Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04332055 |
| Other study ID # |
2015-141-ERVIN |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 30, 2020 |
| Est. completion date |
December 31, 2022 |
Study information
| Verified date |
March 2022 |
| Source |
Northern Orthopaedic Division, Denmark |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The randomised clinical trial investigates the effect of using a clinical decision support
system (CDSS) aiming to provide the patients and surgeons with greater transparency
concerning the obtainable changes in function and health related quality of life (HRQoL) when
patients are to decide if they should undergo hip- or knee replacement surgery.
Description:
Osteoarthritis (OA) affects 20 % of the adult population in Denmark, and the economic burden
to society is estimated to DKK 4.6 billion per year1,2. Symptoms related to evolving OA can
usually be effectively managed, and treatment may slow the progression of the disease,
however, approximately 10,000 and 8,000 hip and knee replacements, respectively, are
performed each year in Denmark due to end-stage OA3-5.
The Danish clinical guidelines for the treatment of OA are compliant with international
guidelines and recommend non-pharmacological and complementary pharmacological treatment as
first-line treatment modalities3. When non-surgical treatment options become insufficient to
relieve pain and improve function, referral to an orthopaedic surgeon for evaluation of
whether the patient is eligible for surgery is advised. However, the guidelines do not
provide clear guidance on which non-pharmacological treatment(s) or when surgery will be most
beneficial for the individual patient, and consequently under- or over-utilisation of
healthcare services may occur 3,6 Furthermore, matching patient's expectations with the
achievable changes in function level after surgery can be challenging, which might be a
contributor to the 20 % proportion of orthopaedic patients that are unsatisfied7,8. It
highlights the importance of an enhanced basis for shared decision-making between surgeon and
patient, as-well-as bringing focus on each patient's wishes and needs, as these are
individual and thus might not be representative of the general population.
Patient-centred care acknowledges the importance of individual values and preferences and
empowers patients to take an active part in decisions concerning their health and treatment
pathway9. It moves beyond the paternalistic approach to treatment, substituting in its place
a partnership-like relation between patient and clinician9,10.
Patient reported outcomes (PRO) have been suggested as a means to improve patient involvement
and patient value through a shift in the perception of what constitute "good outcomes", and
PRO has on several occasions been shown to be important predictors of clinical outcomes11-13.
PRO measures are available for most clinical areas, but implementing a more patient-centred
health-care system through PRO is still challenged by i.a. information asymmetry, and lack of
aligning expectations12,14.
Denmark has a long tradition of collecting patient-specific data in the health care sector.
The challenge today is that the knowledge embedded in these patient-specific health-care data
is not utilized to its full potential, neither within nor between the primary and the
secondary health care sectors, and, currently, there is a lack of knowledge on how to
incorporate data and ePRO (electronic Patient Reported Outcome) to support patients in
clinical decision-making.
ERVIN is state of the art for IT systems, which uses artificial intelligence (AI) and
real-time patient-specific PRO data to support patients and doctors in clinical
decision-making. The system is designed for surgical OA treatment of knee and hip
replacement, and can be used to predict outcome scores for the actual choice OA patients face
in the patient trajectory; to choose surgery or not.
The clinical and health economic rationale for this study is three-folded: one, to explore if
the use of real-time, and predicted ePRO in clinical decision-making impacts patients health;
two, to investigate if the use of ERVIN enhances shared decision-making in clinical practice,
and third, to investigate if the use of ERVIN is cost-effective.
This study aims to establish the health-related effect and cost-effectiveness of using ERVIN
in clinical consultation when the OA patient is referred from the general practitioner to
orthopaedic clinic to decide if the patient should have a total hip- or knee replacement.
The increased focus and endorsement of patient-centred care and increased patient involvement
in clinical decisions in the Danish health care system is a result of political decisions.
The health-related consequences of practising patient centred-care, where patients are more
empowered to make decisions are unknown. Furthermore, there is a lack of knowledge of how,
and under which conditions, CDDS solutions, like ERVIN, create value in health15,16.
Objective The main objective of this randomised controlled trial is to investigate the health
related effects of using ERVIN as a CDSS during consultations, measured by the delta value in
Oxford Hip Score (OHS) and Oxford Knee Score (OKS) pre- and post-treatment modalities.
Secondary outcomes include investigations of cost-effectiveness and the degree of shared
decision-making.
Hypothesis The hypothesis is that the application of ERVIN in consultations, compared with
the conventional approach in surgical decision-making concerning hip- or knee replacement, do
not lead to any change in OHS or OKS between baseline and at 1-year follow-up.
Methods
Trial design The implementation of ERVIN to enhance patient-centeredness is based on a shift
in the government policy for the Danish Health Care system. The new strategy requires
increased use of digital solutions in health care and improvement of patient involvement in
decisions making17,18. However, the impact on patients' health, when patient involvement is
increased by the use of a digital solution like ERVIN is unknown, and for that reason, a
non-inferiority design is chosen in the trial.
The trial is a single centre, randomised, controlled trial, which includes two parallel
groups. The intervention- and the control group will both have the conventional approach
available during the consultation, which includes: A 25-minute consultation in which the
surgeon evaluates the need/no need for surgery based on; the patients' subjective description
of pains and disabilities, and general health. If available, a description of the
aforementioned evaluation criteria from the referring general practitioner will be included
in addition to the orthopaedic surgeons' evaluation of relevant x-rays and possible MRI or
CT-scans and a physical examination.
The intervention group will have the results from ERVIN as an interface with a graphical
presentation of real-time and predicted outcome scores and risk scores.
