Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000932763
Ethics application status
Approved
Date submitted
28/06/2022
Date registered
30/06/2022
Date last updated
4/08/2024
Date data sharing statement initially provided
30/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Patient Perceptions of Hospital Admission Interviews
Scientific title
Patient Perceptions of Hospital Admission Interviews
Secondary ID [1] 307335 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Studies of normal psychology 326621 0
Studies of Behaviour 326623 0
Dehumanisation 326844 0
Quality Improvement of Health Services 326845 0
Hospital Admission Experiences 326846 0
Condition category
Condition code
Mental Health 323872 323872 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 324058 324058 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study aims to investigate the impact of wearing a patient hospital gown on the patient experience, specifically focusing on dehumanisation. The study will also look at the impact of wearing a patient gown on the patient-doctor relationship, and patient behaviour.

The randomised control trial will be a single-centre study conducted at The University of Auckland Grafton Campus.

72 participants for the trial will be recruited from The University of Auckland and wider community via online, email, and poster advertisements. A cover story will be used, whereby participants will be told that the study is looking to evaluate medical admission interview processes and that they will be supporting the researchers in this evaluation via the provision of feedback.

Once the potential participants respond to the advertisements for the study via email, a participant information sheet with study details will be sent to them. Upon meeting eligibility criteria participants will be asked to register via an online booking system to attend a medical interview at a date and time convenient to them. Participants will have a selection of dates and times available to choose from.

Once participants arrive at the research venue, they will be asked to read and sign a written consent form and be given the opportunity to ask any questions they may have about the study. Participants will also complete a baseline questionnaire collecting demographic details. Once paperwork is complete, participants will be randomised to either wear a patient hospital gown or remain in their own clothes. They will not know that there are two groups (gown or normal clothes), only that we are interested in their views of the admission interview. The researcher completing the pre-interview process with participants will be blinded to the randomisation process and will only know which group the participant will be in after opening a sealed envelope with the information post pre-interview procedures. The randomisation will be completed using randomiser.org by the second researcher who will not be present at the research venue during the interviews.

After randomisation of the participants to either the gown wearing or wearing own clothes group, participants will enter the medical interview room to meet the doctor and begin the interview.

The medical interviews will be carried out by either a female or male 5th or 6th year medical student from The University of Auckland. The medical students will be employed by the research team to conduct the interviews. The “doctors” too will be told that they are supporting a study looking to evaluate medical admission interview processes. Their role will be to conduct the interview following a script provided by the researchers. The medical students will be asked to wear what they would normally wear for hospital ward rounds. They will also be asked to sign a confidentiality statement requiring them not to discuss the study, the participants or share their thoughts about the admission interviews with others and each other. The medical interview will follow a standard interview structure and finish by taking the vital signs and listening to heart sounds. Participants will receive either the female or male doctor depending on which gender they identify with. Male participants will see the male medical student, female participants the female medical student and gender diverse participants can choose. The interview times available on the online booking system will reflect availability of the employed medical students and the researcher.

During the medical interview, participants will be asked to answer questions truthfully. It is likely that most participants will not have a specific presenting complaint to share with the medical student, but they will be asked about their current health and symptoms. If the “doctors” have any concerns about the health and wellbeing of the participants following the interview, they will be asked to share these with the researcher who will be able to take the necessary steps to ensure the participant is followed-up, informed and given an opportunity to seek professional support.

During the interview, the conversation between the participant and doctor will be recorded using a voice recorder. This data will later be transcribed and analysed using Linguistic Inquiry and Word Count (LIWC) software post-interview. The blood pressure of participants will also be measured as part of taking the vital signs. After completing the interview with the doctor, participants will be asked to complete The Patient Experience and Feedback Questionnaire.

It is expected that the participants will spend a total of 40 minutes at the clinical research centre. This will include 10 minutes upon arrival spent gowning up if required and completing the baseline questionnaire. The patient-physician consultation is expected to take no more than 20 minutes followed by 10 minutes to complete the post-interview questionnaires. Participants will receive a $20 gift voucher as a gesture of gratitude for volunteering their time for the study as they leave the venue.

Both participants and medical students will be debriefed at the end of the study once all 70 interviews have been completed.
Intervention code [1] 323844 0
Behaviour
Comparator / control treatment
Half the participants will not be wearing patient hospital gowns. This group will complete the same process as the gown wearing group for the medical interview and completion of questionnaires.
Control group
Active

Outcomes
Primary outcome [1] 331771 0
Patient Experience and Feedback Questionnaire

This questionnaire looks to identify how the participants felt, their thoughts and emotions during the medical interview. The questionnaire was developed by the researchers based on proposed factors contributing to dehumanising experiences in healthcare settings. There are currently no other questionnaires available that measure experiences of dehumanisation in the context of healthcare.
Timepoint [1] 331771 0
Measured once, directly after the medical interview.
Secondary outcome [1] 411078 0
Language Analysis

The language used by participants during the interviews will be analysed using LIWC’s student -academic version. Audio recorded language will be transcribed and entered to LIWC. LIWC will read and compare each word in the text to the list of dictionary words and calculate the percentage of total words in the text that match each of the dictionary categories. The study will look at the use of singular first person pronouns and positive/negative emotional language.
Timepoint [1] 411078 0
Measured once - participant's speech is recorded during the interview, transcribed and analysed.
Secondary outcome [2] 411079 0
Blood Pressure

Blood pressure will be measured as an indicator of physiological arousal. The measure will be taken as part of the vital signs during the interview by the doctor.
Timepoint [2] 411079 0
Measured once during the interview as part of the vital signs
Secondary outcome [3] 411293 0
Thematic analysis of the open-ended question in the patient experience questionnaire.
Timepoint [3] 411293 0
This question will be completed once, directly after the medical interview has taken place.

Eligibility
Key inclusion criteria
To be included in the study participants will have to be at least 18 years of age or older, and be able to speak, read and write in English. Participants will be required to attend the hospital admission interview in-person at The Auckland University Grafton Campus.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Those who cannot read, write or understand English. Those who are not able to attend the in-person interview at the research venue.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants in each arm of the study will be blinded to group allocation because knowledge of their allocation may influence and bias their responsiveness to the intervention. Allocations will be placed into opaque sealed consecutively numbered envelopes. These will be opened by the researcher after the participants have signed informed consent and completed baseline questionnaires. The PIS will state that participants may be asked to wear a gown as per the normal hospital admission process. They will not be told that there are two conditions. Participants will be debriefed along with a summary of the study findings once all statistical analyses are completed and the thesis is submitted.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Blinded (masking used). A computer-generated random list will be used to allocate participants to groups by an independent party.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
A power analysis was carried out using G*Power software with a power level of .80 and a two-tailed significance level of a =.05, with an effect size of d = 0.70. Using these parameters gives a required total sample size of 68. The lack of previous experimental data on gown wearing made an estimation of expected effect size more challenging. Research on the effects of submissive posture on self-esteem and first-person singular pronouns has demonstrated effect sizes of d = 0.79, and d = 1.16 (Nair et al., 2015). Given the study is cross-sectional, attrition does not need to be accommodated, but we will recruit 72 participants in case of missing data.

Descriptive statistics will be used to summarize sociodemographic information and baseline characteristics.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/07/2022
Actual
10/07/2022
Date of last participant enrolment
Anticipated
24/08/2022
Actual
9/09/2022
Date of last data collection
Anticipated
14/09/2022
Actual
9/09/2022
Sample size
Target
72
Accrual to date
Final
74
Recruitment outside Australia
Country [1] 24849 0
New Zealand
State/province [1] 24849 0
Auckland

Funding & Sponsors
Funding source category [1] 311626 0
University
Name [1] 311626 0
The University of Auckland
Country [1] 311626 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
85 Park Road
Grafton
Auckland 1023
New Zealand
Country
New Zealand
Secondary sponsor category [1] 313063 0
None
Name [1] 313063 0
NA
Address [1] 313063 0
NA
Country [1] 313063 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311082 0
Auckland Health Research Ethics Committee
Ethics committee address [1] 311082 0
Ethics committee country [1] 311082 0
New Zealand
Date submitted for ethics approval [1] 311082 0
25/05/2022
Approval date [1] 311082 0
27/05/2022
Ethics approval number [1] 311082 0
AH24293

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119878 0
Prof Elizabeth Broadbent
Address 119878 0
The University of Auckland
85 Park Road
Grafton
Auckland 1023
New Zealand
Country 119878 0
New Zealand
Phone 119878 0
+64 9 923 6756
Fax 119878 0
Email 119878 0
[email protected]
Contact person for public queries
Name 119879 0
Chamilka Punchihewa
Address 119879 0
The University of Auckland
85 Park Road
Grafton
Auckland 1023
New Zealand
Country 119879 0
New Zealand
Phone 119879 0
+64 211329902
Fax 119879 0
Email 119879 0
[email protected]
Contact person for scientific queries
Name 119880 0
Chamilka Punchihewa
Address 119880 0
The University of Auckland
85 Park Road
Grafton
Auckland 1023
New Zealand
Country 119880 0
New Zealand
Phone 119880 0
+64 211329902
Fax 119880 0
Email 119880 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16436Ethical approval    384205-(Uploaded-22-06-2022-09-54-52)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.