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Trial registered on ANZCTR


Registration number
ACTRN12616001083482
Ethics application status
Approved
Date submitted
15/06/2016
Date registered
11/08/2016
Date last updated
3/04/2019
Date data sharing statement initially provided
3/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The VOICE Study – Valuing Opinions, Individual Communication and Experience: Building the evidence base for undertaking Patient-Centred Family Meetings in palliative care: a mixed methods study
Scientific title
Is a Patient-Centred Family Meeting intervention feasible and acceptable in specialist palliative care units?
Secondary ID [1] 287009 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
The VOICE Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Palliative Care 298481 0
Condition category
Condition code
Public Health 298572 298572 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The proposed intervention is a planned face to face Patient-Centred Family Meeting held soon after admission to an inpatient unit at the specialist palliative care facility where the intervention is being undertaken. The duration of the meeting will be 60 minutes, although this may vary depending on the needs of the patient and other participants. The patient needs and concerns are pre-eminent, along with those of the family member(s). The intervention is designed to be "patient-centred" with the focus of the meeting being on the patient setting the agenda in advance so that their concerns and issues are addressed. This is in contrast to the usual model of family meetings where the agenda is led by the health care team. The meeting will be scheduled as soon after the patient's admission as is practicable rather than on an "ad hoc" basis and be conducted in a private space unless the condition of the patient makes this inappropriate. The patients will be requested to invite the family member(s) they wish to attend the meeting and will be encouraged to invite whomever they consider as "family", and not necessarily blood relatives. The meeting will be convened with members of the palliative care multidisciplinary team, with facilitation provided by the palliative care consultant or registrar. Discussion at the meeting may include clinical and psycho-social issues, preparation for death, and other key areas of importance for that patient and family.
Intervention code [1] 294540 0
Treatment: Other
Comparator / control treatment
The control arm of the study will be the usual standard of care for palliative care inpatients at two other specialist palliative care facilities. For these patients, standard care may include a family meeting, either planned or "ad hoc", if required by the palliative care team or requested by the their family/carer(s) and/or patient. However patients recruited at the control site may not participate in a family meeting as part of their care. Any scheduled family meeting will be run according to current practice at the control site.
Control group
Active

Outcomes
Primary outcome [1] 298070 0
Assessment of the feasibility of a Patient-Centred Family Meeting in specialist palliative care units for patients, families and clinicians.
Timepoint [1] 298070 0
At the intervention site, a Patient-Centred Family Meeting Semi-structured Interview Schedule will be undertaken with participating patients 1-2 days post-meeting which includes questions related to the feasibility of the Patient-Centred Family Meeting.
At the control site, a Patient semi-structured Interview Schedule will be completed post-meeting if the patient participates in a family meeting as part of standard care.
At the intervention site, a Patient-Centred Family Meeting Feedback Questionnaire will be completed by the family participant post meeting (by Day 14) of the patient admission which includes questions related to the feasibility of the Patient-Centred Family Meeting.
At the control site, a Family Meeting Feedback Questionnaire will be completed post meeting (by Day 14) of the patient admission if a family participates in a family meeting as part of standard care.
At the intervention site, the Patient-Centred Family Meeting Multidisciplinary Staff Focus Group Semi-Structured Interview Schedule will be used to evaluate the feasibility of clinicians participating in Patient-Centred Family Meetings in. Clinicians will only be required to attend one focus group according to their availability.
A Family Meeting Observation Sheet will record key elements of the Patient-Centred Family Meeting during the meeting, including participants' (patients, families, clinicians) attendance, reasons for non-attendance of participants, patient agenda completed and used during the meeting, time of meeting and be used to assess feasibility.
Screening to recruitment ratio, time taken to recruit and recruitment drop-outs will also be recorded.
Primary outcome [2] 298689 0
Assessment of the acceptability of a Patient-Centred Family Meeting in specialist palliative care units for patients, families and clinicians.
Timepoint [2] 298689 0
At the intervention site, a Patient-Centred Family Meeting Semi-structured Interview Schedule will be undertaken with participating patients 1-2 days post-meeting which includes questions related to the acceptability of the Patient-Centred Family Meeting. At the control site, a Patient semi-structured Interview Schedule will be completed post-meeting if the patient participates in a family meeting as part of standard care. At the intervention site, a Patient-Centred Family Meeting Feedback Questionnaire will be completed by the family participant post meeting (by Day 14) of the patient admission which includes questions related to the acceptability of the Patient-Centred Family Meeting. At the control site, a Family Meeting Feedback Questionnaire will be completed post meeting (by Day 14) of the patient admission if a family participates in a family meeting as part of standard care. At the intervention site, a Multidisciplinary Staff Focus Group or individual interview using the Patient-Centred Family Meeting Multidisciplinary Staff Semi-Structured Interview Schedule will be used to evaluate the acceptability of clinicians participating in Patient-Centred Family Meetings. Clinicians will only be required to attend one focus group or an individual interview according to their availability. At the control sites, a Multidisciplinary Staff Focus Group or individual interview using the Family Meeting Multidisciplinary Staff Semi-Structured Interview Schedule will be used to evaluate the current practice related to Family Meetings. A Family Meeting Observation Sheet will record key elements of the Patient-Centred Family Meeting during the meeting and be used to assess acceptability.
Secondary outcome [1] 323082 0
Assessment of the suitability of the measures from the patient and family perspective.
Timepoint [1] 323082 0
At the intervention site, the QUAL-EC (Patient) and National Cancer Collaborative Network (NCCN) Distress Thermometer will be completed by patients prior to participation in a Patient-Centred Family Meeting and 1-2 days post Meeting. At the control site the same measures will be completed with the patient completing the baseline measures Day 3-5 of admission and repeat measures Day 7-10 following admission. Questions will be included in the Patient Semi-structured Interview Schedule to assess the suitability of the patient measures. This will include the patient's views about the relevance of the questions and their preference for any particular measure(s), A proportion of family members from the intervention and control sites will also participate in an interview which will include discussion about the family member's views about the relevance of the questions and their preference for any particular measure(s).
Secondary outcome [2] 323083 0
Assessment of the feasibility of the measures from the patient and family perspective.
Timepoint [2] 323083 0
At the intervention site, the QUAL-E (Family) National Cancer Collaborative Network (NCCN) Distress Thermometer (Holland, 1999) and PHQ-4 (Patient Health Questionnaire-4 Family) will be completed by families prior to participation in a Patient-Centred Family Meeting and Day 14 of patient admission.
At the control site the same measures will be completed at the same time points as the intervention site.
Completion rates of the patient and family measures and amount of missing data will be recorded following completion of the measures by patients and family members.
Questions will be included in the Patient Semi-structured Interview Schedule to assess the feasibility of the patient measures. This will include time taken to complete the measures and any issues the patient had with completing the measures.
A proportion of family members from the intervention and control sites will also participate in an interview which will include discussion about time taken to complete the measures and any issues the family member had with completing the measures,

Eligibility
Key inclusion criteria
Patient inclusion criteria
(a) Adult patient aged over 18 years who have been admitted to a participating specialist palliative inpatient facility within the last 7 days;
(b) Have a terminal illness (a prognosis of less than 12 months, but expected to live at least 14 days i.e. the average length of the protocol);
(c) Able to identify a family member (or equivalent person) who consents to participate in the study involving attendance at the Patient-Centred Family Meeting or standard family meeting if convened;
(d) Are classified in accordance with the Palliative Care Outcomes Collaboration (PCOC) palliative care phases at time of recruitment as being either ‘Stable’, ‘Unstable’ or ‘Deteriorating’;
(e) Able to physically participate in a Patient-Centred Family Meeting assessed using the Australian Modified Karnofsky Performance Score and obtaining a score of greater than or equal to 30;
(f) Be able to read and speak English (patients who are visually impaired will be offered assistance with the consent forms and surveys);
(g) Be able to provide valid, informed consent.

Family inclusion criteria
(a) 18 years of age or older;
(b) Invited by the patient to participate in a Patient-Centred Family Meeting;
(c) English language and cognitive skills are sufficient to complete baseline information and validated questionnaires and who are able to contribute effectively in the Patient-Centred Family Meeting or standard family meeting if convened;
(d) Be able to provide valid, informed consent and participate in the Patient-Centred Family Meeting.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patient exclusion criteria
a) Terminal phase (Phase 4 measured by the PCOC Phase assessment) or imminently dying;
b) Presence of delirium measured by validated tool e.g. NuDESC (Leonard et al.);
c) Be cognitively impaired measured by the Mini-Mental State Examination assessment with a score < 24/30;
d) Not able to identify a family member (or equivalent person) who agrees to participate in the Patient-Centred Family Meeting or standard family meeting if convened;
e) Not able to read and speak English;
f) Patients who experience significant family conflict such as an abusive family relationship or history of domestic violence.

