Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001844235
Ethics application status
Approved
Date submitted
8/11/2018
Date registered
13/11/2018
Date last updated
4/06/2019
Date data sharing statement initially provided
13/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Using pulse oximetry to monitor psychiatric patients at risk of suicide.
Scientific title
Back-to-Base Pulse Oximetry Monitoring for Suicidal Behaviours in Mental Health Care Settings - a feasibility and acceptability study.
Secondary ID [1] 295970 0
Nil known
Universal Trial Number (UTN)
Trial acronym
B2BPO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Suicide attempt 309480 0
Condition category
Condition code
Mental Health 308314 308314 0 0
Suicide
Injuries and Accidents 308315 308315 0 0
Other injuries and accidents
Injuries and Accidents 308316 308316 0 0
Poisoning

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients admitted to the Hunter New England Local Health District Psychiatric Intensive Care Unit (PICU) or Psychiatric Emergency Care Centre (PECC) (from 14 May 2019) in Waratah, NSW will be invited to wear a pulse oximeter on their wrist with a reusable finger sensor.

A baseline reading of each participant's pulse and oxygen saturation levels will be taken. Pulse and oxygen saturation levels will be transmitted to a base unit or computer. Alarm parameters will be set according to percentage variation from the participant's baseline measures. If pulse or oxygen saturation fall outside the configured thresholds, an alarm will sound.

Standard thresholds are +/-50 bpm and a drop in O2 levels of >10%. Expert medical advice will be sought to refine parameters to ensure staff are alerted to serious events quickly, but false alarms are not overly frequent.

Should an alarm be triggered, unit staff will locate the patient and take any necessary action, such as replacing the sensor or, if suicide has been attempted, removing any ligature and resuscitating the patient, for example.

The action taken will be recorded in the comments section of the monitoring software following resolution of the event and in a running sheet for the participant.

Participants will wear the pulse oximeter for the duration of their stay in the intensive care unit - generally 1 to 3 days - unless they elect not to participate or to continue. The maximum length of observation is unlikely to exceed 1 week.

Use of pulse oximetry is in addition to regular observations and other usual practice and will not replace any mandated procedures.

With consent, families, guardians and carers, where feasible, will be asked a few brief questions about their perceptions about the device and its use.

Unit nursing staff or the peer consultant will seek consent for the intervention[1] attach the device to the patient if consent is given, and will set up and monitor the base station or computer software for alarms. Staff will replace and recharge batteries for the device as required. Staff will remove the device from the patient if the patient withdraws from the study, the device becomes too uncomfortable for the participant to continue to wear, or immediately before the patient is discharged.

Staff will continue to carry out regular observations of the patient. Use of pulse oximetry is in addition to regular observations of patients by staff and other practice as usual, and will not replace any mandated procedures, such as NSW Health Policy Directive PD2017_025 ‘Engagement and Observation in Mental Health Inpatient Units’.

[1] Patients with diminished capacity to consent will be provided with decision-making support by an independent (non-staff) individual such as a peer support worker or legal advocate to ensure that their consent, if given, is valid and free from perceived coercion.
Intervention code [1] 312299 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307292 0
Outcome Name: Feasibility (Composite measure)

Metric/Method of Measurement: Semi-structured interview with staff, patients and family/carers. Measures include perception of benefits and concerns, issues attaching and setting up device on participants.

A record of events detected by monitoring and their resolution as recorded by staff. This will include the number of events, reasons (including equipment failure or participant non-compliance, medical events such as obstructive sleep apnea, inadvertent drug overdose, or attempted suicide) and other comments.
Timepoint [1] 307292 0
For patient participants: between admission and discharge or discontinuation (with consent)
For family/carer participants: between admission and discharge of the person they are caring for.

For staff: (a) obtained from running sheets for each participant between the start of the trial and its end. (b) from semi-structured interview at end of study.
Primary outcome [2] 307293 0
Outcome Name: Acceptability (Composite measure)

Metric/Method of Measurement: Semi-structured interview/short questionnaire administered to participants after admission and every 24 hours thereafter, and then on discharge.

