Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000080325
Ethics application status
Approved
Date submitted
5/01/2017
Date registered
16/01/2017
Date last updated
4/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Integrating specialist palliative care into residential care for older people: a stepped wedge trial (INSPIRED trial)
Scientific title
Integrating specialist palliative care into residential care for older people: a stepped wedge trial (INSPIRED trial)
Secondary ID [1] 290797 0
None
Universal Trial Number (UTN)
Trial acronym
INSPIRED
Linked study record

Health condition
Health condition(s) or problem(s) studied:
ageing 301441 0
dementia 301442 0
Dying 301443 0
Condition category
Condition code
Public Health 301161 301161 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Indirect support
1. Needs rounds. Needs rounds are monthly 60minute triage (and risk stratification) meetings, where up to ten residents with a short prognosis and high symptom burden are presented by facility staff to the specialist palliative care clinician. Residents do not attend needs rounds. Discussions focus on treatment/symptom management planned. Case-based education is integrated into the needs round, with each resident’s bio-psycho-social status discussed to promote symptom management, and identify opportunities to extend and reinforce staff knowledge. The markers for a prognosis of six month or less, taken from the Palliative Approach toolkit (Parker & Hughes 2010), are used to identify residents to be discussed in needs rounds:
a. Answering “no” to the question would you be surprised if the resident died within the next six months
b. Significant functional or medical decline
c. Conflict concerning whether goals of care should be curative or palliative in intent (e.g. after an acute event)
d. If the resident is transferred or admitted to the facility specifically for comfort or palliative care
Needs rounds frequently lead to initiating the other elements of the model.

2. Case-based education for staff. There are multiple opportunities for educating staff within the model that the specialist palliative care team engage in. Specifically, education may focus on communicating with residents, relatives and GPs, symptom management approaches, identifying deteriorating patients. Education will be provided at the monthly needs rounds to attending staff. This may include some didactic teaching as well as socratic method. All education will be based on the clinical cases presented during the Needs Rounds. Needs rounds last one hour, the education component may be around half of this time.

3. Case conferences. These meetings between facility staff, resident, relatives and relevant health care providers (including, but not limited to the GP, geriatrician, dementia services) and are facilitated by either the GP or facility staff. Case conferences are attended and facilitated by specialist palliative care staff at the beginning of the intervention to model how to conduct the meetings. As the facility staff gain confidence, they take over the chair function, and specialist palliative care are involved only when resident/family have complex physical, psychological or social needs. The agenda focuses on resident and/or family concerns, moving to discussion of how quality of life could be improved, goals of care (including discussion about hospitalization), and completion of an advance care plan. Medications and care plan may be changed as a consequence of these discussions. The facility staff explain their capacity to achieve the goals which have been described. Case conferences will be organised on an 'as required' basis, as identified in the needs rounds.. Typically, they last one hour. Often only one case conference will be required per resident.

Direct support
4. Clinical work with relevant residents. Both needs rounds and case-conferences may lead to referrals for direct specialist palliative care clinical work with residents. Clinical referrals may also arise from other residents who have not been discussed in needs rounds or case conferences. Direct clinical work involves: symptom assessment, diagnosis, symptom management. At times, direct clinical work with residents also included Chairing case-conferences. However, as the model proposes that these are primarily driven and led by the facilities, they are primarily conceptualised as indirect care. Only the most complex case-conferences are Chaired by the specialist palliative care team, for example where staff report that family conflict over goals of care requires specialist intervention to explain how symptoms and end of life can be supported.


Duration of intervention will vary. Since this is a stepped wedge design, some facilities will receive the intervention for 13 months, and the last facilities to join the study will receive it for four months.
Intervention code [1] 296710 0
Treatment: Other
Comparator / control treatment
Usual care: Usual care involves access to the specialist palliative care team’s two nurses who work in residential aged care. Their role includes elements 3&4 of the model described above. Critically though there is no embedded ‘triage’ element in the form of the needs rounds and limited case-based education for staff. Essentially, the current model of care (usual care) is reactive, whereas the trial intervention is proactive and anticipatory.

