The Development and Implementation of a Rheumatology-Referral Based, General Internal Medicine-Led Fibromyalgia Clinic and Preliminary Patient Outcomes

Introduction

Fibromyalgia is a debilitating pain syndrome affecting 2-10% of Americans (Gota, 2021). Patients with fibromyalgia frequently seek care from their primary care physician (PCP) or rheumatologist; however, patients encounter several barriers to finding high-quality care. Challenges include inadequate fibromyalgia knowledge among PCPs, difficulty accessing rheumatology specialty care, and negative provider perceptions towards patients with fibromyalgia (Battafarano et al., 2018; Byrne et al., 2023; Pang et al., 2021; Van Wilgen et al., 2024). We created a rheumatology-referral based, general internal medicine-led fibromyalgia clinic. The goals of the clinic were multifactorial. The clinic aimed to provide patients with fibromyalgia compassionate, evidence-based care and shift the care of patients with fibromyalgia from rheumatology to general internal medicine. We conducted a quality improvement study to assess the short-term and long-term impacts of our fibromyalgia clinic on patients’ symptom control.

Methods

The Fibromyalgia Clinic Referral Pathway

The fibromyalgia clinic was created via an institutional collaboration between the Division of Rheumatology and the Division of General Internal Medicine and was supported by the Department of Medicine. The Division of Rheumatology was struggling with two issues that prompted the creation of the fibromyalgia clinic: (1) local rheumatology practices were receiving many referrals to aid in the diagnosis and management of fibromyalgia and (2) the burden of increased referrals led to long wait times for new patient appointments. By creating a specific fibromyalgia clinic, we aimed to provide timely, high-quality care and increase access to rheumatology for patients with autoimmune/inflammatory conditions. Rheumatology conducted an initial evaluation to ensure no concomitant autoimmune/inflammatory disease was present and then referred patients to the fibromyalgia clinic for fibromyalgia specific care and ongoing management needs. The initial rheumatology evaluation was conducted in various ways based on patient needs and degree of suspicion for autoimmune/inflammatory disease. Some patients were referred after a brief telemedicine appointment, while others were referred after a lengthier evaluation necessitating several in-person appointments. Although fibromyalgia and autoimmune/inflammatory conditions frequently co-occur, the fibromyalgia clinic targeted patients with only fibromyalgia. Rheumatology continued to managed patients with fibromyalgia and concurrent autoimmune/inflammatory conditions, but the fibromyalgia clinic was available to these patients if the fibromyalgia care team could offer additional services (e.g. medical marijuana certification) that were not readily available through rheumatology.

The Fibromyalgia Clinic Structure

The care team at the fibromyalgia clinic consisted of two pharmacists, two physicians, one behavioral health therapist, and nurses. The initial visit included a 30-minute pharmacist visit and a one-hour physician visit. The pharmacist performed a medication reconciliation, reviewed prior pharmacological therapies, and discussed additional pharmacological options. The pharmacist also made a recommendation to the physician regarding pharmacologic options and was available to help with medication changes or cross tapers (e.g. changing gabapentin to pregabalin or selective serotonin reuptake inhibitors (SSRIs) to selective norepinephrine reuptake inhibitors (SNRIs)). The goals of the initial physician visit were to confirm the diagnosis of fibromyalgia; identify other pain generators (e.g. osteoarthritis) or concurrent chronic pain conditions (e.g. migraines, irritable bowel syndrome); provide empathetic listening, validation, and education about fibromyalgia; review prior treatment modalities and create a new treatment plan involving pharmacologic, non-pharmacologic, and behavioral health interventions.

Pharmacologic management options offered included SNRIs (e.g. duloxetine, milnacipran), tricyclic antidepressants (TCAs) (e.g. nortriptyline, amitriptyline), gabapentinoids (e.g. gabapentin, pregabalin), muscle relaxers (e.g. cyclobenzaprine), low dose naltrexone, and medical marijuana (Bair et al., 2020; Macfarlane et al., 2017; Ram et al., 2023; Strand et al., 2023; Thorpe et al., 2018; Yang et al. 2023). Non-pharmacologic interventions options included physical therapy, aqua therapy, chronic pain occupational therapy, and cognitive rehabilitation (Braz Ade et al., 2011; Poole et al., 2017; Rodriguez-Huguet et al., 2024). Acupuncture and chiropractor services were also discussed depending on patient interest and insurance coverage (Deare et al., 2013; Han et al., 2023; Schneider et al., 2009). Non-pharmacologic services were not co-located at the fibromyalgia clinic and patients had to make separate appointments for these services.

The behavioral health therapist did not routinely evaluate all patients but was available to work with patients if they desired cognitive behavioral therapy, counseling, emotional support, stress reduction techniques and/or for patients with comorbid mood disorders (Cojocaru et al., 2024). Nurses assisted with inter-visit care by answering patient questions or concerns, processing medication refills, and coordinating referrals. The nonpharmacologic management options and the selection of team members was based on guidelines, studies, and expert recommendations in the literature and influenced by the availability of local resources (Bair et al., 2020; Häuser et al., 2009; Giusti et al., 2017; Gota, 2021; Macfarlane et al., 2017.)

Patients were offered 20-minute follow-up physician visits every six weeks for three follow-up visits to review response to treatment modalities and modify the treatment plan as needed. At the end of the four visits, care was returned to the patients’ PCP with anticipatory guidance. This structure allowed us to continually accept new patients on a weekly basis and provide enough follow-up appointments for patients enrolled in the program. Physicians had 4 hours of fibromyalgia clinic time per week (two new patient appointments and six follow-up appointments). Rheumatology was available for re-consultation if new concerns emerged for an autoimmune/inflammatory disease.

Fibromyalgia Clinic Patient Outcomes

We assessed patient outcomes using the Fibromyalgia Impact Questionnaire-Revised (FIQR), a validated questionnaire that quantifies fibromyalgia symptoms, overall impact, and functional impact with scores increasing in severity from 0 to 100 (Bennett, 2005; Bennett et al., 2009; Burckhardt et al., 1991; Williams et al., 2011). The FIQR was administered at the intake appointment (initial FIQR), within six months of the final appointment (final FIQR), and six months or more after the final appointment (post-final FIQR). FIQRs were completed in a variety of ways including paper surveys, electronic surveys through the electronic medical record, and over the phone.

To be included in the study, patients had to satisfy American College of Rheumatology (ACR) 2016 diagnostic criteria for fibromyalgia, complete an initial FIQR, attend a minimum of 2 appointments, and complete either a final FIQR or a post-final FIQR, or both. The primary outcome was change in FIQR score with a score reduction of 8 points considered clinically significant (Williams et al., 2011). Patients were organized into three groups based on FIQR completion status (Figure 1). Patient characteristics of the three groups were compared using Fisher’s Exact test for sex and race, and Kruskal-Wallis test for age, FIQR scores, number of formal non-pharmacologic services utilized per patient, and number of prescribed fibromyalgia specific medications per patient. Non-pharmacologic services included formal programs such as aqua therapy, occupational therapy, and physical therapy within our health system. Fibromyalgia specific medications included SNRIs, TCAs, gabapentinoids, muscle relaxers, low dose naltrexone, and medical marijuana. A mixed model with repeated measures analysis was performed to determine if observed reductions in FIQR scores were statistically significant between timepoints. This study was approved by the institutional quality improvement committee. As this was a service evaluation, ethical approval was not required.

Figure 1.

Study design flow chart

†American College of Rheumatology, ‡Fibromyalgia Impact Questionnaire-Revised

We also collected and reviewed informal verbal and written feedback about aspects of the fibromyalgia clinic. Patients were asked what aspects they found beneficial and what aspects they would change about the fibromyalgia clinic. Patient feedback was collected after the final follow-up visit. Feedback questionnaires were administered through the electronic medical record or verbally if the post or post-final FIQR was administered over the phone and the patient had not previously completed the electronic questionnaire.

Results

Between February 2021 and June 2022, 146 patients were evaluated; 56 patients were included in the study (Figure 1). Most patients were white (50/56, 89%) and women (51/56, 91%); patients’ mean age was 45 years. FIQR scores by group are reported in Figure 2. Group 1, as compared to group 2 and group 3, had lower mean FIQR scores (p = 0.01 and p = 0.04 respectively). There was not a significant difference in mean FIQR scores between group 2 and group 3. All three groups had similar patient characteristics with regards to age, sex, race, number of formal non-pharmacologic services utilized per patient, and number of prescribed fibromyalgia specific medications per patient (Table 1). Groups 1 and 2 demonstrated a statistically and clinically significant reduction from initial FIQR to final FIQR scores. Group 1 maintained a clinically significant, but not statistically significant, FIQR score reduction at the post-final timepoint. Group 3 did not demonstrate a significant change between initial FIQR and post-final FIQR scores.

Figure 2.

Fibromyalgia Impact Questionnaire-Revised scores over time by patient groups

*p< 0.001, †Fibromyalgia Impact Questionnaire-Revised

Table 1:

Select patient characteristics of data groups 1,2, and 3

Patient characteristic	Group 1 Initial, final, and post-final FIQR (n=18)	Group 2 Initial and final FIQR (n=23)	Group 3 Initial and post-final FIQR (n=15)	P-value
Mean age (standard deviation)	46 (12)	43 (12)	45 (8)	0.54
Number of women (percentage)	18 (100%)	20 (87%)	13 (87%)	0.25
Number of white patients (percentage)	16 (89%)	20 (87%)	14 (93%)	1.00
Mean number of formal non-pharmacologic services utilized per patient (standard deviation)	0.2 (0.4)	0.2 (0.4)	0.2 (0.4)	0.99
Mean number of fibromyalgia specific medications per patient (standard deviation)	1.9 (1.0)	2.3 (1.0)	1.8 (0.9)	0.30

Informal verbal and written patient feedback was positive, with patients noting a benefit from empathetic listening, symptom validation, and education. Multiple patients requested long-term follow-up options.

Discussion

The fibromyalgia clinic significantly improved symptom control for patients within six months of program completion, but we observed regression in fibromyalgia control six months or more after program completion. The fibromyalgia clinic has some differences as compared to other programs or clinics previously described. The fibromyalgia clinic provides individualized care whereas other programs are primarily group-based (Häuser et al., 2009; Giusti et al., 2017). Most other programs, as compared to the fibromyalgia clinic, are shorter (less than 12 weeks), but more intense ranging from 8 – 150 hours (Giusti et al., 2017). Despite the unique features of the fibromyalgia clinic, our findings are consistent with other studies of fibromyalgia programs which demonstrated short-term (3-4 month) symptom improvement, but not long-term (6-12 months) symptom improvement (Häuser et al., 2009).

Several factors may have contributed to regression of fibromyalgia control, including returning care to providers without fibromyalgia expertise, the short-term nature of some non-pharmacologic treatments such as a set number of occupational therapy visits, lapse in prescription medications, and the waxing and waning nature of fibromyalgia. As a result of the regression of fibromyalgia control and patient requests for long-term follow-up, the clinic has implemented booster sessions. Booster sessions are 30-minute follow-up appointments reserved for patients who have completed the acute management phase of the program and wish to follow-up at longer intervals (e.g., 6-12 months for check-ins or ongoing medication management) or for patients who previously graduated from the program and wish to be re-evaluated. To implement booster sessions one new patient slot per month per physician was converted to two booster sessions. While this decreased new patient access slightly, we felt this was the best balance between serving new patients and continuing to serve our established patient population.

Limitations of this study include small sample size, lack of a control group, and single institution design. Unfortunately, we are unable to comment as to whether the fibromyalgia clinic led to decreased wait times for rheumatology as several interventions to improve patient access were implemented concurrently. The uptake of formal non-pharmacological services appears low; however, we were only able to quantify patients’ participation in formal programs within our health system. Many patients also participated in nonformal pharmacological therapies at home (e.g. yoga, light exercise) or programs outside of our health system (e.g. private practice acupuncture). Strengths of the study include assessing both short-term and long-term patient outcomes of a novel, individualized fibromyalgia program. Next steps, specifically for our clinic, include continuing to evaluate and develop the clinic in an iterative fashion to ensure we are meeting patient needs. We plan to study short-term and long-term patient outcomes including symptom severity and patient satisfaction after the implementation of booster sessions. Other important areas of study to advance the delivery of care to patients with fibromyalgia include continuing to define the most effective elements of a multicomponent fibromyalgia program and providing ongoing medical education to other providers to enhance the care patients with fibromyalgia receive in all settings.

Conclusion

We described the development and implementation of a novel rheumatology-referral based, general internal medicine-led fibromyalgia clinic. Preliminary findings from a quality improvement study demonstrated improved fibromyalgia control after completion of the program; however, regression in symptom control 6 months after completion. Based on these findings and informal patient feedback, the fibromyalgia clinic implemented booster sessions which provide a 6-12 month follow-up option for patients who prefer to continue to follow with the clinic or patients who have completed the program and experience regression in symptom control.