ERANet-LAC CODE: International Care Of the Dying Evaluation

NCT03566732 | Completed Results DMC

• 1 other identifier: ELAC2015/T07-0545
• Study Type: observational
• Target: 914
• Locations: 7 countries
• Sites: 20

Brief Summary

Providing high quality care for dying patients and their families is very important. One way one can assess the care provided is to ask bereaved relatives to complete a questionnaire after their family member has died. The questionnaire can ask about their experiences and their thoughts about the care provided to their family member. One such questionnaire is the 'Care Of the Dying Evaluation' (or CODE). CODE has been developed with the help and support of bereaved relatives and has been used extensively within the United Kingdom. In this project the investigators want to use the CODE questionnaire to look at bereaved relatives' views about care provided in seven different countries within Europe and Latin America. In the first part of the project CODE was translated into the main language of each country. Volunteers and bereaved relatives in each country were asked to give feedback about whether CODE was easy to understand, sensitive, and easy to complete. Based on the feedback a common version of CODE that is suitable for use across all the countries was developed. In the next phase of the project, relatives who have recently experienced a bereavement where one of their family members has died from cancer in a hospital, will be invited to complete the CODE questionnaire about two months after the patient's death. The relatives may complete CODE on paper, using a computer, or by interview. The aim is to have 100 completed CODE questionnaires from each of the seven countries. The data from the questionnaires will be used to make a report on the current quality of care for dying cancer patients in hospitals across the seven countries. It will also be possible to compare the care between the countries and identify areas needing improvement. In the next phase of the project, health care professionals, researchers and bereaved relatives together will use their knowledge and experience to find effective ways to improve the weak areas identified, and assess the results of putting these changes into practice.

Conditions

Neoplasms; Bereavement; Quality of Life

Keywords

questionnaire survey; care for dying patients

Outcome Measures

Primary Outcomes (2)

• CODE (Care Of the Dying Evaluation) Questionnaire Item 30 Score for Relatives' Perception of How Much of the Time the Deceased Patient Was Treated With Dignity and Respect, by Nurses, and by Doctors

  CODE (Care Of the Dying Evaluation) questionnaire, item 30: How much of the time was the deceased patient treated with dignity and respect, by nurses, and by doctors. Maximum obtainable score 4, minimum 0. The higher score, the better outcome.

  6-8 weeks post bereavement

• Number of Participants (Relatives) Answering "Yes" to CODE (Care Of the Dying Evaluation) Questionnaire Item 31: Were You Adequately Supported in the Patients' Last Days of Life?

  CODE (Care Of the Dying Evaluation) questionnaire, item 31: Were you adequately supported in the patient's last days of life? Yes/no question. The higher percentage of relatives answering 'yes', the better outcome.

  6-8 weeks post bereavement

Other Outcomes (1)

• Individual Items of CODE (Care Of the Dying Evaluation) Questionnaire.

  6-8 weeks post bereavement

Study Arms (1)

Bereaved relatives

Bereaved relatives after cancer deaths in hospitals

Eligibility Criteria

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

Study Population

Next-of-kin to cancer patient who died an expected death in hospital

You may qualify if:

• Next-of-kin to a patient who died an 'expected' death from cancer in hospital
• Has been present at the hospital together with the patient at least some of the time during the patient's last two days. (This might not always be known or recorded, therefore the participant may have the option to pass the questionnaire on to somebody better placed to complete it.)
• Patient was ≥ 18 years of age at the time of Death
• Patient had been admitted to the hospital (not any specific ward) at least three calendar days (e.g., admission August 1st, died August 3rd)
• Able to give written informed consent, which might be implied when the participant completes and returns the questionnaire, in keeping with the ethical stipulations for each country

You may not qualify if:

• Patient had a sudden and unexpected death
• Unable to complete the questionnaire due to language abilities or reduced cognitive functioning (in some countries the offer of a translator would be provided if someone wanted to complete the questionnaire but had difficulty due to languages)

