Social determinants of health (SDoH), defined by the World Health Organization as "the
conditions in which people are born, grow, work, live and age and the wider set of forces and
systems shaping the conditions of daily life" are estimated to be responsible for nearly 90
percent of a person's health outcomes. SDoH are key contributors to racial, ethnic and
socioeconomic disparities in care healthcare access and health outcomes. Among patients with
chronic rheumatic conditions, SDoH including poverty, insurance status, and inadequate access
to care have been shown to contribute to delayed diagnoses, frequent emergency department
visits, medication nonadherence, worse quality of life, increased disease-related damage and
poorer outcomes. Individuals with inflammatory arthritis often require complex, costly
medication regimens and suffer from a high burden of comorbid conditions and physical
disabilities. They face unique healthcare challenges including a high risk of care
fragmentation from multiple subspecialty providers and medications that are both expensive
and challenging to adhere to as prescribed. The role of SDoH on the care and outcomes of
patients with inflammatory arthritis is understudied but living conditions, socioeconomic
status and neighborhood income have been shown to contribute to treatments received and the
likelihood of remission at 12 months. Disparities in inflammatory arthritis care and outcomes
are likely multifactorial and involve both delayed access to subspecialty care as well as
ongoing barriers to sustained, high quality care once referred. Separate comprehensive
interventions are required to address the challenges at every stage of care.
Our ongoing quality improvement initiative aims to collect and document social determinants
of health data for people with inflammatory arthritis across this multi-hospital system. In
this initiative the investigators developed a standard of care where patients have their
needs assessed and if they indicate that they would like information to help address these
needs, they are sent resource lists. A community resource specialist is also available when
indicated to help address needs. In this study, the investigators aim to test different
interventions to address the needs that the investigators uncover using the SDoH screening
protocol. Using an adaptive strategy, patients with SDoH-related needs and appointment no
shows in the past, will be randomized to one of three arms, with the ability to change arms
if they do not improve in their assigned arm. Cost-effectiveness analyses will also be
conducted.
Using an adaptive intervention, this trial will help identify patients who may respond to the
simplest and least expensive intervention
- - a tailored list of resources, those who benefit
from a community-based resource specialist to help address specific SDoH-related needs, and
those who require a nurse-trained navigator to help both coordinate the services provided by
the community-based specialist, and their medical and mental health care and needs.
A cost
effectiveness analysis of the interventions will be conducted. The knowledge gained by this
trial will help guide care and advocacy for vulnerable populations both in resource poor
settings and at major medical centers that have not previously allocated the services needed
to care for the highest risk populations. The overall goal of this study is to provide these
essential data to advocate for a scalable, sustainable program to meet the needs of the most
vulnerable patients with chronic rheumatic conditions with arthritis that can be scaled to
other chronic systemic rheumatic diseases and other complex, subspecialty-managed conditions.
Specific Aims:
1. To conduct a randomized controlled trial with an adaptive intervention to test the
efficacy of a rheumatology clinic-based nurse patient navigator and community resource
specialist intervention to reduce appointment no shows. This intervention will allow for
an understanding of these needs and test three strategies to begin to address them. The
investigators anticipate that all of the interventions will benefit to some degree
through connection to resources. The investigators currently have no data as to whether
one type of intervention is better than another for patients with systemic rheumatic
conditions with arthritis and therefore, the investigators are testing two types of
navigator interventions with the ultimate goal of determining the most beneficial and
cost-effective intervention for high-risk patients based on their specific needs. The
adaptive nature of the intervention will allow the study team to study this further and
will allow for as many individuals as possible to derive potential benefit from this
study.
2. To examine the cost-effectiveness of each of the different study arms for individuals
with systemic rheumatic conditions with arthritis with SDoH-related needs using the
ED-5D questionnaire and cost-related care metrics.
Subjects will be identified using the EHR (EPIC review, EDW, RPDR), and through BRASS.
Rheumatologists will also be asked to refer patients who they feel may be appropriate.
Patients will be recruited via patient gateway, by mail or by rheumatologist referral.
Rheumatologists and the clinic nursing team will also be given fact sheets and recruitment
letters that they can give to patients they feel might be interested in participating. If a
letter is sent to a patient via gateway, via mail, or introduced by the rheumatologist, if
the patient does not opt out, at least one week later, a member of the study team will call
the patient to follow up. If they cannot be reached by phone but have a rheumatology clinic
visit >=1 week after the letter is sent, a member of the research team may approach them in
clinic to see if they might be interested in learning more about the study. The research
assistants will be responsible for identifying and recruiting individuals beginning at the
date of IRB approval. Communication for recruitment will occur in-person, through secure
messaging in the EHR, through secure email (unless the patient opts out of secure email) and
via the telephone. The patients enrolled in this study may have frequent appointment no shows
and some may more frequently come to the Emergency Department or be admitted (either at BWH
or at Faulkner). Therefore, the research team may approach patients for consent while they
are in the ED or on an inpatient floor if unable to reach them by phone or in clinic.
Similarly, the community resource specialist or nurse navigator may interact with the
patients when they are in the ED or admitted due to the nature of their role (especially for
those patients with frequent acute care use, who may also be those with the greatest
SDoH-related needs).
Prior studies have demonstrated that individuals who experience poverty and increased
SDoH-related needs have an increased burden of rheumatic conditions, more severe outcomes,
and increased care fragmentation. As such, the investigators aim to enroll individuals in
this intervention who are at highest risk for adverse outcomes and high acute care use to
address SDoH-related needs and improve receipt of outpatient care. The study team aims to
include a racially and ethnically diverse patient population in this study. The investigators
expect that more females than males will be enrolled because rheumatic conditions are more
prevalent among females. The investigators expect that the majority of patients enrolled will
be English-speaking given the ethnicity distribution of patients served in the rheumatology
clinics at BWH (<10% identify as Latinx). To allow for the inclusion of Spanish-speaking
patients, however, the study team has included translated materials.
The investigators anticipate recruiting 258 patients with systemic rheumatic conditions with
arthritis across Mass General, Brigham and Faulkner hospitals and satellite rheumatology
clinics to participate in the intervention components of this trial (N=86 per arm). Patients
will be associated with the study in Epic so the study staff is notified if patients go to
the ED or are hospitalized. The primary analysis will be intention-to-treat, and since the
primary outcome metric can be obtained from the EHR, even if patients are lost to follow-up,
the study team will still be able to collect these data. However, given the vulnerability of
the patient population and potential loss to follow-up, the investigators will have
statistical power to detect a clinically meaningful difference in medication and appointment
adherence between the two intervention arms with 156 total patients (N=52 per arm) using a
per protocol design, and examining secondary outcomes that require survey completion.
Study Team Interactions with Subjects Patients who agree to participate will be randomized to
one of three arms. Arm 1 is the control arm which will receive the standard of care resource
sheets. Patients in this arm will receive cultivated resource sheets for any SDoH-related
needs that they screen positive for or request additional information on. Arm 2 will receive
the assistance of a community resource specialist (CRS)- an individual without formal medical
training with community-based expertise, who will help guide patients to the necessary
community-based resources to help address their specific SDoH needs that impact their health
and their ability to access sustained, high quality medical care. This may include forms to
arrange for subsidized transportation to and from medical appointments or applications for
Section 8 housing. The community resource specialist will reach out to patients in Arm 2 a
minimum of 2 times per month, with more interactions guided by patients' needs. All outreach
attempts and contacts will be documented in EPIC and in REDCap. Arm 3 will receive the
assistance of a bilingual (English and Spanish) nurse patient navigator with nursing training
and additional rheumatology-specific training who will both work with the CRS to connect the
patient with community-based resources, independently connect the patient with relevant
resources, and also help coordinate the patient's medical care and mental health needs. The
nurse patient navigator will conduct her own needs assessment (the nurse navigator high risk
assessment questionnaire at the time of the first conversation with the patient, originally
developed as part of the MGB integrated care management program) and her actions will be
guided by their responses. She will reach out to patients a minimum of 2 times per month with
an increase in communication around patient appointments as reminders, and more frequent
communication on a case-by-case basis depending on active illnesses, frequency of outpatient
appointments, and needs of the patient. All outreach attempts and contact will be documented
in Epic and REDCap and shared via EPIC with the care team as indicated.
Reassignments after 6 months After six months, individuals who do not respond to Arm 1 will
be reassigned to the Arm 2 intervention (CRS). Response will be determined by >=1 appointment
no shows or same day cancellations during the 6-month period and/or persistence of >=1
SDoH-related need that has not been addressed. Individuals without any no shows who had their
needs addressed will graduate and will receive follow-up surveys at 12 months. Patients in
Arm 2 or Arm 3 with no appointment now shows and who have had their SDoH-related needs
addressed will graduate and complete follow-up surveys at 12 months. If individuals in Arm 2
had >=1 no show and/or persistent SDoH-related needs, they will be reassigned to Arm 3 (nurse
navigator). If individuals in Arm 3 had >=1 no show and/or persistent SDoH-related needs,
they will remain in Arm 3 for another 6 months. All individuals will complete 12-month
surveys.