Questionnaire administered to patients based on modified Whole Systems Demonstrator Service User Technology Acceptance Questionnaire (SUTAQ).
Timepoint [2] 307293 0
On participant consent after admission and at 24-hour intervals until discharge or withdrawal from the study.
Primary outcome [3] 308067 0
Outcome Name: Acceptability

Metric/Method of Measurement: Number and reasons for false alarms and recorded patient adherence issues (e.g., removing the sensor determined from running sheets). Staff reported.
Timepoint [3] 308067 0
At the end of patient participation, either withdrawal or discharge/transfer.
Secondary outcome [1] 351415 0
Outcome Name: Suicidal ideation

Metric/Method of Measurement: Suicidal Ideation Attributes Scale (SIDAS) administered to patients on admission and discharge.
Timepoint [1] 351415 0
On admission and discharge of participant (with participant consent)

Eligibility
Key inclusion criteria
Patients admitted to the Psychiatric Intensive Care Unit (PICU) or the Psychiatric Emergency Care Centre (PECC) (from 14 May 2019) at the Mater Mental Health Centre in Waratah, NSW will be invited to wear a pulse oximeter device.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
If a potential participant does not have the capacity to consent to the study, or is aged under 16 .

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
The intervention is an adjunct to standard care that would normally be provided. The intervention will provide continuous monitoring of pulse and blood oxygen saturation while the patient is wearing the device, and will trigger an alarm at the base station or computer if pulse or O2 levels fall outside pre-determined parameters.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Mixed methods.

Estimated Number of Participants: n=20 patients who complete the monitoring and all relevant questionnaires.

n=20 family members who consent to answer questions about their perception of the study.

n=10 unit staff members (medical, nursing and administrative)

Clinical and Statistical Assumptions: Recruitment of patient participants will largely be done by a Peer Consultant working half days, with support from unit staff. The PICU has eight beds and the PECC four. Stays are usually short (1-3 days) and the units are often near capacity. Assuming an average weekly rate of approximately 20 patient stays, a completion rate of around 10 per cent would provide 26 participants over three months.

At times a clinical decision may be made that a patient is not a suitable candidate for the study, but the intention is to try to normalise the use of pulse oximeters within the unit.
Despite supported decision making some patients may not have the decisional capacity to consent to participate, and/or their guardian will not be available/contactable. These patients will be excluded from the study.

The sample of family members, carers or guardians would require recruitment of approximately 10 per cent of those who accompany patients in the unit. It would be preferable if they were accompanying those in the sample of patients who complete the intervention.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/12/2018
Actual
25/02/2019
Date of last participant enrolment
Anticipated
31/05/2019
Actual
Date of last data collection
Anticipated
3/06/2019
Actual
Sample size
Target
20
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 11761 0
Calvary Mater Newcastle - Waratah
Recruitment postcode(s) [1] 23855 0
2298 - Waratah

Funding & Sponsors
Funding source category [1] 300567 0
Government body
Name [1] 300567 0
NSW Ministry of Health
Country [1] 300567 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
Research Grants and Contracts
Level 3, Rupert Myers Building South Wing (M15)
UNSW Kensington Campus
NSW 2052
Country
Australia
Secondary sponsor category [1] 302919 0
None
Name [1] 302919 0
Address [1] 302919 0
Country [1] 302919 0
Other collaborator category [1] 280724 0
Other Collaborative groups
Name [1] 280724 0
Black Dog Institute
Address [1] 280724 0
Hospital Road
Prince of Wales Hospital
Randwick NSW 2031
Country [1] 280724 0
Australia
Other collaborator category [2] 280725 0
Hospital
Name [2] 280725 0
Hunter New England Mental Health Services
Address [2] 280725 0
Calvary Mater Mental Health Centre
Edith Street,
Waratah, NSW 2298
Country [2] 280725 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301358 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 301358 0
Ethics committee country [1] 301358 0
Australia
Date submitted for ethics approval [1] 301358 0
31/08/2018
Approval date [1] 301358 0
09/11/2018
Ethics approval number [1] 301358 0
2018/ETH00341

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86734 0
Dr Fiona Shand
Address 86734 0
Black Dog Institute
Hospital Road, Randwick NSW 2031
Country 86734 0
Australia
Phone 86734 0
+61 412 454 898
Fax 86734 0
Email 86734 0
[email protected]
Contact person for public queries
Name 86735 0
Fiona Shand
Address 86735 0
Black Dog Institute
Hospital Road, Randwick NSW 2031
Country 86735 0
Australia
Phone 86735 0
+61 412 454 898
Fax 86735 0
Email 86735 0
[email protected]
Contact person for scientific queries
Name 86736 0
Fiona Shand
Address 86736 0
Black Dog Institute
Hospital Road, Randwick NSW 2031
Country 86736 0
Australia
Phone 86736 0
+61 412 454 898
Fax 86736 0
Email 86736 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Insufficient data to date (13 May 2019)


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 375919-(Uploaded-30-09-2019-07-27-31)-Basic results summary.docx

Documents added automatically
No additional documents have been identified.