This is a stepped wedge design, so the length of control period varies for sites throughout the trial. The minimum control period (for sites randomised to receive the intervention first) will be 2 months. The maximum control period will be 10 months for sites receiving the intervention last.
Control group
Active

Outcomes
Primary outcome [1] 300574 0
Length of hospitalisation for residents. This will be measured in days and determined via review of hospital records.
Timepoint [1] 300574 0
Prospectively throughout the control and intervention period.
Secondary outcome [1] 330347 0
Preferred place of death will be measured by recording recorded preference and actual place of death. Data will be drawn from the facility's medical records for the resident. Data will be recorded as a binary of yes/no, regarding whether preferred place of death was achieved.
Timepoint [1] 330347 0
Prospectively throughout control and intervention period, following the death of any resident.
Secondary outcome [2] 330670 0
A 9-item questionnaire measuring staff death literacy and knowledge will be used (the PEPA questionniare). This paper-based questionniare will be administered to staff at facilities.

Timepoint [2] 330670 0
Prospectively throughout the intervention period, This will be conducted monthly at the needs rounds meetings.
Secondary outcome [3] 330671 0
Family views on care will be collected using the Brief Assessment Scale for Caregivers (BASC) of the Medically Ill. This paper-based questionnaire will be given to families to complete.
Timepoint [3] 330671 0
Prospectively at baseline, end of control and at the end of the intervention period.
Secondary outcome [4] 330672 0
Quality of Death (using the QODD, Curtis et al. 2002, Curtis et al. 2013). This is a paper-based questionnaire, which staff will be trained to complete
Timepoint [4] 330672 0
Prospectively throughout control and intervention period, completed following the death of any resident.

Eligibility
Key inclusion criteria
Inclusion criteria for facilities in the trial:
1. Residential facility operating in the Australian Capital Territory from January 2017-December 2018.
2. Senior management agreement to access residents’ records.
3. Staff working at the collaborating facilities who are registered nurses or assistants in nursing (notwithstanding the important role of the whole multi-disciplinary team, these are the staff groups who provide most direct care).
4. Residents whose data is collected must have the facility as their main residence (thereby excluding those on respite stay).

Inclusion criteria for staff completing outcome measures
1. Staff who by virtue of their role, are invited to Needs Rounds meetings. This will include: team leaders, registered nurses, enrolled nurses, site managers, and some carers.
2. Over 18 and willing/able to give informed consent.

Inclusion criteria for relatives completing outcome measures
1. Relative of a resident in one of the participating facilities.
2. Over 18 and willing/able to give informed consent.


Inclusion criteria for the process evaluation:
Recruitment for the process evaluation will proceed through sampling of residents or relatives whose care was considerably shaped and changed by the palliative care team. Five staff, patients or relatives will be recruited per site. Inclusion criteria are:
*Resident able to provide informed consent, as assessed by the clinician, using the mini-mental state examination, cut-off score of 20 (Pachet et al. 2010) to inform eligibility.
*Relative or enduring power of attorney of a resident, able to provide informed consent.
*The resident must have had their clinical care discussed at a needs round.
*Care of the resident was considerably shaped and changed, operationalised as the provision of staff education (for example on death, dying, setting goals of care), or providing advice on symptom management.

Process evaluation will also include data collection from facility staff. Building on data collected in the pilot work, senior staff within the facility will be identified for individual interviews to identify the impact of the intervention on their staff and working practices. Inclusion criteria are:
*Care managers, educators or general managers who have attended needs rounds.
*Willing and able to give informed consent.
*Aged 18 or over.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Stepped wedge
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Given the intrinsic limitation of the study with a high level of turnover for both staff and residents, that staff and patients in each step at each site are to be considered as independent groups. Hence, the comparison on the primary outcome, namely the length of hospitalisation, between the intervention and control phases will adopt an independent two-group comparison approach for the overall intervention effect. Based on the underlying distribution of the outcome measure, an appropriate comparison technique will be applied parametrically or non-pararmetrically. A similar approach will also be adopted for the analyses of secondary outcomes.

