Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001543178
Ethics application status
Approved
Date submitted
23/10/2019
Date registered
8/11/2019
Date last updated
18/07/2022
Date data sharing statement initially provided
8/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
SMART OPS: Shared decision making Multidisciplinary Approach; a Randomised controlled Trial in the Older adult Population considering Surgery.
Scientific title
SMART-OPS: Shared decision making Multidisciplinary Approach; a Randomised controlled Trial in the Older adult Population considering Surgery
Secondary ID [1] 299475 0
none
Universal Trial Number (UTN)
U1111-1242-4621
Trial acronym
SMART OPS
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Ageing 314916 0
Cancer 314917 0
Chronic Obstructive Pulmonary Disease (COPD) 314918 0
cardiovascular disease (such as coronary heart disease and stroke) 314920 0
general surgical conditions 315024 0
vascular pathology 315025 0
Nearing end of life 315026 0
Condition category
Condition code
Surgery 313274 313274 0 0
Other surgery
Cancer 313275 313275 0 0
Any cancer
Anaesthesiology 313355 313355 0 0
Anaesthetics
Cardiovascular 313356 313356 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention arm is a shared decision making multidisciplinary team meeting. The MDT includes the patient along with any support persons they would like, an anaesthetist, surgeon, and social worker or Clinical Nurse Consultant relevant to the surgical area. Consultation with any appropriate health care professionals including the participant’s GP will occur as appropriate to each individual patient.
Shared decision involves 'choice', 'option' and 'preference' talk:
1. ‘Choice’ talk
a. Ensure there is agreement on the nature of the problem
b. Introduce the concept that more than one option exists to investigate, manage or treat the problem. There is an acknowledgement that a choice may be a non-interventional option. Explicitly acknowledging uncertainty in medicine and unpredictable outcomes is essential.
c. A key component of this section is to highlight that patient’s beliefs, values and preferences are important in working out best options
d. It is also essential to check if the patient has understood the choice talk
e. It is important at this initial stage to defer closure of the conversation so that the clinician and patient can move to ‘option talk’.
2. ‘Option’ talk
a. This may begin by checking for existing knowledge as a starting point for listing options
b. A summary list of options may be used, before exploring each option in more detail. This is a way of making sure that the patient does not miss the opportunity to learn about options that they may already have discounted.
c. The clinicians may then start by describing what each option entails. This helps to separate the description of each option from the discussion of the risks and benefits of each.
d. An essential component of this section is to then explore risks, benefits and consequences and the chances (likelihoods) of these benefits and risks actually occurring. This can take the form of, for example, describing the most relevant and common risk or consequence before describing the benefit. Part of the multidisciplinary preparation for the SDM meeting will be to individualise (as far as possible) this particular patient’s risks.
e. The option talk often includes a check by the clinicians that the patient understands what has been discussed about the options and the relevant risk/benefit explanations.
f. As above, patient preference should be woven throughout this section
3. ‘Preference’ talk
a. Whilst patient preferences/values happen throughout the SDM process, it is essential to actively enquire about the patient’s values and preferences as they assimilate information about options. This section refers to values and attitudes of the patient and not directly to the preference for a particular option.
b. At this stage, it is sometimes useful to summarise what has been done and state that it may be appropriate to make a decision at this time
c. It is important to recognise that patients may need time for deliberation before a decision is made. Some patients may wish to access more information etc
d. It may also be appropriate to help the patient to explore the options in terms of what is important to them.
e. If appropriate, patients can, at this point, state their preferences and move to make a decision

a. The MDT aims to occur as soon as possible post referral and will varied. This is due to the complexity of gathering the people that are important to attend this meeting.

b. Content of the meeting: As above - patient values, risks and benefits for ALL management options including 'do nothing'

c. The meeting will be planned for 1 hour and will be 1 face to face with phone follow up and further face to face if necessary for follow up questions

d. As above (mode of administration)

e. MDT with surgeon, anaesthetist, and social worker

f. formal training with follow up training once started. visits to other centers performing SDM. Adherence to SDM protocol (including necessary pre-work, attendance, consultations etc) will be monitored
Intervention code [1] 315875 0
Other interventions
Comparator / control treatment
Control group
The control is usual peri-operative care – either Consultation or Preadmission clinic depending upon referral process as described above.
No singular John Hunter Guideline exists to describe 'Usual Peri-operative care'. If a patient has a 'request for admission' submitted (ie. a request for surgery), they receive a Pre-admission appointment unless considered (after review by a Perioperative Nurse) as low risk. Various components of this Pre-admission process may involve one of many guidelines in existence such as management of diabetes.

