Condition category
Nutritional, Metabolic, Endocrine
Date applied
15/09/2020
Date assigned
09/10/2020
Last edited
09/10/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

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

http://www.irb.emory.edu/

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

Publication citations

Additional files

Editorial Notes

22/09/2020: Trial’s existence confirmed by Emory University Institutional Review Board