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Trial registered on ANZCTR


Registration number
ACTRN12619000499189
Ethics application status
Approved
Date submitted
20/03/2019
Date registered
27/03/2019
Date last updated
2/03/2020
Date data sharing statement initially provided
27/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomized trial to measure if integrating patient agendas into consultations via the Values in Shared Interactions Tool (VISIT) website can improve patient consultation satisfaction.
Scientific title
Effect of the Values in Shared Interactions Tool (VISIT) on patient satisfaction of medical consultations: A single-center block-randomization trial.
Secondary ID [1] 297714 0
Nil known
Universal Trial Number (UTN)
U1111-1230-0970
Trial acronym
VISIT (Values in Shared Interactions Tool)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 312027 0
Diabetes 312119 0
Hyperlipidemia 312120 0
Condition category
Condition code
Cardiovascular 310592 310592 0 0
Hypertension
Metabolic and Endocrine 310594 310594 0 0
Diabetes
Metabolic and Endocrine 310595 310595 0 0
Other endocrine disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
VISIT Consultation Arm
VISIT is a website whereby patients can input their health concerns or agenda that they want to discuss with their doctors before their appointments, so as to enable the doctors to review the agenda prior to the consultation.
The purpose of conducting this intervention is to determine the effect of using this tool in consultations on patient and physician satisfaction, agenda items and length of consultation, compared to regular consultations.
Materials included for the intervention are the VISIT website itself, which patients can access through their own accounts on the hospital website and via the electronic medical record (EMR) for the doctors involved. We will also be giving out participant information sheets for the patients and doctors involved, and have them sign a consent form should they agree to participate. Materials for pre-test data collection include a patient demographic data sheet, and the Mobile Device Proficiency Questionnaire-16 (MDPQ-16). For post-test, a single item "My doctor discussed the issues that were important to me", as well as the Healthcare Provider-Patient Communication Instrument (HCP-PC). As for the doctors, we will be giving a form to record the duration of each consultation and the number of agenda discussed.
Whilst patients are waiting for their appointment, they will be approached to participate in the study. Once they have been informed of the study, agree to participate and give written consent, patients will have to fill in their demographic details and the MDPQ-16. After that, they will need to access the VISIT tool on their own devices to input the health concerns that they want to discuss with the doctor, for approximately 5-10 minutes. Once they have done that, they continue to wait to see the doctor. After the consultation has ended, they will need to fill in the HCP-PC instrument before their participation ends.
As for the doctors, the patients' agenda can be accessed via the EMR prior to seeing the patients. Doctors are expected to discuss these agenda and at the end of the consultation, record the duration of the consultation and the number of agenda items discussed.
About 10 consultations in this arm will be audio-recorded, to explore how the use of VISIT affects the process of aligning the doctor and patient agendas.
The patient intervention and data collection will be carried out by a research assistant who is trained on the use of the VISIT tool and familiar with the data collection process.
As the intervention is an online tool, it will be delivered virtually and individually to each patient's mobile device and each doctor's EMR screen. Patients will only need to access the tool once during one of their scheduled appointments throughout their participation in the study. Whereas, doctors will need to participate for 1.5 to 2 months, until the required number of patients have been reached (approximately 10 patients per doctor).
The intervention will be conducted at the outpatient clinic at the University of Malaya Medical Centre, Malaysia.
Intervention code [1] 313948 0
Treatment: Other
Comparator / control treatment
Usual Consultation Arm
Patients in the control arm will see their doctor as usual, without using the VISIT website. It will involve the use of the same data collection forms as the intervention arm; participant information sheets for the patients and doctors involved, consent form, demographic data sheet, and the Healthcare Provider-Patient Communication Instrument (HCP-PC). As for the doctors, we will be giving a form to record the duration of each consultation and the number of agenda discussed.
The process of recruitment involves the following; whilst patients are waiting for their appointment, they will be approached to participate in the study. Once they have been informed of the study, agree to participate and give written consent, patients will have to fill in only their demographic details and wait to see the doctor. After the consultation has ended, they will also need to fill in the single item and the HCP-PC instrument before their participation ends.
As for the doctors, they will only need to conduct the consultations as they usually do, without the use of VISIT, and to record the duration of the consultation and the number of agenda items discussed at the end of each consultation.
The data collection will be carried out by a research assistant who is familiar with the data collection process.
Patients will only need to participate once during one of their scheduled appointments throughout their participation in the study. Whereas, doctors will need to participate for 1.5 to 2 months, until the required number of patients have been reached (approximately 10 patients per doctor).
The control arm will also be conducted at the outpatient clinic at the University of Malaya Medical Centre, Malaysia.
Control group
Active

Outcomes
Primary outcome [1] 319441 0
Patients' satisfaction with the consultation, assessed on a single item "My doctor discussed the issues that were important to me" on a 4-point likert scale, ranging from 'Strongly disagree' to 'Strongly agree'.
Timepoint [1] 319441 0
After the consultation has ended.
Secondary outcome [1] 368219 0
Average length of consultations for each arm, in minutes, as recorded by the doctors on a given sheet.
Timepoint [1] 368219 0
After the consultation has ended.
Secondary outcome [2] 368220 0
Average number of agenda discussed for each arm, as recorded by the doctors on a given sheet.
Timepoint [2] 368220 0
After the consultation has ended.
Secondary outcome [3] 368221 0
Patients' satisfaction of the consultation using the Healthcare Provider-Patient Communication (HCP-PC) instrument.
Timepoint [3] 368221 0
After the consultation has ended.
Secondary outcome [4] 368362 0
Linguistic analysis of patient-doctor agenda alignment via discourse-pragmatic analysis.
Timepoint [4] 368362 0
During consultations for 10 patients in each arm.
Secondary outcome [5] 368677 0
Doctors' experience on using VISIT during consultations, via individual interviews.
Timepoint [5] 368677 0
After consultations have ended.

Eligibility
Key inclusion criteria
For doctors, we will be recruiting Year 3 and Year 4 family medicine trainees in the clinic.
For patients, those who are on follow-up visits for long-term chronic conditions, such as diabetes, hypertension and high cholesterol, and have smartphones with web browsers and mobile data at the time of the study.
We are selecting patients with chronic conditions as they are more likely to fall into a routine during follow-up consultations and may have certain concerns overlooked by the doctors. As the study is looking to see the effect of the website on addressing these concerns, we feel this population is appropriate for the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Doctors who are not Year 3 and Year 4 family medicine trainees at the clinic, and patients who do not have a follow-up for a chronic condition (i.e; walk-in patients).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomised by computer.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Single-center block randomized trial.
Singe-center because VISIT is attached to iPesakit, an online patient portal only available in one site (University of Malaya Medical Centre), and block randomisation as we are randomizing the doctors involved in the study into either intervention (VISIT) or control (usual consultation) arms, instead of the patients.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size is estimated to be 200 patients (100 in each arm) based on a power of 80% to detect an effect size of OR 2.667 for a difference in patients’ perceptions that the doctor addressed issues that were important to them. In order to compensate for the clustering effect and to retain equivalent power, the sample size will be increased to 272 with the design effect of 1.36.

All data will be analysed at the individual patient level and the analysis will be adjusted for clustering effect. Categorical data will be analysed using Chi-square test to compare proportions between intervention and control groups. Continuous data will be analysed using a student-t test. Linguistic analysis of alignment of the qualitative data will be conducted via discourse-pragmatic analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/05/2019
Actual
13/06/2019
Date of last participant enrolment
Anticipated
17/07/2019
Actual
25/10/2019
Date of last data collection
Anticipated
17/07/2019
Actual
25/10/2019
Sample size
Target
272
Accrual to date
Final
227
Recruitment outside Australia
Country [1] 21348 0
Malaysia
State/province [1] 21348 0
Kuala Lumpur

