NCT04897087

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

May 20, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 21, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2022

Completed
Last Updated

May 21, 2021

Status Verified

May 1, 2021

Enrollment Period

8 months

First QC Date

May 18, 2021

Last Update Submit

May 18, 2021

Conditions

Keywords

openness and learningadverse eventsqualitative research

Outcome Measures

Primary Outcomes (1)

  • Qualitative data

    Telephone interviews lasting up to 60 minutes will be conducted by qualitative researchers

    60 mins

Interventions

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.

Eligibility Criteria

Age16 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients or family members of patients who have experienced a serious health care incident/patient safety event

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

NHS Education for Scotland

Glasgow, Scotland, G3 8BW, United Kingdom

RECRUITING

NHS Education for Scotland

Glasgow, Scotland, G3 8BW, United Kingdom

RECRUITING

MeSH Terms

Interventions

Risk Management

Intervention Hierarchy (Ancestors)

Financial ManagementEconomicsHealth Care Economics and OrganizationsOrganization and AdministrationHealth Services Administration

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Educator

Study Record Dates

First Submitted

May 18, 2021

First Posted

May 21, 2021

Study Start

May 20, 2021

Primary Completion

January 20, 2022

Study Completion

January 20, 2022

Last Updated

May 21, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will share

National Report, Peer Review Journal publication

Shared Documents
STUDY PROTOCOL
Time Frame
05.01.22 for 6 weeks
More information

Locations