Ignite Creation Date:
2024-05-06 @ 9:52 AM
Last Modification Date:
2024-10-26 @ 12:21 PM
Study NCT ID:
NCT03099668
Status:
COMPLETED
Last Update Posted:
2021-09-27
First Post:
2017-03-14
Brief Title:
Multidisciplinary Team Care in Rheumatoid Arthritis
Sponsor:
National University Hospital Singapore
Organization:
National University Hospital Singapore
Study Overview
Official Title:
The Multidisciplinary Team Truly Beneficial or Just the Flavour of the DayA Randomized Controlled Study to Study Outcomes From MDT Care in Rheumatoid Arthritis
Status:
COMPLETED
Status Verified Date:
2017-03
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:
None
Brief Summary:
A randomised study of multidisciplinary care MDT versus routine care in patients with rheumatoid arthritis RA Patients with RA are randomised either to a single visit to a one Stop Arthritis Clinic OSAC or to see their usual rheumatologists Data are collected at the baseline visit and again at subsequent clinic visits approximately 3 and 6 months Outcomes such as quality of life disease activity physical function disease specific knowledge coping and self efficacy are evaluated Assessment of comorbidities and preventative care cancer screening vaccinations cardiovascular risk assessment and optimisation are also assessed between the 2 arms
Detailed Description:
Hypotheses
1 Holistic review by a multidisciplinary team leads to improved outcomes such as improved disease activity physical function and quality of life QOL in patients with rheumatoid arthritis RA
2 These improved outcomes are likely mediated via improvements in medication adherence coping disease specific knowledge and improved self-efficacy
3 A One Stop Arthritis Clinic OSAC where patients are seen by a multidisciplinary team co-located in time and space is an effective solution to delivering multidisciplinary care
Specific aims Primary To determine whether a multidisciplinary review as compared to routine review by the treating rheumatologist leads to improved QOL as measured by the European Quality of Life-5 Dimension 3 Level EQ-5D index at 6 months in patients with RA with deemed stable disease activity
Secondary
1 To examine the effect of the multidisciplinary review as compared to routine rheumatologist review on RA disease activity measured using the disease activity score in 28 joints DAS28 pain measured using a 100mm visual analogue scale VAS and physical function measured using the modified Health Assessment Questionnaire mHAQ
2 To examine the effect of the multidisciplinary review as compared to routine rheumatologist review on several secondary measures including self-efficacy as measured using the Rheumatoid Arthritis Self Efficacy RASE Disease Specific Knowledge DSK using a Patient Knowledge Questionnaire PKC coping medication adherence using the Medication Adherence Report Scale MARS questionnaire pill counts and adherence proportion percentage and Patient Acceptable Symptom State PASS
3 To examine the effect of the multidisciplinary review as compared to routine rheumatologist review on patient experience
Background and Significance Burden of disease Rheumatoid arthritis RA is a chronic disease affecting approximately 05 -07 of the population and most common in working-age adults Inadequately treated RA is a leading cause of disability work loss and productivity loss due to irreversible joint damage in this relatively young group of the population in the prime of their productive work-life
Treat to Target T2T approach It has been clearly shown that a T2T approach in which therapy is escalated at regular intervals according to a pre-determined protocol and driven by consistent measurement of disease activity is superior to routine care in achieving remission and T2T is now standard of care A validated clinically sensitive composite disease activity measure the DAS28 is routinely used to measure disease activity and is a good predictor of disability DAS28 values of 26 are defined as remission About 50 of patients with early RA treated at the NUH rheumatology clinic achieve remission at 6 months unpublished data from the Singapore Early Arthritis Cohort
Multidisciplinary care The multidisciplinary team MDT concept is increasingly gaining popularity and traction and has been shown to improve outcomes in complex cancer care Several rheumatology societies and quality standards recommend that patients with RA should have access to a multidisciplinary team consisting at the minimum of a specialist nurse physiotherapist PT occupational therapist OT and podiatrist This is based on the results of several randomized controlled trials showing the benefit of occupational therapy on grip strength and physiotherapy on physical function and cardiovascular fitness in RA
The multidisciplinary One Stop Arthritis Clinic OSAC at the National University Hospital NUH Singapore An OSAC was set up in the specialist outpatient clinic SOC at the National University Hospital NUH in January 2016 with the aim of providing point of care access to MDT care Prior to the OSAC MDT care for RA patients was sporadic if at all Most patients were treated solely by the physician rheumatologist with referral to members of the MDT on an as needed basis and with appointments made on a different day at a different location Many patients declined the appointment due to the inconvenience of a separate visit and because they often perceived it as unnecessary
The OSAC team currently consists of 6 members namely a rheumatologist specialist nurse PT OT podiatrist and medical social worker Existing RA patients on follow up in NUH may be referred on the discretion of their rheumatologist to the OSAC Consenting patients are seen at the OSAC at the next review in lieu of their routine rheumatologist review Preliminary patient surveys have reported excellent patient experience As previously reported and as per our experience early success has come from careful planning of the logistics and organization of the clinic along with full and equal participation of all stake-holders who share the same egalitarian values thus avoiding conflict
However there have been some barriers to OSAC referral namely
i Cost As outpatient specialist consultation in Singapore is typically paid out of pocket with varying amount of government subsidization patients pay anywhere from twice to 3 times the consultation fee to attend the OSAC as compared to a routine rheumatologist review Therefore cost to the patient plays a major role in health care decisions
ii Poor uptake on the part of the patients A survey among our patients revealed that they have poor general awareness of allied health services This is possibly because Asian cultures traditionally tend to adopt a doctor-centred care delivery especially older patients who have experienced doctor-led consultations through most of their lives
Gaps in knowledge
i Although the individual benefits of OT and PT interventions have been clearly shown these have been mostly limited to intensive regimens involving multiple sessions with close supervision17-20 The recommended annual MDT review has never been shown in a controlled trial to improve outcomes The recommendation for annual MDT review is based mainly on observational studies and expert opinion
ii Most trials of OT and PT were performed prior to the treat to target T2T era It remains to be seen whether with current effective treatments an MDT review can further confer an additive benefit
Our study aims to fill some of these gaps by randomly assigning patients to either the OSAC or to routine rheumatologist care and comprehensively studying outcomes in both groups
Methods
Study design
Single centre randomised single-blind controlled trial
Recruitment
Patients will be recruited from the rheumatology outpatient clinic at NUH and informed consent will be taken for patients who are agreeable to participate Consented patients will be randomised via a random number sequence generated by the Stata statistical software and placed in sealed envelopes
Study visits
The study visits will be at 0 3 and 6 months timed to coincide with routine rheumatology clinic visits The baseline visit will be approximately 3 months after the randomisation visit Patients randomised to the intervention arm will be seen in the OSAC once followed by visits to the routine rheumatology clinic at month 3 and 6 Patients in the control arm will be seen at the routine rheumatology clinic on all visits 0 3 and 6 months
Data collection and follow-up Patients will be followed for 6 months from the baseline visit approximately 9 months from randomisation Data will be collected by self-administered questionnaires and face to face interviews administered by a trained research nurse to both the intervention and control arms and blood will be drawn for potential future research from all participants at the baseline visit Data on demographics disease severity seropositivity presence of erosions and disease activity using the DAS28 will be collected using a standard case report form CRF at baseline and at 6 months Joint counts will be performed by either ML PC AS or the research nurse at the baseline visit At the 3 month and 6-month visit joint count will be performed by an independent assessor a second research nurse who is blinded to the study arm A standardisation session will be conducted to improve inter-rater reliability between the various joint count assessors prior to commencement of the study Physical function will be assessed according to the mHAQ and HR-QOL will be measured using the EQ-5D instrument at baseline and at 6 months Pain score self-efficacy coping adherence and disease specific knowledge will be measured at baseline 3 months and 6 months using the VAS for pain RASE coping MARS and Hennel patient knowledge questionnaires PKC respectively and foot pain will be measured using the Manchester Foot Disability Index MFI In addition data on comorbidities exercise frequency