Patient SafetyNCT04897087
Openness and Learning Joint Commission: Using Patient Experience for Improvement Following a Patient Safety Event
An observational study of Patient Safety, run by NHS Education for Scotland at 2 sites in United Kingdom.
Trial summary
The focus of our work is openness, learning and person-centred involvement following patient safety incidents in health care. We will explore patients, carers and relatives' perspectives on what is important to them, what facilitates and impedes their involvement in patient safety reviews and what matters to them. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Patient Safety
- What is being tested?
- patient safety event
- How many people
- 30 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 20 May 2021to 20 Jan 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 16 years and older
- All sexes
- Child, Adult, Older adult
Study population: Patients or family members of patients who have experienced a serious health care incident/patient safety event
Who may be able to join
- Patients or family members of patients who have experienced a serious health care incident/patient safety event in the last 10 years who reside in Scotland, are aged 18 years or over and speak English. We will exclude participants where an investigation or litigation claim is ongoing or have been involved in an incident that happened less than a year ago, where the investigation is still ongoing or who are currently involved in legal action related to the incident.
Who cannot join
- We will exclude participants where an investigation or litigation claim is ongoing or have been involved in an incident that happened less than a year ago, where the investigation is still ongoing or who are currently involved in legal action related to the incident.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 recruiting
- Recruiting
NHS Education for Scotland
Glasgow, Scotland, G3 8BW
Jean McQueen, 750266631, jean.mcqueen2@nhs.scot
- Recruiting
NHS Education for Scotland
Glasgow, Scotland, G3 8BW
Jean McQueen, 07583033872, jean.mcqueen2@nhs.scot
About this study
Official title: Openness and Learning Following Patient Safety Events: Involving Patients and Carers When Things go Wrong in Health Care a Qualitative Enquiry
The focus of our work is openness, learning and person-centred involvement following patient safety incidents in health care. We will explore patients, carers and relatives' perspectives on what is important to them, what facilitates and impedes their involvement in patient safety reviews and what matters to them. We are interested in exploring how patient, carer and relative involvement can assist reconciliation, organisational and national learning. Information gained will be used to support the development of national guidance around involving people in a compassionate and caring way and how their experience could help organisational and national learning when things go wrong in health care.
Read the detailed description
INTRODUCTION:
Scotland is committed to a person-centred approach to social care and health services. This includes a duty of candour towards service users and families when things go wrong. Typical of service users and families who are involved in patient safety incidents or make complaints about services is the stated intent that they "don't want anyone else to go through what they have experienced". Inherent in this sentiment is the desire that services learn from feedback, safety incidents, complaints and near misses where unnecessary harm is caused (or could have been) when interacting with health care services. Current guidance suggests health and care providers offer an explanation of the incident, an apology, and a commitment to prevent recurrence. There is growing recognition among health care providers and policy makers that when things go wrong, the patient or their families should be heard and participate in the incident investigation process (Kok et al 2018). Guidance on how best to involve patients, carers and relatives in a caring and compassionate manner is lacking and current practice variable. The joint commission for openness and learning is committed to understanding and learning what 'good' patient involvement in patient safety reviews could look like as part of improving patient safety in health care.
AIMS:
This study is part of a larger programme of work being undertaken by NHS Education for Scotland (NES) and Health Improvement Scotland (HIS) on behalf of the Scottish Government. The focus of our work is openness, learning and person-centred involvement following patient safety incidents in health care. We will explore patients, carers and relatives' perspectives on what is important to them, what facilitates and impedes their involvement in patient safety reviews and what matters to them. We are interested in exploring how patient, carer and relative involvement can assist reconciliation, organisational and national learning. Information gained will be used to support the development of national guidance around involving people in a compassionate and caring way and how their experience could help organisational and national learning when things go wrong in health care.
OBJECTIVES:
- To identify factors that facilitate and impede patient, carer and relative involvement using patient perspectives to guide and strengthen how the NHS involves, communicates and learns with patients their carers and relatives
- To explore how to involve people in a compassionate and caring way and how their experience can be harnessed to assist national and organisational learning
- Conditions
- Patient Safety
- Being tested
- patient safety event
- Keywords
- openness and learning, adverse events, qualitative research
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patient safety eventOther
This study will explore the perceptions of patients, carers and relatives who have experienced a patient safety event. Telephone interviews will be undertaken lasting up to 60 minutes This study involves NHS patients, their carers or relatives. We will ask participants about their experience of being involved a patient safety event and the barriers and enablers to participation in the review. We will ask what 'good' patient involvement in patient safety reviews should look like from those with lived experience. This is because we wish to understand from their perspective what matters to them when things go wrong and how best to involve them.
