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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

B2BPO

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Suicide attempt

Condition category

Condition code

Mental Health

Suicide

Injuries and Accidents

Other injuries and accidents

Injuries and Accidents

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]

Treatment: Devices

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

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]

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]

On participant consent after admission and at 24-hour intervals until discharge or withdrawal from the study.

Primary outcome [3]

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]

At the end of patient participation, either withdrawal or discharge/transfer.

Secondary outcome [1]

Outcome Name: Suicidal ideation

Metric/Method of Measurement: Suicidal Ideation Attributes Scale (SIDAS) administered to patients on admission and discharge.

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Calvary Mater Newcastle - Waratah

Recruitment postcode(s) [1]

2298 - Waratah

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NSW Ministry of Health

Address [1]

73 Miller Street, North Sydney NSW 2060

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Other Collaborative groups

Name [1]

Black Dog Institute

Address [1]

Hospital Road
Prince of Wales Hospital
Randwick NSW 2031

Country [1]

Australia

Other collaborator category [2]

Hospital

Name [2]

Hunter New England Mental Health Services

Address [2]

Calvary Mater Mental Health Centre
Edith Street,
Waratah, NSW 2298

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Hunter New England Human Research Ethics Committee

Ethics committee address [1]

Research Ethics and Governance Unit
Hunter New England Human Research Ethics Committee
Hunter New England Local Health District
Locked Bag 1, New Lambton NSW 2305

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

31/08/2018

Approval date [1]

09/11/2018

Ethics approval number [1]

2018/ETH00341

Summary

Brief summary

The study aims to see if it is feasible and acceptable to patients, families and carers as well as staff to use pulse oximetry to help keep patients safe while they are in a psychiatric intensive care unit. 

Pulse oximetry is a proven technology that is widely used in other medical and health settings. This is a new application of the technology. 

Participation in the study is voluntary and non-participation or withdrawal from the study at a later stage will not affect the treatment received at the unit.

Trial website

Trial related presentations / publications

Public notes

Although relatively infrequent, suicide still occurs in mental health inpatient settings, despite regular patient observations by staff and the removal of common ligature points.

The current study arises following a coronial inquest into the death of a young woman while an inpatient at the Psychiatric Intensive Care Unit in Waratah NSW, and a recommendation by the Coroner to the NSW Minister for Health that back-to-base pulse oximetry be trialled in mental health inpatient settings to help ameliorate the risk of suicide.[1]

The concept of using back-to-base pulse oximetry to prevent inpatient suicide was initially suggested in 2016. [2]

Suicide is a tragic loss and has serious impacts on those close to the deceased. When the person who dies by suicide is an inpatient at a health facility, staff are often adversely impacted by the death.

Those admitted to psychiatric care are at increased risk of suicide compared with the general population and general medical patients.

Pulse oximetry is a proven technology that is widely used in other medical and health settings. This is a new application of the technology. What sets this study apart is the use of wireless pulse oximeters to provide back-to-base readings, as well as the characteristics of some of the patient participants.

Wireless monitors allow more freedom of movement than traditional monitors but will alarm once oxygen saturation drops below a certain level, if the device is removed, or if the patient moves beyond wireless reception. The system would alert nursing staff when a patient’s parameters fall below a set threshold, and this would trigger immediate action. This approach to patient monitoring would provide early detection of a patient’s deterioration whatever the reason. Back-to-base pulse oximetry ‘would alert nursing staff to bradycardia or low oxygen saturation levels regardless of the cause’.

For use of back-to-base pulse oximetry to be feasible in mental health settings it needs to be acceptable to patients, families and carers, and staff, as well as being able to reliably detect any adverse events, whether attempted suicide or life-threatening medical events such as accidental overdose, drug-drug interactions, choking or asphyxiation.

[1] http://www.coroners.justice.nsw.gov.au/Documents/RAFTERY%20Ahlia%20-%20Findings%20-%20redactedv3.pdf

[2] Nicholas O’Connor and Michael Paton (2016) Back-to-base pulse oximetry to prevent inpatient suicide. Australasian Psychiatry Vol 24, Issue 2, pp. 204 – 205. https://doi.org/10.1177/1039856215623166

Contacts

Principal investigator

Name

Dr Fiona Shand

Address

Black Dog Institute
Hospital Road, Randwick NSW 2031

Country

Australia

Phone

+61 412 454 898

Fax

fionas@unsw.edu.au

Contact person for public queries

Name

Fiona Shand

Address

Black Dog Institute
Hospital Road, Randwick NSW 2031

Country

Australia

Phone

+61 412 454 898

Fax

fionas@unsw.edu.au

Contact person for scientific queries

Name

Fiona Shand

Address

Black Dog Institute
Hospital Road, Randwick NSW 2031

Country

Australia

Phone

+61 412 454 898

Fax

fionas@unsw.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Basic results	No			375919-(Uploaded-30-09-2019-07-27-31)-Basic results summary.docx

Documents added automatically

No additional documents have been identified.

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