ERANet-LAC CODE: International Care Of the Dying Evaluation

Sponsor
University of Bergen (Other)
Overall Status
Completed
CT.gov ID
NCT03566732
Collaborator
Sue Ryder House administered by Pallmed (Other), Mutualista Asociación Hospital Evangélico (Other), Pallium Latinoamérica N.G.O (Other), University Medical Center Mainz (Other), University of Campinas, Brazil (Other), University of Liverpool (Other)
914
Enrollment
20
Locations
15.7
Actual Duration (Months)
45.7
Patients Per Site
2.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase

    Detailed Description

    ABSTRACT

    Background: In order to ensure the highest quality of care is provided for dying patients and their families, one needs to first be able to robustly evaluate the current quality of care. One identified method is to assess this from the user-perspective by conducting bereaved relatives' surveys. 'Care Of the Dying Evaluation' (CODE) is a recognised, validated post-bereavement questionnaire which has been extensively used within the United Kingdom. The ERANet-LAC CODE project aims to use CODE in a wider international context. In Work Package 1 of the project, CODE will be translated and pilot tested in volunteers and bereaved relatives in the partner countries. Using a consensus procedure, a final version of the international CODE (i-CODE) questionnaire will be developed.

    Aims: The present project (Work Package 2) aims to advance the international evidence in care for dying cancer patients by undertaking an observational study of bereaved relatives' views across seven participating countries. The overall aims of Work Package 2 (WP2) are to:

    • Conduct an international survey of bereaved relatives of cancer patients dying in hospitals, using the CODE questionnaire

    • Use the CODE data to provide feedback about the quality of care and level of family support at an international and national level, allowing for cross-country comparisons

    • Conduct a web survey of all participating institutions to be able to interpret the survey data in the context of information about each organisation and the level of specialist palliative care provision at each site / country

    Methods: Bereaved adult relatives, to adult cancer patients who had an 'expected' death in hospital, will be approached face to face, by telephone or in writing and invited to complete the CODE questionnaire. The CODE questionnaire pack will be sent out 6-8 weeks after bereavement. CODE may be completed via self-completion paper questionnaire, via on-line questionnaire, or facilitated via a researcher using a tablet, telephone or face-to-face interview, according to what is feasible and acceptable in each country. The aim is 100 completed questionnaires per country. Basic demographics will be recorded for all potential participants and for the patients who died.

    Analysis of results: Data will be analysed using SPSS and according to the CODE user guide, to present a common international report, individual country reports and cross-country comparisons. Data will be interpreted in the context of knowledge about the individual sites/countries.

    Conclusions: The expected outcomes from WP2 are an international survey and cross-country comparisons about the current quality of care for dying cancer patients as perceived by bereaved people, including key areas where care needs to be improved. WP3 of the project will use the results of the international survey to implement changes to improve the care.

    INTRODUCTION

    The present project was proposed in response to the ERANet-LAC 2nd Joint Call on Research and Innovation and approved for funding under the European Commission's 7th framework program. The aim of the project is to inform and develop an evidence based approach to systematically standardize assessment and care of dying cancer patients, using relative generated outcomes. The project will be conducted in four European and three South American countries three years starting from January 2017. The project contains three Work Packages (parts). This protocol describes the work to be undertaken in Work Package 2 (CODE International Survey).

    BACKGROUND

    The delivery of appropriate care for dying cancer patients remains a key medical, social, economic and political issue. However, the quality of care for the dying is diverse both within and between EU-LAC countries.

    Based on the international evidence base, a set of core principles for care of the dying has been defined. These principles are applicable to the care of dying cancer patients, as well as other patients, worldwide.

    In order to ensure the highest quality of care provisions, one needs to first be able to robustly evaluate the current quality of care. One method is to assess this from the user-perspective by conducting bereaved relatives' surveys.

    'Care Of the Dying Evaluation' Questionnaire

    One post-bereavement questionnaire is 'Care Of the Dying Evaluation' (CODE). This is a 42-item self-completion questionnaire, developed within the UK, and focused on the quality of care and the level of support provided to individuals and their families in the last days of life and the immediate post-bereavement period.

    CODE has been used and validated with bereaved relatives, including undertaking cognitive 'think aloud' interviews to assess face and content validity; assessing CODE's stability over time by conducting test-retest reliability analysis; and assessing the construct validity and internal consistency of CODE. Subsequently, CODE has been used across hospices, hospitals and community settings.

    In Work Package 1 of the present project, CODE was translated from English into the main language of each partner country according to established international procedures, and pilot tested in volunteers and bereaved relatives to assure understanding and appropriate cultural adaptation. Based on feedback from the testing in each country, a common, international version of CODE (iCODE) has been established through a consensus procedure.

    AIMS & OBJECTIVES

    The present project (Work Package 2) aims to advance the international evidence in care for dying patients by undertaking an observational study of bereaved relatives' views across seven participating countries, by use of the CODE questionnaire.

    The overall aims of Work Package 2 (WP2) are:
    • Conduct an international survey of bereaved relatives of cancer patients dying in hospitals, using the CODE questionnaire

    • Conduct a web survey of all participating institutions to aid in the interpretation of the survey data

    • Use the CODE data to provide feedback about the quality of care and level of family support at an international and national level, allowing for cross-country comparisons

    METHODS

    Study sites

    The necessary number of hospitals caring for adult cancer patients will be recruited as study sites. The study will only be performed in institutions defined as hospitals

    Recruitment

    The relative / next-of-kin must be approached after the patient's death. The investigators will approach the person recorded as next-of-kin in the patient's hospital record.

    Only one completed questionnaire will be included per deceased patient.

    Recruitment will be done prospectively. The method of recruitment will be adapted as to what is feasible and in the individual country.

    DATA COLLECTION

    CODE International Survey

    Data to be collected The CODE questionnaire is the common data collection tool of the study. CODE also includes demographic data. Information about the hospital stay will be included for all cases, as part of the inclusion procedure.

    Method of data collection

    The CODE questionnaire will be sent to the participants 6-8 weeks post bereavement, with on reminder. CODE International Survey was intended as a postal survey, but other data collection methods will also be accepted.

    Sample estimation:

    Minimum acceptable number of questionnaires per country is 100 (with this number, a 95% confidence interval will give a margin of error of +/- 10% of the primary outcome).

    Data transfer

    The electronic version and database for CODE for each country/language will be developed in Norway using the Corporate Surveyor software. The databases will be merged in Norway for the final common analyses.

    A web survey of study sites will also be conducted.

    DATA ANALYSIS

    Data will be analysed using the R statistical package, using descriptive statistics (proportions (%) for categorical data; means and standard deviations for continuous parametric data and medians and interquartile range for continuous non-parametric data).

    The dataset, anonymised at patient, site and country level, will be aggregated at international level to enable an international report. Results will be summarised in tabular and graphical format, as appropriate.

    Free text comments will be analysed using qualitative methods (text condensation).

    PROJECT MANAGEMENT AND WORK PLAN

    All partners have signed the consortium agreement. The PIs are responsible for the CODE international survey in their respective countries. The group of PIs constitute the project General Assembly and decision-making body.

    WP1 (Preparation and Piloting) ran from month 1 to month 7 of the project, i.e. from January to August 2017.

    WP2 is designed to run from month 8 to month 22 of the project, i.e. from September 2017 to November 2018.

    Time line and deliverables

    Confirmation of ethical approval for CODE International Survey in each country: month 6 (July 2017) Web survey of institutions ready for use: month 6 (July 2017) Fully developed, tested and web-accessible data collection tools: month 6 (July 2017) i-CODE ready for use: month 7 (Aug 2017) Completed web survey of inclusion sites: month 10 (Nov 2017) Completed international survey with at least 600 completed CODE questionnaires: month 22 (Nov 2018) Report on CODE International Survey data: month 22 (Nov 2018)

    SPONSORSHIP AND BUDGET

    Financial support for the project was granted from national research funding agencies in the participating countries, except in the UK. The University of Liverpool, UK, takes part in the project as self-financed partner.

    No commercial interests are involved in the study. No conflicts of interest have been declared. Participants receive no financial benefit for participation.

    ETHICAL APPROVAL AND GOVERNANCE

    The Project Lead (PI) for each country will seek the necessary approvals for CODE International Survey, from their local/regional ethics committee, and from their institutional review board as needed. All countries will need ethical approval for WP2.

    All potential participants will be given a Participant Information Sheet detailing the aims of the study and informing that participation is fully voluntary.

    PATIENT AND PUBLIC INVOLVEMENT Both volunteers and bereaved relatives will be deeply involved in developing i-CODE to be used for the international survey.

    After the survey has been performed, bereaved relatives will be involved in the action planning on how to address the main areas of concern identified.

    CONFIDENTIALITY AND DATA MANAGEMENT

    The Project Lead for each country will preserve the confidentiality of participants taking part in the study. All data will be anonymised and individual participants will not be identifiable from published data.

    All data will be stored on a secure, password protected research server. Data will be stored for up to five years after the completion of the project before being confidentially shredded or deleted.

    DISSEMINATION AND PUBLICATIONS

    A website for the project will be established.

    Authorship will be defined according to the Vancouver Guidelines. National data may be published by the study group in each country.

    The last project meeting with presentations and discussions of the project findings will be arranged as an open international conference.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    914 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    International Care Of the Dying Evaluation (CODE): Quality of Care for Cancer Patients as Perceived by Bereaved Relatives
    Actual Study Start Date :
    Aug 15, 2017
    Actual Primary Completion Date :
    Dec 7, 2018
    Actual Study Completion Date :
    Dec 7, 2018

    Arms and Interventions

    ArmIntervention/Treatment
    Bereaved relatives

    Bereaved relatives after cancer deaths in hospitals

    Outcome Measures

    Primary Outcome Measures

    1. 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 [6-8 weeks post bereavement]

      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.

    2. 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? [6-8 weeks post bereavement]

      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.

    Other Outcome Measures

    1. Individual Items of CODE (Care Of the Dying Evaluation) Questionnaire. [6-8 weeks post bereavement]

      Individual questionnaire items of the CODE (Care Of the Dying Evaluation) questionnaire. Maximum value 4, minimum value 0. The higher score, the better outcome.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • 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

    Exclusion Criteria:
    • 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)

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Hospital Carlos B. UdaondoBuenos AiresArgentina
    2Instituto de Investigaciones Médicas Alfredo Lanari. Universidad de Buenos AiresBuenos AiresArgentina
    3Hospital Universitario Privado de CórdobaCórdobaArgentina
    4Sumare State HospitalSão PauloBrazil
    5Katholisches Klinikum MainzMainzGermany
    6University Medical Centre of the Johannes Gutenberg University of MainzMainzGermany
    7Haukeland University HospitalBergenNorwayN-5021
    8Haraldsplass Deaconal HospitalBergenNorway
    9Bærum Hospital, Vestre VikenBærumNorway
    10Førde Central HospitalFørdeNorway
    11Haugesund HospitalHaugesundNorway
    12Stavanger University HospitalStavangerNorway
    13St Olavs HospitalTrondheimNorway
    14Pulmonological Hospital in BydgoszczBydgoszczPoland
    15D. Wladyslaw Biegański Regional Specialist HospitalGrudziądzPoland
    16F. Dłutek Autonomic Public Healthcare CentreRypinPoland
    17Provincial Specialist Hospital in name of the blessed priest PopiełuszkoWloclawekPoland
    18Paluckie Health Centre, Żnin HospitalŻninPoland
    19Royal Liverpool University HospitalLiverpoolUnited Kingdom
    20Mutualista Asociación Hospital EvangélicoMontevideoUruguay

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Dagny F. Haugen, PhD, University of Bergen

