- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05013411
Rethinking Observations in Mental Health
Study Overview
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Varsha Gandhi
- Phone Number: 01865900599
- Email: vgandhi@oxehealth.com
Study Contact Backup
- Name: Oliver Gibson
- Phone Number: 01865900599
- Email: oliver.gibson@oxehealth.com
Study Locations
-
-
-
London, United Kingdom, SW1V 2RH
- Recruiting
- Ade Odunlade
-
Contact:
- Ade Odunlade
- Phone Number: 020 3317 2987
- Email: ade.odunlade@nhs.net
-
Contact:
- Tasha Vandepeer
- Phone Number: 020 3317 2987
- Email: tashavandepeer@nhs.net
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
Students and clinicians in training who do not carry out independent patient observations.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Healthcare workers
Healthcare workers with patient care experience and are willing to share their experience of current practices of obtaining patient observations.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
Day 1 of participation, during a one-off interview/focus group
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Views on use of technology in obtaining patient observations
Time Frame: Day 1 of participation, during a one-off interview/focus group
|
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.
|
Day 1 of participation, during a one-off interview/focus group
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ade Odunlade, Central North West London NHS Foundation Trust
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 295362
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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