AzTrials
AzTrials

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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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
  • 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

    Recruiting

Other trials in United Kingdom

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.

  1. 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.

  1. First posted21 May 2021
  2. Study start20 May 2021 (estimated)
  3. Primary completion20 Jan 2022 (estimated)
  4. Study completion20 Jan 2022 (estimated)

Resources

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)
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

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.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in