NCT05715463Fut, nem toboroz
Rheumatology-based Adaptive Intervention for Social Determinants and Health Equity
Achieving Equity in Inflammatory Arthritis Care: An Adaptive Trial To Understand and Address Social Determinants of Health
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. okt. 15.
Rövid összefoglaló (regiszter, angolul)
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. The goal of this clinical trial is to identify patients with inflammatory arthritis or with a systemic rheumatic condition with arthritis who may respond to the simplest and least expensive intervention to address their SDoH-related needs- a tailored list of resources, those who benefit from a community-based resource specialist to help address specific 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. The main questions the clinical trial aims to answer are: 1. To test the efficacy of a rheumatology clinic-based nurse navigator and community resource specialist to reduce appointment no-shows and same-day cancellations in patients with systemic rheumatic conditions with arthritis. 2. To examine the cost-effectiveness of each of the different study interventions for individuals with systemic rheumatic conditions with arthritis with SDoH-related needs using questionnaires and cost-related care metrics. Participants will be randomly assigned to 1 of 3 arms. In Arm 1, patients will receive a cultivated list of resources related to the needs that patients indicate on the social determinants of health questionnaire. Arm 1 is the control arm which receives the current standard of care. In Arm 2, patients will receive the assistance of a community resource specialist (CRS) - an individual without formal medical training with community-based expertise. In Arm 3, patients will receive the assistance of a nurse patient navigator with additional systemic rheumatic condition-specific training who will work with the CRS. After 6 months, patients who do not respond to Arm 1 will move to Arm 2. Patients who do not respond to Arm 2, will move to Arm 3. Patients who do not respond to Arm 3 will remain in Arm 3. Patients who respond to any arm will graduate the program at 6 months. The patients who do not respond be in their new arm for 6 months. At 12 months, all patients remaining in the study will graduate.
- Állapot (regiszter)
- Fut, nem toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 101 (tényleges)
- Első benyújtás
- 2023. jan. 19.
- Kezdés
- 2023. márc. 1.
- Elsődleges befejezés
- 2025. okt. 14.
- Fő szponzor
- Brigham and Women's Hospital
- Betegségek
- Rheumatoid arthritis, Spondylitis ankylopoetica (Bechterew-kór), Pikkelysömör, Arthritis psoriatica, Szisztémás szklerózis (szkleroderma), Sjögren-szindróma
- NCT-szám
- NCT05715463
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Bevont résztvevők: 101
- 2023. márc. 1. és az elsődleges befejezés (2025. okt. 14.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.
Egyéb
- Incarcerated individuals
- Indicated through our EHR that they do not want to be contacted for research
- Patients already actively enrolled in an integrated care management program through their primary care provider
- Medical complexity that requires urgent nursing involvement and thus not medically appropriate for randomization
Kiket keres a vizsgálat
- English or Spanish-speaking
- 18+ years of age
- diagnosis of a systemic rheumatic condition with arthritis
- 1+ prior no-show(s) or same day cancellation(s) to an ambulatory care provider in the past year
- 1+ social determinants of health needs on Mass General Brigham questionnaire (excluding unemployment and education)
- Receiving rheumatology care at a Mass General Hospital, Brigham and Women's Hospital or Faulkner Hospital affiliated clinic
Életkor a regiszterben: 18 év – 100 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Brigham & Women's Hospital | Boston | Egyesült Államok | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.