Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03099668 |
| Other study ID # |
2016/00848 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 17, 2016 |
| Est. completion date |
February 28, 2019 |
Study information
| Verified date |
March 2017 |
| Source |
National University Hospital, Singapore |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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 0.5 -0.7% 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 <2.6 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 supervision.17-20 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 ≤ 2.6, low
disease activity = DAS28 > 2.6 & ≤ 3.2) 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 0.722 with a standard deviation (SD) of 0.156. Allowing for an alpha
error of 5%, and 95% power to demonstrate a minimal clinically important improvement of
0.1 in the EQ-5D index, we would need a sample size of 128 for a 1:1 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 Student's t-test. Logistic regression will be used to calculate the
odds of achieving a minimal clinically important difference in QOL (as measured by a 0.1
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.
