Use of Guidance Videos to Increase Engagement and Decrease Anxiety in Patients Undergoing Pleural Tap

The Effect of Personalized Custom Training Videos on Patient Engagement in Hospitalized Patients Undergoing Thoracocentesis

Patients planned to undergo a pleural tap will get verbal explanation or watch a personalized guidance video in addition to verbal explanation. Questionnaires will be filled to assess the effect of the video training on understanding, cooperation and anxiety.

Study Overview

• Status: Unknown
• Conditions: Pleural Effusion, Malignant; Pleural Effusion; Pleural Pleurisy Effusion
• Intervention / Treatment: Other: Personalized training video

Detailed Description

100 patients with pleural effusion, planned to undergo a diagnostic or therapeutic pleural tap, will be randomized to watch a personalized custom video training, explaining the procedure, in addition to the verbal explanation given by the medical staff, or to get the standard verbal explanation alone. Questionnaires regarding their understanding of the procedure, their feelings and the level of anxiety will be filled before and after the video/verbal explanation, and after the procedure. the study aims to check whether the video training provides better understanding of the procedure, increases cooperation and engagement and decreases anxiety.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Orit Neudorfer, MD; Phone Number: +972-54-8886421; Email: orit.neudorfer@gmail.com
• Study Contact Backup: Name: Ori Rogovsky, MD; Phone Number: +972-52-4266770; Email: orirog@gmail.com

Study Locations

• Israel
  • Tel Aviv, Israel
    • Recruiting
    • Tel Aviv Sourasky Medical Center
    • Contact: Mor Gur Arie; Phone Number: 0503317516

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients hospitalized in Internal medicine C and D, Tel-Aviv Sourasky Medical Centers
• Patients with pleural effusion, planned to undergo diagnostic or therapeutic pleural tap
• Patients who can read and understand the questions
• Patients who were interested in participating in the clinical trial and signed an informed consent form

Exclusion Criteria:

• Minors < 18 years of age
• Pregnant women
• Patients who cannot read and understand, at the discretion of the investigator
• Patients which their medical condition does not allow them to undergo the study procedure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Training video arm; Patients will watch a personalized custom training video, in addition to the standard explanation provided by the medical staff	Other: Personalized training video; Using a few demographic and medical details of the patients, provided by the medical staff, the video generator will create a 2-minute personalized custom video, suitable to the age, gender, language, and medical condition of the patients. No identifying information will be used, to protect patient's privacy.
No Intervention: Verbal explanation arm; Patients will standard explanation about the procedure, provided by the medical staff

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fulfillment of need for information gap	Improvement of subjective self-assessment of the patient's need of information on the tap procedure following the explanation received, based on the short form of the Quality from Patient Perspective (QPP) measurement. The improvement in the intervention arm will be compared to the one of the control arm	30 minutes
Assessment of Anxiety	Delta of subjective self-assessment on his/her anxiety about the procedure, following the explanation received (using visual scale of 1-100, based on the Visual Analog Scale (VAS)). The reduction of anxiety in the intervention arm will be compared to the one of the control arm	30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The need of an active role	The patients will be asked to score whether the explanation allowed them the active role they needed, based on the Picker Patient Experience (PPE-15) Questionnaire. The score in the intervention arm will be compared to the one of the control arm	30 Minutes
Confidence and Knowledge to take actions	The patient would be asked to score whether the information they received allowed them to understand what they should do next, based on the Patient Activation Measure (PAM) Questionnaire. The score in the intervention arm will be compared to the one of the control arm	30 minutes

Collaborators and Investigators

• Sponsor: GistMed Ltd.
• Investigators: Study Director: Orit Neudorfer, MD, GistMed Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2020
• Primary Completion (Anticipated): May 30, 2020
• Study Completion (Anticipated): June 30, 2020

Study Registration Dates

• First Submitted: January 5, 2020
• First Submitted That Met QC Criteria: February 2, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): February 18, 2020
• Last Update Submitted That Met QC Criteria: February 16, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Personalized video training; Thoracocentesis; Pleural tap
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Neoplasms; Neoplasms by Site; Pleural Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Pleural Neoplasms; Pleural Effusion, Malignant; Pleural Effusion; Pleurisy
• Other Study ID Numbers: 0009-19-TLV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No