Clinical trial NCT02720874: Multidisciplinary Approach for Treat To Target In Rheumatoid Arthritis
Official title: Multidisciplinary Approach to Patient-Physician Partnership In Treating To Target In Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Arthritis, Rheumatoid
Lead sponsor: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2016-03-28
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research will evaluate a multifaceted patient-centered intervention in a sample of socioeconomically disadvantaged Hispanic adults with rheumatoid arthritis (RA) that capitalizes on a partnership between the extended rheumatology healthcare team and each patient in order to promote understanding, uptake and adherence to the principles of treat-to-target strategy. The primary hypothesis of this study is that the addition of a multifaceted intervention incorporating integrated multidisciplinary rheumatologic care, nurse-directed self-management education and supportive follow-up, and technology-based at home RA symptom monitoring and reporting to clinical guideline-based care will increase RA remission rate at 6 months.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of participants achieving remission based on the Clinical Disease Activity Index at 6 months
timeFrame: 6 months
measure: Percentage of participants achieving remission based on the Routine Assessment Patient Index Data at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Percentage of participants achieving remission based on the Clinical Disease Activity Index at 12 months
timeFrame: 12 months
measure: Percentage of participants achieving remission based on the Routine Assessment Patient Index Data at 12 months
timeFrame: 12 months
measure: Percentage of participants with low disease activity based on the Clinical Disease Activity Index
timeFrame: 6 months, 12 months
measure: Percentage of participants with low disease activity based on the Routine Assessment Patient Index Data
timeFrame: 6 months, 12 months
measure: Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) from baseline
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months
measure: Change in Patient Health Questionnaire (PHQ-9) depression from baseline
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months
measure: Change in Patient Global Assessment of disease activity (PGA) from baseline
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months
measure: Change in Pain Visual Analogue Scale (VAS) from baseline
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months
measure: Change in Fatigue Visual Analogue Scale (VAS) from baseline
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months
measure: Change in SF-36 health status from baseline
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months
measure: Change in Rheumatoid Arthritis Specific Work Productivity Survey (WPS-RA) from baseline
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months
Other outcomes:
measure: Brief Illness Perception Questionnaire (BIPQ)
timeFrame: Baseline, 6 months, 12 months
measure: Single Item Health Literacy Screener (SILS)
timeFrame: Baseline, 6 months, 12 months
measure: Patient Knowledge Questionnaire in Rheumatoid Arthritis (PKQ-RA)
timeFrame: Baseline, 6 months, 12 months
measure: Simplified Medication Adherence Questionnaire (SMAQ)
timeFrame: Baseline, 6 months, 12 months
measure: Health Education Impact Questionnaire (heiQ)
timeFrame: Baseline, 6 months, 12 months
measure: Shared Decision Making Questionnaire (SDM-Q-9)
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months
Locations:
city: Torrance
country: United States
facility: The Lundquist Institute at Harbor-UCLA Medical Center
state: California
Study officials:
affiliation: The Lundquist Institute at Harbor-UCLA Medical Center
name: George A Karpouzas, MD
role: PRINCIPAL_INVESTIGATOR
References: