Keeping Stable Inflammatory Arthritis Patients in Their Communities With the Advanced Clinician Practitioner in Arthritis Care

Inflammatory Arthritis Clinical Trial

— ACPAC  

Official title:

Keeping Stable Inflammatory Arthritis Patients in Their Communities With the Advanced Clinician Practitioner in Arthritis Care (ACPAC)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04249817
• Other study ID #: 238-2019
• Status: Terminated
• Phase: N/A
• Start date: September 5, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: July 2021
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Inflammatory Arthritis

Intervention

Other:
• Video Conferencing with Exteneded Role Practitioner (VC-ERP)
Participant goes to Ontario Telemedicine site for follow-up. At site, participant will get a physical assessment by an extended role practitioner and then will connect to their rheumatologist by videoconferencing for completion of follow-up.

Locations

Country	Name	City	State
Canada	Dr. Henry Averns	Kingston	Ontario
Canada	Dr. Ashley Sterrett	Ottawa	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	Canadian Initiative for Outcomes in Rheumatology Care

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	European Quality of Life Questionnaire with 5 Dimensions and 5 Levels (EQ5D-5L)	Overall health: Rated in five dimensions as follows: Mobility from 1 (no problems) to 5 (unable to); Self-care from 1 (no problems) to 5 (unable to); Usual Activities from 1 (no problems) to 5 unable to); Pain/Discomfort from 1 (no pain) to 5 (extreme pain); Anxiety/Depression from 1 (not anxious/depressed) to 5 (extremely anxious/depressed); Rated on a visual analog scale from 0 (worst health you can imagine) to 100 (best health you can imagine).	13 months
Secondary	9-item Visit Satisfaction Questionnaire (VSQ9)	9 items on satisfaction with visit rated on a scale of 1 (poor) to 5 (excellent).	13 months
Secondary	5-item Compliance Questionnaire Rheumatology	5 items on medication adherence rated on a scale of 1(strongly disagree) to 4 (strongly agree). Higher ratings indicate better adherence.	13 months
Secondary	Health Assessment Questionnaire Disability Index (HAQ-DI)	Disability is evaluated by: rating 2 to 3 items in 8 dimensions (dressing & grooming, arising, eating, walking, hygiene, reach, grip, activities) from 0 (without any difficulty) to 3 (unable to do); indicating which aids, devices and assistance are needed; Rating ability to carry out daily activities from 0 (completely) to 4 (not at all); Rating pain from 0 (no pain) to 100 (severe pain); rating overall health from 0 (very well) to 100 (very poor)	13 months
Secondary	28-joint Disease Activity Score (DAS28- for rheumatoid arthritis)	Disease activity measure for IA patients with Rheumatoid Arthritis. Calculated with an algorithm using the following four items: Total number of swollen joints (out of a selected 28 joints specific to the disease); Total number of tender joints (out of a selected 28 joints specific to the disease); Global Health rated on a visual analog scale from 0 (well) to 100 (poor); Erythrocyte sedimentation rate (mm/hr) or C-reactive protein (mg/dl)	13 months
Secondary	Disease Activity for Psoriatic Arthritis (DAPSA)	Disease Activity measure for IA patients with Psoriatic Arthritis Calculated as the sum of the following five items: Total number of swollen joints (out of a selected 66 joints specific to the disease); Total number of tender joints (out of a selected 66 joints specific to the disease); C-reactive protein (mg/dl); Disease activity rated on a visual analog scale from 0 (not active) to 10 (very active); Joint pain rated on a visual analog scale from 0 (none) to 10 (very severe)	13 months
Secondary	Ankylosing Spondylitis Disease Activity Score (ASDAS)	Disease activity measure for IA patients with Ankylosing Spondylitis. Calculated with an algorithm using the following five items: Back pain rated on a visual analog scale from 0 (none) to 10 (very severe); Peripheral pain/swelling rated on a visual analog scale from 0 (none) to 10 (very severe); Duration of morning stiffness rated on a visual analog scale from 0 (0 hrs) to 10 (2 hrs); Global health rated on a visual analog scale from 0 (well) to 10 (poor); Erythrocyte sedimentation rate (mm/hr) or C-reactive protein (mg/dl)	13 months