Promoting Patient-Centered Care Through a Heart Failure Simulation Study

NCT01917188 | Completed Results

• 1 other identifier: 1024572
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Full simulation and education

ACTIVE COMPARATOR

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

Behavioral: Full simulation and education

See simulation room, usual education

OTHER

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

Behavioral: See simulation room, usual education

Usual care

NO INTERVENTION

Patients will receive usual care by bedside nurse.

Interventions

Full simulation and education BEHAVIORAL

Full simulation and education

See simulation room, usual education BEHAVIORAL

See simulation room, usual education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Intermountain Health Care, Inc.: lead
• Intermountain Research and Medical Foundation: collaborator

Study Sites (1)

Intermountain Medical Center

Murray, Utah, 84107, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Results Point of Contact

• Title: Patti Spencer
• Organization: Intermountain Heart Institute

patti.spencer@imail.org

8015074700

Study Officials

• Kismet D Rasmusson, FNP-BC

  Intermountain Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2013
• First Posted: August 6, 2013
• Study Start: November 1, 2013
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: January 16, 2019
• Results First Posted: January 16, 2019

Record last verified: 2018-07

Locations

US (1)