|
Brief Summary
|
STUDY PROTOCOL
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PROTOCOL TITLE:
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|
ASIAN PATIENT
PERSPECTIVES REGARDING OUTCOMES, AWARENESS, CARE & HEALTH (APPROACH II)
|
|
|
|
PROTOCOL NUMBER:
|
|
INSERT PROTOCOL
NUMBER HERE
|
|
|
|
PROTOCOL VERSION:
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1
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PROTOCOL DATE:
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27/10/2023
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|
|
|
OVERALL PRINCIPAL INVESTIGATOR:
Eric Finkelstein, Director, Lien Centre for Palliative Care, Duke-NUS
Medical School
|
|
SITE PRINCIPAL INVESTIGATOR:
Dr Somnath Dey
MPMMCC/HBCH, Tata
Memorial Centre
Varanasi
|
|
|
|
|
|
|
|
|
|
|
|
|
Table
of Contents
1. BACKGROUND AND RATIONALE. 3
2. HYPOTHESIS AND OBJECTIVES. 4
3. EXPECTED
RIKS AND BENEFITS. 6
4. STUDY
POPULATION.. 6
4.1. List the number and
nature of subjects to be enrolled. 6
4.2. Criteria for Recruitment and Recruitment Process. 7
4.3. Inclusion Criteria. 7
4.4. Exclusion Criteria. 7
5. STUDY
DESIGN AND PROCEDURES/METHODOLOGY. 7
6. SAFETY
MEASUREMENTS. 8
6.1. Safety Monitoring Plan. 8
6.2. Complaint Handling. 8
7. DATA
ANALYSIS. 8
7.1. Data Quality Assurance. 8
7.2. Data Entry and Storage. 8
8. SAMPLE
SIZE AND STATISTICAL METHODS. 9
8.1. Determination of Sample Size. 9
8.2. Statistical and Analytical Plans. 9
9. DIRECT
ACCESS TO SOURCE DATA/DOCUMENTS. 9
10. QUALITY
CONTROL AND QUALITY ASSURANCE. 9
11. ETHICAL
CONSIDERATIONS. 9
11.1. Informed Consent. 10
11.2. Confidentiality of Data and Patient Records. 10
12. PUBLICATIONS. 10
13. RETENTION
OF STUDY DOCUMENTS. 11
14. FUNDING
and INSURANCE. 11
|
|
Measuring
the quality of end-of-life (EOL) care from the patient and caregiver’s
perspective is a crucial step towards patient-centric healthcare management.
Yet, few efforts have focussed on systematically measuring how well various
entities and countries deliver EOL care.
Despite a lack of systematic reporting in most countries, there
is overwhelming evidence that even high-functioning health systems often fail
to deliver on aspects of end-of-life care that are important to patients with
advanced illness and their caregivers. Most end-of-life patients, even in
high income countries, die in pain and after experiencing serious
health-related suffering, not at their place of choice, under severe
psychological distress and prior to death, often express regret about how the
last period of their life was spent. 1,2,3
Many patients also routinely undergo expensive and marginal or
non-beneficial treatments that may inadvertently worsen their EOL experience.
4 As a result, poor care, serious health-related suffering,
medical bankruptcy and treatment regret are common in both more and less
developed countries. Under an effort undertaken by the Lien Centre for
Palliative Care, a Quality of Death and Dying Index (QODDI) 2021, was
undertaken to systematically rank and grade countries on the quality of EOL
care taking patient and caregiver preferences into account while developing
the weighting criteria. An extensive scoping review was performed to identify
the core domains of end-of-life care that matters most to patients and
caregivers. 5
The scoping review systematically analysed 309 articles to
identify 13 domains capturing key aspects of ‘quality of death’ that can
guide EOL care reform. Based on this review a 15-item instrument called Quality
of Care for Patients with Advance Illnesses (QCPAI) was developed for
measuring EOL care.
Although many studies on end-of-life care have been carried out
in developed countries, reports on end-of-care needs in Asia are very few.
This study can highlight the end-of-life care in India and it can also serve as a basic data for
end-of-life care in Asia. It can also identify the barriers and areas in need which could
call attention of health care system planners to augment the development of end-of-life care services in the country.
|
2.
HYPOTHESIS AND OBJECTIVES
|
|
The current study seeks to
increase our understanding of patients’ perspectives regarding their quality
of life and end of life care. To meet this aims, several specific research
objectives outlined below will be examined.
Domain
1: Prognostic beliefs
Aim
1: Assess patients’ prognostic beliefs and compare it with their perception
of their physicians’ prognostic beliefs.
Aim
2: Assess patients’ own prognostic beliefs and compare it with their
perception of prognosis for a hypothetical patient with the same diagnosis.
Aim
3: Assess association between prognostic beliefs and sense of suffering.
Domain 2: Survival
expectations, bias and hope in the face of advanced illness.
Aim
1: Whether patients who have advanced illness in LMICs have similar survival
expectations, and experience hope in the same way as patients who have
advanced illness in high-income countries. Do patients in low-income
countries carry high levels of hope.
Aim
2: Assess survival expectations of patients with advanced illness in low and
middle-income countries and whether patients display evidence of cognitive
bias.
Aim
3: Explore the relationship between hope and (1) survival predictions and (2)
health seeking behaviours.
Domain 3: Quality of Care in Patients with Advanced Illness (QCPAI)
Aim 1: Explore the extent to which
responses on QCPAI vary based on observable characteristics of the health
care institute and the individual (e.g., race, income, gender, hope).
Aim 2: Through vignettes, explore
whether or not differences in QCPAI scores are driven by reporting
heterogeneity.
|
|
|
Participants are not expected to
benefit directly from participation in this study. However, this study will
lead us to understand more about patients’ quality of life and quality of
care, their prognostic belief and treatment preferences. This understanding
will be the important step to identify the areas that need improvement and
integrate optimal end-of-life care in current practice and health care
policies surrounding end-of-life care.
The study involves no
foreseeable physical risk to participants. Participants may experience some
emotional discomfort while responding to survey items. While they complete
the survey form, they may deeply think of their actual situation and may feel
less hopeful. Participants can withdraw from the survey any time they want.
|
|
|
4.1. List the number and nature of subjects to be enrolled.
|
|
1)
Patients will be eligible to be recruited if they are diagnosed
with (a) histology of any type of solid cancer in stage IV. Site will recruit 200 patients diagnosed
with advanced stage cancer and their family caregiver.
|
4.2. Criteria for Recruitment and Recruitment Process
|
|
·
Treating physicians at
participating sites will help to identify eligible patients. The workflow for
recruitment of eligible patients will be determined in consultation with each
collaborator at each site.
·
Research coordinator/
interviewer will obtain list from clinics where the physicians had given
approval to recruit and identify patients who meet the eligibility criteria.
·
The eligible patients and their
caregiver will then be approached by the research coordinator and the details
of the study will be explained to them. Consent will be obtained.
The site PIs will be responsible for recruitment and
establishing a recruitment process. It will be made clear that decision to
participate in this study is entirely voluntary and will not affect/influence
the healthcare services they receive. Duke-NUS research team will not be
involved in any interaction with participants.
|
|
|
Patients must meet the criteria listed
below in order to be able to participate:
2) Citizen of their country
3) Over 21 years of age
4) Physically and mentally well enough
to participate in the survey.
5) Histology of any type of solid cancer
in stage IV
6) Patients should be aware of their
diagnosis.
7) Can understand and speak either
English, Hindi.
8) Agreeable to provide consent.
|
|
|
Patients meeting
any of the criteria listed below will be excluded from participation:
1)
Patients with impaired cognitive function
2)
Patients who are too sick to answer the survey.
3)
Patients who are not aware of their illness
4)
Patients who are not willing to provide consent to participate
in the study.
1) At least 21 years of age
2) Involved in providing care or
ensuring provision of care or in making decisions regarding treatment/care of
the patient.
3) Patient they are caring for is
enrolled in the study.
Exclusion criteria
for caregivers:
1)
Domestic workers/maids will be excluded from the study.
|
|
|
|
This is a cross-sectional study. Patients
with advanced cancer admitted to the inpatient and outpatient clinics at the hospital
will be recruited to the study. All possible effort will be made to find a
quiet place to conduct the consent and to administer the survey.
Participants will be asked to complete
the survey through a tablet. The survey will not ask participants for any
identifying information. Each participant will be assigned a unique code.
Validated versions of the instrument
will be used whenever available. In instances where it is not available,
instruments will be professionally translated in local languages before being
used. The survey will be pilot tested before commencing the main survey and
will be kept short to minimize patient burden. The survey was originally
developed in English. All surveys for both patient and caregiver will be
administered in his/her preferred language.
