | Behavioral: See simulation room, usual education<br> <br> |
| No Intervention: Usual care<br>Patients will receive usual care by bedside nurse. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Differences in Minnesota Living With Heart Failure Questionnaire (MLHFQ) Results | The mean differences in heart failure knowledge (from study enrollment to the 30 day study follow up) in each of the arms as assessed by the MLHFQ. Lower scores indicate improvement and a better health-related quality of life (HRQoL). The MLHFQ is a self-administered questionnaire for patients with HF, comprising 21 items rated on six-point Likert scales, representing different degrees of impact of HF on HRQoL, from 0 (none) to 5 (very much). It provides a total score (range 0-105, from best to worst HRQoL), as well as scores for two dimensions, physical (8 items, range 0-40) and emotional (5 items, range 0-25). The other eight items (of the total of 21) are only considered for the calculation of the total score. | 30 days |