Clinical trial NCT05379127: Comparing Use of Radiographs Versus Patient Empowerment (CURVE)
Official title: "The (Cost-)Effectiveness of a Patient Empowered Protocol Without Routine X-rays for Follow-up of Adolescent Idiopathic Scoliosis Patients; A Pragmatic Randomized Trial"
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Adolescent Idiopathic Scoliosis
Keywords: Scoliosis
Spine
Quality of Health Care
Cost-Benefit Analysis
Patient Participation
Radiology
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
name: Trialbureau Zorgevaluatie Nederland
name: Nederlandse Orthopaedische Vereniging
name: Vereniging Scoliose Patiënten
name: Dutch Adolescent Idiopathic Scoliosis (AIS) Consortium
First posted: 2022-05-18
Enrollment: 812
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A multicentre pragmatic randomized trial design with two arms, combined with a patient preference cohort for each arm (partially randomized preference trial; PRPT).

The PRPT consists of three separate randomized controlled trials (RCTs) including patients in the pre-treatment phase, post-brace phase or post-operative phase. Alongside the RCTs prospective preference cohorts are included for each treatment arm (patient empowered follow up \[PE-FU\] or standard follow up \[standard FU\]). In the preference cohorts all patients are monitored who are not willing (i.e. who have a preference for either the standard FU or PE-FU) to be randomized to either treatment arm, but who are still willing to participate in the study. By including preference cohorts the generalizability of study results is studied while the internal validity is assured.

* Half of participants (n=406) allocation: randomized (RCT)
* Half of participants (n=406) allocation: based on preference (preference cohorts)
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Objective: To evaluate the (cost-)effectiveness of a new patient-empowered follow up (FU) protocol in patients with Adolescent idiopathic Scoliosis (AIS) that is based on patient-reported outcome measures (PROMs), self-assessment tools and physical examination, which is compared to standard FU care by: 1) Effect evaluation, 2) Economic evaluation, 3) Implementation (process) evaluation.

Study design: A multicentre pragmatic randomized trial design with two arms, combined with a patient preference cohort for each arm (partially randomized preference trial \[PRPT\]).

Study population: A total of 812 AIS patients (age 10-18 years) treated by the Dutch AIS Consortium, representing the scoliosis treatment centres in the Netherlands, will be included.

Three subgroups of AIS patients are distinguished, which are monitored over two years:

1. Pre-treatment group: adolescents with curve 10-25° (n=132 per arm; total n=264)
2. Post-brace treatment group (n=122 per arm; total n=244)
3. Post-surgery group (n=152 per arm; total n=304)

Intervention: The new patient-empowered FU protocol (PE-FU) is based on PROMs, self-assessment tools and clinical assessment including physical examination. The protocol aims to detect curve progression or postoperative complications based on these patient-based and clinical parameters to substitute the need to obtain routine x-rays. X-rays will only be taken when progression or postoperative complications are suspected in the pre- and post-intervention groups based on predefined criteria. The standard FU protocol consists of routine full-spine radiographs and routine clinical evaluations.


Eligibility criteria: Inclusion Criteria:

* Patients with adolescent idiopathic scoliosis (AIS).
* Age: 10-18 years old.
* Patients scheduled for follow up in one of the participating centres.
* Understanding of the Dutch language.
* Signed informed consent.
* Biplanar (Posterior-Anterior \[PA\] and Lateral) full-spine x-rays within the last 3 months.

Specifically for the pre-treatment group:

* Girls aged ≤14 years (i.e. 10-14 years) and boys \<16 years (i.e. 10-15 years). These patients still have generally 2 years of remaining skeletal growth. Patients above this age with a curve below 25 degrees have a limited risk for progression
* Girls: pre-menarche up to 6 months post-menarche (to estimate end of growth)
* A primary coronal curve of 10-25 degree.

