Focus of Study: The Safety of an Online Pre-assessment ToolNCT02724189
The Evaluation of MyPreOp, an Online Preoperative Assessment Tool
An observational study of Focus of Study: The Safety of an Online Pre-assessment Tool, run by Michelle Cole.
Trial summary
This pilot study will intend to assess the feasibility and acceptability of MyPreOp (online pre-operative assessment tool). The study will aim to assess the quality of the MyPreOp assessment in comparison to standard practice of a nurse led face to face assessment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Focus of Study: The Safety of an Online Pre-assessment Tool
- What is being tested?
- MyPreOp assessment and Nurse led assessment
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Jun 2016
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study group will be taken from a single centre. The patient population will be patients being assessed prior to general, gynaecological, urological and orthopaedic surgery. The investigators selected this population as they represent a diverse sample of patients of both genders with a varying range of ages and co-morbidities for both ambulatory and inpatient surgery.
Who may be able to join
- All patients due to see a pre-assessment nurse on that day
- Read and able to write English
- Lucid patients with mental capacity
Who cannot join
- Patients unable to understand spoken or written English.
- Not able to see a pre-assessment nurse on the same day
- Patients too unwell or confused to be able to complete the questionnaire.
- Patient refusal.
About this study
Official title: The Evaluation of MyPreOp© (Online Pre-assessment Tool) Over a Conventional Nurse Led Pre-assessment Clinic: a Pilot and Feasibility Study.
This pilot study will intend to assess the feasibility and acceptability of MyPreOp (online pre-operative assessment tool). The study will aim to assess the quality of the MyPreOp assessment in comparison to standard practice of a nurse led face to face assessment. The investigators will also assess the acceptability of MyPreOp amongst patient participants and staff participants.
Read the detailed description
MyPreOp is a patient online pre-assessment tool that has been developed as a means of an alternative to the current existing model of a nurse led pre-assessment service.
This pilot study will intend to assess the feasibility and acceptability of MyPreOp. The study will primarily evaluate the quality of the MyPreOp assessment in comparison to standard practice of a nurse led assessment. The investigators will also assess the acceptability of MyPreOp amongst patient participants and pre-assessment nurses and anaesthetists.
Participants will be recruited directly from the pre-assessment clinic. Consenting participants will alternate undergoing either the MyPreOp assessment or the nurse assessment first. Participants will complete the MyPreOp assessment on a computer device at the hospital. Participants will also complete a nurse led pre-assessment process as per standard practice. Following the completion of both the MyPreOp assessment and the nurse assessment, participants will be asked to complete a satisfaction questionnaire about their experience of using MyPreOp, together with further questions about their home internet access, usage and their preference of electronic or nurse led assessments.
Similarly pre-assessment nurses will review a random sample of MyPreOp assessments and complete a questionnaire about their views of the MyPreOp assessment summary and recommended actions.
The MyPreOp assessments will be compared with the nurse assessments through an independent adjudication process. Nominated adjudicators will be Consultant Anaesthetists with regular clinical duties in the pre-assessment clinic. Adjudicators will not be blinded with respects to the assessments so that the manner in which the patient data is presented can also be compared as well as the data itself. Adjudicators will assess the performance of the MyPreOp assessment in two domains, medical history and recommended investigations, and assign them into graded categories of over or under assessment, with or without clinical significance.
- Being tested
- MyPreOp assessment, Nurse led assessment
- Keywords
- electronic pre-assessment, preoperative assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyPreOp assessmentDevice
MyPreOp is an online preoperative assessment programme created by a medical software company called Ultramed.
Nurse led assessmentOther
Also called Standard
Standard practise is where patients undergo a face to face preoperative assessment led by a qualified nurse specialising in this field.
| Study group | Role | What they receive |
|---|---|---|
| Patients attending the preoperative assessment clinic | Patients in preoperative assessment clinic Receives: Device: MyPreOp assessment; Other: Nurse led assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The event rate of MyPreOp assessments that are judged as under assessments that would affect perioperative management following an adjudication review
Measured: Through study completion,an average of 6 months
Secondary outcomes (5)
Percentage of participants requiring assistance to complete MyPreOp
Measured: Through study completion,an average of 6 months
The median time taken for a nurse assessment of the MyPreOp summaries
This will be collected from the nurse questionnaire data ie the nurse would report the time taken to assess the MyPreOp summaries. The investigators will not be directly measuring the time.
Measured: Through study completion,an average of 6 months
Patient satisfaction
Qualitative analysis of patient satisfaction when using MyPreOp. The data will be extracted from the patient satisfaction questionnaire.
Measured: Through study completion,an average of 6 months
Nurse satisfaction
Qualitative analysis of nurse satisfaction when evaluating the MyPreOp summaries. The data will be extracted from the nurse satisfaction questionnaire.
Measured: Through study completion,an average of 6 months
Anaesthetist satisfaction
Qualitative analysis of anaesthetic satisfaction when evaluating the MyPreOp summaries. The data will be extracted from the anaesthetic satisfaction questionnaire.
Measured: Through study completion,an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2016 (estimated)
- Study startApr 2016
- Primary completionJun 2016
- Study completionJun 2016
Why it stopped: Lack of logistic capabilities at the study site
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focus of Study: The Safety of an Online Pre-assessment ToolStudies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michelle Cole
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michelle Cole, University College London Hospitals
- Investigators
- Ramani Moonesinghe, FRCA MD(Res), Study chair, Director UCL/UCLH Surgical Outcomes Resource Centre, Consultant Anaesthetics and Intensive Care Medicine, UCLH Honorary Lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02724189
- Sponsor's protocol ID
- 15/0795
- Status last verified
- Oct 2016
- First submitted
- 21 Mar 2016
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: The investigators plan to publish anonymised study results on the Surgical Outcome Research Centre website. http://www.uclsource.com/
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of MyPreOp© (Online Pre-assessment Tool) Over a Conventional Nurse Led Pre-assessment Clinic: a Pilot and Feasibility Study.
- ClinicalTrials.gov ID
- NCT02724189
- Acronym / sponsor ID
- 15/0795
- Keywords
- electronic pre-assessment, preoperative assessment
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of logistic capabilities at the study site
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Michelle ColeUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 31 Mar 2016 (estimated)
- 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.
This pilot study will intend to assess the feasibility and acceptability of MyPreOp (online pre-operative assessment tool). The study will aim to assess the quality of the MyPreOp assessment in comparison to standard practice of a nurse led face to face assessment. The investigators will also assess the acceptability of MyPreOp amongst patient participants and staff participants.
Detailed description
MyPreOp is a patient online pre-assessment tool that has been developed as a means of an alternative to the current existing model of a nurse led pre-assessment service.
This pilot study will intend to assess the feasibility and acceptability of MyPreOp. The study will primarily evaluate the quality of the MyPreOp assessment in comparison to standard practice of a nurse led assessment. The investigators will also assess the acceptability of MyPreOp amongst patient participants and pre-assessment nurses and anaesthetists.
Participants will be recruited directly from the pre-assessment clinic. Consenting participants will alternate undergoing either the MyPreOp assessment or the nurse assessment first. Participants will complete the MyPreOp assessment on a computer device at the hospital. Participants will also complete a nurse led pre-assessment process as per standard practice. Following the completion of both the MyPreOp assessment and the nurse assessment, participants will be asked to complete a satisfaction questionnaire about their experience of using MyPreOp, together with further questions about their home internet access, usage and their preference of electronic or nurse led assessments.
Similarly pre-assessment nurses will review a random sample of MyPreOp assessments and complete a questionnaire about their views of the MyPreOp assessment summary and recommended actions.
The MyPreOp assessments will be compared with the nurse assessments through an independent adjudication process. Nominated adjudicators will be Consultant Anaesthetists with regular clinical duties in the pre-assessment clinic. Adjudicators will not be blinded with respects to the assessments so that the manner in which the patient data is presented can also be compared as well as the data itself. Adjudicators will assess the performance of the MyPreOp assessment in two domains, medical history and recommended investigations, and assign them into graded categories of over or under assessment, with or without clinical significance.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients attending the preoperative assessment clinic | – | Device: MyPreOp assessment, Other: Nurse led assessmentPatients in preoperative assessment clinic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study group will be taken from a single centre. The patient population will be patients being assessed prior to general, gynaecological, urological and orthopaedic surgery. The investigators selected this population as they represent a diverse sample of patients of both genders with a varying range of ages and co-morbidities for both ambulatory and inpatient surgery.
Key inclusion criteria (3 listed)
- All patients due to see a pre-assessment nurse on that day
- Read and able to write English
- Lucid patients with mental capacity
Key exclusion criteria (4 listed)
- Patients unable to understand spoken or written English.
- Not able to see a pre-assessment nurse on the same day
- Patients too unwell or confused to be able to complete the questionnaire.
- Patient refusal.
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 |
|---|---|---|
| MyPreOp assessmentMyPreOp is an online preoperative assessment programme created by a medical software company called Ultramed. | Device | Patients attending the preoperative assessment clinic |
| Nurse led assessmentAlso: StandardStandard practise is where patients undergo a face to face preoperative assessment led by a qualified nurse specialising in this field. | Other | Patients attending the preoperative assessment clinic |
Primary outcome
The event rate of MyPreOp assessments that are judged as under assessments that would affect perioperative management following an adjudication review
Time frame: Through study completion,an average of 6 months
5 secondary outcomes
Percentage of participants requiring assistance to complete MyPreOp
Time frame: Through study completion,an average of 6 months
The median time taken for a nurse assessment of the MyPreOp summaries
Time frame: Through study completion,an average of 6 months
Patient satisfaction
Time frame: Through study completion,an average of 6 months
Nurse satisfaction
Time frame: Through study completion,an average of 6 months
Anaesthetist satisfaction
Time frame: Through study completion,an average of 6 months
Results and safety
The study was stopped early (reason given: Lack of logistic capabilities at the study site). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2016.
- Individual participant dataSharing planned: Yes. The investigators plan to publish anonymised study results on the Surgical Outcome Research Centre website. http://www.uclsource.com/
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.
Ramani Moonesinghe, FRCA MD(Res) study chair
Director UCL/UCLH Surgical Outcomes Resource Centre, Consultant Anaesthetics and Intensive Care Medicine, UCLH Honorary Lecturer
Questions about this trial
What is this clinical trial studying?
An observational study of Focus of Study: The Safety of an Online Pre-assessment Tool, run by Michelle Cole.
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 3 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: stopped early, as of the sponsor's last update on 27 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early (reason given: Lack of logistic capabilities at the study site). Results are not available in the source record.
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?
The event rate of MyPreOp assessments that are judged as under assessments that would affect perioperative management following an adjudication review (time frame: Through study completion,an average of 6 months). 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 27 Oct 2016.