Avoidable Mortality Case Note Review Trial

NCT01998191 | Unknown DMC

• 2 other identifiers: STDA3106133513
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

Brief Summary

TITLE A randomized controlled trial to assess the best method for evaluating avoidable mortality in hospitals using medical record review. DESIGN Randomised controlled trial This trial will be conducted in concordance with the CONSORT guidelines for randomised controlled trials. AIMS Compare explicit versus implicit case review methods for detecting avoidable mortality in patients who have died in hospital Assess the accuracy and efficiency of physicians versus nurses in detecting avoidable mortality in patients who have died in hospital OUTCOME MEASURES Rate of adverse event detection between explicit and implicit review methods Type of adverse event detection between explicit and implicit review methods Kappa score of agreement for inter-rater reliability for the above outcomes:

• Between individual reviewers within using the same review method
• Between different reviewer types. PARTICIPANTS Physician reviewers and nurses No patient participation. Case records of patients who had inpatient hospital mortality will be reviewed. ELIGIBILITY Over 18, Able to consent, English Language Speaking, Able to participate in case note review training, appropriate level of clinical experience. DURATION 2 years with extension if required and reviewed.

Conditions

In Hospital Mortality

Keywords

mortality; adverse events

Outcome Measures

Primary Outcomes (1)

• Avoidable mortality detection

  Whether avoidability of mortality was comparable between implicit and explicit groups and between different reviewer types, using kappa scores

  During hospital stay

Secondary Outcomes (2)

• Confidence scoring of reviewers after each case.

  During hospital stay

• Rate of adverse event detection

  During hospital stay

Study Arms (3)

Implicit Case note review (nurse)

ACTIVE COMPARATOR

Notes to be reviewed using the implicit method by a nurse to be compared with interventions: 'Explicit case note review checklist (nurse)' 'Explicit case note review checklist (physician)' 'Explicit case note review checklist (MDT)' and the other two implicit arms

Other: Explicit case note review checklist (nurse); Other: Explicit case note review checklist (physician); Other: Explicit case note review checklist (MDT)

Implicit Case note review (MDT)

ACTIVE COMPARATOR

Notes to be reviewed using the implicit method by an expert physician and nurse team. to be compared with interventions: 'Explicit case note review checklist (nurse)' 'Explicit case note review checklist (physician)' 'Explicit case note review checklist (MDT)' and the other two implicit arms

Other: Explicit case note review checklist (nurse); Other: Explicit case note review checklist (physician); Other: Explicit case note review checklist (MDT)

Implicit Case note review (physician)

ACTIVE COMPARATOR

Notes to be reviewed using the implicit method by an expert physician to be compared with interventions: 'Explicit case note review checklist (nurse)' 'Explicit case note review checklist (physician)' 'Explicit case note review checklist (MDT)' and the other two implicit arms

Other: Explicit case note review checklist (nurse); Other: Explicit case note review checklist (physician); Other: Explicit case note review checklist (MDT)

Interventions

Explicit case note review checklist (nurse) OTHER

A checklist to be used to screen notes for features of avoidable death used by nurses. to be compared with 'Implicit Case note review (physician)' 'Implicit Case note review (MDT)' 'Implicit Case note review (nurse)' and the other two intervention arms.

Also known as: Imperial College avoidable mortality checklist

Implicit Case note review (MDT); Implicit Case note review (nurse); Implicit Case note review (physician)

Explicit case note review checklist (physician) OTHER

A checklist to be used to screen notes for features of avoidable death, used by a nurse. to be compared with 'Implicit Case note review (physician)' 'Implicit Case note review (MDT)' 'Implicit Case note review (nurse)' and the other two intervention arms.

Also known as: Imperial College avoidable mortality checklist

Implicit Case note review (MDT); Implicit Case note review (nurse); Implicit Case note review (physician)

Explicit case note review checklist (MDT) OTHER

A checklist to be used to screen notes for features of avoidable death used by a nurse and an expert physician. to be compared with 'Implicit Case note review (physician)' 'Implicit Case note review (MDT)' 'Implicit Case note review (nurse)' and the other two intervention arms.

Also known as: Imperial College avoidable mortality checklist

Implicit Case note review (MDT); Implicit Case note review (nurse); Implicit Case note review (physician)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• FOR REVIEWERS
• Over 18, with capacity to consent and fluent in English language
• Able to commit to training and reviewing process
• Nurses • Senior nurses, either senior band 5 or band 6 and above, preferably with at least 5 years general ward experience.
• Physicians
• At least five years clinical practice in either medical/surgical/primary care/emergency care/critical care/anaesthesia as a consultant.
• If retired, have been out of medical practice no less than 5 years.
• FOR CASE NOTES/SAMPLING STRATEGY
• All case notes where the patient has died during admission from Imperial College Healthcare Trust, Northwest London Hospitals National Health Service (NHS) Trust and The Hillingdon Hospitals NHS Foundation Trust will be listed and then randomly sampled. They should fulfil the following criteria:
• Deceased patients with closed records (all coding completed)
• Length of stay at least 24 hours
• Over 18.
• Admitted between 2010 and 2013

You may not qualify if:

• FOR REVIEWERS
• Cannot participate in this review if part of the clinical team caring for the patient whose notes are being reviewed.
• FOR CASE NOTES
• Incomplete records.
• Paediatric records/ maternity records/ inpatient Psychiatric records.

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (3)

The Hillingdon Hospitals NHS Foundation Trust

Uxbridge, Middlesex, UBB 3NN, United Kingdom

Location

North West London Hospitals NHS Trust

London, HA1 3UJ, United Kingdom

Location

Imperial College Healthcare Trust

London, W2 1NY, United Kingdom

Location

MeSH Terms

Interventions

Nurses; Physicians

Intervention Hierarchy (Ancestors)

Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• Ara Darzi

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2013
• First Posted: November 28, 2013
• Study Start: February 1, 2014
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: May 5, 2022

Record last verified: 2022-05

Locations

GB (3)