Optimizing Patient Experience During Myocardial Perfusion Imaging

Myocardial Infarction Clinical Trial

— OPTIMIZE  

Official title:

Optimizing Patient Experience During Myocardial Perfusion Imaging

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05896982
• Other study ID #: NL81600.028.22
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 2, 2022
• Est. completion date: August 1, 2024

Study information

• Verified date: April 2024
• Source: Tilburg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The present study focusses on the effects of the diagnostic testing environment on psychological wellbeing, cardiac symptoms and patient satisfaction during cardiac stress testing (CST) in patients who are referred to the Institute Verbeeten for SPECT myocardial perfusion imaging (MPI).

The diagnostic procedure consists of two days of MPI using SPECT: day 1 of MPI involves obtaining a resting image and day 2 (typically 3 or 4 days later) a stress MPI following exercise or pharmacological challenge with adenosine. The diagnostic procedure can result in undesirable effects on psychological wellbeing, such as anxiety or psychological distress. These effects can be related to anticipatory anxiety (day 1 of MPI) and/or responses to the exercise or adenosine stress testing (day 2 of MPI). The present investigation aims to develop methods to further improve patients' experiences and wellbeing during the diagnostic process for the presence of inducible myocardial ischemia.

This research project will compare four groups to establish the effect of providing information and supportive coaching: (1) care as usual, (2) information support using video materials, (3) supportive coaching during the diagnostic testing procedure, and (4) a combination of both interventions. The video-based information and supportive coaching are aimed at reducing feelings of anxiety, uncertainty and psychological distress during the diagnostic testing procedure. In addition to standardized self-report questionnaires, this project will utilize facial expression analysis software to measure emotional states during CST as well as 24- hour ambulatory assessments to evaluate autonomic nervous system activity, cardiac symptoms and psychological wellbeing during everyday life activities in the period between the two days of MPI. It is hypothesized that additional video-based information and supportive coaching during the diagnostic process for the inducibility of myocardial ischemia will result in improved psychological wellbeing (reduced acute negative emotions; primary outcome) as well as less cardiac and other physical symptoms and improved patient satisfaction (secondary outcomes) of the diagnostic clinic visit. The innovative aspect of the present proposal is its focus on emotional expression during evaluation for myocardial ischemia using FaceReader software in combination with self-reported momentary mood and perceived stress assessments. Knowledge about the interaction between psychological wellbeing and cardiac function obtained in this project will strengthen the development of future interventions aimed to reduce symptom burden and psychological distress in patients undergoing diagnostic evaluations for heart disease.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 180
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• referred to the Institute Verbeeten Tilburg and eligible for adenosine-exercise SPECT MPI

• capable of answering questionnaires and receiving information and coaching in Dutch.

Exclusion Criteria:

• a life-threatening disease with < 1 year survival (e.g., metastatic cancer)

• refusal to informed consent.

Related Conditions & MeSH terms

• Autonomic Dysfunction
• Autonomic Nervous System Diseases
• Infarction
• Ischemia
• Myocardial Infarction
• Myocardial Ischemia
• Primary Dysautonomias

Intervention

Other:
• Care as usual with information support
Comprises of additional visual information in the form of two videos that show details about the procedure on both days of the MPI diagnostic procedure. Each of these two videos are approximately 5 minutes long and are made available to the patients before the first day (video 1), and in between the first and second day (video 2).
• Care as usual with supportive coaching
Patients receive coaching from one person who is present throughout the complete diagnostic process. The coach is available for answering questions as well as comforting the patients when necessary (e.g., to reassure patients if they are anxious or stressed).
• Care as usual with information support and supportive coaching
This intervention comprises additional visual information in the form of two videos and coaching throughout the diagnostic process as described above.

Locations

Country	Name	City	State
Netherlands	Institute Verbeeten	Tilburg	Noord-Brabant

Sponsors (3)

Lead Sponsor	Collaborator
Tilburg University	ETZ TweeSteden Hospital Tilburg, Institute Verbeeten Tilburg

Country where clinical trial is conducted

Netherlands, 

References & Publications (7)

Adelstein SJ. Administered radionuclides in pregnancy. Teratology. 1999 Apr;59(4):236-9. doi: 10.1002/(SICI)1096-9926(199904)59:43.0.CO;2-6. — View Citation

Baik SH, Fox RS, Mills SD, Roesch SC, Sadler GR, Klonoff EA, Malcarne VL. Reliability and validity of the Perceived Stress Scale-10 in Hispanic Americans with English or Spanish language preference. J Health Psychol. 2019 Apr;24(5):628-639. doi: 10.1177/1359105316684938. Epub 2017 Jan 5. — View Citation

