Promoting Patient-Centered Care Through a Heart Failure Simulation Study (HF SIM)

Intermountain Health Care, Inc.

Status: Completed

Conditions: Heart Failure

Treatments: Behavioral: See simulation room, usual education; Behavioral: Full simulation and education

Study type: Interventional

Funder types: Other

Identifiers

NCT01917188

1024572

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female > 18 years of age.
2. Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures.
3. Documentation of HF of any etiology based on clinical assessment of the Primary Investigator, using standard-of-care criteria for diagnosis.
4. Heart failure of either preserved or reduced ventricular function.

Exclusion criteria

1. Patients requiring ICU monitoring
2. LVAD candidate/recipient
3. Cardiac transplant candidate/recipient
4. Confusion
5. Sepsis
6. Terminal illness (other than HF) with expected survival of less than 1 year
7. Enrollment or planned enrollment in another randomized clinical trial during this hospitalization
8. Inability to comply with planned study procedures
9. Active illicit drug use
10. Participation in any other clinical trials involving investigational or marketed products within 30 days prior to entry in the study.
11. 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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72 participants in 3 patient groups

Full simulation and education

Active Comparator group

Description:

Patients who will receive full simulation and education session prior to discharge.

Treatment:

Behavioral: Full simulation and education

See simulation room, usual education

Other group

Description:

Patients will be shown the simulation room prior to discharge but will only receive usual education.

Treatment:

Behavioral: See simulation room, usual education

Usual care

No Intervention group

Description:

Patients will receive usual care by bedside nurse.