Research

Effect of “collaborative requesting” on consent rate for organ donation: randomised controlled trial (ACRE trial)

BMJ 2009; 339 doi: 10.1136/bmj.b3911 (Published 8 October 2009)
Cite this as: BMJ 2009;339:b3911
  1. The ACRE Trial Collaborators
  1. Correspondence to: D Young, Intensive Care Society Clinical Trials Group, Kadoorie Centre for Critical Care Research and Education, John Radcliffe Hospital, Oxford OX3 9DU duncan.young{at}nda.ox.ac.uk
  • Accepted 29 May 2009

Abstract

Objective To determine whether collaborative requesting increases consent for organ donation from the relatives of patients declared dead by criteria for brain stem death.

Design Unblinded multicentre randomised controlled trial using a sequential design. Centralised 24 hour telephone randomisation based on randomised permuted blocks of 10.

Setting 79 general, neuroscience, and paediatric intensive care units in the United Kingdom.

Participants 201 relatives of patients meeting criteria for brain stem death. Relatives were blind to the intervention and to the trial; all other participants were necessarily unblinded.

Interventions Collaborative requesting for consent for organ donation by the potential donor’s clinician and a donor transplant coordinator (organ procurement officer) compared with routine requesting by the clinical team alone.

Main outcome measure Proportion of relatives consenting to organ donation.

Results 101 relatives were randomised to routine requesting and 100 to collaborative requesting. All were analysed on an intention to treat basis. In the routine requesting group, 62 relatives consented to organ donation. In the collaborative requesting group, 57 relatives consented. After correction for the ethnicity, age, and sex of the potential donors the risk adjusted ratio of the odds of consent in the collaborative requesting group relative to the routine group was 0.80 (95% confidence interval 0.43 to 1.53), with a P value of 0.49 adjusted for interim analysis and trial over-running. The conversion rate (donors with consent from whom any organs were retrieved) was 92% (57/62) in the routine requesting group and 79% (45/57) in the collaborative requesting group (P=0.043). There were 140 approaches to relatives in the per protocol analysis, leading to 60.3% (44/73) consent after routine and 67.2% (45/67) after collaborative requesting (risk adjusted odds ratio of consent 1.47, 0.67 to 3.20, P=0.33).

Conclusion There is no increase in consent rates for organ donation when collaborative requesting is used in place of routine requesting by the patient’s clinician.

Trial registration ISRCTN01169903

Footnotes

  • Trial steering committee

  • Chris Danbury (chair), ICU consultant; Vicki Barber, trials manager; Dave Collett, statistician; Barry Jenkins, donor family representative; Karen Morgan, donor care and coordination regional manager; Lesley Morgan, trials manager; Ella Poppitt, donor transplant coordinator team leader; Susan Richards, donor transplant coordinator team leader; Duncan Young, ICU consultant, chief Investigator; Sarah Edwards, ACRE trial coordinator; Sandip Patel, ACRE trial coordinator.

  • Data monitoring and ethics committee

  • Mark Palazzo, ICU consultant, Susan Todd, statistician; Tom Woodcock, ICU consultant.

