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NCT04923880 · ClinicalTrials.gov registry record · NA
Pragmatic Implementation Trial of a CF Primary Palliative Care Intervention
A NA study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- NA
- Development phase
- 643
- Enrollment target
NCT04923880: Completed NA study, sponsored by Massachusetts General Hospital.
NCT04923880 is a NA study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 643 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04923880, a NA study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 643 participants
- Enrollment target
Study Summary
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, CF
Interventions
- OTHER Implementation of Primary Palliative Care Intervention in CF Centers
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 643 participants |
| Start Date | 2021-06-25 |
| Est. Completion | 2025-06-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04923880
The ClinicalTrials.gov registry entry for NCT04923880 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 643 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Implementation of Primary Palliative Care Intervention in CF Centers is the first listed.
NCT04923880 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04923880 about?
NCT04923880 is a clinical study titled "Pragmatic Implementation Trial of a CF Primary Palliative Care Intervention". 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 necessar...
What is the current status of trial NCT04923880?
This trial is currently completed. It is a NA study. The enrollment target is 643 participants. The study started on 2021-06-25. Estimated completion is 2025-06-30.
What interventions are being tested in trial NCT04923880?
The interventions under investigation include: Implementation of Primary Palliative Care Intervention in CF Centers (OTHER).
Who is sponsoring clinical trial NCT04923880?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
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