Multidisciplinary Approach for Treat To Target In Rheumatoid Arthritis

One hundred and fifty Hispanic RA patients will be recruited for this proposal and randomized
1:1 to Intervention and Control arms for a period of 12 months. Participants will be
recruited from the Adult Rheumatology clinic at Harbor-UCLA. Patients who meet enrollment
criteria based on review of electronic medical records will be provided information about the
study during regular outpatient visits. Interested patients will be formally screened.

After providing informed consent, eligible patients will complete baseline measures and be
randomly assigned into Intervention and Control arms using a minimization protocol, with a
goal of enrolling 150 patients (75 in each group). All participants will attend rheumatology
clinic appointments scheduled quarterly for the 12-month trial duration, during which they
will also complete assessments (at 3, 6, 9, and 12 months post-baseline; see description of
outcomes for full detail). Between appointments with their assigned rheumatologist,
participants will regularly self-monitor their RA symptoms using the Routine Assessment
Patient Index Data (RAPID3) questionnaire administered via an interactive voice response
(IVR) phone survey weekly for 12 months.

At baseline, participants will be enrolled in the IVR system and the study coordinator will
provide a detailed orientation to the automated phone survey as well as written instructions
including the toll-free phone number, and a unique study personal identification number.
Participants will each select the day and the hours between which they will complete the
weekly phone survey. After entering their unique study personal identification number,
participants will complete the 12-item RAPID3 questionnaire, entering responses using their
telephone keypad. If they do not call in and complete the survey on their preselected day
during the specified time frame, they will receive a reminder call an hour later from the
time by which they would have been expected to call in.

At the baseline visit, all participants will receive a rheumatoid arthritis educational
booklet that provides general disease state information, including an overview of RA (e.g.,
its causes, associated symptoms, how it is diagnosed), RA medications and other treatment
options, pain management, physical activity, nutrition and diet. The material is written at a
sixth grade reading level and incorporates simple figures and graphics to enhance readability
and promote participant comprehension and engagement. The study coordinator will also give
each participant a pedometer and provide instruction for its use. Participants will be
encouraged to wear the pedometer during waking hours and record their total daily steps in a
log, along with the type and duration of other activities like swimming that pedometers do
not capture.

Control arm participants will receive standard of care treatment from their assigned
rheumatologists. Pharmacotherapy will be monitored and adjusted by the treating
rheumatologist in accordance with evidence-based clinical practice guidelines. Physical
Therapy referrals and evaluations will occur as indicated for addressing specific problems.
Referral for psychological services will be provided when patients endorse symptoms of
depression in response to a verbal screen or participant-initiated discussion. Control arm
participants will also have regularly scheduled 20-30 minute monthly phone calls with the
healthcare coordinator. While questions and concerns specifically raised by participants
regarding study procedure and the content of the educational booklet will be addressed, these
phone calls are primarily designed to control for potential benefit participants may derive
from time on the phone with a health professional. The healthcare coordinator will engage
participants using a non-directive approach based on use of active listening, reflective
statements and similar techniques.

Intervention arm participants will receive integrated treatment from a multidisciplinary
healthcare team during the routine clinic visits. In addition to appointments with their
assigned rheumatologist, a physical therapist will assess participants' physical functioning,
provide joint protection guidance and assist patients in making physical fitness plans based
on their own goals and tailored to patients' abilities and physical limitations. Interim
individual physical therapy sessions will be scheduled in accordance with the physical
therapist's recommendations. Additionally, if during any routine clinic appointment a
participant scores 10 or higher on the PHQ-9 and/or endorses symptoms of depression in
response to a verbal screen, they will receive a same-day, in-clinic psychological
evaluation. The psychologist will assess whether patient symptoms meet diagnostic criteria
for a depressive disorder and, when clinically indicated, provide recommendations for
treatment. Follow-up treatment appointments will be scheduled with patients by the
psychologist.

In addition to regularly scheduled rheumatology appointments, if between-visit patient
self-monitoring reports indicate an increase in RA disease activity (flare), participants in
the intervention arm will be scheduled for an ad hoc evaluation with their assigned
rheumatologist. Specifically, if participants' RAPID3 surveys show two consecutive
week-to-week score increases and the cumulative two week RAPID3 increase is greater than 1.2
points, they will be contacted by the study coordinator that day (or following morning if
surveys are completed after regular office hours) to schedule an ad-hoc appointment with
their rheumatologist within 2 working days. During routine and ad hoc intervention arm
patient visits, while clinical practice guidelines will inform rheumatologist monitoring of
pharmacotherapy, the treatment planning process will be grounded in a shared decision making
framework.

Participants in the intervention arm will further be provided a one-on-one tailored education
session with a trained rheumatology nurse that will encompass a general disease state
education, incorporating pictograms and short slide presentations, an introduction of the
treat to target concept, overview of treatment options, and discussion of patient priorities
and identification of personally salient long-term treatment-related goals. During regularly
scheduled 20-30 minute monthly follow-up phone calls with each intervention arm participant,
the rheumatology nurse will address individual educational needs, answer questions and
reinforce learning. Goal setting, planning and review will also be conducted. Specifically,
participants will select goals to be achieved in the upcoming month and be assisted in
developing specific action plans. The rheumatology nurse will also check in about their work
and progress on action plans discussed in the last phone call. Any barriers encountered will
be explored and participants will be engaged in a problem-solving process, revising existing
action plans as needed.

Inclusion Criteria:

- Reside in Greater Los Angeles area and receive rheumatologic care at the adult
rheumatology clinic at Harbor-UCLA Medical Center in Torrance, California

- Fulfill the 2010 American College of Rheumatology revised diagnostic criteria for RA

- Have at least moderate disease activity as indicated by a Clinical Disease Activity
Index (CDAI) score >10 and Routine Assessment Patient Index Data (RAPID3) score >2

- Be able and willing to provide written informed consent and to adhere to the study
visit schedule and other protocol

- Availability of a touch-tone landline or mobile telephone

- Of self-identified Hispanic/Latino descent

Exclusion Criteria:

- Known irreversible articular damage, including subluxations, arthrodesis, fusion, or
prosthesis

- Functional class IV as defined by the American College of Rheumatology Classification
of Functional Status in rheumatoid arthritis

- Overlapping autoimmune or mixed connective tissue syndromes

- Serious medical conditions, including: chronic infection, advanced or decompensated
heart failure, higher than class II chronic kidney disease, cancer (unless in
remission for period of 5 years or more), or any uncontrolled medical condition that
is deemed by the investigators to interfere with the study protocol

- At risk for suicide