Specifically for the post-brace group:

* Patients aged 12-18 years
* Within 3 months after termination of brace treatment
* Minimum of 6 months of brace treatment

Specifically for the post-surgery group:

• Patients aged 12-18 years

Exclusion Criteria:

* Patients with juvenile or infantile idiopathic scoliosis with the diagnosis of onset under the age of 10.
* Patients who are undergoing brace treatment. These patients are not included because of the need to monitor brace therapy with radiographs.
* Patients who have undergone previous spinal surgery and are undergoing revision surgery.
* Skeletally mature patients.

Primary outcomes:
measure: The proportion of radiographs that has led to treatment consequences
timeFrame: 24 months
Secondary outcomes:
measure: The safety of the standard and the new protocol
timeFrame: for pre-treatment and the post-brace group at 6, 12,18 and 24 months and for the postsurgery group at 3,12 and 24 months
measure: The specificity, negative predictive value and positive predictive value of the standard and new patient empowered follow up protocol.
timeFrame: 24 months
measure: The change in readiation exposure
timeFrame: 24 months
measure: Participants perspective: Numeric pain rating scale [NPRS 0-10]
timeFrame: 24 Months
measure: Participants perspective: condition-specific quality of life [SRS-22r]
timeFrame: 24 months
measure: Participants perspective: health-related quality of life [EQ5D-5L]
timeFrame: 24 months
measure: Participants perspective: Scoliosis Appearance questionnaire short version [short SAQ])
timeFrame: 24 months
measure: Global perceirved effect [GPE]
timeFrame: 24 months
measure: educational status
timeFrame: 24 months
measure: Self-assessment tool: Scolioscoop
timeFrame: or pre-treatment and the post-brace group at 6, 12,18 and 24 months and for the postsurgery group at 3,12 and 24 months
measure: Cost-Benefit analysis: Patient outcome analysis using Quality-Adjusted Life Years (QALY).
timeFrame: 24 months
measure: Cost-Benefit analysis: Cost analysis
timeFrame: 24 months
Other outcomes:
Locations:
city: Zwolle
country: Netherlands
facility: Isala
state: Drenthe
city: Almere
country: Netherlands
facility: Flevo ziekenhuis
state: Flevoland
city: Arnhem
country: Netherlands
facility: Rijnstate
state: Gelderland
city: Harderwijk
country: Netherlands
facility: St Jansdal
state: Gelderland
city: Maastricht
country: Netherlands
facility: Maastricht UMC+
state: Limburg
city: Venlo
country: Netherlands
facility: Viecuri
state: Limburg
city: Boxmeer
country: Netherlands
facility: Sint Maartenskliniek
state: Noord-Brabant
city: Breda
country: Netherlands
facility: Amphia
state: Noord-Brabant
city: Tilburg
country: Netherlands
facility: ETZ Elisabeth
state: Noord-Brabant
city: Alkmaar
country: Netherlands
facility: Noordwestziekenhuis groep
state: Noord-Holland
city: Amsterdam
country: Netherlands
facility: OLVG
state: Noord-Holland
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
state: Noord-Holland
city: Haarlem
country: Netherlands
facility: Spaarne Gasthuis
state: Noord-Holland
city: Hoorn
country: Netherlands
facility: Dijklander
state: Noord-Holland
city: Amersfoort
country: Netherlands
facility: Meander
state: Utrecht
city: Den Haag
country: Netherlands
facility: Juliana kinderziekenhuis
state: Zuid-Holland
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer ziekenhuis
state: Zuid-Holland
city: Gouda
country: Netherlands
facility: Groene Hart ziekenhuis
state: Zuid-Holland
city: Leiden
country: Netherlands
facility: Leiden UMC
state: Zuid-holland
city: Rotterdam
country: Netherlands
facility: Erasmus MC
state: Zuid-Holland
city: Rotterdam
country: Netherlands
facility: Maasstad ziekenhuis
state: Zuid-Holland
city: Groningen
country: Netherlands
facility: UMC Groningen
city: Utrecht
country: Netherlands
facility: UMC Utrecht
Study officials:
affiliation: Radboud University Medical Center
name: Miranda L van Hooff, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Radboud University Medical Center
name: Marinus de Kleuver, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: