Clinical trial NCT04249817: Keeping Stable Inflammatory Arthritis Patients in Their Communities With the Advanced Clinician Practitioner in Arthritis Care
Official title: Keeping Stable Inflammatory Arthritis Patients in Their Communities With the Advanced Clinician Practitioner in Arthritis Care (ACPAC)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Inflammatory Arthritis
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Canadian Initiative for Outcomes in Rheumatology Care
First posted: 2020-01-31
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: In Ontario, rheumatology services are in short supply. Many people with inflammatory arthritis (IA) are traveling long distances for care and face geographical/ financial challenges in so doing. Travel burden may be decreased and satisfaction with care improved by integrating existing health care resources. A few rheumatologists in Ontario have adopted a video conferencing (VC) model for follow-up of stable IA patients using the Ontario Telemedicine Network (OTN) with Extended Role Practitioners (ERPs) doing on-site assessments. Anecdotal evidence suggests this model benefits both patient and rheumatologist. We will determine how people with stable well-controlled IA, living more than 100 km round-trip from the rheumatology clinic, perceive quality of life before, during and after VC with ERP follow-up visits compared to usual care. Disease activity, functional status, medication adherence, patient satisfaction, and barriers to care will also be measured.

Detailed description: Rationale: To determine, using a mixed-methods design, the impact of a rheumatology appointment via video conferencing combined with on-site pre-assessment by an Advance Clinician Practioner in Arthritis Care (ACPAC)-trained ERP compared to usual in-clinic care during a one-year period of follow-up for a cohort of persons with stable, well-controlled inflammatory arthritis residing in areas of low rheumatology supply.

Research Questions: For people with stable IA residing in areas of low rheumatology supply, is it feasible to provide follow-up to people with stable, well-controlled IA using videoconferencing and an assessment by an extended role practitioner? Does VC with ERP pre-assessment change quality of life and barriers to care perceived by people with stable, well-controlled IA?

Methods: Mixed-methods design. Randomized controlled trial with 2 groups: VC with ERP (VC-ERP) and usual care (UC). Pre- and Post-trial Interviews. Study procedures will be as follows:

1. Pre-trial Interview - 15 minute telephone interview that will be audio taped. Will take place no more than one month before baseline study visit. Participant will be asked about experience traveling to rheumatologist and barriers to receiving care closer to home.
2. Baseline visit - This visit will be a regularly scheduled appointment with the participant's rheumatologist. The participant will complete a package of four questionnaires and the rheumatologist will assess disease activity.
3. Randomization - after completion of the baseline visit, participants will be randomized either to VC-ERP or UC.
4. Follow-up Visits - There will be three follow-up visits 6, 12, and 13 months after the baseline study visit. Participants assigned to UC will be seen by their rheumatologist at the clinic as usual for all visits. At each visit, the participant wil complete a package of four questionnaires and the rheumatologist will assess disease activity. Participants assigned to VC-ERP will have their first two follow-up visits at an OTN site. There they will complete a package of four questionnaires, meet with the ERP for an assessment of disease activity, then connect with their rheumatologist by video conference. The final visit will take place in the rheumatologist's office, where the patient will complete a package of four questionnaires and the rheumatologist will assess disease activity.
5. Post-trial interview - 15 minute telephone interview that will be audio taped. Will take place no more than one month after final follow-up visit. Participants assigned to UC, will be asked the same questions as first interview. Participants assigned to VC-ERP, will be asked questions about their experience with the therapist and OTN during the study period

Significance: From perspective of people with stable, well-controlled IA, we will understand the barriers they perceive when travelling for rheumatology care far from their communities and whether this new model of care might help to mitigate some of that burden. This model already exists in Ontario and it's important to understand its value to people with stable IA and determine whether it is good use of an extended role practitioner's time.

Eligibility criteria: Inclusion Criteria:

* adults ≥18 years
* clinical diagnosis of inflammatory arthritis (i.e. rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis)
* inflammatory arthritis that is in remission or a low disease state as determined using a valid measure prior to study start
* travel to clinic ≥100 km round-trip
* able to read and write English
* willing/able to provide informed consent
* OHIP coverage.

Exclusion Criteria:

* Inflammatory arthritis that is neither in remission or in a low disease state as determined using a valid measure prior to study start
* complex rheumatic disease (i.e. lupus, vasculitis)
* travel to clinic \<100 km round-trip
* children/youth \< 18 years
* unable to read and write English
* unwilling/unable to provide informed consent
* no OHIP coverage.

Primary outcomes:
measure: European Quality of Life Questionnaire with 5 Dimensions and 5 Levels (EQ5D-5L)
timeFrame: 13 months
Secondary outcomes:
measure: 9-item Visit Satisfaction Questionnaire (VSQ9)
timeFrame: 13 months
measure: 5-item Compliance Questionnaire Rheumatology
timeFrame: 13 months
measure: Health Assessment Questionnaire Disability Index (HAQ-DI)
timeFrame: 13 months
measure: 28-joint Disease Activity Score (DAS28- for rheumatoid arthritis)
timeFrame: 13 months
measure: Disease Activity for Psoriatic Arthritis (DAPSA)
timeFrame: 13 months
measure: Ankylosing Spondylitis Disease Activity Score (ASDAS)
timeFrame: 13 months
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Dr. Henry Averns
state: Ontario
city: Ottawa
country: Canada
facility: Dr. Ashley Sterrett
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
References: