Pragmatic Implementation Trial of a CF Primary Palliative Care Intervention

Completed · Not applicable

Conditions studied: Cystic Fibrosis, Quality of Life

In brief

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).

Key facts

Study ID

NCT04923880

Run by

Massachusetts General Hospital

People needed

643

Starts

2021-06-25

Expected to finish

2025-06-30

Last updated by the study team

2025-10-30

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Emory University — Atlanta, Georgia, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Northwell Health-Lenox Hill — New York, New York, United States
• Northwell Health — New York, New York, United States
• Stonybrook University — New York, New York, United States

Full record on ClinicalTrials.gov

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