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.
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
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- 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.
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.
- Conditions
- Anesthesia, Computer, Attitude to
- 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 group | Role | What they receive |
|---|---|---|
| Electronic health screening | Active comparator | Self-administered electronic health screening on tablet Receives: Procedure: Self-administered electronic health screening |
| Paper-based health screening | No intervention | Routine-care nurse-administered, paper-based health screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance of responses
% concordance between responses obtained from self-administration vs nurse administration of the questionnaires
Measured: 1 year
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)
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.
- First posted9 Nov 2018
- Study start3 May 2018
- Primary completion2 Jan 2021
- Study completion2 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Collaborators
- Nanyang Technological University
- Responsible party
- Sponsor
- Investigators
- Eileen Lew, Principal investigator, KK Women's and Children's Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of Pre-Anaesthesia CompuTerized Health Assessment (PATCH)
- ClinicalTrials.gov ID
- NCT03737396
- Acronym / sponsor ID
- PATCH / PATCH01/11/17
- Conditions
- Anesthesia, Computer, Attitude to
- Keywords
- Preanaesthesia health assessment, Computerized health assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 402 participants (actual)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Collaborators
- Nanyang Technological University
- Study start
- 3 May 2018 (actual)
- Primary completion
- 2 Jan 2021 (actual)
- Study completion
- 2 Jan 2021 (actual)
- First posted
- 9 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Electronic health screening | Active comparator | Procedure: Self-administered electronic health screeningSelf-administered electronic health screening on tablet |
| Paper-based health screening | No intervention | –Routine-care nurse-administered, paper-based health screening |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Listed for elective surgery requiring preanaesthesia health assessment at the Preadmission Service
- English-literate
- Able to use an iPad / tablet device
- Of any nationality
Key exclusion criteria (4 listed)
- Patients who are severely ill or listed for emergency operations
- Visually impaired
- Not English-literate
- Unable or refuses to use an iPad / tablet device
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-administered electronic health screeningHealth assessment using an electronic device | Procedure or surgery | Electronic health screening |
Primary outcome
Concordance of responses
Time frame: 1 year
% concordance between responses obtained from self-administration vs nurse administration of the questionnaires
Duration of nurse assessment at Preadmission Service
Time frame: 1 year
Duration of nurse assessment will be compared between digital and standard care patients
1 secondary outcome
Patient's perception and experience in using self-administered digital preanaesthesia health assessment tool
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eileen Lew principal investigator
KK Women's and Children's Hospital
1 site in 1 country: see every site and its status.
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.