Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03737396 |
| Other study ID # |
PATCH01/11/17 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 3, 2018 |
| Est. completion date |
January 2, 2021 |
Study information
| Verified date |
October 2019 |
| Source |
KK Women's and Children's Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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". 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.
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.