Funding & Sponsors
Funding source category [1] 302239 0
University
Name [1] 302239 0
University of Malaya Research University Grant
Country [1] 302239 0
Malaysia
Primary sponsor type
Individual
Name
Lee Yew Kong
Address
Department of Primary Care Medicine,
Faculty of Medicine,
University of Malaya,
Jalan Universiti,
50603 Kuala Lumpur,
Wilayah Persekutuan Kuala Lumpur
Country
Malaysia
Secondary sponsor category [1] 302132 0
Individual
Name [1] 302132 0
Ng Chirk Jenn
Address [1] 302132 0
Department of Primary Care Medicine,
Faculty of Medicine,
University of Malaya,
Jalan Universiti,
50603 Kuala Lumpur,
Wilayah Persekutuan Kuala Lumpur
Country [1] 302132 0
Malaysia
Secondary sponsor category [2] 302134 0
Individual
Name [2] 302134 0
Lee Ping Yein
Address [2] 302134 0
Department of Family Medicine,
Faculty of Medicine and Health Sciences,
Putra University of Malaysia,
43400 Serdang,
Selangor
Country [2] 302134 0
Malaysia
Secondary sponsor category [3] 302135 0
Individual
Name [3] 302135 0
Chiew Thiam Kian
Address [3] 302135 0
Department of Software Engineering,
Faculty of Computer Science and Information Technology,
University of Malaya,
Jalan Universiti,
50603 Kuala Lumpur,
Wilayah Persekutuan Kuala Lumpur
Country [3] 302135 0
Malaysia
Secondary sponsor category [4] 302136 0
Individual
Name [4] 302136 0
Adina Binti Abdullah
Address [4] 302136 0
Department of Primary Care Medicine,
Faculty of Medicine,
University of Malaya,
Jalan Universiti,
50603 Kuala Lumpur,
Wilayah Persekutuan Kuala Lumpur
Country [4] 302136 0
Malaysia
Secondary sponsor category [5] 302137 0
Individual
Name [5] 302137 0
Charity Lee Chin Ai
Address [5] 302137 0
Department of Asian and European Languages,
Faculty of Languages and Linguistics,
University of Malaya,
Jalan Universiti,
50603 Kuala Lumpur,
Wilayah Persekutuan Kuala Lumpur
Country [5] 302137 0
Malaysia
Secondary sponsor category [6] 302138 0
Individual
Name [6] 302138 0
Tun Firzara Binti Abdul Malik
Address [6] 302138 0
Department of Primary Care Medicine,
Faculty of Medicine,
University of Malaya,
Jalan Universiti,
50603 Kuala Lumpur,
Wilayah Persekutuan Kuala Lumpur
Country [6] 302138 0
Malaysia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302917 0
Medical Research Ethics Committee
Ethics committee address [1] 302917 0
Ethics committee country [1] 302917 0
Malaysia
Date submitted for ethics approval [1] 302917 0
31/01/2019
Approval date [1] 302917 0
27/02/2019
Ethics approval number [1] 302917 0
2019131-7084

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

Contacts
Principal investigator
Name 91842 0
Dr Lee Yew Kong
Address 91842 0
Department of Primary Care Medicine,
Faculty of Medicine,
University of Malaya,
Jalan Universiti,
50603 Kuala Lumpur,
Wilayah Persekutuan Kuala Lumpur
Country 91842 0
Malaysia
Phone 91842 0
+60 3 7949 2306
Fax 91842 0
Email 91842 0
leeyk@um.edu.my
Contact person for public queries
Name 91843 0
Lee Yew Kong
Address 91843 0
Department of Primary Care Medicine,
Faculty of Medicine,
University of Malaya,
Jalan Universiti,
50603 Kuala Lumpur,
Wilayah Persekutuan Kuala Lumpur
Country 91843 0
Malaysia
Phone 91843 0
+60 3 7949 2306
Fax 91843 0
Email 91843 0
leeyk@um.edu.my
Contact person for scientific queries
Name 91844 0
Lee Yew Kong
Address 91844 0
Department of Primary Care Medicine,
Faculty of Medicine,
University of Malaya,
Jalan Universiti,
50603 Kuala Lumpur,
Wilayah Persekutuan Kuala Lumpur
Country 91844 0
Malaysia
Phone 91844 0
+60 3 7949 2306
Fax 91844 0
Email 91844 0
leeyk@um.edu.my

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This study has limited generalisability for comparing trial effects with other web-based consultation communication interventions. Therefore, there is no need to share IPD data for this trial.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1654Ethical approval    377196-(Uploaded-18-03-2019-18-54-49)-Study-related document.pdf
1655Study protocol    377196-(Uploaded-18-03-2019-18-59-00)-Study-related document.pdf



Results publications and other study-related documents

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Documents added automatically
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