The survey will be tested
extensively with at least 50 patients and 50 caregivers to test the
readability of the survey and to assess whether certain items/questions are
difficult to understand. Based on the feedback received such questions will
be simplified/amended.
Patients who are
recruited into the study will complete a survey that will be administered by a
trained interviewer or research coordinator.
The survey is estimated to take at most 30-45 minutes to
complete.
Assisted Personal Interviewing will
be used to administer the survey through an electronic format. The interviewer
will read the survey to the participants and record the answers. The survey
will be completed electronically. The interviewer
will ensure adequate privacy so that the participants will be comfortable
answering the survey without concerns of privacy. The survey will be
administered at a time that is convenient to the participants in order to
ensure that they are free from intrusions. The survey will be
conducted by a trained interviewer who will be able to converse with
participants in their language of choice.
The surveys, identified by study
codes for each participant and their caregiver, will be administered through
survey tool-Qualtrics. The participant’s response to survey will be uploaded
to an online Qualtrics account. This account will be username/password
protected. Data will be stored for a period of ten years after the study in an online Qualtrics account.
|
|
|
|
|
|
|
The site Principal Investigator will monitor and report any
adverse events to the IEC. The study involves minimal risk to participants.
For this reason, this study is deemed to not be in need of a Data and Safety
Monitoring Board and meetings will be scheduled as needed.
|
|
|
Participants who wish to express and lodge their
complaints may do so with the site Principal Investigator.
|
|
|
|
|
Survey interviews will be monitored for quality
control on a regular basis. The survey will be conducted by interviewers who
will be trained extensively on administering the survey before being allowed
to make contact with the participants. The interviewer will be provided a
comprehensive guide detailing the protocol of administering the survey. There
will be frequent re-training session conducted for the interviewer in order
to ensure that the data obtained from this research is accurate, complete and
reliable.
The site Principal Investigator will oversee data collection of
participants. The site Principal
Investigator will be able to contact the Lien Centre for Palliative Care at
Duke-NUS Medical School, Singapore for any guidance on data collection
matters.
|
|
|
Each participant will be identified by generated study code,
such that the identity of the subject remains anonymous. The e-surveys,
identified by study codes for each participant and their caregiver, will be
administered through survey tool- Qualtrics. The participant’s response to
survey will be uploaded to an online Qualtrics account. This account will be
username/password protected. The surveys that are administered on hard copy format
will be inputted into the Qualtrics account by the interviewer after
completion of the survey.
De-identified information will be shared by
participating sites with the Duke-NUS team for data analyses.
|
|
|
|
As this study is not an RCT, the sample size is not based on
testing a single endpoint. Rather, the goal is to enrol an appropriate number
of subjects such that the study is feasible, while simultaneously ensuring a
sample size large enough to conduct analyses and estimate models.
|
|
|
|
Data
will be processed and analyzed in STATA and will be described using
percentage and relevant data displayed in tables and figures. The
associations among study variables will be assessed by correlation
coefficients analyses (bi-serial, parametric or non-parametric, whichever is
appropriate) and regression analyses. Mixed modelling methods will be used to
identify patient characteristics and disease/treatment factors associated
with topics of interest (i.e., awareness and preferences for prognostic
information, quality of life, quality of care).
|
|
The
site Principal Investigator will be the only one who will have access to the
files with identifiable data. The rest of the research team and the Duke-NUS
research team will have access to the data with no identifiable information.
The
Principal Investigator will be directly involved in overseeing recruitment
and data collection. The Principal
Investigator will be mentored by the Lien Centre for Palliative Care, Duke-NUS
and will have occasional meetings to ensure study quality. More frequent meetings in the initial
stages and monthly meetings in the later stages will be held to discuss and
troubleshoot issues that may arise and maintain quality of protocol adherence. The study investigators will also train and
monitor closely other research staff (e.g., medical students, research
assistant) involved in data collection.
This
study will be conducted in accordance with the ethical principles that have
their origin in the Declaration of Helsinki and that are consistent with the
local regulatory requirements of India.
This
final study protocol, including the final version of the Patient Information
and Informed Consent Form, must be approved in writing by the Institutional
Review Board (IRB), prior to enrolment of any patient into the study.
The
site Principal Investigator is responsible for informing the IRB of any
amendments to the protocol or other study-related documents, as per local
requirement.
|
|
|
The consent process will take place before the participant
answering any survey questions. Recruitment and consent will take place in
the inpatient and outpatient settings. In the case of outpatient setting, in
all cases every effort will be made to provide a private room in which the survey
can be administered. The consent process will involve explaining the study
and asking participants to check “ I agree to participate†box to the
participants. The consent process will be conducted by trained
interviewers.
|
|
|
The information collected from this
research will be kept confidential. Participants will have their own ID code
number for this study. Survey forms will be coded by ID number only.
Electronic data in password-protected files can be accessed only by the principal
investigator. All study findings will be reported in aggregate form and
individual participants will not be identified in public reports or
documents.
Data Sharing
This study is part of a
multi-country collaborative project managed by the Lien Centre for Palliative
Care, Duke-NUS Medical School, Singapore. Original data collected in this
current study will be kept and maintained at the Department of Palliative and
Rehabilitation Medicine, Aster Hospital. To facilitate data analyses,
electronic de-identified data will be sent to Duke-NUS using
password-protected files.
|
|
|
|
|
Data
will be stored for a period of 10 years. The
records will be accessible for inspection and copying by relevant authorities.
|
|
|
References
1. FM Knaul, PE Farmer, EL Krakauer, et
al. Alleviating the access abyss in palliative care and pain relief-an
imperative of universal health coverage: The Lancet Commission report. Lance,
391 (2018)
2. AE Singer, JR Giebel, YM Kim, et al.
Populations and interventions for palliative care and end-of-life care: a
systematic review. J Palliative Med, 19 (2016)
3. D Clark, N Baur, D Clellan, et al.
Mapping levels of palliative care development in 198 countries: the situation
in 2017, J Pain Symptom Management, 59 (2020)
4. M Cardona-Morell, JCH Kim, M Bradbrand,
et al. What is inappropriate hospital use for elderly people near the end of
life? A systematic review. Eur J Intern Med, 42 (2017)
5. A Bhadelia, LE Oldfield, JL Cruz et
al. Identifying the core domains to assess the ‘quality of death’: a scoping
review. J Pain Symptom Management (2021)
STUDY PROTOCOL
|
PROTOCOL TITLE:
|
|
ASIAN PATIENT
PERSPECTIVES REGARDING OUTCOMES, AWARENESS, CARE & HEALTH (APPROACH II)
|
|
|
|
PROTOCOL NUMBER:
|
|
INSERT PROTOCOL
NUMBER HERE
|
|
|
|
PROTOCOL VERSION:
|
1
|
|
PROTOCOL DATE:
|
27/10/2023
|
|
|
|
OVERALL PRINCIPAL INVESTIGATOR:
Eric Finkelstein, Director, Lien Centre for Palliative Care, Duke-NUS
Medical School
|
|
SITE PRINCIPAL INVESTIGATOR:
Dr Somnath Dey
MPMMCC/HBCH, Tata
Memorial Centre
Varanasi
|
|
|
|
|
|
|
|
|
|
|
|
|
Table
of Contents
1. BACKGROUND AND RATIONALE. 3
2. HYPOTHESIS AND OBJECTIVES. 4
3. EXPECTED
RIKS AND BENEFITS. 6
4. STUDY
POPULATION.. 6
4.1. List the number and
nature of subjects to be enrolled. 6
4.2. Criteria for Recruitment and Recruitment Process. 7
4.3. Inclusion Criteria. 7
4.4. Exclusion Criteria. 7
5. STUDY
DESIGN AND PROCEDURES/METHODOLOGY. 7
6. SAFETY
MEASUREMENTS. 8
6.1. Safety Monitoring Plan. 8
6.2. Complaint Handling. 8
7. DATA
ANALYSIS. 8
7.1. Data Quality Assurance. 8
7.2. Data Entry and Storage. 8
8. SAMPLE
SIZE AND STATISTICAL METHODS. 9
8.1. Determination of Sample Size. 9
8.2. Statistical and Analytical Plans. 9
9. DIRECT
ACCESS TO SOURCE DATA/DOCUMENTS. 9
10. QUALITY
CONTROL AND QUALITY ASSURANCE. 9
11. ETHICAL
CONSIDERATIONS. 9
11.1. Informed Consent. 10
11.2. Confidentiality of Data and Patient Records. 10
12. PUBLICATIONS. 10
13. RETENTION
OF STUDY DOCUMENTS. 11
14. FUNDING
and INSURANCE. 11
|
|
Measuring
the quality of end-of-life (EOL) care from the patient and caregiver’s
perspective is a crucial step towards patient-centric healthcare management.
Yet, few efforts have focussed on systematically measuring how well various
entities and countries deliver EOL care.
Despite a lack of systematic reporting in most countries, there
is overwhelming evidence that even high-functioning health systems often fail
to deliver on aspects of end-of-life care that are important to patients with
advanced illness and their caregivers. Most end-of-life patients, even in
high income countries, die in pain and after experiencing serious
health-related suffering, not at their place of choice, under severe
psychological distress and prior to death, often express regret about how the
last period of their life was spent. 1,2,3
Many patients also routinely undergo expensive and marginal or
non-beneficial treatments that may inadvertently worsen their EOL experience.
4 As a result, poor care, serious health-related suffering,
medical bankruptcy and treatment regret are common in both more and less
developed countries. Under an effort undertaken by the Lien Centre for
Palliative Care, a Quality of Death and Dying Index (QODDI) 2021, was
undertaken to systematically rank and grade countries on the quality of EOL
care taking patient and caregiver preferences into account while developing
the weighting criteria. An extensive scoping review was performed to identify
the core domains of end-of-life care that matters most to patients and
caregivers. 5
The scoping review systematically analysed 309 articles to
identify 13 domains capturing key aspects of ‘quality of death’ that can
guide EOL care reform. Based on this review a 15-item instrument called Quality
of Care for Patients with Advance Illnesses (QCPAI) was developed for
measuring EOL care.
Although many studies on end-of-life care have been carried out
in developed countries, reports on end-of-care needs in Asia are very few.
This study can highlight the end-of-life care in India and it can also serve as a basic data for
end-of-life care in Asia. It can also identify the barriers and areas in need which could
call attention of health care system planners to augment the development of end-of-life care services in the country.
|
2.
HYPOTHESIS AND OBJECTIVES
|
|
The current study seeks to
increase our understanding of patients’ perspectives regarding their quality
of life and end of life care. To meet this aims, several specific research
objectives outlined below will be examined.
Domain
1: Prognostic beliefs
Aim
1: Assess patients’ prognostic beliefs and compare it with their perception
of their physicians’ prognostic beliefs.
Aim
2: Assess patients’ own prognostic beliefs and compare it with their
perception of prognosis for a hypothetical patient with the same diagnosis.
Aim
3: Assess association between prognostic beliefs and sense of suffering.
Domain 2: Survival
expectations, bias and hope in the face of advanced illness.
Aim
1: Whether patients who have advanced illness in LMICs have similar survival
expectations, and experience hope in the same way as patients who have
advanced illness in high-income countries. Do patients in low-income
countries carry high levels of hope.
Aim
2: Assess survival expectations of patients with advanced illness in low and
middle-income countries and whether patients display evidence of cognitive
bias.
Aim
3: Explore the relationship between hope and (1) survival predictions and (2)
health seeking behaviours.
Domain 3: Quality of Care in Patients with Advanced Illness (QCPAI)
Aim 1: Explore the extent to which
responses on QCPAI vary based on observable characteristics of the health
care institute and the individual (e.g., race, income, gender, hope).
Aim 2: Through vignettes, explore
whether or not differences in QCPAI scores are driven by reporting
heterogeneity.
|
|
|
Participants are not expected to
benefit directly from participation in this study. However, this study will
lead us to understand more about patients’ quality of life and quality of
care, their prognostic belief and treatment preferences. This understanding
will be the important step to identify the areas that need improvement and
integrate optimal end-of-life care in current practice and health care
policies surrounding end-of-life care.
The study involves no
foreseeable physical risk to participants. Participants may experience some
emotional discomfort while responding to survey items. While they complete
the survey form, they may deeply think of their actual situation and may feel
less hopeful. Participants can withdraw from the survey any time they want.
|
|
|
4.1. List the number and nature of subjects to be enrolled.
|
|
1)
Patients will be eligible to be recruited if they are diagnosed
with (a) histology of any type of solid cancer in stage IV. Site will recruit 200 patients diagnosed
with advanced stage cancer and their family caregiver.
|
4.2. Criteria for Recruitment and Recruitment Process
|
|
·
Treating physicians at
participating sites will help to identify eligible patients. The workflow for
recruitment of eligible patients will be determined in consultation with each
collaborator at each site.
·
Research coordinator/
interviewer will obtain list from clinics where the physicians had given
approval to recruit and identify patients who meet the eligibility criteria.
·
The eligible patients and their
caregiver will then be approached by the research coordinator and the details
of the study will be explained to them. Consent will be obtained.
The site PIs will be responsible for recruitment and
establishing a recruitment process. It will be made clear that decision to
participate in this study is entirely voluntary and will not affect/influence
the healthcare services they receive. Duke-NUS research team will not be
involved in any interaction with participants.
|
|
|
Patients must meet the criteria listed
below in order to be able to participate:
2) Citizen of their country
3) Over 21 years of age
4) Physically and mentally well enough
to participate in the survey.
5) Histology of any type of solid cancer
in stage IV
6) Patients should be aware of their
diagnosis.
7) Can understand and speak either
English, Hindi.
8) Agreeable to provide consent.
|
|
|
Patients meeting
any of the criteria listed below will be excluded from participation:
1)
Patients with impaired cognitive function
2)
Patients who are too sick to answer the survey.
3)
Patients who are not aware of their illness
4)
Patients who are not willing to provide consent to participate
in the study.
1) At least 21 years of age
2) Involved in providing care or
ensuring provision of care or in making decisions regarding treatment/care of
the patient.
3) Patient they are caring for is
enrolled in the study.
Exclusion criteria
for caregivers:
1)
Domestic workers/maids will be excluded from the study.
|
|
|
|
This is a cross-sectional study. Patients
with advanced cancer admitted to the inpatient and outpatient clinics at the hospital
will be recruited to the study. All possible effort will be made to find a
quiet place to conduct the consent and to administer the survey.
Participants will be asked to complete
the survey through a tablet. The survey will not ask participants for any
identifying information. Each participant will be assigned a unique code.
Validated versions of the instrument
will be used whenever available. In instances where it is not available,
instruments will be professionally translated in local languages before being
used. The survey will be pilot tested before commencing the main survey and
will be kept short to minimize patient burden. The survey was originally
developed in English. All surveys for both patient and caregiver will be
administered in his/her preferred language.
The survey will be tested
extensively with at least 50 patients and 50 caregivers to test the
readability of the survey and to assess whether certain items/questions are
difficult to understand. Based on the feedback received such questions will
be simplified/amended.
Patients who are
recruited into the study will complete a survey that will be administered by a
trained interviewer or research coordinator.
The survey is estimated to take at most 30-45 minutes to
complete.
Assisted Personal Interviewing will
be used to administer the survey through an electronic format. The interviewer
will read the survey to the participants and record the answers. The survey
will be completed electronically. The interviewer
will ensure adequate privacy so that the participants will be comfortable
answering the survey without concerns of privacy. The survey will be
administered at a time that is convenient to the participants in order to
ensure that they are free from intrusions. The survey will be
conducted by a trained interviewer who will be able to converse with
participants in their language of choice.
The surveys, identified by study
codes for each participant and their caregiver, will be administered through
survey tool-Qualtrics. The participant’s response to survey will be uploaded
to an online Qualtrics account. This account will be username/password
protected. Data will be stored for a period of ten years after the study in an online Qualtrics account.
|
|
|
|
|
|
|
The site Principal Investigator will monitor and report any
adverse events to the IEC. The study involves minimal risk to participants.
For this reason, this study is deemed to not be in need of a Data and Safety
Monitoring Board and meetings will be scheduled as needed.
|
|
|
Participants who wish to express and lodge their
complaints may do so with the site Principal Investigator.
|
|
|
|
|
Survey interviews will be monitored for quality
control on a regular basis. The survey will be conducted by interviewers who
will be trained extensively on administering the survey before being allowed
to make contact with the participants. The interviewer will be provided a
comprehensive guide detailing the protocol of administering the survey. There
will be frequent re-training session conducted for the interviewer in order
to ensure that the data obtained from this research is accurate, complete and
reliable.
