NCT03737396

Brief 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". 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
402

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 3, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 9, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2021

Completed
Last Updated

February 18, 2021

Status Verified

October 1, 2019

Enrollment Period

2.7 years

First QC Date

November 8, 2018

Last Update Submit

February 16, 2021

Conditions

AnesthesiaComputer, Attitude to

Keywords

Preanaesthesia health assessmentComputerized health assessment

Outcome Measures

Primary Outcomes (2)

  • Concordance of responses

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

    1 year

  • Duration of nurse assessment at Preadmission Service

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

    1 year

Secondary Outcomes (1)

  • Patient's perception and experience in using self-administered digital preanaesthesia health assessment tool

    1 year

Study Arms (2)

Electronic health screening

ACTIVE COMPARATOR

Self-administered electronic health screening on tablet

Procedure: Self-administered electronic health screening

Paper-based health screening

NO INTERVENTION

Routine-care nurse-administered, paper-based health screening

Interventions

Self-administered electronic health screeningPROCEDURE

Health assessment using an electronic device

Electronic health screening

Eligibility Criteria

Age21 Years - 90 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KK Women's and Children's Hospital

Singapore, 229899, Singapore

Location

Study Officials

  • Eileen Lew

    KK Women's and Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
In the validation phase of the study, patients, nurses and investigators are aware of participating patients' allocation in the cross over validation study. However, nurses would be blinded to the electronic responses of patients. In the randomized phase of the study, patient, nurses and investigators will be aware of group allocation and no blinding is involved.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2018

First Posted

November 9, 2018

Study Start

May 3, 2018

Primary Completion

January 2, 2021

Study Completion

January 2, 2021

Last Updated

February 18, 2021

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)