A Randomized Controlled Trial to Assess the Best Method for Evaluating Avoidable Mortality in Hospitals Using Retrospective Record Review.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Imperial College London
- Enrollment
- 200
- Locations
- 3
- Primary Endpoint
- Avoidable mortality detection
Study Overview
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.
Detailed Description
BACKGROUND
What is avoidable mortality?
As emphasized by the recent Francis Report into care at the Mid-Staffordshire hospital, avoidable mortality is an important measure of safety and quality of healthcare. Measures of risk-adjusted mortality (SHMI and HSMR) based on population mortality statistics have previously been criticized for overestimating harm. It is difficult to determine within these measures the degree to which deaths could have been prevented with adequate medical care. To assess the quality of healthcare, it is more useful to focus on deaths that have objective evidence of being related to adverse events or complications.
Adverse events are defined as injuries or complications that occur as a result of health care management and not as a result of the patient's pathology, causing prolonged hospital stay, morbidity and mortality. Avoidable mortality can be defined as a death where an adverse event or events has occurred that contributed to or precipitated this death.
What methods are there for measuring avoidable mortality?
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •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
- •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.
Arms & Interventions
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
Intervention: Explicit case note review checklist (nurse) (Other)
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
Intervention: Explicit case note review checklist (physician) (Other)
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
Intervention: Explicit case note review checklist (MDT) (Other)
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
Intervention: Explicit case note review checklist (nurse) (Other)
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
Intervention: Explicit case note review checklist (physician) (Other)
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
Intervention: Explicit case note review checklist (MDT) (Other)
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
Intervention: Explicit case note review checklist (nurse) (Other)
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
Intervention: Explicit case note review checklist (physician) (Other)
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
Intervention: Explicit case note review checklist (MDT) (Other)
Outcomes
Primary Outcomes
Avoidable mortality detection
Time Frame: During hospital stay
Whether avoidability of mortality was comparable between implicit and explicit groups and between different reviewer types, using kappa scores
Secondary Outcomes
- Confidence scoring of reviewers after each case.(During hospital stay)
- Rate of adverse event detection(During hospital stay)