smoking alcohol traditional medication use vaccination status and adherence to recommended cancer screening will be collected Laboratory tests and imaging will be done as part of the routine clinical care of patients with RA and relevant data will be abstracted from the electronic medical record Treatment changes at each visit will be recorded Resource utilisation in the form of number of clinic visits including separate visits to see allied healthcare professionals laboratory tests imaging prescriptions and procedures will be abstracted from the hospital billing database Utilisation of the specialist nurse helpline will be recorded Work status and number of days off work for both the patient and the caregiver if any will also be collected Data on patient experience will be abstracted from the hospital electronic patient experience survey which will be administered to all patients at the baseline visit
Primary outcome measure
European Quality of Life-5 Dimension 3 Level EQ-5D index at 6 months
Secondary outcome measures
i Proportion of patients in clinical remission or low RA disease activity measured using the disease activity score in 28 joints DAS28 remission DAS28 26 low disease activity DAS28 26 32 ii Pain measured using a 100mm visual analogue VAS scale iii Physical function measured using the modified Health Assessment Questionnaire mHAQ
iv Self-efficacy measured using the Rheumatoid Arthritis Self Efficacy RASE v Disease Specific Knowledge DSK using a Patient Knowledge Questionnaire PKC vi Coping vii Medication adherence using the MARS questionnaire and pill count to calculate medication adherence proportion percentage viii Patient experience using the standard hospital electronic patient experience survey e-PES ix Foot pain using the Manchester foot disability index MFI x Proportion of patients who achieve adherence to guidelines for vaccination xi Proportion of patients who achieve adherence to guidelines for cardiovascular risk management xii Proportion of patients who achieve adherence to guidelines for bone health optimisation xiii Proportion of patients who achieve adherence to guidelines for cancer screening xiv Utilisation of healthcare resources clinic visits laboratory imaging procedures prescriptions calls to the nurse helpline xv Days off work patient xvi Days off work caregiver xvii Hours per week in productive paid or unpaid work patient xviii Hours per week in productive paid or unpaid work caregiver
Sample size calculation and feasibility
Using baseline values from patients seen at OSAC the mean baseline EQ-5D index descriptive is 0722 with a standard deviation SD of 0156 Allowing for an alpha error of 5 and 95 power to demonstrate a minimal clinically important improvement of 01 in the EQ-5D index we would need a sample size of 128 for a 11 randomisation 64 in each arm After allowing for a 10 dropout rate we plan to recruit 140 patients 70 in each arm to this study
Approximately 60 patients with RA are seen weekly at NUH The OSAC runs once a week and has a capacity of 6 patients per clinic session If we can randomize 8 patients per week of which half would be randomized to the intervention arm to be seen at OSAC we would be able to recruit an adequate number of subjects in about 18 weeks The consultation fee for the study participants baseline visit OSAC or routine rheumatology review would be paid for through the grant funding thus providing an incentive for patients to participate and also overcoming the cost barrier for referral to OSAC Follow up for all patients would be completed about 9 months after the last patient is recruited thus the study can be completed in about 14 months
Statistical analysis All analysis will be done using Stata statistical software The mean EQ-5D index at 6 months of patients in the intervention and control groups will be compared using the Students t-test Logistic regression will be used to calculate the odds of achieving a minimal clinically important difference in QOL as measured by a 01 increase in the EQ-5D index between the intervention vs the control group while controlling for confounders such as age gender disease duration disease severity seropositivity presence of erosions at baseline disease activity DAS28 and mHAQ at baseline We will further determine whether self-efficacy coping adherence and DSK can improve prediction of QOL when they are added to the regression model
Strengths and limitations This is a randomized controlled study thus controlling for bias in terms of allocation of patients to MDT care Disease activity outcomes are blinded as joint counts will be performed by a blinded assessor The case report form is designed to be comprehensive such that all possible outcomes of importance will be collected Though cost-effectiveness is not one of the outcomes to be studied the data collected are adequate to do a cost -effectiveness analysis if necessary
The main limitation of the study is that the patients cannot be blinded to the intervention MDT care This is inherent to the nature of the intervention In addition outcome assessors cannot be blinded to several of the outcomes as they are determined from patient reported questionnaires thus may be biased in favour of MDT care Radiographic outcomes in terms of joint space narrowing and erosions are not collected as part of this study as typically changes in these need time 1 year and are relatively insensitive to subtle interventions such as ours However increasingly outcomes important to the patient are thought to be the most preferred outcomes to study and have been shown to be predictive of radiographic damage
1 Holistic review by a multidisciplinary team leads to improved outcomes such as improved disease activity physical function and quality of life QOL in patients with rheumatoid arthritis RA
2 These improved outcomes are likely mediated via improvements in medication adherence coping disease specific knowledge and improved self-efficacy
3 A One Stop Arthritis Clinic OSAC where patients are seen by a multidisciplinary team co-located in time and space is an effective solution to delivering multidisciplinary care
Specific aims Primary To determine whether a multidisciplinary review as compared to routine review by the treating rheumatologist leads to improved QOL as measured by the European Quality of Life-5 Dimension 3 Level EQ-5D index at 6 months in patients with RA with deemed stable disease activity
Secondary
1 To examine the effect of the multidisciplinary review as compared to routine rheumatologist review on RA disease activity measured using the disease activity score in 28 joints DAS28 pain measured using a 100mm visual analogue scale VAS and physical function measured using the modified Health Assessment Questionnaire mHAQ
2 To examine the effect of the multidisciplinary review as compared to routine rheumatologist review on several secondary measures including self-efficacy as measured using the Rheumatoid Arthritis Self Efficacy RASE Disease Specific Knowledge DSK using a Patient Knowledge Questionnaire PKC coping medication adherence using the Medication Adherence Report Scale MARS questionnaire pill counts and adherence proportion percentage and Patient Acceptable Symptom State PASS
3 To examine the effect of the multidisciplinary review as compared to routine rheumatologist review on patient experience
Background and Significance Burden of disease Rheumatoid arthritis RA is a chronic disease affecting approximately 05 -07 of the population and most common in working-age adults Inadequately treated RA is a leading cause of disability work loss and productivity loss due to irreversible joint damage in this relatively young group of the population in the prime of their productive work-life
Treat to Target T2T approach It has been clearly shown that a T2T approach in which therapy is escalated at regular intervals according to a pre-determined protocol and driven by consistent measurement of disease activity is superior to routine care in achieving remission and T2T is now standard of care A validated clinically sensitive composite disease activity measure the DAS28 is routinely used to measure disease activity and is a good predictor of disability DAS28 values of 26 are defined as remission About 50 of patients with early RA treated at the NUH rheumatology clinic achieve remission at 6 months unpublished data from the Singapore Early Arthritis Cohort
Multidisciplinary care The multidisciplinary team MDT concept is increasingly gaining popularity and traction and has been shown to improve outcomes in complex cancer care Several rheumatology societies and quality standards recommend that patients with RA should have access to a multidisciplinary team consisting at the minimum of a specialist nurse physiotherapist PT occupational therapist OT and podiatrist This is based on the results of several randomized controlled trials showing the benefit of occupational therapy on grip strength and physiotherapy on physical function and cardiovascular fitness in RA
The multidisciplinary One Stop Arthritis Clinic OSAC at the National University Hospital NUH Singapore An OSAC was set up in the specialist outpatient clinic SOC at the National University Hospital NUH in January 2016 with the aim of providing point of care access to MDT care Prior to the OSAC MDT care for RA patients was sporadic if at all Most patients were treated solely by the physician rheumatologist with referral to members of the MDT on an as needed basis and with appointments made on a different day at a different location Many patients declined the appointment due to the inconvenience of a separate visit and because they often perceived it as unnecessary
The OSAC team currently consists of 6 members namely a rheumatologist specialist nurse PT OT podiatrist and medical social worker Existing RA patients on follow up in NUH may be referred on the discretion of their rheumatologist to the OSAC Consenting patients are seen at the OSAC at the next review in lieu of their routine rheumatologist review Preliminary patient surveys have reported excellent patient experience As previously reported and as per our experience early success has come from careful planning of the logistics and organization of the clinic along with full and equal participation of all stake-holders who share the same egalitarian values thus avoiding conflict
However there have been some barriers to OSAC referral namely
i Cost As outpatient specialist consultation in Singapore is typically paid out of pocket with varying amount of government subsidization patients pay anywhere from twice to 3 times the consultation fee to attend the OSAC as compared to a routine rheumatologist review Therefore cost to the patient plays a major role in health care decisions
ii Poor uptake on the part of the patients A survey among our patients revealed that they have poor general awareness of allied health services This is possibly because Asian cultures traditionally tend to adopt a doctor-centred care delivery especially older patients who have experienced doctor-led consultations through most of their lives
Gaps in knowledge
i Although the individual benefits of OT and PT interventions have been clearly shown these have been mostly limited to intensive regimens involving multiple sessions with close supervision17-20 The recommended annual MDT review has never been shown in a controlled trial to improve outcomes The recommendation for annual MDT review is based mainly on observational studies and expert opinion
ii Most trials of OT and PT were performed prior to the treat to target T2T era It remains to be seen whether with current effective treatments an MDT review can further confer an additive benefit
Our study aims to fill some of these gaps by randomly assigning patients to either the OSAC or to routine rheumatologist care and comprehensively studying outcomes in both groups
Methods
Study design
Single centre randomised single-blind controlled trial
Recruitment
Patients will be recruited from the rheumatology outpatient clinic at NUH and informed consent will be taken for patients who are agreeable to participate Consented patients will be randomised via a random number sequence generated by the Stata statistical software and placed in sealed envelopes
Study visits
The study visits will be at 0 3 and 6 months timed to coincide with routine rheumatology clinic visits The baseline visit will be approximately 3 months after the randomisation visit Patients randomised to the intervention arm will be seen in the OSAC once followed by visits to the routine rheumatology clinic at month 3 and 6 Patients in the control arm will be seen at the routine rheumatology clinic on all visits 0 3 and 6 months
Data collection and follow-up Patients will be followed for 6 months from the baseline visit approximately 9 months from randomisation Data will be collected by self-administered questionnaires and face to face interviews administered by a trained research nurse to both the intervention and control arms and blood will be drawn for potential future research from all participants at the baseline visit Data on demographics disease severity seropositivity presence of erosions and disease activity using the DAS28 will be collected using a standard case report form CRF at baseline and at 6 months Joint counts will be performed by either ML PC AS or the research nurse at the baseline visit At the 3 month and 6-month visit joint count will be performed by an independent assessor a second research nurse who is blinded to the study arm A standardisation session will be conducted to improve inter-rater reliability between the various joint count assessors prior to commencement of the study Physical function will be assessed according to the mHAQ and HR-QOL will be measured using the EQ-5D instrument at baseline and at 6 months Pain score self-efficacy coping adherence and disease specific knowledge will be measured at baseline 3 months and 6 months using the VAS for pain RASE coping MARS and Hennel patient knowledge questionnaires PKC respectively and foot pain will be measured using the Manchester Foot Disability Index MFI In addition data on comorbidities exercise frequency smoking alcohol traditional medication use vaccination status and adherence to recommended cancer screening will be collected Laboratory tests and imaging will be done as part of the routine clinical care of patients with RA and relevant data will be abstracted from the electronic medical record Treatment changes at each visit will be recorded Resource utilisation in the form of number of clinic visits including separate visits to see allied healthcare professionals laboratory tests imaging prescriptions and procedures will be abstracted from the hospital billing database Utilisation of the specialist nurse helpline will be recorded Work status and number of days off work for both the patient and the caregiver if any will also be collected Data on patient experience will be abstracted from the hospital electronic patient experience survey which will be administered to all patients at the baseline visit
