Assessing the Feasibility of the Patient-Reported Outcomes Based Model for Community Care of Patients With Axial Spondyloarthritis Via a Type 1 Pilot Hybrid Effectiveness-Implementation Trial Using the RE-AIM Framework (PROMise-Pilot)

Singapore Health Services (SingHealth)

Status: Not yet enrolling

Conditions: Axial Spondyloarthritis

Treatments: Procedure: PROMise Model of Care

Study type: Interventional

Funder types: Other

Identifiers

NCT06968247

2024-4044

AM/HRT048/2025 (SRDUKAMR25H8) (Other Grant/Funding Number)

Details and patient eligibility

About

The goal of this clinical trial is to facilitate the implementation of PROMs-based care for patients with axial spondyloarthritis.

The main questions it aims to answer are:

• What are the barriers, facilitators and strategies to implement PROMs-based care?
• Can the PROMise algorithm successfully review and postpone appointments of eligible patients?
• How feasible is PROMs-based care in patients with axial spondyloarthritis?

Researchers will implement PROMs-Based care and see if PROMs-Based care is feasible and understand patient's opinions on PROMs-Based care implemented.

Participants will:

• Be randomized to either receive intervention (PROM-based care) or control (usual care). Randomisation means assigning you to one of two groups by chance, like tossing a coin or rolling dice.
• That receive PROMs-based care, will be sent PROMs questionnaires that ask them about their health conditions via SMS at a regular interval of 4 months.
• Have their appointments postponed by 4 months, if the PROMise algorithm with specific thresholds (with overview from the rheumatology care team) assess their condition as stable through their blood test results and PROMs questionnaire.
• Have a cap of 12 months between physician visits.

Enrollment: 70 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosed with axial spondyloarthritis according to the 2009 ASAS Classification Criteria of AxSpA
• has been receiving care in Singapore General Hospital for at least 6 months
• aged 21 years and above

Exclusion criteria

• Bath Ankylosing Spondylitis Disease Activity Index score of >4

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

PROMise Model of Care

Experimental group

Description:

Patients will go for blood tests and be sent PROMs questionnaire prior to planned clinic appointments. The results of the blood tests and questionnaire will be reviewed by a physician. The physician will postpone patient's appointment if the patient is assessed as stable. Any physician-endorsed medication will be sent via a medication delivery service.

Treatment:

Procedure: PROMise Model of Care

Control

No Intervention group

Description:

Usual care