Ignite Creation Date:
2024-05-06 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 12:46 PM
Study NCT ID:
NCT03535922
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-05
First Post:
2018-04-30
Brief Title:
Evaluation of Routinely Measured Patient-reported Outcomes in Hemodialysis Care
Sponsor:
University of Alberta
Organization:
University of Alberta
Study Overview
Official Title:
Evaluation of Routinely Measured PATtient Reported Outcomes in HemodialYsis Care EMPATHY Trial A Cluster Randomized Controlled Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EMPATHY
Brief Summary:
Patient-reported outcome measures PROMs are reports coming directly from patients about how they function or feel in relation to a health condition and its therapy without interpretation of the patients responses by a clinician or anyone else PROMs capture patients experiences of symptoms and impact of disease on functioning and can support clinicians to monitor disease progression and facilitate patient-centered care
The EMPATHY trial will determine the effects of routinely measuring PROMs on the experiences of patients undergoing hemodialysis in Alberta and Ontario In this study two kinds of PROMs will be used a disease-specific PROM and a generic PROM The disease-specific PROM focuses on health symptoms related to kidney failure and the generic PROM focuses on general health
In the trial patients will be invited to complete the PROMs and results of the measures will be linked to treatment aids for clinicians providing specific information on how symptoms can best be managed These care pathways will also be available to patients not receiving PROMs The main outcome of this study will be patient-clinician communication which will be assessed using a questionnaire called the Communication Assessment Tool In addition to assessing the effect of using these questionnaires on patient-provider communication this study will allow us to explore whether their use affects patient management and symptoms use of healthcare services and the overall cost of implementing these questionnaires in clinical practice
Each dialysis unit including all patients will be randomized to one of four study groups 1 Patients will complete the disease-specific PROM 2 Patients will complete the generic PROM 3 Patients will complete both the disease-specific and generic PROM 4 Patients will receive usual care
Clinicians in dialysis units randomized to PROMs groups 1-3 will receive the results of the questionnaires completed by the patients This is intended to trigger the clinician to ask the patient about certain symptoms if any exist All clinicians in all study groups will have access to the clinical treatment aids which are tools that help identify and manage certain symptoms that patients might have For example people with severe itching will be cared for based on a step-wise treatment algorithm Patients will also receive a report of their questionnaires results with an explanation of what it means
The EMPATHY trial will determine the effects of routinely measuring PROMs on the experiences of patients undergoing hemodialysis in Alberta and Ontario In this study two kinds of PROMs will be used a disease-specific PROM and a generic PROM The disease-specific PROM focuses on health symptoms related to kidney failure and the generic PROM focuses on general health
In the trial patients will be invited to complete the PROMs and results of the measures will be linked to treatment aids for clinicians providing specific information on how symptoms can best be managed These care pathways will also be available to patients not receiving PROMs The main outcome of this study will be patient-clinician communication which will be assessed using a questionnaire called the Communication Assessment Tool In addition to assessing the effect of using these questionnaires on patient-provider communication this study will allow us to explore whether their use affects patient management and symptoms use of healthcare services and the overall cost of implementing these questionnaires in clinical practice
Each dialysis unit including all patients will be randomized to one of four study groups 1 Patients will complete the disease-specific PROM 2 Patients will complete the generic PROM 3 Patients will complete both the disease-specific and generic PROM 4 Patients will receive usual care
Clinicians in dialysis units randomized to PROMs groups 1-3 will receive the results of the questionnaires completed by the patients This is intended to trigger the clinician to ask the patient about certain symptoms if any exist All clinicians in all study groups will have access to the clinical treatment aids which are tools that help identify and manage certain symptoms that patients might have For example people with severe itching will be cared for based on a step-wise treatment algorithm Patients will also receive a report of their questionnaires results with an explanation of what it means
Detailed Description:
The overall aim of this study is to explore the usefulness of integrating PROM assessments in the clinical management of hemodialysis patients The specific objectives are as follows
Primary objective to determine the effects of routine measurement and reporting to clinicians of PROMs namely the Edmonton Symptom Assessment System- revised Renal ESAS-r Renal or the Integrated Palliative care Outcome Scale - Renal IPOS-Renal andor the EQ-5D-5L on patient-reported experience particularly patient-clinician communication measured by the Communication Assessment Tool CAT for patients with kidney failure requiring hemodialysis
Secondary objectives
1 To determine if there is a difference in patient-reported experience and other outcomes induced by a condition-specific ESAS-r Renal IPOS-Renal versus a generic EQ-5D-5L PROM
2 To determine the effects of routinely measuring and reporting the ESAS-r RenalIPOS-Renal andor the EQ-5D-5L on the clinical management of symptoms
3 To determine the effects of routinely measuring and reporting the ESAS-r Renal IPOS-Renal andor the EQ-5D-5L on overall HRQL
4 To determine the effects of routinely measuring and reporting the ESAS-r RenalIPOS-Renal andor the EQ-5D-5L on symptom burden mental health outcomes and healthcare utilization
5 To determine the cost-effectiveness of routinely measuring the ESAS-r RenalIPOS-Renal andor the EQ-5D-5L for patients with kidney failure requiring hemodialysis
6 To explore the perspectives and experience of patients and clinicians with routine measurement and reporting of PROMs in clinical practice
Study Design
The investigators propose the use of a cluster RCT design to avoid any potential contamination between the study groups This study is a pragmatic RCT that will involve the random allocation of clusters ie dialysis units into four groups
Group 1 Completes disease-specific PROM
Group 2 Completes generic PROM
Group 3 Completes both PROMs
Group 4 Usual care does not complete any of the PROMs control
Treatment aids for symptoms assessed by the PROMs will be made available for all clinicians in all study groups Details about intervention and treatment aids are provided below
Hypotheses
The investigators hypothesize that the routine measurement and reporting of PROMs will lead to improvement in communication between CKD patients and clinicians in dialysis units in Canada compared to usual care The investigators also hypothesized that this will lead to better symptom and disease management and improvement in mental health and quality of life Furthermore the investigators anticipate that this intervention will be cost-effective and will be acceptable and feasible in the dialysis units environment
Setting and Population
All available dialysis units from Alberta Alberta Kidney Care - North AKC-N and Alberta Kidney Care - South AKC-S and selected units in Ontario Ontario Renal Network - ORN will be invited to participate in this study The unit of randomization will be the dialysis units within AKC-NAKC-SORN not dialysis programs or individual patients Randomization will be done within each renal program AKC-NAKC-SORN to ensure that units from all programs are represented in all study groups
Dialysis Unit Eligibility Criteria
Inclusion Criteria
The unit provides chronic in-center hemodialysis
Hemodialysis clinicians are willing to review individual patients routinely collected ESAS-r Renal or IPOS-Renal andor EQ-5D-5L as part of routine patient assessment
Exclusion Criteria
The unit is unable to administer the ESAS-r Renal or IPOS-Renal and EQ-5D-5L to in-centre hemodialysis patients as part of clinical workflow to all possible patients
The unit is part of a long-term care facility
There are 5 or fewer patients treated at that unit
Lack of WiFi connectivity Alberta only
Inclusionexclusion criteria for individual patients All patients undergoing hemodialysis who are 18 years or older at the start of the study and are willing and able to complete the PROMs as part of the trial will be eligible to participate in this study Patients with cognitive impairment undergoing acute dialysis or transiently dialyzing in the unit are not included
Interventions
Since blinding is not feasible in this trial it will be conducted as an open trial Consequently research staff clinicians and all patients will be aware of group allocation cluster randomization is intended to minimize potential biases associated with an open trial design Eligible dialysis units will be randomly allocated to one of 4 study groups
1 The disease-specific PROM group The disease-specific PROM will be administered every 2 months to all patients able to complete the instrument for a period of 12 months The PROMs results will be reported back to the patient and patients will be prompted to follow-up with their care providers if they provide a positive response to any of the symptoms assessed by the PROM The PROMs results will also be printed in a report form and added to the patients medical chart for review by clinicians The report will display each patients most recent results in comparison with their previous results and in comparison with the general dialysis population The PROMs report will be accompanied by treatment aids for all symptoms
2 The generic PROM group The generic PROM will be administered every 2 months to all patients able to complete the instrument for a period of 12 months The PROMs results will be reported back to the patient and patients will be prompted to follow-up with their care providers if they provide a positive response to any of the symptoms assessed by the PROM The PROMs results will also be printed in a report form and added to the patients medical chart for review by clinicians The report will display each patients most recent results in comparison with their previous results and in comparison with the general dialysis population The PROMs report will be accompanied by treatment aids for all symptoms The proposed generic PROM is the EQ-5D-5L
3 The disease-specific and generic PROM group The disease-specific and generic PROMs will be administered every 2 months to all patients able to complete the instrument for a period of 12 months The PROMs results will be reported back to the patient and patients will be prompted to follow-up with their care providers if they provide a positive response to any of the symptoms assessed by the PROM The PROMs results will also be printed in a report form and added to the patients medical chart for review by clinicians The report will display each patients most recent results in comparison with their previous results and in comparison with the general dialysis population The PROMs report will be accompanied by treatment aids for all symptoms
4 The control or usual care group Patients in this group will follow usual care as provided in the dialysis unit and will not complete any PROM however all the treatment aids will be made available for clinicians in this study group during the trial period
Treatment aids
Treatment aids are assessment and treatment resources developed by expert clinicians for the management of certain symptoms and disorders Each renal program developed treatment aids specific to symptoms assessed by the ESAS-r Renal or IPOS-Renal eg itchiness restless leg syndrome nausea and the EQ-5D-5L eg pain anxietydepression Treatment aids are intended to support clinicians in the assessment and management of symptoms identified by these PROMs and will be made available for all clinicians at all study sites regardless of to which group they are randomized
Patient-facing materials are also provided to patients to help them better understand the reasons why their symptomproblem may have developed treatment options that might be considered as well as self-care activities they can undertake to alleviate the symptom or problem
Data Analysis
The primary analysis will assess change in the overall CAT score between study groups from baseline to 12 months using a linear mixed-effects model with the mean CAT for the dialysis unit at baseline as a fixed effect covariate and dialysis unit cluster as a random intercept Our primary analytic plan will be based on changes in mean CAT score at the unit level from baseline to 12 months The primary analysis will be based on all of the PROMs intervention groups combined compared to the control group as fixed effects As one of our secondary objectives assessing differences between specific and generic PROMs we will compare the individual interventions groups ie ESAS-r Renal IPOS alone EQ-5D-5D alone or the combination to the control group
We will also compare the proportion of patients reporting symptomsproblems on the ESAS-r Renal or IPOS-Renal and EQ-5D-5L and the management of such symptomsproblems Through clinical records we will link PROMs scores with the use of specific treatments as per the treatment aids We will obtain medication lists allied health referrals and chart notes to capture how symptoms are being treated Each renal program ie AKC-N AKC-S and ORN will be analyzed separately then we will use meta-analyses to analyze the data from each renal program
Economic Evaluation
A cost-effectiveness analysis will be employed of the different study groups compared to the usual care group as the reference case The incremental costs and incremental QALYs of the different interventions relative to the usual care group will be compared to calculate incremental cost per QALYs gained ratios Costs will be estimated for patients in the different study groups including treatments received by patients taking the perspective of the provincial health care system personnel costs for training and delivery of the PROMs assessments and subsequent health care utilization for patients in each of the study groups Health care utilization will be estimated through linkage with provincial administrative health care databases at the individual patient-level Costs associated with the provision of the intervention including training and nursing time will be estimated through observations for time and valued using standard staffing wage scales for the respective geographic regions QALYs will be calculated based on changes in the EQ-5D-5L index score using the Canadian preference weighting
Study Period
The study will be implemented over 48 months The first 6 months will involve the administrative approvals completing ethics requirements training of clinicians on the use of PROMs the following 18 months will involve trial implementation including assessments and interventions The last 12-24 months will involve compiling the data from all study sites data analysis and reporting of results
Primary objective to determine the effects of routine measurement and reporting to clinicians of PROMs namely the Edmonton Symptom Assessment System- revised Renal ESAS-r Renal or the Integrated Palliative care Outcome Scale - Renal IPOS-Renal andor the EQ-5D-5L on patient-reported experience particularly patient-clinician communication measured by the Communication Assessment Tool CAT for patients with kidney failure requiring hemodialysis
Secondary objectives
1 To determine if there is a difference in patient-reported experience and other outcomes induced by a condition-specific ESAS-r Renal IPOS-Renal versus a generic EQ-5D-5L PROM
2 To determine the effects of routinely measuring and reporting the ESAS-r RenalIPOS-Renal andor the EQ-5D-5L on the clinical management of symptoms
3 To determine the effects of routinely measuring and reporting the ESAS-r Renal IPOS-Renal andor the EQ-5D-5L on overall HRQL
4 To determine the effects of routinely measuring and reporting the ESAS-r RenalIPOS-Renal andor the EQ-5D-5L on symptom burden mental health outcomes and healthcare utilization
5 To determine the cost-effectiveness of routinely measuring the ESAS-r RenalIPOS-Renal andor the EQ-5D-5L for patients with kidney failure requiring hemodialysis
6 To explore the perspectives and experience of patients and clinicians with routine measurement and reporting of PROMs in clinical practice
Study Design
The investigators propose the use of a cluster RCT design to avoid any potential contamination between the study groups This study is a pragmatic RCT that will involve the random allocation of clusters ie dialysis units into four groups
Group 1 Completes disease-specific PROM
Group 2 Completes generic PROM
Group 3 Completes both PROMs
Group 4 Usual care does not complete any of the PROMs control
Treatment aids for symptoms assessed by the PROMs will be made available for all clinicians in all study groups Details about intervention and treatment aids are provided below
Hypotheses
The investigators hypothesize that the routine measurement and reporting of PROMs will lead to improvement in communication between CKD patients and clinicians in dialysis units in Canada compared to usual care The investigators also hypothesized that this will lead to better symptom and disease management and improvement in mental health and quality of life Furthermore the investigators anticipate that this intervention will be cost-effective and will be acceptable and feasible in the dialysis units environment
Setting and Population
All available dialysis units from Alberta Alberta Kidney Care - North AKC-N and Alberta Kidney Care - South AKC-S and selected units in Ontario Ontario Renal Network - ORN will be invited to participate in this study The unit of randomization will be the dialysis units within AKC-NAKC-SORN not dialysis programs or individual patients Randomization will be done within each renal program AKC-NAKC-SORN to ensure that units from all programs are represented in all study groups
Dialysis Unit Eligibility Criteria
Inclusion Criteria
The unit provides chronic in-center hemodialysis
Hemodialysis clinicians are willing to review individual patients routinely collected ESAS-r Renal or IPOS-Renal andor EQ-5D-5L as part of routine patient assessment
Exclusion Criteria
The unit is unable to administer the ESAS-r Renal or IPOS-Renal and EQ-5D-5L to in-centre hemodialysis patients as part of clinical workflow to all possible patients
The unit is part of a long-term care facility
There are 5 or fewer patients treated at that unit
Lack of WiFi connectivity Alberta only
Inclusionexclusion criteria for individual patients All patients undergoing hemodialysis who are 18 years or older at the start of the study and are willing and able to complete the PROMs as part of the trial will be eligible to participate in this study Patients with cognitive impairment undergoing acute dialysis or transiently dialyzing in the unit are not included
Interventions
Since blinding is not feasible in this trial it will be conducted as an open trial Consequently research staff clinicians and all patients will be aware of group allocation cluster randomization is intended to minimize potential biases associated with an open trial design Eligible dialysis units will be randomly allocated to one of 4 study groups
1 The disease-specific PROM group The disease-specific PROM will be administered every 2 months to all patients able to complete the instrument for a period of 12 months The PROMs results will be reported back to the patient and patients will be prompted to follow-up with their care providers if they provide a positive response to any of the symptoms assessed by the PROM The PROMs results will also be printed in a report form and added to the patients medical chart for review by clinicians The report will display each patients most recent results in comparison with their previous results and in comparison with the general dialysis population The PROMs report will be accompanied by treatment aids for all symptoms
2 The generic PROM group The generic PROM will be administered every 2 months to all patients able to complete the instrument for a period of 12 months The PROMs results will be reported back to the patient and patients will be prompted to follow-up with their care providers if they provide a positive response to any of the symptoms assessed by the PROM The PROMs results will also be printed in a report form and added to the patients medical chart for review by clinicians The report will display each patients most recent results in comparison with their previous results and in comparison with the general dialysis population The PROMs report will be accompanied by treatment aids for all symptoms The proposed generic PROM is the EQ-5D-5L
3 The disease-specific and generic PROM group The disease-specific and generic PROMs will be administered every 2 months to all patients able to complete the instrument for a period of 12 months The PROMs results will be reported back to the patient and patients will be prompted to follow-up with their care providers if they provide a positive response to any of the symptoms assessed by the PROM The PROMs results will also be printed in a report form and added to the patients medical chart for review by clinicians The report will display each patients most recent results in comparison with their previous results and in comparison with the general dialysis population The PROMs report will be accompanied by treatment aids for all symptoms
4 The control or usual care group Patients in this group will follow usual care as provided in the dialysis unit and will not complete any PROM however all the treatment aids will be made available for clinicians in this study group during the trial period
Treatment aids
Treatment aids are assessment and treatment resources developed by expert clinicians for the management of certain symptoms and disorders Each renal program developed treatment aids specific to symptoms assessed by the ESAS-r Renal or IPOS-Renal eg itchiness restless leg syndrome nausea and the EQ-5D-5L eg pain anxietydepression Treatment aids are intended to support clinicians in the assessment and management of symptoms identified by these PROMs and will be made available for all clinicians at all study sites regardless of to which group they are randomized
Patient-facing materials are also provided to patients to help them better understand the reasons why their symptomproblem may have developed treatment options that might be considered as well as self-care activities they can undertake to alleviate the symptom or problem
Data Analysis
The primary analysis will assess change in the overall CAT score between study groups from baseline to 12 months using a linear mixed-effects model with the mean CAT for the dialysis unit at baseline as a fixed effect covariate and dialysis unit cluster as a random intercept Our primary analytic plan will be based on changes in mean CAT score at the unit level from baseline to 12 months The primary analysis will be based on all of the PROMs intervention groups combined compared to the control group as fixed effects As one of our secondary objectives assessing differences between specific and generic PROMs we will compare the individual interventions groups ie ESAS-r Renal IPOS alone EQ-5D-5D alone or the combination to the control group
We will also compare the proportion of patients reporting symptomsproblems on the ESAS-r Renal or IPOS-Renal and EQ-5D-5L and the management of such symptomsproblems Through clinical records we will link PROMs scores with the use of specific treatments as per the treatment aids We will obtain medication lists allied health referrals and chart notes to capture how symptoms are being treated Each renal program ie AKC-N AKC-S and ORN will be analyzed separately then we will use meta-analyses to analyze the data from each renal program
Economic Evaluation
A cost-effectiveness analysis will be employed of the different study groups compared to the usual care group as the reference case The incremental costs and incremental QALYs of the different interventions relative to the usual care group will be compared to calculate incremental cost per QALYs gained ratios Costs will be estimated for patients in the different study groups including treatments received by patients taking the perspective of the provincial health care system personnel costs for training and delivery of the PROMs assessments and subsequent health care utilization for patients in each of the study groups Health care utilization will be estimated through linkage with provincial administrative health care databases at the individual patient-level Costs associated with the provision of the intervention including training and nursing time will be estimated through observations for time and valued using standard staffing wage scales for the respective geographic regions QALYs will be calculated based on changes in the EQ-5D-5L index score using the Canadian preference weighting
Study Period
The study will be implemented over 48 months The first 6 months will involve the administrative approvals completing ethics requirements training of clinicians on the use of PROMs the following 18 months will involve trial implementation including assessments and interventions The last 12-24 months will involve compiling the data from all study sites data analysis and reporting of results
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None