Vital SignsNCT05013411
Rethinking Observations in Mental Health
An observational study of Vital Signs, run by Oxehealth Limited at 1 site in United Kingdom.
Trial summary
To gain healthcare workers' perception of the current observations practices used in patient care and explore the benefits of using technology to enhance observations in inpatient mental health setting in the United Kingdom. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Vital Signs
- What is being tested?
- Qualitative study
- How many people
- 7 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Oct 2021to 1 Feb 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Healthcare workers with experience of taking patient observations in inpatient mental health setting in the UK
Who may be able to join
- Healthcare workers such as nurse directors, matrons, ward managers, nurses, healthcare support workers, including; nurse associates, nurse assistants and assistant practioners who work in inpatient mental health settings
- Healthcare workers with at least two years' experience of working in inpatient mental settings
- Healthcare workers who conduct or have conducted patient observations, and have used it for at least two years
Who cannot join
- Students and clinicians in training who do not carry out independent patient observations.
Trial locations and contacts
1 site in 1 country.
About this study
To gain healthcare workers' perception of the current observations practices used in patient care and explore the benefits of using technology to enhance observations in inpatient mental health setting in the United Kingdom.
Read the detailed description
Periodic intermittent clinical observations are commonly used in mental health services at admission for risk assessment and then for the clinical management of patients.
Nurses follow these practices as routine care to ensure patient well-being. However, being observed may make patients feel uncomfortable and anxious.
The Department of Health (2006) stipulated for the practice of observation to be implemented in a manner that would enable patients to experience it as a healing and compassionate practice. This is apparently not always realised as there are reported differences on how patients are observed, and clinical data obtained.
Whilst this may be attributed in part to lack of or limited training on the use of observations, it can also in part be attributed to lack of a standardised approach to implementation and documentation of the outcomes of observations (Stewart \& Bowers 2012).This contributes to variability among healthcare workers in their interpretation of the outcomes/data of observations. Given that patients' care pathways are influenced by the outcomes/data of observations, it is critical to reduce the variability in the use of this practice. Doing so would lead to obtaining consistent and dependable data that reflect patients' mental state to guide their individual care pathways.
The focus of this qualitative study is to document how clinicians perform routine patient observations, the essential aspects of observations through a clinician's point of view and how can application of modern technology aid this process. This systematic documentation will capture the strengths and limitations of current practice creating a service provide based dataset to inform focused improvements.
- Conditions
- Vital Signs
- Being tested
- Qualitative study
- Keywords
- Nurse Observations, Clinical Observations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qualitative studyOther
Individual interviews and focus groups will be conducted to explore current strengthens and barriers in obtaining patient observations. Views on use of technology in assisting with patient observations will also be discussed and documented.
| Study group | Role | What they receive |
|---|---|---|
| Healthcare workers | Healthcare workers with patient care experience and are willing to share their experience of current practices of obtaining patient observations. Receives: Other: Qualitative study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Strengthens and Limitations of current practice of clinical observations
Exploratory method, conducted in the form of individual and focus groups to document strengthens and barriers to current ways of obtaining clinical observations in in patient mental health setting.(qualitative method)
Measured: Day 1 of participation, during a one-off interview/focus group
Secondary outcomes (1)
Views on use of technology in obtaining patient observations
Exploratory method to gain healthcare workers' perspective on using modern technology such as a contact free patient monitoring system to aid the practice of patient observations through individual interviews and focus groups.
Measured: Day 1 of participation, during a one-off interview/focus group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start15 Oct 2021
- Primary completion1 Feb 2022
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vital SignsStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxehealth Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Central and North West London NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Ade Odunlade, Principal investigator, Central North West London NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05013411
- Sponsor's protocol ID
- 295362
- Status last verified
- Mar 2025
- First submitted
- 12 Aug 2021
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Quotes maybe shared making reference to participant's job descriptions.
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rethinking Observations in Mental Health
- ClinicalTrials.gov ID
- NCT05013411
- Acronym / sponsor ID
- 295362
- Conditions
- Vital Signs
- Keywords
- Nurse Observations, Clinical Observations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Oxehealth LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Central and North West London NHS Foundation Trust
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 19 Aug 2021 (actual)
- 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.
To gain healthcare workers' perception of the current observations practices used in patient care and explore the benefits of using technology to enhance observations in inpatient mental health setting in the United Kingdom.
Detailed description
Periodic intermittent clinical observations are commonly used in mental health services at admission for risk assessment and then for the clinical management of patients.
Nurses follow these practices as routine care to ensure patient well-being. However, being observed may make patients feel uncomfortable and anxious.
The Department of Health (2006) stipulated for the practice of observation to be implemented in a manner that would enable patients to experience it as a healing and compassionate practice. This is apparently not always realised as there are reported differences on how patients are observed, and clinical data obtained.
Whilst this may be attributed in part to lack of or limited training on the use of observations, it can also in part be attributed to lack of a standardised approach to implementation and documentation of the outcomes of observations (Stewart \& Bowers 2012).This contributes to variability among healthcare workers in their interpretation of the outcomes/data of observations. Given that patients' care pathways are influenced by the outcomes/data of observations, it is critical to reduce the variability in the use of this practice. Doing so would lead to obtaining consistent and dependable data that reflect patients' mental state to guide their individual care pathways.
The focus of this qualitative study is to document how clinicians perform routine patient observations, the essential aspects of observations through a clinician's point of view and how can application of modern technology aid this process. This systematic documentation will capture the strengths and limitations of current practice creating a service provide based dataset to inform focused improvements.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthcare workers | – | Other: Qualitative studyHealthcare workers with patient care experience and are willing to share their experience of current practices of obtaining patient observations. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Healthcare workers with experience of taking patient observations in inpatient mental health setting in the UK
Key inclusion criteria (3 listed)
- Healthcare workers such as nurse directors, matrons, ward managers, nurses, healthcare support workers, including; nurse associates, nurse assistants and assistant practioners who work in inpatient mental health settings
- Healthcare workers with at least two years' experience of working in inpatient mental settings
- Healthcare workers who conduct or have conducted patient observations, and have used it for at least two years
Key exclusion criteria (1 listed)
- Students and clinicians in training who do not carry out independent patient observations.
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 |
|---|---|---|
| Qualitative studyIndividual interviews and focus groups will be conducted to explore current strengthens and barriers in obtaining patient observations. Views on use of technology in assisting with patient observations will also be discussed and documented. | Other | Healthcare workers |
Primary outcome
Strengthens and Limitations of current practice of clinical observations
Time frame: Day 1 of participation, during a one-off interview/focus group
Exploratory method, conducted in the form of individual and focus groups to document strengthens and barriers to current ways of obtaining clinical observations in in patient mental health setting.(qualitative method)
1 secondary outcome
Views on use of technology in obtaining patient observations
Time frame: Day 1 of participation, during a one-off interview/focus group
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Individual participant dataSharing planned: Undecided. Quotes maybe shared making reference to participant's job descriptions.
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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.
Ade Odunlade principal investigator
Central North West London NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vital Signs, run by Oxehealth Limited at 1 site in United Kingdom.
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 1 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: finished, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Strengthens and Limitations of current practice of clinical observations (time frame: Day 1 of participation, during a one-off interview/focus group). 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 20 Mar 2025.