Plain English Summary
Background and study aims
Cystic fibrosis (CF) is a genetic disease that affects more than 30,000 individuals in the United States and their families. People with CF experience multiple physical and emotional symptoms, including shortness of breath, tiredness, pain, depression, and anxiety.
Palliative care is a medical speciality of experts who work to reduce suffering and improve quality of life for people with serious illness, like CF. Although there is evidence for the benefits of palliative care in illnesses like cancer and heart disease, we do not know if it has the same benefits for people living with CF. The goal of this study is to test whether palliative care, delivered alongside usual CF care, improves outcomes for people with CF.
Aims:
1. To compare integrated palliative care to usual care for effects on patient quality of life, physical and psychological symptom burden, and advance care planning
2. To compare integrated palliative care to usual care for effects on caregiver quality of life, psychological distress and burden
3. To evaluate the mechanisms of providing integrated palliative care and barriers and facilitators to broader implementation
Who can participate?
English-speaking adults ages 18 and over who have cystic fibrosis with reduced lung function (FEV1 less than or equal to 70% of predicted), and unmet palliative needs as indicated by: 1) one or more moderate or severe symptom, 2) reduced quality of life, and/or 3) two or more hospitalizations in the past year. Caregivers who are identified by the patient as being involved in their care also are eligible.
What does the study involve?
Participants will be assigned by chance to receive either usual CF care or usual care plus at least four visits with a palliative care nurse practitioner. The visits will address physical and emotional symptoms, participants’ understanding of their condition, and goals and concerns for the future, including advance care planning.
What are the possible risks and benefits of participating?
The study includes the risk of exposure of sensitive personal information, as well as potentially uncomfortable conversations about serious illness.
Where is the study run from?
The study is led by researchers at Emory University, with additional study sites at University of North Carolina at Chapel Hill, St. Michael’s Hospital (Toronto, Canada), University of California San Diego, and the University of Alabama at Birmingham. Data analysis will occur at the University of Pittsburgh.
When is the study starting and how long is it expected to run for?
April 2020 to June 2023
Who is funding the study?
The Cystic Fibrosis Foundation
Who is the main contact?
Dr Dio Kavalieratos
d.kavalieratos@emory.edu
Trial website
Contact information
Type
Scientific
Primary contact
Dr Dionysios Kavalieratos
ORCID ID
http://orcid.org/0000-0001-5283-0792
Contact details
Emory University Palliative Care Center
1821 Clifton Road
Suite 1016
Atlanta
30329
United States of America
+1 (0)412 805 8381
d.kavalieratos@emory.edu
Type
Public
Additional contact
Dr Jane Lowers
ORCID ID
http://orcid.org/0000-0003-2364-512X
Contact details
Emory University Palliative Care Center
1821 Clifton Road
Suite 1016
Atlanta
30329
United States of America
+1 (0)4152798917
jlowers@emory.edu
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
KAVALI20Q10
Study information
Scientific title
Integrating specialist palliative care to improve care and reduce suffering: cystic fibrosis
Acronym
InSPIRe:CF
Study hypothesis
What is the effect of adding specialist palliative care to usual care for adults with cystic fibrosis (CF)?
Ethics approval
Approved 03/09/2020, Emory University Institutional Review Board (1599 Clifton Road, Atlanta, GA 30322, USA; +1 (0)404 712 0720; irb@emory.edu) ref: STUDY00000071
Study design
Partially blinded multi-center randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
Cystic fibrosis in adults
Intervention
Randomization to either quarterly visits and monthly calls with a palliative care nurse practitioner embedded in the cystic fibrosis (CF) clinic, or usual CF care. The visits will address physical and emotional symptoms, participants’ understanding of their condition, and goals and concerns for the future, including advance care planning.
The duration of the intervention is 9 months (quarterly visits at months 0, 3, 6, 9).
Participant randomizaton (1:1 allocation) is stratified by site with permuted blocks of varying sizes. Patient participants are randomized to control or intervention groups after providing informed consent and baseline data.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
1. Patient quality of life, measured by FACIT-PAL at baseline and quarterly for 15 months (months 3, 6, 9, 12, 15)
2. Caregiver quality of life, measured by PROMIS Global 10 at baseline and quarterly for 15 months (months 3, 6, 9, 12, 15)
Secondary outcome measures
1. CF-specific quality of life measured by Cystic Fibrosis Questionnaire-Revised (collected monthly, primary endpoint 12 months, secondary endpoint 15 months)
2. Symptom burden measured by Memorial Symptom Assessment Scale-CF (collected monthly, primary endpoint 12 months, secondary endpoint 15 months)
3. Psychological distress measured by Hospital Anxiety and Depression Scale (HADS) (collected monthly, primary endpoint 12 months, secondary endpoint 15 months)
4. Coping measured by Brief COPE (collected monthly, primary endpoint 12 months, secondary endpoint 15 months)
5. Satisfaction with care measured by FAMCARE-16 (collected monthly, primary endpoint 12 months, secondary endpoint 15 months)
6. Healthcare utilization measured by emergency department visits, inpatient hospitalization, unplanned outpatient visits, vital status (baseline and 15 months)
7. Advance care planning measured by presence of documentation of discussion of care wishes or signed ACP documents (baseline and 15 months)
8. Caregiver burden measured by Zarit Burden Interview (collected monthly, primary endpoint 12 months, secondary endpoint 15 months)
Overall trial start date
01/04/2020
Overall trial end date
30/06/2023
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. English-speaking
2. Age ≥18 years
3. Palliative needs, as indicated by the following criteria:
3.1. ≥1 moderate or severe symptom (captured by the Integrated Palliative Outcomes Scale [IPOS]); OR
3.2. Reduced QoL (as captured by the IPOS); OR
3.3. ≥2 hospitalizations in the preceding year
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
264
Participant exclusion criteria
1. Post lung transplant
2. Patient does not receive primary CF care from the study site or intends to transfer primary CF care elsewhere over the next year
3. Received outpatient specialty palliative care within the past 12 months
4. Lack of reliable telephone or internet access
5. Active suicidal ideation
Recruitment start date
01/11/2020
Recruitment end date
01/11/2021
Locations
Countries of recruitment
United States of America
Trial participating centre
Emory University
1821 Clifton Road
Suite 1016
Atlanta
30329
United States of America
Trial participating centre
University of Alabama at Birmingham
1713 6th Ave S
Birmingham
35233
United States of America
Trial participating centre
University of North Carolina
101 Manning Dr.
Chapel Hill
27514
United States of America
Trial participating centre
St. Michael's Hospital
30 Bond St.
Toronto
M5B 1W8
Canada
Trial participating centre
University of California San Diego
9350 Campus Point Drive
La Jolla
92037
United States of America
Sponsor information
Organisation
Emory University
Sponsor details
1599 Clifton Rd
Atlanta
30322
United States of America
+1 (0)404 712 0720
irb@emory.edu
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Cystic Fibrosis Foundation
Alternative name(s)
The Cystic Fibrosis Foundation, CF Foundation, The CF Foundation
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both public and private)
Location
United States of America
Results and Publications
Publication and dissemination plan
Planned publication in high-impact, peer-reviewed journals of the study protocol, primary and secondary findings, fidelity plan.
IPD sharing statement:
The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository, the Palliative Care Research Cooperative Group, palliativecareresearch.org. Deidentified data will become available within 1 year of completion of data analysis. Further details about criteria for data access will be added at a later date.
Intention to publish date
30/06/2024
Participant level data
Stored in repository
Basic results (scientific)
Publication list