Pragmatic Implementation Trial of a CF Primary Palliative Care Intervention

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, CFTR modifier treatment, psychological distress, and varied indicators reflecting intervention implementation).

Conditions

• Cystic Fibrosis
• Quality of Life

Interventions

OTHER

Implementation of Primary Palliative Care Intervention in CF Centers

Individuals with CF ages 12 years and above will complete an annual palliative care needs assessment with the CF care team using the IPOS (Integrated Palliative Care Outcome Scale). Individuals with CF under 12 years of age will complete an annual palliative care needs assessment with the CF care team using IPOS as a conversation guide. Caregivers of Individuals with CF of all ages will be offered the BASC (Brief Assessment Scale for Caregivers). In addition to annual needs assessment, palliative care needs assessment will take place when triggered by changes in disease status, such as hospitalization, new diagnosis of CF related Diabetes or referral to transplant.

Sponsors & Collaborators

• MJHS Institute for Innovation in Palliative Care

  collaborator OTHER

• Emory University

  collaborator OTHER

• Stony Brook University

  collaborator OTHER

• Feinstein Institute for Medical Research

  collaborator OTHER

• Massachusetts General Hospital

  lead OTHER

Principal Investigators

• Anna M Georgiopoulos, MD · Massachusetts General Hospital (MGH)

• Lara Dhingra, PhD · MJHS Institute for Innovation in Palliative Care (MJHS Institute)

Study Design

Allocation

NA

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-06-25

Primary Completion

2025-06-30

Completion

2025-06-30

Countries

• United States

Study Locations