Clinical trial NCT05199363: Pediatric Patient Experience on a Diagnostic Path
Official title: Pediatric Patient Experience on a Diagnostic Path
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Headache
Urinary Incontinence
Growth Deficiency
Visual Impairment
Psychomotor Retardation, Mild to Severe
Demyelinating Diseases
Brain Tumor
Keywords: child
magnetic resonance imaging
anxiety
patient experience
Lead sponsor: Children's Memorial Health Institute, Poland
Sponsor class: OTHER
Collaborators: name: Siemens Healthcare Sp. z o.o.
First posted: 2022-01-20
Enrollment: 300
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study participants will be randomly assigned into one of 4 groups:

* Group A, 25% of the sample - patients subject to intervention No 1: "Information leaflet"
* Group B, 25% of the sample - patients subject to intervention No. 2: "Educational movie"
* Group C, 25% of the sample - patients subject to intervention No. 3 "Demonstration"
* Group D, 25% of the sample - control group, with no intervention.
Primary purpose: OTHER

Brief summary: The trial will determine the impact of an information- and education-focused interventions on the anxiety levels, and patients' experiences as well as satisfaction of patients aged 10-14 and their caregivers during the MR examination.

Detailed description: The aims of the trial

1. Examining the level of anxiety of individuals undergoing magnetic resonance imaging (MRI) as patients or caregivers (anxiety is measured at two points: before and after the MRI procedure).

2. Examining subjective patients' and caregivers' assessments of the key factors which make up the Patient Experience, i.e. the sum of all interactions which influence perceptions of the patients and their caregivers. The Patient Experience in this sense includes what is perceived, understood and remembered by the patient and their relatives in terms of:

* access to services and resources
* coordination and safety
* effectiveness of the services
* communication and education
* patient empowerment
* respect and dignity
* ensuring physical wellbeing
* ensuring psychological wellbeing
* environment and comfort and consequent levels of satisfaction. The full set of factors will only be examined for the patients' caregivers, while for the patients themselves the set of factors will be limited to those which can be competently assessed by persons aged 10-14 years.

  3. Examining the extent to which education- and information-focused interventions, using a variety of media (information leaflets, educational video, demonstration with props), impact anxiety levels, individual elements of the experience, and patients' and caregivers' satisfaction levels.

  4. Examining the extent to which educational- and informational-focused interventions can increase patients' co-operation and thus contribute to shorter examination times (avoidance of repetition of sequences) and a reduction in the rate of interrupted examinations.
  1. The participants will be recruited by the registration staff of the Magnetic Resonance (MR) Laboratory from those enrolled for magnetic resonance examinations for clinical indications. It will be done during a routine reminder of the upcoming examination date. The staff member informs the patient's caregiver of a possibility to participate in the examination and, after obtaining a preliminary declaration of participation, of the necessity to arrive 1 hour before the predetermined time.
  2. When the patient and their caregiver arrive at the Registration of the Magnetic Resonance Laboratory, a registration staff member hands over the "Information on the Trial regarding the Paediatric Patient Experience on the Diagnostic Pathway" which contains details of the objectives, design, scope and duration of the procedures and inconvenience of the trial which will be conducted, the expected benefits to participants of the trial which is a research experiment, and the health risks and hazards for the participants, the arrangements regarding handling any adverse events, the measures undertaken to ensure respect for the participants' privacy and the confidentiality of their personal data, and the rules for access to relevant information concerning the participants obtained during implementation of the experiment and the overall results thereof and for further use of the results thereof. The investigator also informs the participants of the possibility of withdrawing from the trial at any stage, of the rules on compensation in the event of any harm and of the source of funding of the medical experiment. After answering any questions from the subject, the investigator collects a signed Informed Consent Form from both the caregiver and the child, together with the information about the trial attached to it.
  3. A staff member of the Registration of the Magnetic Resonance Laboratory draws an allocation to one of the Groups (A/B/C/D) from a pool of sealed envelopes together with a unique code for the trial and enters the code into all questionnaires used in the trial.
  4. An radiology technologist or psychologist (after receiving training in the objectives, protocol and tools of the trial) provides the interventions as they are appropriate to groups:

     * to Group A: the investigator gives the information leaflet "Information for young patients and their caregivers. What is MRI and what is the examination like?" and ensures that the patient and caregiver read it.
     * to Group B: the investigator plays the educational video "What is an MRI and what is the examination like?" to the patient and caregiver and ensures that the patient and caregiver familiarise themselves with it.
     * to Group C: the investigator conducts a scenario-based demonstration using props in the form of a model scanner and a multimedia presentation ("Scenario for demonstration before a magnetic resonance examination for young patients and their caregivers")." No intervention is carried out in Group D.
  5. The patient's caregiver completes the State-Trait Anxiety Inventory (STAI) questionnaire.
  6. The patient (assisted by a technician or psychologist) completes the State-Trait Anxiety Inventory for Children (STAIC) form.
  7. A standard process of preparing for the magnetic resonance examination by a technician follows, and the magnetic resonance examination is performed as clinically indicated.
  8. The technician completes the questionnaire entitled "Assessment of the patient's and their caregiver's cooperation during magnetic resonance examination".
  9. The caregiver again completes the State-Trait Anxiety Inventory (STAI) questionnaire.
  10. The patient's caregiver completes the questionnaire "Assessment of the experience of the patient's caregiver during magnetic resonance examination".
  11. The patient (assisted by a technician or psychologist) again fills in the "State-Trait Anxiety Inventory for Children (STAIC) questionnaire.
  12. The patient (assisted by a technician or psychologist) fills in the questionnaire "Evaluation of the patient's experience during the magnetic resonance examination".

Eligibility criteria: Inclusion Criteria:

* Patients aged 10-14 years.
* Referred for magnetic resonance imaging due to clinical indications.
* Patients undergoing magnetic resonance examination for the first time.
* Possibility of cooperating with the patient during the examination, no need for sedation.
* Consent of the patients' caregivers to participate in the examination; in the case of patients ≥ 13 years of age, also the patients' consents.
* Absence of contraindications to magnetic resonance imaging

Exclusion Criteria:

* Lack of parental or patient consent to participate in the trial.
* Contraindications to undergo magnetic resonance imaging.
* Lack of possibility to cooperate with the patient during the examination and/or the need for general anaesthesia for the MR examination.

Primary outcomes:
measure: State-Trait Anxiety Inventory for Children
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: State-Trait Anxiety Inventory
timeFrame: through study completion, an average of 1 year
Other outcomes:
measure: Patient's experience questionaire
timeFrame: through study completion, an average of 1 year
measure: Patient's caregiver/parent experience questionaire
timeFrame: through study completion, an average of 1 year
measure: Patient's and caregiver's co-operation during the MR examination questionaire
timeFrame: through study completion, an average of 1 year
Locations:
city: Warszawa
country: Poland
facility: Children Memorial Health Institute (CMHI)
Study officials:
affiliation: CMHI
name: Elżbieta Jurkiewicz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Makanjee CR, Bergh AM, Hoffmann WA. Healthcare provider and patient perspectives on diagnostic imaging investigations. Afr J Prim Health Care Fam Med. 2015 May 20;7(1):801. doi: 10.4102/phcfm.v7i1.801.
citation: Carlsson S, Carlsson E. 'The situation and the uncertainty about the coming result scared me but interaction with the radiographers helped me through': a qualitative study on patients' experiences of magnetic resonance imaging examinations. J Clin Nurs. 2013 Nov;22(21-22):3225-34. doi: 10.1111/jocn.12416.
citation: Munn Z, Pearson A, Jordan Z, Murphy F, Pilkington D, Anderson A. Addressing the Patient Experience in a Magnetic Resonance Imaging Department: Final Results from an Action Research Study. J Med Imaging Radiat Sci. 2016 Dec;47(4):329-336. doi: 10.1016/j.jmir.2016.04.007. Epub 2016 Jun 27.
citation: Bolderston A. Patient Experience in Medical Imaging and Radiation Therapy. J Med Imaging Radiat Sci. 2016 Dec;47(4):356-361. doi: 10.1016/j.jmir.2016.09.002. Epub 2016 Oct 15.
citation: Jensen JD, Allen L, Blasko R, Nagy P. Using Quality Improvement Methods to Improve Patient Experience. J Am Coll Radiol. 2016 Dec;13(12 Pt B):1550-1554. doi: 10.1016/j.jacr.2016.09.005.