Sponsors & Collaborators

• University of Bergen: lead
• Sue Ryder House: collaborator
• Mutualista Asociación Hospital Evangélico: collaborator
• Pallium Latinoamérica N.G.O: collaborator
• University Medical Center Mainz: collaborator
• University of Campinas, Brazil: collaborator
• University of Liverpool: collaborator

Study Sites (20)

Hospital Carlos B. Udaondo

Buenos Aires, Argentina

Location

Instituto de Investigaciones Médicas Alfredo Lanari. Universidad de Buenos Aires

Buenos Aires, Argentina

Location

Hospital Universitario Privado de Córdoba

Córdoba, Argentina

Location

Sumare State Hospital

São Paulo, Brazil

Location

Katholisches Klinikum Mainz

Mainz, Germany

Location

University Medical Centre of the Johannes Gutenberg University of Mainz

Mainz, Germany

Location

Haukeland University Hospital

Bergen, N-5021, Norway

Location

Haraldsplass Deaconal Hospital

Bergen, Norway

Location

Bærum Hospital, Vestre Viken

Bærum, Norway

Location

Førde Central Hospital

Førde, Norway

Location

Haugesund Hospital

Haugesund, Norway

Location

Stavanger University Hospital

Stavanger, Norway

Location

St Olavs Hospital

Trondheim, Norway

Location

Pulmonological Hospital in Bydgoszcz

Bydgoszcz, Poland

Location

D. Wladyslaw Biegański Regional Specialist Hospital

Grudziądz, Poland

Location

F. Dłutek Autonomic Public Healthcare Centre

Rypin, Poland

Location

Provincial Specialist Hospital in name of the blessed priest Popiełuszko

Włocławek, Poland

Location

Paluckie Health Centre, Żnin Hospital

Żnin, Poland

Location

Royal Liverpool University Hospital

Liverpool, United Kingdom

Location

Mutualista Asociación Hospital Evangélico

Montevideo, Uruguay

Location

Related Publications (28)

• The 2015 Quality of Death index. Ranking palliative care across the world. The Economist Intelligence Unit. A report by The Economist Intelligence Unit. Lien Foundation 2015.

  BACKGROUND

• Pastrana T, De Lima L, Wenk R, et al. Atlas de Cuidados Paliativos de Latinoamérica. Houston,TX: IAHPC Press, 2012.

  BACKGROUND

• Pastrana T, Eisenchlas J, Centeno C, De Lima L. Status of palliative care in Latin America: looking through the Latin America Atlas of Palliative Care. Curr Opin Support Palliat Care. 2013 Dec;7(4):411-6. doi: 10.1097/SPC.0000000000000008.

  PMID: 24145682 BACKGROUND

• National care of the dying audit for hospitals, England. National report, Royal College of Physicians, May 2014

  BACKGROUND

• The International Collaborative for Best Care for the Dying Person. Supporting Care in the Last Hours or Days of Life. May 2014.

  BACKGROUND

• Department of Health (2008). End of life care strategy. Promoting high quality care for all adults at the end of life. Department of Health: London.

  BACKGROUND

• Burge F, Lawson B, Johnston G, Asada Y, McIntyre PF, Grunfeld E, Flowerdew G. Bereaved family member perceptions of patient-focused family-centred care during the last 30 days of life using a mortality follow-back survey: does location matter? BMC Palliat Care. 2014 May 14;13:25. doi: 10.1186/1472-684X-13-25. eCollection 2014.

  PMID: 24855451 BACKGROUND

• Office of National Statistics (2014). National Survey of Bereaved People (VOICES) 2014. Office of National Statistics.

  BACKGROUND

• van der Heide A, de Vogel-Voogt E, Visser AP, van der Rijt CC, van der Maas PJ. Dying at home or in an institution: perspectives of Dutch physicians and bereaved relatives. Support Care Cancer. 2007 Dec;15(12):1413-21. doi: 10.1007/s00520-007-0254-7. Epub 2007 Apr 20.

