Pragmatic Implementation Trial of a CF Primary Palliative Care Intervention

NCT04923880 | Completed

• 1 other identifier: 2020P004090
• Study Type: interventional
• Target: 643
• Locations: 1 country
• Sites: 5

Brief 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. 1.\> 80% of individuals with CF of all ages will receive an annual palliative care screening.
2. 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.

Conditions

Cystic Fibrosis; Quality of Life

Keywords

Palliative Care; Symptom Management

Outcome Measures

Primary Outcomes (1)

• Proportion of individuals with CF receiving annual palliative care screening

  Evaluate uptake of annual palliative care needs assessment process across 5 CF centers

  2 years

Secondary Outcomes (13)

• Proportion of individuals with CF receiving triggered palliative care screening

  2 years

• Use of primary palliative care provider education materials

  2 years

• Integrated Palliative Care Outcome Scale (IPOS)

  2 years

• Memorial Symptom Assessment Scale-Cystic Fibrosis (MSAS-CF)

  2 years

• Cystic Fibrosis Questionnaire-Revised (CFQ-R)

  2 years

Study Arms (1)

Implementation of Primary Palliative Care Intervention in CF Centers

OTHER

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 in 5 CF centers.

Other: Implementation of Primary Palliative Care Intervention in CF Centers

Interventions

Implementation of Primary Palliative Care Intervention in CF Centers OTHER

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.

Implementation of Primary Palliative Care Intervention in CF Centers

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• MJHS Institute for Innovation in Palliative Care: collaborator
• Emory University: collaborator
• Stony Brook University: collaborator
• Feinstein Institute for Medical Research: collaborator

Study Sites (5)

Emory University

Atlanta, Georgia, 30322, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Northwell Health-Lenox Hill

New York, New York, 10075, United States

Location

Northwell Health

New York, New York, 11040, United States

Location

Stonybrook University

New York, New York, 11794, United States

Location

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Related Links

• Science of Behavior change: Parent Related stress (NIH perceived scale)
• Palliative care outcome scale

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Anna M Georgiopoulos, MD

  Massachusetts General Hospital (MGH)

  PRINCIPAL INVESTIGATOR

• Lara Dhingra, PhD

  MJHS Institute for Innovation in Palliative Care (MJHS Institute)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: We have created a framework for a nationally generalizable model to improve best practices in generalist-level palliative care in CF. This framework links the screening approach of the CF Foundation Models of Palliative Care Guidelines to new sets of provider-level clinical best practice guides and practice-level processes of care, supported by targeted education and quality management. This protocol describes an implementation trial of this model that will rigorously evaluate its feasibility, uptake, and preliminary outcomes.

Study Record Dates

• First Submitted: June 7, 2021
• First Posted: June 11, 2021
• Study Start: June 25, 2021
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: October 30, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months after study publication.
• Access Criteria: Investigators submitting a methodologically sound proposal, as determined by the study's lead investigators. Proposals should be directed to ldhingra@mjhs.org.

Locations

US (5)