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    Responsible Party:
    University of Bergen
    ClinicalTrials.gov Identifier:
    NCT03566732
    Other Study ID Numbers:
    • ELAC2015/T07-0545
    First Posted:
    Jun 25, 2018
    Last Update Posted:
    Jan 6, 2022
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Bergen

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group TitleBereaved Relatives
    Arm/Group DescriptionBereaved relatives after cancer deaths in hospitals
    Period Title: Overall Study
    STARTED914
    COMPLETED914
    NOT COMPLETED0

    Baseline Characteristics

    Arm/Group TitleBereaved Relatives
    Arm/Group DescriptionBereaved relatives after cancer deaths in hospitals
    Overall Participants914
    Age, Customized (Count of Participants)
    18-29 years
    26
    2.8%
    30-39 years
    95
    10.4%
    40-49 years
    148
    16.2%
    50-59 years
    241
    26.4%
    60-69 years
    208
    22.8%
    70-79 years
    150
    16.4%
    80-89 years
    35
    3.8%
    Missing
    11
    1.2%
    Sex: Female, Male (Count of Participants)
    Female
    610
    66.7%
    Male
    304
    33.3%
    Race and Ethnicity Not Collected (Count of Participants)
    Region of Enrollment (Count of Participants)
    Argentina
    105
    11.5%
    Norway
    194
    21.2%
    Uruguay
    125
    13.7%
    Poland
    100
    10.9%
    Brazil
    105
    11.5%
    United Kingdom
    102
    11.2%
    Germany
    183
    20%
    Type of ward where the patient died (Count of Participants)
    Medical or surgical ward
    447
    48.9%
    Palliative care unit
    231
    25.3%
    Oncology ward
    119
    13%
    Intensive care unit
    69
    7.5%
    Emergency unit
    42
    4.6%
    Missing
    6
    0.7%

    Outcome Measures

    1. Primary Outcome
    TitleCODE (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
    DescriptionCODE (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.
    Time Frame6-8 weeks post bereavement

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleBereaved Relatives
    Arm/Group DescriptionBereaved relatives after cancer deaths in hospitals
    Measure Participants914
    Mean (95% Confidence Interval) [score on a scale]
    3.7
    2. Primary Outcome
    TitleNumber 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?
    DescriptionCODE (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.
    Time Frame6-8 weeks post bereavement

    Outcome Measure Data

    Analysis Population Description
    Not all participants (bereaved relatives) answered this question. 30 answers missing.
    Arm/Group TitleBereaved Relatives
    Arm/Group DescriptionBereaved relatives after cancer deaths in hospitals
    Measure Participants884
    Count of Participants [Participants]
    788
    86.2%
    3. Other Pre-specified Outcome
    TitleIndividual Items of CODE (Care Of the Dying Evaluation) Questionnaire.
    DescriptionIndividual questionnaire items of the CODE (Care Of the Dying Evaluation) questionnaire. Maximum value 4, minimum value 0. The higher score, the better outcome.
    Time Frame6-8 weeks post bereavement

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description

    Adverse Events

    Time FrameOne year, during the data collection.
    Adverse Event Reporting Description
    Arm/Group TitleBereaved Relatives
    Arm/Group DescriptionBereaved relatives after cancer deaths in hospitals
    All Cause Mortality
    Bereaved Relatives
    Affected / at Risk (%)# Events
    Total0/914 (0%)
    Serious Adverse Events
    Bereaved Relatives
    Affected / at Risk (%)# Events
    Total0/914 (0%)
    Other (Not Including Serious) Adverse Events
    Bereaved Relatives
    Affected / at Risk (%)# Events
    Total0/914 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/TitleProfessor Dagny F. Haugen
    OrganizationUniversity of Bergen
    Phone+4747606633
    Emaildagny.haugen@uib.no
    Responsible Party:
    University of Bergen
    ClinicalTrials.gov Identifier:
    NCT03566732
    Other Study ID Numbers:
    • ELAC2015/T07-0545
    First Posted:
    Jun 25, 2018
    Last Update Posted:
    Jan 6, 2022
    Last Verified:
    Dec 1, 2021