  PMID: 17447086 BACKGROUND

• Mayland CR, Williams EM, Ellershaw JE. Assessing quality of care for the dying: the development and initial validation of a postal self-completion questionnaire for bereaved relatives. Palliat Med. 2012 Oct;26(7):897-907. doi: 10.1177/0269216311424953. Epub 2011 Nov 1.

  PMID: 22045726 BACKGROUND

• Department of Health (2013) The NHS Friends and Family Test: Publication Guidelines.

  BACKGROUND

• Mayland CR, Williams EM, Addington-Hall J, Cox TF, Ellershaw JE. Does the 'Liverpool Care Pathway' facilitate an improvement in quality of care for dying cancer patients? Br J Cancer. 2013 May 28;108(10):1942-8. doi: 10.1038/bjc.2013.203. Epub 2013 May 16.

  PMID: 23681186 BACKGROUND

• Mayland CR, Williams EM, Addington-Hall J, Cox TF, Ellershaw JE. Assessing the quality of care for dying patients from the bereaved relatives' perspective: further validation of "Evaluating care and health outcomes--for the dying". J Pain Symptom Manage. 2014 Apr;47(4):687-96. doi: 10.1016/j.jpainsymman.2013.05.013. Epub 2013 Nov 5.

  PMID: 24210451 BACKGROUND

• Mayland C, Williams E, Ellershaw J. How well do current instruments using bereaved relatives' views evaluate care for dying patients? Palliat Med. 2008 Mar;22(2):133-44. doi: 10.1177/0269216307085742.

  PMID: 18372378 BACKGROUND

• Mayland CR, Lees C, Germain A, Jack BA, Cox TF, Mason SR, West A, Ellershaw JE. Caring for those who die at home: the use and validation of 'Care Of the Dying Evaluation' (CODE) with bereaved relatives. BMJ Support Palliat Care. 2014 Jun;4(2):167-174. doi: 10.1136/bmjspcare-2013-000596. Epub 2014 Mar 28.

  PMID: 24681559 BACKGROUND

• Mayland C. User-guide for 'Care of the Dying Evaluation' (CODETM). The Marie Curie Palliative Care Institute Liverpool, 2015.

  BACKGROUND

• Mayland CR, Mulholland H, Gambles M, Ellershaw J, Stewart K. How well do we currently care for our dying patients in acute hospitals: the views of the bereaved relatives? BMJ Support Palliat Care. 2017 Sep;7(3):316-325. doi: 10.1136/bmjspcare-2014-000810. Epub 2017 Jan 17.

  PMID: 28096171 BACKGROUND

• Quality Assurance for Care of the Dying: Cheshire & Merseyside Strategic Clinical Network. Network Report. October 2015.

  BACKGROUND

• Stiel S, Heckel M, Bussmann S, Weber M, Ostgathe C. End-of-life care research with bereaved informal caregivers--analysis of recruitment strategy and participation rate from a multi-centre validation study. BMC Palliat Care. 2015 May 2;14:21. doi: 10.1186/s12904-015-0020-4.

  PMID: 25934560 BACKGROUND

• Malterud K. Systematic text condensation: a strategy for qualitative analysis. Scand J Public Health. 2012 Dec;40(8):795-805. doi: 10.1177/1403494812465030.

  PMID: 23221918 BACKGROUND

• Germain A, Mayland CR, Jack BA. The potential therapeutic value for bereaved relatives participating in research: An exploratory study. Palliat Support Care. 2016 Oct;14(5):479-87. doi: 10.1017/S1478951515001194. Epub 2015 Oct 29.

  PMID: 26510786 BACKGROUND

• Mayland CR, Gerlach C, Sigurdardottir K, Hansen MIT, Leppert W, Stachowiak A, Krajewska M, Garcia-Yanneo E, Tripodoro VA, Goldraij G, Weber M, Zambon L, Passarini JN, Saad IB, Ellershaw J, Haugen DF. Assessing quality of care for the dying from the bereaved relatives' perspective: Using pre-testing survey methods across seven countries to develop an international outcome measure. Palliat Med. 2019 Mar;33(3):357-368. doi: 10.1177/0269216318818299. Epub 2019 Jan 10.

