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AnesthesiaPATCHNCT03737396

Pre-Anaesthesia CompuTerized Health Assessment

A study testing Self-administered electronic health screening in people with Anesthesia and Computer, Attitude to, run by KK Women's and Children's Hospital at 1 site in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Pre-anaesthesia assessment is an important component of preoperative care of surgical patients. With the increasing prevalence of same-day-admission and ambulatory surgery, patients no longer undergo preanaesthesia assessment as an inpatient in traditional "premed rounds". Read more about this study

Who is it for?
Ages 21 to 90 years, women only
Conditions the study is for
Anesthesia, Computer, Attitude to
What is being tested?
Self-administered electronic health screening
Could I receive a placebo?
No, everyone receives an active treatment
How many people
402 participants
Where
1 siteSingapore
Study dates
3 May 2018to 2 Jan 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 90 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Listed for elective surgery requiring preanaesthesia health assessment at the Preadmission Service
  • English-literate
  • Able to use an iPad / tablet device
  • Of any nationality

Who cannot join

  • Patients who are severely ill or listed for emergency operations
  • Visually impaired
  • Not English-literate
  • Unable or refuses to use an iPad / tablet device

Trial locations and contacts

1 site in 1 country.

Singapore1 site
  • KK Women's and Children's Hospital

    Singapore, 229899

Other trials in Singapore

About this study

Official title: Development and Validation of Pre-Anaesthesia CompuTerized Health Assessment (PATCH)

Pre-anaesthesia assessment is an important component of preoperative care of surgical patients. With the increasing prevalence of same-day-admission and ambulatory surgery, patients no longer undergo preanaesthesia assessment as an inpatient in traditional "premed rounds". Currently, a nurse-administered paper-based health screening questionnaire is used at the Preadmission Service to identify patients who require outpatient evaluation by anaesthetists prior to elective surgery. In this study, the investigators aim to re-design and convert the current paper-based, nurse-administered health screening questionnaire into a reliable patient self-administered digital tool- Pre-Anaesthesia CompuTerized Health-assessment (PATCH). The electronic questionnaires will be validated by comparison of responses from digital self-administration against that obtained from a nurse interview structured to the same format. The investigators hypothesize that the responses obtained using PATCH will have at least 95% agreement with responses obtained in a nurse-led structured interview. Finally, the use of PATCH would be compared with standard nurse-led paper-based interview in a non-blinded, randomised controlled trial with regard to time taken for nurse processing of the patient at the clinic.

Read the detailed description

Pre-anaesthesia assessment is an important component of preoperative care of surgical patients. Early engagement of medically-complex patients is critical to allow ample time for risk evaluation, discussion of anaesthetic plan and medical optimization. Timely and optimal preparation of patients before elective surgery could reduce morbidity and mortality, and day-of-surgery case cancellations. Due to the implementation of same-day-admission and ambulatory surgeries, medically complex patients would require preanaesthesia evaluation at an appropriate time interval prior to their elective surgery, in an outpatient facility. Currently, a nurse-administered, paper-based health screening questionnaire is used at the Preadmission Service to determine the need for outpatient specialized assessment by an anaesthetist prior to elective surgery. This process is labour-intensive and time-consuming for both patients and nurses.

The need for efficient and cost-saving processes are driving healthcare practice. Computer-assisted history-taking systems have been shown to assist clinicians in the accurate eliciting of information from patients. Increasing evidence supports the use of such systems to triage patients and determine the timing of specialist-led anaesthetic review. Low-risk patients could be evaluated by an anaesthetist on the day of surgery while high-risk patients could be channeled into appropriate pathways for evaluation and optimisation prior to day of elective surgery.

This study is planned to be conducted in several phases:

In the first phase, the investigators aim to re-design and convert the current paper-based, nurse-administered health screening questionnaire into a reliable patient self-administered digitized tool - Pre-Anaesthesia CompuTerized Health-assessment (PATCH). The feasibility of introducing a digital pre-anaesthesia health assessment screening tool will first be assessed by conducting two discrete anonymized surveys on healthcare providers and elective surgical patients to explore their needs, attitudes and acceptability towards having a digitized tool. Next, a new paper-based preanaesthesia health screening questionnaire will be designed after extensive literature review of published, validated preanaesthesia screening questionnaires and a focus group evaluation by clinicians of the anaesthesia department.

Using the draft self-administered paper questionnaire, a pilot study of about 100 patients would be conducted after obtaining written informed consent. Feedback would be sought through a short structured interview that focuses on patient's perception of language, relevance of content and ease of completion. Patients would then be processed, as per standard of care, through a nurse-led interview using the paper-based tool. Validity of each assessment question is determined by percentage agreement method. Percentage agreement of 95% or higher is considered as good criterion validity. Analysis would also include measurement of identical, contradictory and non-contradictory response rates.

In the second phase, the paper-based questionnaire will be converted to a digitized tool on an iOS platform and accessible via a tablet, called Pre-Aneshtesia CompuTerized Health assessment (PATCH). PATCH and its server would be developed using a JavaScript framework. Patient responses using self-administration of PATCH would be validated against the responses obtained by a nurse using the same platform. After written informed consent, participating patients (n=250) will complete the health screening questionnaires on a tablet without help, after which a nurse who is blinded to the patient's responses, would conduct the health screening using the same platform . Responses for each screening question will be compared for agreement and percentage agreement of 95% or higher will be considered good criterion validity.

In the final phase, a two-arm, non-blinded randomized trial would be conducted at the Preadmission Service after written informed consent, comparing duration of nurse assessment in patients who have completed the self-administration of preanaesthesia health assessment using a tablet vs those undergoing standard care nurse-led interview. Based on an expected difference in means of 3 minutes and standard deviation of 3.5 minutes at 80% power and a level of significance of 5%, the total sample size for power of analysis is 44. To account for drop-outs, the investigators aim to recruit 52 patients in this phase. Duration of nurse assessment ("service time") will be measured by the "1Q 1Payment" system and is defined from the moment the nurse clicks on the queue system to call for the patient, to completion of the nurse assessment.

Primary aim(s):

To convert a paper-based preanaesthesia health screening questionnaire into an electronic tool, with at least 95% concordance of responses from patients

To compare the duration of nurse assessment at the Preadmission Service in patients randomized to self-administration of digital preanaesthesia health assessment vs those undergoing standard nurse interview

Primary hypotheses:

The conversion of a paper-based preanaesthesia health screening questionnaire can be converted into an electronic tool, with at least 95% concordance of responses from patients.

Self-administration of a digital preanaesthesia health assessment tool does not prolong nurse assessment at the Preadmission Service, compared with standard care nurse interview.

As a secondary aim, the patients' perceptions and experience in using PATCH will be evaluated.

Being tested
Self-administered electronic health screening
Keywords
Preanaesthesia health assessment, Computerized health assessment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Self-administered electronic health screeningProcedure or surgery

    Health assessment using an electronic device

Study groups in NCT03737396
Study groupRoleWhat they receive
Electronic health screeningActive comparatorSelf-administered electronic health screening on tablet
Receives: Procedure: Self-administered electronic health screening
Paper-based health screeningNo interventionRoutine-care nurse-administered, paper-based health screening

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Concordance of responses

    % concordance between responses obtained from self-administration vs nurse administration of the questionnaires

    Measured: 1 year

  2. Duration of nurse assessment at Preadmission Service

    Duration of nurse assessment will be compared between digital and standard care patients

    Measured: 1 year

Secondary outcomes (1)
  1. Patient's perception and experience in using self-administered digital preanaesthesia health assessment tool

    Patients' experience and perception of using PATCH would be assessed

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2018
  2. Study start3 May 2018
  3. Primary completion2 Jan 2021
  4. Study completion2 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Crossover
Model description
Participating patients performs self-administered preanaesthesia health screening on an electronic tablet, before receiving nurse-administered health screening by nurses blinded to their electronic responses. This cross over study design aims to validate the electronic patient responses. In another phase, a randomized controlled trial design will be adopted to compare nurse processing time between patients who are assessed by self-administration of PATCH vs patients who undergo standard nurse-led health assessment interview.
Masking
None (open label)
Enrolment
402 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03737396
Sponsor's protocol ID
PATCH01/11/17
Acronym
PATCH
Status last verified
Oct 2019
First submitted
8 Nov 2018
Last updated
18 Feb 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Self-administered electronic health screening in people with Anesthesia and Computer, Attitude to, run by KK Women's and Children's Hospital at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Concordance of responses (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021.

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Pre-Anaesthesia CompuTerized Health Assessment | AzTrials