Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000625774
Ethics application status
Approved
Date submitted
29/05/2013
Date registered
31/05/2013
Date last updated
19/08/2019
Date data sharing statement initially provided
19/08/2019
Date results information initially provided
19/08/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
A mixed methods study exploring the differences in communication between patients, the family care giver and health care professionals in an outpatient psychosocial clinic setting
Scientific title
A mixed methods study exploring the differences in communication style when patients and their caregivers are seen together by the health care professional versus when they are seen alone by the health care professional in an outpatient psychosocial palliative care clinic.
Secondary ID [1] 282587 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
TvD study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Communication study in the palliative care popultaion 289281 0
Condition category
Condition code
Mental Health 289605 289605 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The study will be conducted within the routine early assessment clinic at GP Plus Marion. Patients are asked to allow 2 hours for this clinic but each clinician works to a 30 minute assessment schedule. The intervention for this study is the tape recording of the sessions as outlined below.
The patient accompanied by their caregiver is first assessed by the Nurse Practitioner for a 30 minute physical assessment. The patient and caregiver are then seen together by the social worker for a 30 minute assessment of social needs. After the social work assessment the patient is assessed alone by the psychosocial nurse for coping and adjustment to illness while the caregiver is assessed alone by the Caregiver Network Facilitator. These individual assessments take 30 minutes.
The whole clinic assessment should not take any longer than 90 minutes.
Intervention code [1] 287258 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289697 0
The primary objective is to quantify the differences in communication that occurs within the patient, family care giver and health professional triadic consultation.
The tape recorded interviews will be transcribed verbatim and the content coded to quantify communication variables. A grounded theory approach is utilised for the qualitative component of the study.NVivo software will be utilised to analyse the qualitative component of the study.
Timepoint [1] 289697 0
Conducted at the initial clinic appointment
Secondary outcome [1] 303044 0
Secondary objective is to establish the emotional content of consultation clinics when patients are seen together with their caregivers and compare that to when they are seen apart. This will be assessed through coding of the transcripts. The coding will identify the use of open and closed questions, cues that are ignored, who is dominating the conversation and any expression of tears will be coded as high emotional impact.
Timepoint [1] 303044 0
Conducted at the initial clinic appointment

Eligibility
Key inclusion criteria
> 18 years of age
Eligible to attend the psychosocial palliative care clinic (in that they have a high performance status and can manage a 90 minute appointment.)
Communicate in English
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cognitive impairment with a mini mental state <22 for the patient or caregiver
Palliative care clients choosing not to provide consent
Patients attending the clinic without a family caregiver.

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
A sample of 30 patients and 30 caregivers has been chosen. This is a mixed methods study. The sample size for the qualitative components will be reached through saturation of themes. The coding of communication variables will be conducted on the transcripts of consultations with 30 patients and their caregivers combined with the health care professional, and then with the same 30 patients alone with health care professionals and the same 30 caregivers alone with health care professionals. This will provide a total of 90 transcripts to be coded, which will provide sufficient power to enable group comparisons.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/05/2013
Actual
22/05/2013
Date of last participant enrolment
Anticipated
30/06/2014
Actual
25/06/2014
Date of last data collection
Anticipated
Actual
30/06/2014
Sample size
Target
30
Accrual to date
Final
25
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 1067 0
Repatriation Hospital - Daw Park
Recruitment postcode(s) [1] 6925 0
5041 - Daw Park

Funding & Sponsors
Funding source category [1] 287372 0
Self funded/Unfunded
Name [1] 287372 0
Country [1] 287372 0
Primary sponsor type
Hospital
Name
Repatriation General Hospital
Address
700 Goodwood road
Daw Park, SA 5041
Country
Australia
Secondary sponsor category [1] 286118 0
University
Name [1] 286118 0
Flinders University
Address [1] 286118 0
Flinders Drive
Bedford park, SA, 5042
Country [1] 286118 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289347 0
Southern Adelaide Human Research and Ethics Committee
Ethics committee address [1] 289347 0
The Flats
Flinders Drive
Bedford Park, SA 5042
Ethics committee country [1] 289347 0
Australia
Date submitted for ethics approval [1] 289347 0
Approval date [1] 289347 0
09/04/2013
Ethics approval number [1] 289347 0
038.13

Summary
Brief summary
Research design: This will be conducted as a mixed methods study within the psychosocial outpatient clinic setting where patients are seen together by the Nurse Practitioner and Social Worker and then separated so that the patient is seen by the psychosocial nurse alone and the caregiver is seen by the Caregiver Network Facilitator alone. The Caregiver Network Facilitator is a relatively new role introduced into the palliative care team as a support role to assist family caregivers to mobilise their own social networks.
Methods:
Tape recorded interviews of patients and their caregivers seen both together and separately will be transcribed verbatim, and the content coded to quantify communication variables. The coding will identify the use of open and closed questions, cues that are ignored, who is dominating the conversation and any crying that takes place. Coding will be conducted by the chief investigator with one other investigator coding some of the transcripts to ensure coding reliability.
A grounded theory approach is utilised for the qualitative component of the study, as it involves the reading of transcripts, identifying possible themes, comparing and contrasting themes and building theoretical models. NVivo software will be utilised to analyse the qualitative component of the study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40398 0
Ms Kate Swetenham
Address 40398 0
Southern Adelaide Palliative Services
Repatriation General Hospital
700 Goodwood Road
Daw Park
SA 5041
Country 40398 0
Australia
Phone 40398 0
+61 8 82751732
Fax 40398 0
Email 40398 0
[email protected]
Contact person for public queries
Name 40399 0
Ms Kate Swetenham
Address 40399 0
Southern Adelauide Palliative Services
Repatriation General Hospital
700 Goodwood Road
Daw Park, SA 5041
Country 40399 0
Australia
Phone 40399 0
+61 8 92751732
Fax 40399 0
Email 40399 0
[email protected]
Contact person for scientific queries
Name 40400 0
Prof David Currow
Address 40400 0
Department of Palliative and Supportive Services
Flinders University
700 Goodwood Road
Daw Park, SA 5041
Country 40400 0
Australia
Phone 40400 0
+61882751732
Fax 40400 0
Email 40400 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This field was added 5 years after study had concluded.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Swetenham, K. Tieman J, Butow P, Currow D ( 2015) ... [More Details]

Documents added automatically
No additional documents have been identified.