NCT04923880

Pragmatic Implementation Trial of a CF Primary Palliative Care Intervention

Completed NA Last updated 30 October 2025

What this trial tests

NA trial testing Implementation of Primary Palliative Care Intervention in CF Centers in Cystic Fibrosis in 643 participants. Completed in 30 June 2025.

Timeline

25 June 2021

Primary endpoint
30 June 2025

30 June 2025

Quick facts

Lead sponsor	Massachusetts General Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	health services research
Enrollment	643
Start date	25 June 2021
Primary completion	30 June 2025
Estimated completion	30 June 2025
Sites	5 locations across United States

Drugs / interventions tested

• Implementation of Primary Palliative Care Intervention in CF Centers

Conditions studied

• Cystic Fibrosis — all drugs for Cystic Fibrosis →
• Quality of Life — all drugs for Quality of Life →

Sponsor

Massachusetts General Hospital

Who can join

12 and older, any sex, with Cystic Fibrosis or Quality of Life. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.