Consultation occurs if a surgeon subjectively feels that an anaesthetist review is warranted before listing a patient for surgery.
Control group
Active

Outcomes
Primary outcome [1] 321767 0
Patient decisional conflict (Decisional conflict scale)
Timepoint [1] 321767 0
24 – 72 hours after treatment trajectory decision making (primary outcome)
30D, 90D, 6M and 1yr (secondary outcome).
Secondary outcome [1] 376144 0
Treatment trajectory (initial suggested surgery vs modified surgery vs non-surgical) - from medical records
Timepoint [1] 376144 0
At time of referral for surgery till 1 year post MDT
Secondary outcome [2] 376145 0
Patient service costs - Data for resource use within HNEH will be obtained from routinely populated health service databases. Data requested will include all contacts/events within the health service including general admissions, ICU admissions, emergency attendances, consultations, surgery, diagnostics, medications, any out-patient services provided by HNEH, etc. for each participant.
Timepoint [2] 376145 0
24 – 72 hours after treatment trajectory decision making (primary outcome)
30D, 90D, 6M and 1yr (secondary outcome).
Secondary outcome [3] 376409 0
Quality of Life: EQ5D scores
Timepoint [3] 376409 0
At 30 days and 90 days, post treatment as changed from baseline.
6 months and 1-year post intervention/ control.
Secondary outcome [4] 376410 0
Life impact
Timepoint [4] 376410 0
Days out of hospital and alive at 30 days, 90 days, 6 months and 1-year post treatment
Secondary outcome [5] 376411 0
On the day surgery cancellations
Timepoint [5] 376411 0
When surgery cancelled
Secondary outcome [6] 376412 0
Intensive Care days admitted
Timepoint [6] 376412 0
Recorded at discharge from hospital
Secondary outcome [7] 376413 0
Modified Rankin Score
Timepoint [7] 376413 0
At time of patient recruitment and at 30 days post treatment
Secondary outcome [8] 376414 0
Readmissions/ representations to hospital
Timepoint [8] 376414 0
Up to 1 year post treatment.
Changes made prior to enrolment commencement.
Secondary outcome [9] 376415 0
Patient Mortality
Timepoint [9] 376415 0
Recorded as soon as patient dies. Notification via the clinical applications portal or general practitioner/surgeon. The outcome of this assessment is up to 1 year post treatment.
Secondary outcome [10] 391844 0
ICECAP-O: (ICEpop CAPability measure for Older people)
Timepoint [10] 391844 0
Baseline at time of recruitment and at 30D, 90D, 6M, and 1yr.

Eligibility
Key inclusion criteria
All patients aged > 65 or > 45 if Aboriginal or Torres Strait Islander undergoing Major General or Vascular Elective or Semi-urgent surgery will undergo SORT tool risk stratification.
patients with a SORT predicted 30 day mortality of >4% for patients if planned for a laparoscopic cholecystectomy or > 3% for all other major general surgical or vascular procedures will be eligible.
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients from the above group will be excluded if they have opted out from this study.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analysis- Results will be analysed using the intention to treat principle. For continuous outcomes (QoL, patient and clinician satisfaction ratings, acceptance and engagement in process) obtained at multiple time points (7, 30 and 90 days) a linear mixed model will be used to compare the repeated measures across the 2 groups, avoiding the need for multiple comparisons at each time point; mixed models are also able to handle missing data in the event that a participant does not complete a questionnaire at a given follow-up time point. The models will also include a time x group interaction term to check if the effect of the intervention differs over time, and a term for randomisation strata.
For count outcomes (days alive and out of hospital, and ICU days) a Poisson or negative binomial regression model will be used with a term accounting for randomisation strata; depending on the distribution of values, a zero-inflated model may also have to be used.
For surgery types (initial, modified, cancelled) a logistic regression will be used to compare intervention and control groups, accounting for randomisation strata.
For the Modified Glasgow Outcome scale, an ordinal regression mixed model will be used to detect if there is shift towards better functional status in the intervention vs control group at each time point adjusting for strata.
For readmissions/representations and mortality, a time to event analysis will be done using Kaplan-Meier curves, with a Wilcoxon test for early differences and a log rank test for late differences. In the event that only readmissions/representations are used as the outcome, then mortality will be used in a competing risk analysis.
Economic analysis – A within trial cost-utility analyses (CUA) will be undertaken. The analysis will be conducted from the perspective of Hunter New England Health, as the key decision maker. Resource utilisation will account for the cost of implementing and delivering the intervention, as well as patient utilisation of HNEH services. Results will be expressed via an assessment of the incremental costs and outcomes of the intervention against usual care. Quality adjusted life years (QALYs) will be calculated using the EQ-5D or ICECAP-O outcome measures, and appropriate preference-based utility weights. The analysis will report the incremental cost-effectiveness ratio (ICER). Bootstrapping will estimate the uncertainty surrounding the ICER. Uncertainty will be graphically represented on cost-effectiveness planes. Cost-effectiveness acceptability curves (CEACs) will be derived to illustrate the probability that the intervention is cost effective in comparison with usual care for commonly-accepted thresholds. The analysis will be presented alongside additional economic considerations, such as differences in patient residence within aged care institutions and any impacts upon primary or allied health service utilisation.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
2/03/2020
Actual
20/02/2020
Date of last participant enrolment
Anticipated
30/05/2021
Actual
22/09/2021
Date of last data collection
Anticipated
16/12/2022
Actual
Sample size
Target
148
Accrual to date
Final
148
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 15035 0
John Hunter Hospital - New Lambton
Recruitment postcode(s) [1] 28319 0
2305 - New Lambton

Funding & Sponsors
Funding source category [1] 303975 0
Government body
Name [1] 303975 0
Medical Research Future Fund Rapid Applied Research Translation Grant.
Country [1] 303975 0
Australia
Funding source category [2] 307873 0
Charities/Societies/Foundations
Name [2] 307873 0
Anaesthesia Charitable Trust Foundation
Country [2] 307873 0
Australia
Primary sponsor type
Hospital
Name
John Hunter Hospital
Address
Locked Bag 1
Hunter Regional Mail Centre
NSW 2310
Country
Australia
Secondary sponsor category [1] 304147 0
Individual
Name [1] 304147 0
Dr Pragya Ajitsaria
Address [1] 304147 0
Peri-operative Services
John Hunter Hospital
Locked Bag 1
Hunter Regional Mail Centre NSW 2310
Country [1] 304147 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304475 0
Hunter New England Human Research Committee
Ethics committee address [1] 304475 0
Ethics committee country [1] 304475 0
Australia
Date submitted for ethics approval [1] 304475 0
25/10/2019
Approval date [1] 304475 0
16/12/2019
Ethics approval number [1] 304475 0
2019/ETH13349

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

Contacts
Principal investigator
Name 97078 0
Dr Pragya Ajitsaria
Address 97078 0
Staff Specialist, Anaesthetist
Peri-operative Services
John Hunter Hospital
Locked Bag 1
Hunter Regional Mail Centre NSW 2310
Country 97078 0
Australia
Phone 97078 0
+61 04 77340275
Fax 97078 0
+61 02 4921 4274
Email 97078 0
[email protected]
Contact person for public queries
Name 97079 0
Natalie Lott
Address 97079 0
Study Coordinator
John Hunter Hospital
Locked Bag 1
Hunter Regional Mail Centre NSW 2310
Country 97079 0
Australia
Phone 97079 0
+61 0418215968
Fax 97079 0
+61 02 4921 4274
Email 97079 0
[email protected]
Contact person for scientific queries
Name 97080 0
Natalie Lott
Address 97080 0
Study Coordinator
John Hunter Hospital
Locked Bag 1
Hunter Regional Mail Centre NSW 2310
Country 97080 0
Australia
Phone 97080 0
+61 0418215968
Fax 97080 0
+61 02 4921 4274
Email 97080 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


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
EmbaseProtocol paper for SMART OPS: Shared decision-making Multidisciplinary Approach - a Randomised controlled Trial in the Older adult Population considering Surgery.2023https://dx.doi.org/10.1136/bmjopen-2022-070159
N.B. These documents automatically identified may not have been verified by the study sponsor.