Clinical trial NCT07022756: Personalized Outreach for Equitable Treatment in Rheumatology
Official title: Personalized Outreach for Equitable Treatment in Rheumatology: A Randomized Controlled Trial of Patient Outreach and Honoraria in an Inner City Rheumatology Clinic
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Rheumatic Diseases
Inflammatory Arthritis
Rheumatoid Arthritis (RA)
Psoriatic Arthritis (PsA)
Connective Tissue Disease
Keywords: Rheumatology
Inflammatory Arthritis
Inner City Health
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Mary Pack Arthritis Center
First posted: 2025-06-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The primary goal of this study is to determine whether providing patient honoraria and/or outreach services can improve the attendance rate of appointments at an inner city rheumatology clinic in Vancouver, British Columbia.

The main question it aims to answer are:

* Does providing a financial honorarium ($20 for each follow-up appointment with completed bloodwork) improve attendance rate at an inner city rheumatology clinic?
* Does providing a personalized outreach service for rheumatic diseases improve attendance rate at an inner city rheumatology clinic?

The researchers will compare providing patient honoraria to providing both honoraria and outreach services, and compare each of these to the regular appointment schedule without honoraria or outreach.

Participants will:

* Undergo randomization to receive honoraria or honoraria and outreach services together
* Complete surveys about their health and understanding of their rheumatic disease at baseline, 3-month, and 6-month intervals
* Visit the clinic every month for check-ups and monitoring bloodwork if they are started on immunosuppressants for their condition

Detailed description: Our study aims to enhance the existing twice-monthly rheumatology clinic at the Pender Community Health Centre with a rheumatology-specific outreach service for patients with inflammatory arthritis. This service will be provided by a rheumatology subspecialty trainee under the supervision of two attending rheumatologists. This will consist of biweekly phone calls, text messages, or home visits as per the patient's preference, at times flexible to patient needs. This will be in addition to monthly in-person assessment and bloodwork monitoring with adjustment as clinically indicated by their treating rheumatologist. Outreach services will include management of medications and side effects, proactive screening for infections, coordination of rheumatologic and general healthcare with their Primary Care Provider, social service navigation, and reminders for appointments and lab monitoring. All participants will be provided with a $20 honorarium for each in-person assessment they attend as part of the study.

We will aim to enroll 20 participants between July 2025 and October 2025. Participants will be randomized to either honorarium with outreach or honorarium alone arms in a 1:1 fashion, stratified by housing status (unhoused and emergency sheltered in one strata, provisionally accommodated and stably housed in the second strata).

All enrolled participants will receive a $20 honorarium for each in-person assessment with completed monitoring bloodwork as requested by the treating rheumatologist. The program will last 6 months for each patient from time of enrolment, or until a patient chooses to leave the program, whichever is sooner. At baseline, participants will complete two surveys: one on their general health status, and one specific to their rheumatic disease. At the 3-month and 6-month visits, these surveys will be repeated, and a semi-structured interview will be completed to obtain feedback on the pilot program.

The outcomes of this study will inform how we can better care for those who live with inflammatory arthritis and are also marginalized by extreme poverty and/or housing instability. We plan on disseminating and discussing results with our participants, community members, inner city physicians, and rheumatologists. If there are specific positive themes or outcomes from the study, we will advocate for additional resources to permit long-term implementation and further study to confirm results, make further improvements to our program, and improve generalizability.

Eligibility criteria: Inclusion Criteria:

* Have a diagnosis of inflammatory arthritis secondary to an autoimmune rheumatic disease
* Be attached to one of the Vancouver Coastal Health Community Health Centres for primary care
* Be willing to attend in-person appointments at Pender Community Health Centre
* Be at least 18 years of age and capable of consenting to participation
* Be able to receive medical care in English.

Exclusion Criteria:

* Have cognitive impairment or an untreated psychiatric condition that would severely impair ability to engage with outreach or treatment
* Have no reasonably reliable method of contact (phone, email, social media, etc.)

Primary outcomes:
measure: Attendance at in-person follow-up appointments
timeFrame: Cumulative over 6 months
Secondary outcomes:
measure: Clinical Disease Activity Index (CDAI)
timeFrame: 3-month and 6-month intervals.
measure: Patient Qualitative Feedback
timeFrame: 3-month and 6-month intervals.
measure: Patient Reported Understanding of Disease and Medications
timeFrame: 3-month and 6-month intervals.
measure: Patient reported pain related to arthritis
timeFrame: 3-month and 6-month intervals
Other outcomes:
measure: Tender Joint Count
timeFrame: At the 6-month interval.
measure: Swollen joint count
timeFrame: At the 6-month interval.
measure: Number of Emergency Department Visits During the Study Period
timeFrame: Cumulative over 6 months
measure: Number of Days in Hospital During the Study Period
timeFrame: Cumulative over 6 months
measure: Serious Infections
timeFrame: Cumulative over 6 months
Locations:
city: Vancouver
country: Canada
facility: Pender Community Health Centre
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Brent R Ohata, MD
role: PRINCIPAL_INVESTIGATOR
References: