NCT04923880Completed
Pragmatic Implementation Trial of a CF Primary Palliative Care Intervention
Source: ClinicalTrials.gov · Last updated 30 Oct 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 643 (actual)
- First submitted
- 7 Jun 2021
- Start date
- 25 Jun 2021
- Primary completion date
- 30 Jun 2025
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Cystic fibrosis
- NCT number
- NCT04923880
What you commit to
- Study type: Interventional
- Participants enrolled: 643
- From 25 Jun 2021 to the primary completion date, 30 Jun 2025
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Who the study is looking for
- 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.
Criteria the registry did not label
- 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:
Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Emory University Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Northwell Health Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Stonybrook University Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Northwell Health - Lenox Hill Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.