A multi-site trial of specialist palliative care in cystic fibrosis
| ISRCTN | ISRCTN53323164 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN53323164 |
| Secondary identifying numbers | KAVALI20Q10 |
- Submission date
- 15/09/2020
- Registration date
- 09/10/2020
- Last edited
- 17/03/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Current plain English summary as of 09/03/2021:
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 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
_____
Previous 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 March 2024
Who is funding the study?
The Cystic Fibrosis Foundation
Who is the main contact?
Dr Dio Kavalieratos
d.kavalieratos@emory.edu
Contact information
Scientific
Emory University Palliative Care Center
1821 Clifton Road, Suite 1016
Atlanta
30329
United States of America
 ORCID ID |
0000-0001-5283-0792 |
|---|---|
| Phone | +1 (0)412 805 8381 |
| d.kavalieratos@emory.edu |
Public
Emory University Palliative Care Center
1821 Clifton Road, Suite 1016
Atlanta
30329
United States of America
| ORCID ID |
0000-0003-2364-512X |
|---|---|
| Phone | +1 (0)4152798917 |
| jlowers@emory.edu |
Study information
| Study design | Partially blinded multi-center randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Integrating specialist palliative care to improve care and reduce suffering: cystic fibrosis |
| Study acronym | InSPIRe:CF |
| Study objectives | What is the effect of adding specialist palliative care to usual care for adults with cystic fibrosis (CF)? |
| Ethics approval(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/04/2020 |
| Completion date | 31/03/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 264 |
| Total final enrolment | 264 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/11/2020 |
| Date of final enrolment | 15/03/2023 |
Locations
Countries of recruitment
- Canada
- United States of America
Study participating centres
Suite 1016
Atlanta
30329
United States of America
Birmingham
35233
United States of America
Chapel Hill
27514
United States of America
Toronto
M5B 1W8
Canada
La Jolla
92037
United States of America
Sponsor information
University/education
1599 Clifton Rd
Atlanta
30322
United States of America
| Phone | +1 (0)404 712 0720 |
|---|---|
| irb@emory.edu | |
| Website | http://www.irb.emory.edu/ |
Funders
Funder type
Charity
Government organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- CF Foundation, CFF
- Location
- United States of America
Results and Publications
| Intention to publish date | 30/06/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | Planned publication in high-impact, peer-reviewed journals of the study protocol, primary and secondary findings, fidelity plan. |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 01/09/2022 | 27/09/2022 | Yes | No |
Editorial Notes
17/03/2023: The following changes have been made:
1. The recruitment end date has been changed from 31/03/2023 to 15/03/2023.
2. Total final enrolment added.
28/02/2023: The recruitment end date has been changed from 28/02/2023 to 31/03/2023.
19/01/2023: The recruitment end date has been changed from 31/01/2023 to 28/02/2023.
11/10/2022: The following changes have been made:
1. The recruitment end date has been changed from 01/10/2022 to 31/01/2023.
2. The overall trial end date has been changed from 30/06/2023 to 31/03/2024 and the plain English summary updated accordingly.
27/09/2022: Publication reference added.
21/04/2022: The recruitment end date has been changed from 01/04/2022 to 01/10/2022.
09/03/2021: The plain English summary was changed.
09/02/2021: The recruitment end date was changed from 01/11/2021 to 01/04/2022.
22/09/2020: Trial’s existence confirmed by Emory University Institutional Review Board