  • Principal investigators and donor transplant coordinators

  • Rahim Ahmed, Mayday University Hospital; Ryck Albertyn, Worthing Hospital; Ian Andrews, Eastbourne District General Hospital; Karen Austin, Alexandra Hospital, Redditch; Stephen Austin, Mater Infirmorum Hospital, Belfast; Lee Baldwin, Kent and Sussex Hospital, Tunbridge Wells; Andy Ball, Dorset County Hospital, Dorchester; Susan Beards, Wythenshawe Hospital, Manchester; John Bleasdale, City Hospital, Birmingham; Jonathan Benson, Manchester Royal Infirmary; Keith Bresland, Darlington Memorial Hospital; Bradley Browne, Taunton and Somerset Hospital; Sharon Buchanan, Horton Hospital, Banbury; George Bugelli, Glan Clwyd, Rhyl; Vincent Bulso, Sandwell General Hospital, West Bromwich; Alistair Challiner, Maidstone General Hospital; Kay Chidley, Gloucestershire Royal Hospital, Gloucester; Andy Cohen, Barnet Hospital; Mehrengise Cooper, St. Mary’s Hospital PICU, London; Jason Cupitt, Blackpool Victoria Hospital; Chris Danbury, Royal Berkshire Hospital, Reading; Steve Dumont, Royal Gwent Hospital, Newport; Michael Ferguson, Leicester Royal Infirmary ICU; James Fraser, Bristol Royal Hospital For Children; Sarah Gillis, Whittington Hospital; Arthur Goldsmith, Royal Hampshire County Hospital, Winchester; Charlie Granger, Royal Lancaster Infirmary; Rob Griffiths, Withybush Hospital, Haverfordwest; Jeremy Groves, Chesterfield and North Derbyshire Royal Hospital; Dave Harling, Rotherham District General; Kay Hawkins, Royal Manchester Childrens’ Hospital; Russell Hedley, Princess Royal University Hospital, Orpington; David Higgins, Southend University Hospital; Jonathan Howes, Yeovil District Hospital; Paul Hughes, Wrexham Maelor Hospital; Julian Hull, Good Hope Hospital, Sutton Coldfield and Solihull Hospital; Tuba Hussain, Peterborough District Hospital; Brian Jenkins, Prince Charles Hospital, Merthyr Tydfil; Chris Kearns, John Radcliffe Hospital, Oxford NICU; Shond Laha, Chorley and South Ribble Hospital and Royal Preston; Richard Longbottom, Trafford General Hospital, Urmston; Rory Mackenzie, Monklands District General Hospital, Airdrie; Michael Margarson, St Richards Hospital, Chichester; Cathy Maskill, Hillingdon Hospital, Middlesex; Nick Mcneillis, Conquest Hospital; Kevin Morris, Birmingham Children’s Hospital; Alex Manara, Frenchay Hospital, Bristol; Hamid Manji, Milton Keynes General; Chris Newson, Manor Hospital, Walsall; Marlies Ostermann, Guy’s And St. Thomas’ Hospital; Josep Panisello, John Radcliffe Hospital, Oxford PICU; Tim Peters, West Middlesex University Hospital; Tony Pickworth, Great Western Hospital, Swindon; Jagtar Pooni, New Cross Hospital, Wolverhampton; Ian Roberts, George Eliot Hospital, Nuneaton; Peter Royle, University Hospital Of Hartlepool and University Of North Tees; David Simpson, Medway Maritime Hospital, Gillingham; Susan Smith, Cheltenham General Hospital; Clare Stapleton, Wexham Park Hospital; Roger Stedman, Birmingham Heartlands Hospital; Lynn Swanson, Queen Elizabeth Hospital, Gateshead; Michael Swart, Torbay Hospital, Torquay; Philippa Swayne, Salisbury District Hospital; Angus Vincent, Newcastle General Hospital ICU/PICU; Umeer Waheed, Hammersmith Hospital, London; Martin Walker, Derriford Hospital, Plymouth; Duncan Watson, University Hospital (Walsgrave); Chris Watters, Causeway Hospital, Coleraine; Martin White, Cumberland Infirmary; Dewi Williams, Dumfries and Galloway Royal Infirmary; Peter Wilson, Southampton General Hospital PICU; Paul Woodsford, Royal Glamorgan General Hospital, Pontypridd; Maggie Wright, James Paget Hospital, Gorleston; Duncan Young, John Radcliffe Hospital, Oxford ICU.

  • Regional ACRE representatives

  • Nicki Ashby, Portsmouth; Sarah Beale, South Thames; Gregory Bleakley, Manchester; Sharon Bradshaw, Plymouth; Marian Ryan, Cambridge; Louise Collar, Cardiff; Trish Collins, Portsmouth; Gordon Crowe, Sheffield; Deirdre Cunningham, East Midlands; Eleanor Donaghy, Belfast; Jessica Gregory, South Thames; Sally Holmes, Bristol; Dawn Lee, Manchester; Emma Linnacre, Liverpool; Ella Poppitt, Oxford; Susan Richards, Birmingham; Lynn Robson, Newcastle; Teressa Tymkewycz, North Thames; Deirdre Walsh, Glasgow.

  • Contributors: Ella Poppitt conceived the study, which was designed by Duncan Young, Dave Collett, Ella Poppitt, and Sarah Edwards. Dave Collett and Claire Hamilton analysed the data. Duncan Young, Dave Collett, Ella Poppitt, and Chris Danbury wrote the manuscript. Duncan Young is guarantor.

  • Funding: This study was funded by NHS Blood and Transplant.

  • The study sponsor (Oxford University) had no role in any aspect of the design or implementation of the study. The funder’s role in study design was limited to the practicalities of setting up the randomisation service and linking the study data with the National Transplant database. The study funder took no part in the interpretation of data, writing the article and the decision to submit it for publication. All the researchers (TSC) had access to the data and approved the final analysis and manuscript.

  • Competing interests: Dave Collett and Karen Morgan are employed by the study funder, NHS Blood and Transplant. Chris Danbury and Susan Richards serve on the donor advisory group organised by NHS Blood and Transplant.

  • Ethical approval: The study was approved by Oxford REC A (reference No 06/Q1604/119), with a waiver of the requirement for consent as explained in the text.

This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/2.0/ and http://creativecommons.org/licenses/by-nc/2.0/legalcode.

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