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

• ClinicalTrials.gov Identifier: NCT01917188
• Recruitment Status: Completed
• First Posted: August 6, 2013
• Results First Posted: January 16, 2019
• Last Update Posted: January 16, 2019
• Sponsor: Intermountain Health Care, Inc.
• Collaborator: Intermountain Research and Medical Foundation
• Information provided by (Responsible Party): Intermountain Health Care, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Heart Failure	Behavioral: Full simulation and education; Behavioral: See simulation room, usual education	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 72 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Promoting Patient-Centered Care Through a Heart Failure Simulation Study
• Study Start Date: November 2013
• Actual Primary Completion Date: September 2016
• Actual Study Completion Date: September 2016

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Full simulation and education; Patients who will receive full simulation and education session prior to discharge.	Behavioral: Full simulation and education
See simulation room, usual education; Patients will be shown the simulation room prior to discharge but will only receive usual education.	Behavioral: See simulation room, usual education
No Intervention: Usual care; Patients will receive usual care by bedside nurse.

Outcome Measures

Primary Outcome Measures :

1. Mean Differences in Minnesota Living With Heart Failure Questionnaire (MLHFQ) Results [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Utah

Intermountain Medical Center

Murray, Utah, United States, 84107

Sponsors and Collaborators

Intermountain Health Care, Inc.

Intermountain Research and Medical Foundation

Investigators

• Principal Investigator: Kismet D Rasmusson, FNP-BC; Intermountain Medical Center

More Information

• Responsible Party: Intermountain Health Care, Inc.
• ClinicalTrials.gov Identifier: NCT01917188
• Other Study ID Numbers: 1024572
• First Posted: August 6, 2013
• Results First Posted: January 16, 2019
• Last Update Posted: January 16, 2019
• Last Verified: July 2018

Additional relevant MeSH terms:

Heart Failure; Heart Diseases; Cardiovascular Diseases