Trial Outcomes & Findings for Promoting Patient-Centered Care Through a Heart Failure Simulation Study (NCT NCT01917188)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

72 participants

Primary outcome timeframe

30 days

Results posted on

2019-01-16

Participant Flow

Participant milestones

Participant milestones
Measure	Full Simulation and Education Patients who will receive full simulation and education session prior to discharge. 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. See simulation room, usual education	Usual Care Patients will receive usual care by bedside nurse.
Overall Study STARTED	29	23	20
Overall Study COMPLETED	17	17	11
Overall Study NOT COMPLETED	12	6	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Promoting Patient-Centered Care Through a Heart Failure Simulation Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Full Simulation and Education n=17 Participants Patients who will receive full simulation and education session prior to discharge. Full simulation and education	See Simulation Room, Usual Education n=17 Participants Patients will be shown the simulation room prior to discharge but will only receive usual education. See simulation room, usual education	Usual Care n=11 Participants Patients will receive usual care by bedside nurse.	Total n=45 Participants Total of all reporting groups
Age, Continuous	66 years STANDARD_DEVIATION 13 • n=5 Participants	67.9 years STANDARD_DEVIATION 8.2 • n=7 Participants	62.7 years STANDARD_DEVIATION 11.6 • n=5 Participants	65.3 years STANDARD_DEVIATION 11.1 • n=4 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	11 Participants n=4 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	15 Participants n=7 Participants	10 Participants n=5 Participants	34 Participants n=4 Participants

PRIMARY outcome

Timeframe: 30 days

Population: Only a small number of people completed and returned the quiz.

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.

Outcome measures

Outcome measures
Measure	Full Simulation and Education n=16 Participants Patients who will receive full simulation and education session prior to discharge. Full simulation and education	See Simulation Room, Usual Education n=17 Participants Patients will be shown the simulation room prior to discharge but will only receive usual education. See simulation room, usual education	Usual Care n=11 Participants Patients will receive usual care by bedside nurse.
Mean Differences in Minnesota Living With Heart Failure Questionnaire (MLHFQ) Results Total Score Difference	-4.69 score on a scale Standard Deviation 35.06	-26.59 score on a scale Standard Deviation 28.25	-29.36 score on a scale Standard Deviation 35.69
Mean Differences in Minnesota Living With Heart Failure Questionnaire (MLHFQ) Results Physical Score Difference	-4.31 score on a scale Standard Deviation 15.25	-13.24 score on a scale Standard Deviation 11.51	-15.09 score on a scale Standard Deviation 14.58
Mean Differences in Minnesota Living With Heart Failure Questionnaire (MLHFQ) Results Emotional Score Difference	-0.88 score on a scale Standard Deviation 8.60	-6.59 score on a scale Standard Deviation 8.28	-5.27 score on a scale Standard Deviation 8.88

Adverse Events

Full Simulation and Education

Serious events: 0 serious events

Other events: 1 other events

Deaths: 2 deaths

See Simulation Room, Usual Education

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Usual Care

Serious events: 1 serious events

Other events: 1 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Full Simulation and Education n=29 participants at risk Patients who will receive full simulation and education session prior to discharge. Full simulation and education	See Simulation Room, Usual Education n=23 participants at risk Patients will be shown the simulation room prior to discharge but will only receive usual education. See simulation room, usual education	Usual Care n=20 participants at risk Patients will receive usual care by bedside nurse.
Skin and subcutaneous tissue disorders Knee wound dehiscence	0.00% 0/29 • 30 days	4.3% 1/23 • Number of events 1 • 30 days	0.00% 0/20 • 30 days
Nervous system disorders Subarachnoid hemorrhage after a fall	0.00% 0/29 • 30 days	0.00% 0/23 • 30 days	5.0% 1/20 • Number of events 1 • 30 days

Other adverse events

Other adverse events
Measure	Full Simulation and Education n=29 participants at risk Patients who will receive full simulation and education session prior to discharge. Full simulation and education	See Simulation Room, Usual Education n=23 participants at risk Patients will be shown the simulation room prior to discharge but will only receive usual education. See simulation room, usual education	Usual Care n=20 participants at risk Patients will receive usual care by bedside nurse.
Cardiac disorders lightheaded	3.4% 1/29 • Number of events 1 • 30 days	0.00% 0/23 • 30 days	0.00% 0/20 • 30 days
Vascular disorders hypertension	0.00% 0/29 • 30 days	0.00% 0/23 • 30 days	5.0% 1/20 • Number of events 1 • 30 days

Additional Information

Patti Spencer

Intermountain Heart Institute

Phone: 8015074700

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place