Primary outcome measure
European Quality of Life-5 Dimension 3 Level EQ-5D index at 6 months
Secondary outcome measures
i Proportion of patients in clinical remission or low RA disease activity measured using the disease activity score in 28 joints DAS28 remission DAS28 26 low disease activity DAS28 26 32 ii Pain measured using a 100mm visual analogue VAS scale iii Physical function measured using the modified Health Assessment Questionnaire mHAQ
iv Self-efficacy measured using the Rheumatoid Arthritis Self Efficacy RASE v Disease Specific Knowledge DSK using a Patient Knowledge Questionnaire PKC vi Coping vii Medication adherence using the MARS questionnaire and pill count to calculate medication adherence proportion percentage viii Patient experience using the standard hospital electronic patient experience survey e-PES ix Foot pain using the Manchester foot disability index MFI x Proportion of patients who achieve adherence to guidelines for vaccination xi Proportion of patients who achieve adherence to guidelines for cardiovascular risk management xii Proportion of patients who achieve adherence to guidelines for bone health optimisation xiii Proportion of patients who achieve adherence to guidelines for cancer screening xiv Utilisation of healthcare resources clinic visits laboratory imaging procedures prescriptions calls to the nurse helpline xv Days off work patient xvi Days off work caregiver xvii Hours per week in productive paid or unpaid work patient xviii Hours per week in productive paid or unpaid work caregiver
Sample size calculation and feasibility
Using baseline values from patients seen at OSAC the mean baseline EQ-5D index descriptive is 0722 with a standard deviation SD of 0156 Allowing for an alpha error of 5 and 95 power to demonstrate a minimal clinically important improvement of 01 in the EQ-5D index we would need a sample size of 128 for a 11 randomisation 64 in each arm After allowing for a 10 dropout rate we plan to recruit 140 patients 70 in each arm to this study
Approximately 60 patients with RA are seen weekly at NUH The OSAC runs once a week and has a capacity of 6 patients per clinic session If we can randomize 8 patients per week of which half would be randomized to the intervention arm to be seen at OSAC we would be able to recruit an adequate number of subjects in about 18 weeks The consultation fee for the study participants baseline visit OSAC or routine rheumatology review would be paid for through the grant funding thus providing an incentive for patients to participate and also overcoming the cost barrier for referral to OSAC Follow up for all patients would be completed about 9 months after the last patient is recruited thus the study can be completed in about 14 months
Statistical analysis All analysis will be done using Stata statistical software The mean EQ-5D index at 6 months of patients in the intervention and control groups will be compared using the Students t-test Logistic regression will be used to calculate the odds of achieving a minimal clinically important difference in QOL as measured by a 01 increase in the EQ-5D index between the intervention vs the control group while controlling for confounders such as age gender disease duration disease severity seropositivity presence of erosions at baseline disease activity DAS28 and mHAQ at baseline We will further determine whether self-efficacy coping adherence and DSK can improve prediction of QOL when they are added to the regression model
Strengths and limitations This is a randomized controlled study thus controlling for bias in terms of allocation of patients to MDT care Disease activity outcomes are blinded as joint counts will be performed by a blinded assessor The case report form is designed to be comprehensive such that all possible outcomes of importance will be collected Though cost-effectiveness is not one of the outcomes to be studied the data collected are adequate to do a cost -effectiveness analysis if necessary
The main limitation of the study is that the patients cannot be blinded to the intervention MDT care This is inherent to the nature of the intervention In addition outcome assessors cannot be blinded to several of the outcomes as they are determined from patient reported questionnaires thus may be biased in favour of MDT care Radiographic outcomes in terms of joint space narrowing and erosions are not collected as part of this study as typically changes in these need time 1 year and are relatively insensitive to subtle interventions such as ours However increasingly outcomes important to the patient are thought to be the most preferred outcomes to study and have been shown to be predictive of radiographic damage
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