Economic analysis of anticipated cost savings will be derived from cost per bed day in local acute hospitals, comparing the control and intervention time periods.

Qualitative data will be analysed adopting a five-stage process of familiarisation: identifying a thematic framework, indexing the data, synthesising across respondents and data interpretation to form key themes (Braun & Clarke 2006). A more fine-grained approach to analyzing data from patients may be adopted, for example conversation or discourse analysis which has been used to positive effect with adults with cognitive impairment (Pierce et al. 2015).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2017
Actual
1/02/2017
Date of last participant enrolment
Anticipated
29/04/2018
Actual
1/06/2018
Date of last data collection
Anticipated
30/06/2018
Actual
30/06/2018
Sample size
Target
720
Accrual to date
Final
1701
Recruitment in Australia
Recruitment state(s)
ACT

Funding & Sponsors
Funding source category [1] 295219 0
Hospital
Name [1] 295219 0
Calvary Public Hosptial, Canberra
Country [1] 295219 0
Australia
Funding source category [2] 295330 0
University
Name [2] 295330 0
Australian Catholic University
Country [2] 295330 0
Australia
Funding source category [3] 298430 0
Government body
Name [3] 298430 0
ACT Health
Country [3] 298430 0
Australia
Primary sponsor type
University
Name
Australian Catholic University
Address
Antill Street, Watson,
Canberra,
2600, Australian Capital Territory
Country
Australia
Secondary sponsor category [1] 294047 0
Hospital
Name [1] 294047 0
Calvary Public Hospital, Bruce
Address [1] 294047 0
Calvary Public Hospital
Mary Potter Circuit
Canberra,
Australian Capital Territory, 2617
Country [1] 294047 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296564 0
Calvary Public Hospital Bruce
Ethics committee address [1] 296564 0
Ethics committee country [1] 296564 0
Australia
Date submitted for ethics approval [1] 296564 0
28/09/2016
Approval date [1] 296564 0
21/12/2016
Ethics approval number [1] 296564 0
Ethics committee name [2] 296565 0
ACT Health HREC
Ethics committee address [2] 296565 0
Ethics committee country [2] 296565 0
Australia
Date submitted for ethics approval [2] 296565 0
09/01/2017
Approval date [2] 296565 0
Ethics approval number [2] 296565 0
Not approved

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

Contacts
Principal investigator
Name 71310 0
Prof Liz Forbat
Address 71310 0
Australian Catholic University
Antill Street
Watson
Canberra
ACT, 2600
Country 71310 0
Australia
Phone 71310 0
+44 1786 467796
Fax 71310 0
Email 71310 0
[email protected]
Contact person for public queries
Name 71311 0
Liz Forbat
Address 71311 0
Australian Catholic University
Antill Street
Watson
Canberra
ACT, 2600
Country 71311 0
Australia
Phone 71311 0
+44 1786 467796
Fax 71311 0
Email 71311 0
[email protected]
Contact person for scientific queries
Name 71312 0
Liz Forbat
Address 71312 0
Australian Catholic University
Antill Street
Watson
Canberra
ACT, 2600
Country 71312 0
Australia
Phone 71312 0
+44 (0)1786 467796
Fax 71312 0
Email 71312 0
[email protected]

No information has been provided regarding IPD availability


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
EmbaseImproved Quality of Death and Dying in Care Homes: A Palliative Care Stepped Wedge Randomized Control Trial in Australia.2020https://dx.doi.org/10.1111/jgs.16192
EmbaseReducing time in acute hospitals: A stepped-wedge randomised control trial of a specialist palliative care intervention in residential care homes.2020https://dx.doi.org/10.1177/0269216319891077
N.B. These documents automatically identified may not have been verified by the study sponsor.