Optimizing Patient Experience During Myocardial Perfusion Imaging

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

149 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-02

Study Completion Date

2024-06-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Myocardial Ischemia Myocardial Infarction Autonomic Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Experimental 2x2 factorial design.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Care as usual

Patients in this group will not receive any additional information materials or support on top of care as usual, but information videos will be made available after completion of the MPI procedures.

Group Type NO_INTERVENTION

No interventions assigned to this group

Care as usual with information support

Patients in this group will primarily receive additional information on the diagnostic process that they will go through with the use of video materials. Supportive coaching will not be provided in this group.

Group Type EXPERIMENTAL

Care as usual with information support

Intervention Type OTHER

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 in this group will receive supportive coaching throughout their clinic visit. The coach is available for questions as well as specific support for each patient. Information support using video materials will not be supplied to the patients during the diagnostic process in this group, but will be made available after completion of the MPI procedures.

Group Type EXPERIMENTAL

Care as usual with supportive coaching

Intervention Type OTHER

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

Patients in this group will receive both information support as well as supportive coaching during their diagnostic clinic visit.

Group Type EXPERIMENTAL

Care as usual with information support and supportive coaching

Intervention Type OTHER

This intervention comprises additional visual information in the form of two videos and coaching throughout the diagnostic process as described above.

Interventions

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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).

Intervention Type OTHER

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).

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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.