Openness and Learning Joint Commission: Using Patient Experience for Improvement Following a Patient Safety Event

May 18, 2021 updated by: Jean McQueen, NHS Education for Scotland

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Scotland
      • Glasgow, Scotland, United Kingdom, G3 8BW
        • Recruiting
        • NHS Education for Scotland
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 20, 2021

Primary Completion (Anticipated)

January 20, 2022

Study Completion (Anticipated)

January 20, 2022

Study Registration Dates

First Submitted

May 18, 2021

First Submitted That Met QC Criteria

May 18, 2021

First Posted (Actual)

May 21, 2021

Study Record Updates

Last Update Posted (Actual)

May 21, 2021

Last Update Submitted That Met QC Criteria

May 18, 2021

Last Verified

May 1, 2021

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)?

Yes

IPD Plan Description

National Report, Peer Review Journal publication

IPD Sharing Time Frame

05.01.22 for 6 weeks

IPD Sharing Supporting Information Type

  • Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Subscribe