Avoidable Mortality Case Note Review Trial

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2013 by Imperial College London
Sponsor:
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01998191
First received: October 31, 2013
Last updated: November 25, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
In Hospital Mortality
Other: Explicit case note review checklist (nurse)
Other: Explicit case note review checklist (physician)
Other: Explicit case note review checklist (MDT)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: A Randomized Controlled Trial to Assess the Best Method for Evaluating Avoidable Mortality in Hospitals Using Retrospective Record Review.

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Avoidable mortality detection [ Time Frame: During hospital stay ] [ Designated as safety issue: No ]
    Whether avoidability of mortality was comparable between implicit and explicit groups and between different reviewer types, using kappa scores


Secondary Outcome Measures:
  • Confidence scoring of reviewers after each case. [ Time Frame: During hospital stay ] [ Designated as safety issue: No ]
    How confident the reviewer felt about their decision to score a case as avoidable or unavoidable.

  • Rate of adverse event detection [ Time Frame: During hospital stay ] [ Designated as safety issue: No ]
    Number and type of adverse events detected per case note file using implicit versus explicit methods and between different reviewers


Estimated Enrollment: 200
Study Start Date: February 2014
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Implicit Case note review (nurse)

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)

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.

Other Name: Imperial College avoidable mortality checklist
Other: Explicit case note review checklist (physician)

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.

Other Name: Imperial College avoidable mortality checklist
Other: Explicit case note review checklist (MDT)

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.

Other Name: Imperial College avoidable mortality checklist
Active Comparator: Implicit Case note review (MDT)

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)

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.

Other Name: Imperial College avoidable mortality checklist
Other: Explicit case note review checklist (physician)

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.

Other Name: Imperial College avoidable mortality checklist
Other: Explicit case note review checklist (MDT)

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.

Other Name: Imperial College avoidable mortality checklist
Active Comparator: Implicit Case note review (physician)

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)

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.

Other Name: Imperial College avoidable mortality checklist
Other: Explicit case note review checklist (physician)

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.

Other Name: Imperial College avoidable mortality checklist
Other: Explicit case note review checklist (MDT)

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.

Other Name: Imperial College avoidable mortality checklist

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01998191

Contacts
Contact: Ann-Marie Howell, MBBS 07766004708 a.howell@imperial.ac.uk

Locations
United Kingdom
The Hillingdon Hospitals NHS Foundation Trust Not yet recruiting
Uxbridge, Middlesex, United Kingdom, UBB 3NN
Contact: Abbas Khakii       abbas.khakoo@tht.nhs.uk   
Imperial College Healthcare Trust Not yet recruiting
London, United Kingdom, W2 1NY
Contact: Naomi Spurr       n.spurr@imperial.ac.uk   
Sub-Investigator: Ann-Marie Howell         
Principal Investigator: Elaine Burns, MBBS, PhD         
North West London Hospitals NHS Trust Not yet recruiting
London, United Kingdom, HA1 3UJ
Contact: Simon Lewis    02088695173    nwlh-tr.Research@nhs.net   
Principal Investigator: Elaine Burns, MBBS, PhD         
Sub-Investigator: Ann-Marie Howell, MBBS         
Sub-Investigator: George Bouras, MBBS, FRCS         
Sub-Investigator: Trish Winn         
Sponsors and Collaborators
Imperial College London
Investigators
Principal Investigator: Ara Darzi Imperial College London
  More Information

No publications provided

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01998191     History of Changes
Other Study ID Numbers: STDA3106, 133513
Study First Received: October 31, 2013
Last Updated: November 25, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Imperial College London:
mortality
adverse events

ClinicalTrials.gov processed this record on September 18, 2014