Family exclusion criteria
(a) Less than 18 years of age;;
(b) Has been excluded by the patient to participate in the Patient-Centred Family Meeting;
(c) English language or cognitive skills are not sufficient to complete baseline information and validated questionnaires and who are unable to contribute effectively in the Patient-Centred Family Meeting or a standard family meeting if convened.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The intervention arm will be Greenwich Hospital (HammondCare), Greenwich and all patients eligible for the study will be recruited to the intervention.
The control arm will include Sacred Heart Supportive and Palliative Care Service, St Vincent's Hospital, Darlinghurst and Calvary Health Care Kogarah..
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Mixed method quasi-experimental study with pre-post-test data collection using a control and an intervention site.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The Statistical Package for the Social Sciences (SPSS) will be used to analyze the quantitative data.
Descriptive statistics will be used to summarise the baseline and follow-up data including demographics, Distress Thermometer, PHQ-4, QUAL-EC, QUAL-E (Family). Differences on these variables (Distress Thermometer, QUAL-EC and QUAL-E (Family) between the intervention group and control group will be assessed.
The data from the Patient Semi-structured Interviews, Family Feedback Questionnaires and staff focus groups will be analysed taking theoretical and procedural direction from grounded theory.
As this is a feasibility study there is no way to conduct a sample size calculation since no information on the effect size of the outcome is available. The number of participants for the qualitative component of the study has been considered to be a minimum of 10 for each patient and family group in the two arms of the study making a total sample size of 40. Creswell (1998) supported a 20-30 sample size when using grounded theory and this method will be used for the qualitative analysis. The qualitative nature of the study will be supplemented by the addition of patient and family quantitative measures.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/11/2016
Actual
17/08/2017
Date of last participant enrolment
Anticipated
27/07/2018
Actual
11/12/2018
Date of last data collection
Anticipated
Actual
19/12/2018
Sample size
Target
40
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 5654 0
Sacred Heart Hospice - Darlinghurst
Recruitment hospital [2] 9337 0
Greenwich Hospital - Greenwich
Recruitment hospital [3] 13546 0
Calvary Health Care Sydney Ltd - Kogarah
Recruitment postcode(s) [1] 13141 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 18011 0
2065 - Greenwich
Recruitment postcode(s) [3] 26169 0
2217 - Kogarah

Funding & Sponsors
Funding source category [1] 293432 0
University
Name [1] 293432 0
University of Notre Dame Australia
Country [1] 293432 0
Australia
Primary sponsor type
Individual
Name
Professor Jane Phillips
Address
Professor of Nursing,
Director IMPACCT - Improving Palliative, Aged and Chronic Care through Clinical Research and Translation
Faculty of Health
University of Technology Sydney
PO Box 123
Ultimo NSW 2007
Country
Australia
Secondary sponsor category [1] 292254 0
Individual
Name [1] 292254 0
Professor Liz Lobb
Address [1] 292254 0
Research Cottage
Calvary Health Care Kogarah
PO Box 261
Kogarah NSW 1485
Country [1] 292254 0
Australia
Secondary sponsor category [2] 296959 0
Individual
Name [2] 296959 0
Dr Christine Sanderson
Address [2] 296959 0
C/O Research Cottage
Calvary Health Care Kogarah
PO Box 261
Kogarah NSW 1485
Country [2] 296959 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294876 0
St Vincent’s Hospital, Darlinghurst HREC Executive Committee
Ethics committee address [1] 294876 0
Ethics committee country [1] 294876 0
Australia
Date submitted for ethics approval [1] 294876 0
02/02/2015
Approval date [1] 294876 0
20/04/2015
Ethics approval number [1] 294876 0
HREC/15/SVH/33

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58478 0
Prof Jane Phillips
Address 58478 0
IMPACCT - Improving Palliative, Aged and Chronic Care through Clinical Research and Translation
Faculty of Health
University of Technology Sydney
Country 58478 0
Australia
Phone 58478 0
+612 95144822
Fax 58478 0
Email 58478 0
jane.phillips@uts.edu.au
Contact person for public queries
Name 58479 0
Philippa Cahill
Address 58479 0
C/O Research Cottage
Calvary Health Care Kogarah
PO Box 261
Kogarah NSW 1485
Country 58479 0
Australia
Phone 58479 0
+61 434077674
Fax 58479 0
Email 58479 0
philippa.cahill1@my.nd.edu.au
Contact person for scientific queries
Name 58480 0
Philippa Cahill
Address 58480 0
C/O Research Cottage
Calvary Health Care Kogarah
PO Box 261
Kogarah NSW 1485
Country 58480 0
Australia
Phone 58480 0
+61 434077674
Fax 58480 0
Email 58480 0
philippa.cahill1@my.nd.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
All individual participant data will remain confidential and de-identified as per research protocol and NEAF.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe VOICE Study: Valuing Opinions, Individual Communication and Experience: Building the evidence base for undertaking Patient-Centred Family Meetings in palliative care - a mixed methods study.2018https://dx.doi.org/10.1186/s40814-017-0225-9
Dimensions AI“Standing Shoulder to Shoulder to Tell the Family What Was Really Going On”: A Qualitative Study Exploring Palliative Care Clinicians' Perceptions of “Patient-Centered Family Meetings”2020https://doi.org/10.1089/jpm.2019.0380
EmbasePatients Receiving Palliative Care and Their Families' Experiences of Participating in a "patient-Centered Family Meeting": A Qualitative Substudy of the Valuing Opinions, Individual Communication, and Experience Feasibility Trial.2021https://dx.doi.org/10.1089/pmr.2020.0109
N.B. These documents automatically identified may not have been verified by the study sponsor.