NCT04923880Befejeződött
Pragmatic Implementation Trial of a CF Primary Palliative Care Intervention
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. okt. 30.
Rövid összefoglaló (regiszter, angolul)
Five Cystic Fibrosis (CF) centers, key stakeholders, and a palliative care institute have collaborated to create a novel primary palliative care intervention for patients with CF, "Improving Life with CF: A Primary Palliative Care Partnership," and established the infrastructure and support necessary for a follow-on implementation study. This intervention provides a framework for a nationally generalizable model to improve best practices in generalist-level palliative care in CF. Objectives: Aim 1: Implement a primary palliative care intervention comprising screening-and-triage workflows, best practice treatment guides for high frequency problems, patient/family and provider education, and a quality improvement (QI) toolkit. Aim 2: Evaluate feasibility, uptake, and preliminary outcomes during a multisite pragmatic, implementation trial of the intervention at 5 diverse Cystic Fibrosis (CF) Centers. Subaim 2.1: Evaluate feasibility and uptake as measured by rates of screening and treatment delivery. Hypothesis 1: Related to feasibility and uptake of the intervention: 1. > 80% of individuals with CF of all ages will receive an annual palliative care screening. 2. > 25% of individuals with CF will receive a palliative care screening prompted by hospitalization, new diagnosis of CF-Related Diabetes, need for transplantation, or another disease- or treatment-specific trigger. Hypothesis 2: Related to provider education: a) > 80% will access >1 training(s) (on-demand webinars or in-service by trained site educators). Subaim 2.2: Evaluate data on preliminary outcomes for individuals with CF by comparing ratings on patient- and caregiver-reported outcome measures (e.g., Integrated Palliative Care Outcome Scale, Cystic Fibrosis Questionnaire-Revised, Memorial Symptom Assessment Scale-Cystic Fibrosis, and Brief Assessment Scale for Caregivers) during the trial to baseline ratings and exploring covariates of change (age, race/ethnicity, gender, disease severity, CFTR modifier treatment, psychological distress, and varied indicators reflecting intervention implementation).
- Állapot (regiszter)
- Befejeződött
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 643 (tényleges)
- Első benyújtás
- 2021. jún. 7.
- Kezdés
- 2021. jún. 25.
- Elsődleges befejezés
- 2025. jún. 30.
- Fő szponzor
- Massachusetts General Hospital
- Betegségek
- Cisztás fibrózis
- NCT-szám
- NCT04923880
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Bevont résztvevők: 643
- 2021. jún. 25. és az elsődleges befejezés (2025. jún. 30.) között
- 5 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.
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Más betegség
- Any subjects who are deemed unable to participate will be excluded, including those with evidence of cognitive impairment severe enough to prevent implied informed consent or completing the survey instruments, or at the PI's discretion.
Kiket keres a vizsgálat
- Patients (age > 12 years) who are treated at the participating CF Centers will be eligible for participation in the study if the following inclusion/exclusion criteria are met:
- Have a diagnosis of CF.
- Receive treatment at one of the participating CF Care Centers in the study.
- Age ≥ 12 years.
- For patients age 12-17 years, willingness and ability to provide implied informed consent by a parent or legal guardian for the patient's participation in the study, with child's implied assent, AND willingness and ability to provide consent by the parent or legal guardian for the parent's or guardian's participation in the caregiver assessment, for proxy completion of selected study measures.
- For patients age >18 years, willingness and ability to provide implied informed consent for participation in the study.
- Willingness to complete questionnaires two times.
- English or Spanish as the primary language.
- In order to ensure generalizability of the intervention, participants will not be excluded from the study for any of the following reasons:
- Extent of CF disease severity or lung/liver transplant status.
- Current use of CFTR modulators or other medical, psychological, or complementary therapies.
- Concomitant participation in another clinical research study.
- Lack of a participating caregiver for patients age > 18 years.
- Caregivers (age > 18 years) will be eligible for participation if the following inclusion/exclusion criteria are met:
- Are an identified caregiver of a patient with CF of any age, who receives treatment at one of the participating CF Care Centers in the study.
- For patients age < 18 years, the caregiver will be a parent or legal guardian.
- For patients age ≥ 18 years, the caregiver will be chosen by the patient (e.g., parent, spouse, partner, other relative or friend).
- Willingness and ability to provide implied informed consent.
- Willingness to complete questionnaires two times.
- English or Spanish as the primary language.
- The CF patient(s) (age > 12) for whom the caregiver provides CF care may accept or decline participation.
A regiszterben nem jelölt feltételek
- The primary palliative care intervention will be clinically implemented at a practice level at all CF centers and offered to all patients and families. For the baseline and outcome research questionnaire based surveys, inclusion and exclusion criteria are as follows:
Életkor a regiszterben: 12 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (5)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Emory University | Atlanta | Egyesült Államok | Ismeretlen állapot |
| Massachusetts General Hospital | Boston | Egyesült Államok | Ismeretlen állapot |
| Northwell Health | New York | Egyesült Államok | Ismeretlen állapot |
| Stonybrook University | New York | Egyesült Államok | Ismeretlen állapot |
| Northwell Health - Lenox Hill | New York | Egyesült Államok | Ismeretlen állapot |
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