Promoting Patient-Centered Care Through a Heart Failure Simulation Study

NCT ID: NCT01917188

Last Updated: 2019-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2016-09-30

Brief Summary

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Full simulation and education

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

Group Type: ACTIVE_COMPARATOR

Full simulation and education

Intervention Type: BEHAVIORAL

See simulation room, usual education

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

Group Type: OTHER

See simulation room, usual education

Intervention Type: BEHAVIORAL

Usual care

Patients will receive usual care by bedside nurse.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Full simulation and education

Intervention Type: BEHAVIORAL

See simulation room, usual education

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Intermountain Research and Medical Foundation

OTHER

Sponsor Role: collaborator

Intermountain Health Care, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kismet D Rasmusson, FNP-BC

Role: PRINCIPAL_INVESTIGATOR

Intermountain Medical Center

Locations

Intermountain Medical Center

Murray, Utah, United States

Countries

United States

Other Identifiers

1024572

Identifier Type: -

Identifier Source: org_study_id