  PMID: 30628867 RESULT

• Hansen MIT, Haugen DF, Sigurdardottir KR, Kvikstad A, Mayland CR, Schaufel MA; ERANet-LAC CODE project group. Factors affecting quality of end-of-life hospital care - a qualitative analysis of free text comments from the i-CODE survey in Norway. BMC Palliat Care. 2020 Jul 7;19(1):98. doi: 10.1186/s12904-020-00609-x.

  PMID: 32635903 RESULT

• Haugen DF, Hufthammer KO, Gerlach C, Sigurdardottir K, Hansen MIT, Ting G, Tripodoro VA, Goldraij G, Yanneo EG, Leppert W, Wolszczak K, Zambon L, Passarini JN, Saad IAB, Weber M, Ellershaw J, Mayland CR; ERANet-LAC CODE Project Group. Good Quality Care for Cancer Patients Dying in Hospitals, but Information Needs Unmet: Bereaved Relatives' Survey within Seven Countries. Oncologist. 2021 Jul;26(7):e1273-e1284. doi: 10.1002/onco.13837. Epub 2021 Jun 17.

  PMID: 34060705 RESULT

• Goldraij G, Tripodoro VA, Aloisio M, Castro SA, Gerlach C, Mayland CR, Haugen DF; ERANet-LAC CODE Project Group; ERANet-LAC CODE project group. One chance to get it right: improving clinical handovers for better symptom control at the end of life. BMJ Open Qual. 2021 Sep;10(3):e001436. doi: 10.1136/bmjoq-2021-001436.

  PMID: 34588188 RESULT

• Hjorth NE, Hufthammer KO, Sigurdardottir K, Tripodoro VA, Goldraij G, Kvikstad A, Haugen DF; ERANet-LAC CODE project group; Core scientific group. Hospital care for the dying patient with cancer: does an advance care planning invitation influence bereaved relatives' experiences? A two country survey. BMJ Support Palliat Care. 2024 Jan 8;13(e3):e1038-e1047. doi: 10.1136/bmjspcare-2021-003116.

  PMID: 34848559 RESULT

• Mayland CR, Keetharuth AD, Mukuria C, Haugen DF. Validation of 'Care Of the Dying Evaluation' (CODETM) within an international study exploring bereaved relatives' perceptions about quality of care in the last days of life. J Pain Symptom Manage. 2022 Jul;64(1):e23-e33. doi: 10.1016/j.jpainsymman.2022.02.340. Epub 2022 Mar 5.

  PMID: 35257928 RESULT

• Gerlach C, Baus M, Gianicolo E, Bayer O, Haugen DF, Weber M, Mayland CR; ERANet-LAC CODE Core scientific group. What do bereaved relatives of cancer patients dying in hospital want to tell us? Analysis of free-text comments from the International Care of the Dying Evaluation (i-CODE) survey: a mixed methods approach. Support Care Cancer. 2022 Dec 23;31(1):81. doi: 10.1007/s00520-022-07490-9.

  PMID: 36562882 RESULT

Related Links

• Short description of project, ERANet-LAC website
• Innovations Umbrella booklet - a collection of ideas and experiences from the ERANet-LAC CODE project

MeSH Terms

Conditions

Neoplasms

Results Point of Contact

• Title: Professor Dagny F. Haugen
• Organization: University of Bergen

dagny.haugen@uib.no

+4747606633

Study Officials

• Dagny F. Haugen, PhD

  University of Bergen

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2018
• First Posted: June 25, 2018
• Study Start: August 15, 2017
• Primary Completion: December 7, 2018
• Study Completion: December 7, 2018
• Last Updated: August 28, 2023
• Results First Posted: October 28, 2021

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

UR (1); BR (1); AR (3); DE (2); NO (7); PL (5); GB (1)