The site Principal Investigator will oversee data collection of
participants. The site Principal
Investigator will be able to contact the Lien Centre for Palliative Care at
Duke-NUS Medical School, Singapore for any guidance on data collection
matters.
|
|
|
Each participant will be identified by generated study code,
such that the identity of the subject remains anonymous. The e-surveys,
identified by study codes for each participant and their caregiver, will be
administered through survey tool- Qualtrics. The participant’s response to
survey will be uploaded to an online Qualtrics account. This account will be
username/password protected. The surveys that are administered on hard copy format
will be inputted into the Qualtrics account by the interviewer after
completion of the survey.
De-identified information will be shared by
participating sites with the Duke-NUS team for data analyses.
|
|
|
|
As this study is not an RCT, the sample size is not based on
testing a single endpoint. Rather, the goal is to enrol an appropriate number
of subjects such that the study is feasible, while simultaneously ensuring a
sample size large enough to conduct analyses and estimate models.
|
|
|
|
Data
will be processed and analyzed in STATA and will be described using
percentage and relevant data displayed in tables and figures. The
associations among study variables will be assessed by correlation
coefficients analyses (bi-serial, parametric or non-parametric, whichever is
appropriate) and regression analyses. Mixed modelling methods will be used to
identify patient characteristics and disease/treatment factors associated
with topics of interest (i.e., awareness and preferences for prognostic
information, quality of life, quality of care).
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The
site Principal Investigator will be the only one who will have access to the
files with identifiable data. The rest of the research team and the Duke-NUS
research team will have access to the data with no identifiable information.
The
Principal Investigator will be directly involved in overseeing recruitment
and data collection. The Principal
Investigator will be mentored by the Lien Centre for Palliative Care, Duke-NUS
and will have occasional meetings to ensure study quality. More frequent meetings in the initial
stages and monthly meetings in the later stages will be held to discuss and
troubleshoot issues that may arise and maintain quality of protocol adherence. The study investigators will also train and
monitor closely other research staff (e.g., medical students, research
assistant) involved in data collection.
This
study will be conducted in accordance with the ethical principles that have
their origin in the Declaration of Helsinki and that are consistent with the
local regulatory requirements of India.
This
final study protocol, including the final version of the Patient Information
and Informed Consent Form, must be approved in writing by the Institutional
Review Board (IRB), prior to enrolment of any patient into the study.
The
site Principal Investigator is responsible for informing the IRB of any
amendments to the protocol or other study-related documents, as per local
requirement.
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The consent process will take place before the participant
answering any survey questions. Recruitment and consent will take place in
the inpatient and outpatient settings. In the case of outpatient setting, in
all cases every effort will be made to provide a private room in which the survey
can be administered. The consent process will involve explaining the study
and asking participants to check “ I agree to participate†box to the
participants. The consent process will be conducted by trained
interviewers.
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The information collected from this
research will be kept confidential. Participants will have their own ID code
number for this study. Survey forms will be coded by ID number only.
Electronic data in password-protected files can be accessed only by the principal
investigator. All study findings will be reported in aggregate form and
individual participants will not be identified in public reports or
documents.
Data Sharing
This study is part of a
multi-country collaborative project managed by the Lien Centre for Palliative
Care, Duke-NUS Medical School, Singapore. Original data collected in this
current study will be kept and maintained at the Department of Palliative and
Rehabilitation Medicine, Aster Hospital. To facilitate data analyses,
electronic de-identified data will be sent to Duke-NUS using
password-protected files.
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Data
will be stored for a period of 10 years. The
records will be accessible for inspection and copying by relevant authorities.
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References
1. FM Knaul, PE Farmer, EL Krakauer, et
al. Alleviating the access abyss in palliative care and pain relief-an
imperative of universal health coverage: The Lancet Commission report. Lance,
391 (2018)
2. AE Singer, JR Giebel, YM Kim, et al.
Populations and interventions for palliative care and end-of-life care: a
systematic review. J Palliative Med, 19 (2016)
3. D Clark, N Baur, D Clellan, et al.
Mapping levels of palliative care development in 198 countries: the situation
in 2017, J Pain Symptom Management, 59 (2020)
4. M Cardona-Morell, JCH Kim, M Bradbrand,
et al. What is inappropriate hospital use for elderly people near the end of
life? A systematic review. Eur J Intern Med, 42 (2017)
5. A Bhadelia, LE Oldfield, JL Cruz et
al. Identifying the core domains to assess the ‘quality of death’: a scoping
review. J Pain Symptom Management (2021)
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