Promoting Patient-Centered Care Through a Heart Failure Simulation Study

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Behavioral: Full simulation and education; Behavioral: See simulation room, usual education

• Registration Number: NCT01917188
• Lead Sponsor: Intermountain Health Care, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-08-01
• Study First Submitted QC: 2013-08-02
• Study First Posted: 2013-08-06
• Study Start: 2013-11
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Results First Submitted: 2017-09-13
• Status Verified: 2018-07
• Results First Submitted QC: 2018-07-25
• Last Update Submitted: 2018-07-25
• Results First Posted: 2019-01-16
• Last Update Posted: 2019-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Full simulation and education	Full simulation and education	Patients who will receive full simulation and education session prior to discharge.
See simulation room, usual education	See simulation room, usual education	Patients will be shown the simulation room prior to discharge but will only receive usual education.

Primary Outcome Measures

Name	Time	Method
Mean Differences in Minnesota Living With Heart Failure Questionnaire (MLHFQ) Results	30 days	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.

Trial Locations

Locations (1)

Intermountain Medical Center; 🇺🇸 Murray, Utah, United States