- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04897087
Openness and Learning Joint Commission: Using Patient Experience for Improvement Following a Patient Safety Event
Openness and Learning Following Patient Safety Events: Involving Patients and Carers When Things go Wrong in Health Care a Qualitative Enquiry
Study Overview
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Scotland
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Glasgow, Scotland, United Kingdom, G3 8BW
- Recruiting
- NHS Education for Scotland
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Contact:
- Jean McQueen
- Phone Number: 07583033872
- Email: jean.mcqueen2@nhs.scot
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Qualitative data
Time Frame: 60 mins
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Telephone interviews lasting up to 60 minutes will be conducted by qualitative researchers
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60 mins
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
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
Other Study ID Numbers
- 21/WS/0048
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- Study Protocol
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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