Bekendam MT, Kop WJ, Vermeltfoort IAC, Widdershoven JW, Mommersteeg PMC. Facial Expressions of Emotions During Pharmacological and Exercise Stress Testing: the Role of Myocardial Ischemia and Cardiac Symptoms. Int J Behav Med. 2021 Dec;28(6):692-704. doi: 10.1007/s12529-021-09963-3. Epub 2021 Feb 23. — View Citation

Bekendam MT, Mommersteeg PMC, Kop WJ, Widdershoven JW, Vermeltfoort IAC. Anxiety and hemodynamic reactivity during cardiac stress testing: The role of gender and age in myocardial ischemia. J Nucl Cardiol. 2021 Dec;28(6):2581-2592. doi: 10.1007/s12350-020-02079-3. Epub 2020 Feb 28. — View Citation

Bekendam MT, Mommersteeg PMC, Vermeltfoort IAC, Widdershoven JW, Kop WJ. Facial Emotion Expression and the Inducibility of Myocardial Ischemia During Cardiac Stress Testing: The Role of Psychological Background Factors. Psychosom Med. 2022 Jun 1;84(5):588-596. doi: 10.1097/PSY.0000000000001085. Epub 2022 Apr 14. — View Citation

Bekendam MT, Vermeltfoort IAC, Kop WJ, Widdershoven JW, Mommersteeg PMC. Psychological factors of suspect coronary microvascular dysfunction in patients undergoing SPECT imaging. J Nucl Cardiol. 2022 Apr;29(2):768-778. doi: 10.1007/s12350-020-02360-5. Epub 2020 Oct 6. — View Citation

Gabbay FH, Krantz DS, Kop WJ, Hedges SM, Klein J, Gottdiener JS, Rozanski A. Triggers of myocardial ischemia during daily life in patients with coronary artery disease: physical and mental activities, anger and smoking. J Am Coll Cardiol. 1996 Mar 1;27(3):585-92. doi: 10.1016/0735-1097(95)00510-2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychological wellbeing - self report using Profile of Mood States	Will be assessed using self-report measures of emotional states on a scale from 0 to 10 (stressed, anxious, insecure, relaxed, worried, irritated, excited, and tired) with a higher score representing more of this emotional state.These measures of psychological well-being will be compared between the four groups.	During the two day diagnostic process.
Primary	Psychological wellbeing - Facial expressions of emotions	Will be assessed using facial expression of emotions based on video recordings during the diagnostic testing procedure. Facial expressions will be analyzed (valence and intensity; e.g., anxiety) using FaceReader software as in our prior METC-approved research projects at Institute Verbeeten. A value between 0 and 1 will be the outcome measure for each emotion (happy, sad, angry, surprised, scared, disgusted and neutral). These measures of psychological well-being will be compared between the four groups.	During the stress test on day 2.
Secondary	Cardiac symptoms	The intensity of cardiac symptoms and other common symptoms during MPI SPECT (e.g., headache, dizziness, fatigue, nausea) will be assessed using self-report measures on a scale from 0 to 10. Higher scores represent a higher intensity of the symptoms.	During the two day diagnostic process.
Secondary	Patient experience - PSQ-18	Patient experience and satisfaction of the clinic visit, cardiac tests, and coaching will be assessed using a validated questionnaire with a higher score representing a better patient experience.	At the end of the two day diagnostic process.
Secondary	Physiological measures - heart rate	During the cardiac stress test, heart rate is routinely collected. This data will be used as a physiological measure that is relevant to emotional experiences, cardiac symptoms, and the inducibility of myocardial ischemia.	During the cardiac stress test on the second day of the diagnostic process.
Secondary	Physiological measure - blood pressure	During the cardiac stress test, blood pressure is routinely collected. This data will be used as a physiological measure that is relevant to emotional experiences, cardiac symptoms, and the inducibility of myocardial ischemia.	During the cardiac stress test on the second day of the diagnostic process.
Secondary	Ambulatory ECG monitoring	A 24-hour Holter-ECG will be used to assess heart rate variability during everyday life activities. These assessments are obtained out-of-clinic during the day between the resting and stress MPI SPECT assessment.	For 24 hours between the first and second day of the diagnostic process.
Secondary	SPECT images	As part of the patient's clinical care, single-photon emission computed tomography will be used to obtain myocardial perfusion images on the rest and cardiac stress test days. The presence or absence of ischemia can be evaluated based on these images.	At the end of the first and second day of the diagnostic process.