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative data
Telephone interviews lasting up to 60 minutes will be conducted by qualitative researchers
Measured: 60 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start20 May 2021 (estimated)
- Primary completion20 Jan 2022 (estimated)
- Study completion20 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient SafetyStudies 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
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Education for Scotland
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jean McQueen, NHS Education for Scotland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04897087
- Sponsor's protocol ID
- 21/WS/0048
- Status last verified
- May 2021
- First submitted
- 18 May 2021
- Last updated
- 21 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: National Report, Peer Review Journal publication
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Openness and Learning Following Patient Safety Events: Involving Patients and Carers When Things go Wrong in Health Care a Qualitative Enquiry
- ClinicalTrials.gov ID
- NCT04897087
- Acronym / sponsor ID
- 21/WS/0048
- Conditions
- Patient Safety
- Keywords
- openness and learning, adverse events, qualitative research
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- NHS Education for ScotlandOther government
- Study start
- 20 May 2021 (estimated)
- Primary completion
- 20 Jan 2022 (estimated)
- Study completion
- 20 Jan 2022 (estimated)
- First posted
- 21 May 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.
The focus of our work is openness, learning and person-centred involvement following patient safety incidents in health care. We will explore patients, carers and relatives' perspectives on what is important to them, what facilitates and impedes their involvement in patient safety reviews and what matters to them. We are interested in exploring how patient, carer and relative involvement can assist reconciliation, organisational and national learning. Information gained will be used to support the development of national guidance around involving people in a compassionate and caring way and how their experience could help organisational and national learning when things go wrong in health care.
Detailed description
INTRODUCTION:
Scotland is committed to a person-centred approach to social care and health services. This includes a duty of candour towards service users and families when things go wrong. Typical of service users and families who are involved in patient safety incidents or make complaints about services is the stated intent that they "don't want anyone else to go through what they have experienced". Inherent in this sentiment is the desire that services learn from feedback, safety incidents, complaints and near misses where unnecessary harm is caused (or could have been) when interacting with health care services. Current guidance suggests health and care providers offer an explanation of the incident, an apology, and a commitment to prevent recurrence. There is growing recognition among health care providers and policy makers that when things go wrong, the patient or their families should be heard and participate in the incident investigation process (Kok et al 2018). Guidance on how best to involve patients, carers and relatives in a caring and compassionate manner is lacking and current practice variable. The joint commission for openness and learning is committed to understanding and learning what 'good' patient involvement in patient safety reviews could look like as part of improving patient safety in health care.
AIMS:
This study is part of a larger programme of work being undertaken by NHS Education for Scotland (NES) and Health Improvement Scotland (HIS) on behalf of the Scottish Government. The focus of our work is openness, learning and person-centred involvement following patient safety incidents in health care. We will explore patients, carers and relatives' perspectives on what is important to them, what facilitates and impedes their involvement in patient safety reviews and what matters to them. We are interested in exploring how patient, carer and relative involvement can assist reconciliation, organisational and national learning. Information gained will be used to support the development of national guidance around involving people in a compassionate and caring way and how their experience could help organisational and national learning when things go wrong in health care.
OBJECTIVES:
- To identify factors that facilitate and impede patient, carer and relative involvement using patient perspectives to guide and strengthen how the NHS involves, communicates and learns with patients their carers and relatives
- To explore how to involve people in a compassionate and caring way and how their experience can be harnessed to assist national and organisational learning
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients or family members of patients who have experienced a serious health care incident/patient safety event
Key inclusion criteria (1 listed)
- Patients or family members of patients who have experienced a serious health care incident/patient safety event in the last 10 years who reside in Scotland, are aged 18 years or over and speak English. We will exclude participants where an investigation or litigation claim is ongoing or have been involved in an incident that happened less than a year ago, where the investigation is still ongoing or who are currently involved in legal action related to the incident.
Key exclusion criteria (1 listed)
- We will exclude participants where an investigation or litigation claim is ongoing or have been involved in an incident that happened less than a year ago, where the investigation is still ongoing or who are currently involved in legal action related to the incident.
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 |
|---|---|---|
| patient safety eventThis study will explore the perceptions of patients, carers and relatives who have experienced a patient safety event. Telephone interviews will be undertaken lasting up to 60 minutes This study involves NHS patients, their carers or relatives. We will ask participants about their experience of being involved a patient safety event and the barriers and enablers to participation in the review. We will ask what 'good' patient involvement in patient safety reviews should look like from those with lived experience. This is because we wish to understand from their perspective what matters to them when things go wrong and how best to involve them. | Other | – |
Primary outcome
Qualitative data
Time frame: 60 mins
Telephone interviews lasting up to 60 minutes will be conducted by qualitative researchers
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2021.
- Individual participant dataSharing planned: Yes. National Report, Peer Review Journal publication
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Safety, run by NHS Education for Scotland at 2 sites 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 1 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: status not confirmed, as of the sponsor's last update on 21 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative data (time frame: 60 mins). 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 21 May 2021.