Video-recOrded hospItal dischaRge (VOIR) (VOIR)

July 19, 2024 updated by: Anglia Ruskin University

Evaluating Feasibility and Acceptability of Video Discharge Hosted in Patient Knows Best or Ortus-iHealth Apps: A Feasibility Randomised Controlled Trial

This study evaluates the suitability and acceptability of video-recorded discharge via the Patient Knows Best app. Through a randomized control trial, patients receive either standard discharge care or standard care supplemented with video-recorded discharge. Clinical teams record briefings covering medication and wound care, which patients can access multiple times on their smart devices. Patients and clinical staff complete questionnaires to assess acceptance and feasibility. Feasibility is determined by recruitment, retention, and completion rates, with patient engagement and viewing habits also analyzed. The study aims to enhance patient understanding and continuity of care through accessible discharge information.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Study Design

The study aims to assess how suitable and acceptable the use of video-recorded discharge via the Patient Knows Best or Ortus-iHealth application is. It employs a randomised control trial design, with one group receiving standard discharge care and another receiving the standard care plus video-recorded discharge.

Upon discharge from hospital, the clinical team (e.g, nurses and doctors) will record the routine discharge briefing, covering aspects such as medication and wound care, for consenting patients. This briefing will be based on the discharge letter from the medical team and will last approximately up to three minutes. It will take place in a private hospital ward room, using the patient's or their relative's smart device (e.g., mobile or tablet). Subsequently, the recorded video will be uploaded to the patient's Patient Knows Best app account. Patients can review the video multiple times to reinforce their understanding of the discharge information, including medication advice, wound dressing, and exercise. Additionally, they can share it with their relatives, as well as community and district nursing teams, to enhance the clarity of shared information and continuity of care.

Both control and intervention group patients will receive a self-reported questionnaire regarding their acceptance of the discharge process, satisfaction levels, and its impact on their quality of life. Clinical staff involved in the recording will also complete a questionnaire assessing the feasibility, practicality, and satisfaction with the new intervention.

The feasibility of the study will be evaluated based on recruitment numbers, retention rates, completion rates, and the chosen questionnaire's suitability. Questionnaires will be administered post-discharge, one week after discharge, and thirty days later. Additionally, patient engagement with the Patient Knows Best platform and video viewing habits will be analysed to explore any differences among demographic groups.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age >18 years old
  • Anticipated to be discharged to their own home or that of a relative;
  • Staying for at least one night on a participating hospital ward;
  • Recently discharge (in the last 2 months) from the participating hospital ward with the same clinical problem as assessed by the care professionals;
  • From cardiothoracic centre-Basildon or Elderly ward-Southend
  • Have a personal digital device (e.g., mobile or tablet)/ or their close relative and mobile app
  • Able to read and understand English.
  • Relative or patient willing and able to give informed consent
  • Clinical Frailty scale of ≤ 8 using Rockwood Frailty Scale

Exclusion Criteria:

  • Patients live out of the area or plan to be transferred to another acute hospital;
  • Discharged after recurrent admissions for the same clinical complaint as assessed by the care professionals;
  • Patient or immediate carer don't have a personal digital device capable of hosting Patient Knows Best/ Ortus-iHealth app;
  • Patient or relative unable or unwilling to upload the personalised discharge video to mobile app;
  • Admitted for psychiatric reasons (other than dementia/delirium);
  • Identified as being at the end of life and whose care has become palliative / clinical Frailty scale of > 8 using Rockwood Frailty Scale

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control group
Usual hospital discharge include medical discharge letter and verbal advice from healthcare team.
Other: Intervention group
Usual hospital discharge + video recorded medical advice from the healthcare team uploaded in a mobile app
Other: Video recorded shared using a mobile application

The routine hospital discharge explanation is video recorded [up to three minutes].

The video is uploaded by to a mobile app for the patient and patient/ relatives can review the advice multiple times

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Acceptability of video-discharge
Time Frame: 7 days and 30 days post-discharge
Questionnaire with close ended and open ended question based on validated questionnaire
7 days and 30 days post-discharge

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient satisfaction
Time Frame: 7 and 30 days post discharge
Brief questionnaire on patient satisfaction
7 and 30 days post discharge
Care of Transitions
Time Frame: 7 and 30 days post discharge
Three questions measuring validated tool
7 and 30 days post discharge
Staff satisfaction of video recorded discharge
Time Frame: within 7 days of post-discharge experience
Close and opened questionnaire
within 7 days of post-discharge experience

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Anglia Ruskin University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Southend NHS Foundation Trust
Basildon and Thurrock Hospitals NHS FoundationTrust

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Naim Abdulmohdi, PhD, Anglia Ruskin University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 16, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 22, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 320936
  • 423607 (Other Identifier: 423607)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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