Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000142538
Ethics application status
Approved
Date submitted
12/12/2022
Date registered
15/02/2024
Date last updated
15/02/2024
Date data sharing statement initially provided
15/02/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Addressing safety, quality and cost of care through a novel, telehealth, outpatient transitional care model – the TTOMMI trial
Scientific title
Addressing safety, quality and cost of care through a novel, telehealth, outpatient transitional care model to determine the impact on preventable hospitalisations in people with multimorbidity– the TTOMMI trial
Secondary ID [1] 306635 0
None
Universal Trial Number (UTN)
Trial acronym
TTOMMI Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
preventable hospital readmission 325556 0
multimorbidity 325557 0
Condition category
Condition code
Public Health 322930 322930 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention in this study will require implementation of a transition coordination service, focusing on the use of nursing transition coordinators, known as ‘STARnurses’ – i.e., nurses that Support Transitions And Referrals. The Stokes’ ‘Foundations Framework' will be used to guide implementation of the intervention to develop and test a transitional model of care (MoC) to optimally support people living with multimorbidity, via telehealth (including telephone), and support continuity of care between the secondary (acute) and primary healthcare sectors to minimise direct contact with hospital services.

The STARnurses will receive role and research orientation training on commencement of employment into the STARnurse role. The role is at a Level 2 Registered Nurse, and a Position Description has been designed.

Physical or informational materials used in the intervention include:
• Participant consent and patient information sheets
• Participant health information and folder
• Supporting Transitions and Referrals nurse (STARnurse). Information re STARnurse role and Service description
• Nursing and other validated assessment tools (e.g., Kessler K 10, ESAS-r, [Edmonton Symptom assessment]GSE & MUST tools
• Referral Pathways
• Patients will use their own mobile phone or device for telehealth or phone conversations. If no device available to an iPad will be offered.
Procedures, activities, and/or processes:
• Consent procedure
• Nursing, health, and transition assessment with the patient and family/significant other(s)
• Transition management and care planning and phone call follow up with the patient and family/significant other(s), GP, practice nurse and service providers/supports
• Follow up phone calls with participant, for the purpose of monitoring their condition and progress post-discharge and coordination support services required.

Intervention delivery
The intervention will be delivered, either over the phone or via teledirect – an interactive online health platform.

The mode of delivery: Initial assessment and planning will be face to face. Following discharge, the participant will be followed up via telephone or teledirect.

The number of times the intervention will be delivered and over what period of time: The intervention will be delivered once, over a period of 6 – 8 weeks.

The location/setting where the intervention occurs: the intervention will be over the phone or online, from the hospital (Supporting Transitions and Referrals nurse [STARnurse]) to the patients’ location (most often at home).

Any strategies used to assess or monitor adherence or fidelity to the intervention: Training of the STARnurses to ensure fidelity of assessment and intervention delivery has been provided. This involved a week of orientation and 1 month piloting of the intervention. Similarly, the multidisciplinary team have had education and information regarding the nature of the intervention and their role.

When there is multi-D staff turnover (i.e., new interns or registrars) the incumbent staff will handover patients and the STAR nurses and researcher will provide education to new or rotating staff.

Intervention fidelity: The Lead investigator (Professor Sepehr Shakib) will review and audit participants’ electronic medical records and data collection for quality and consistency. The STARnurses will be supported and supervised operationally by a Level 3 registered nurse. The trial will be governed by clinical research expert advisory group.

The intervention will involve four main stages:
Phase 1: In-hospital ‘risk of readmission’ transition screening. This will be delivered by ‘STARnurses’, Transition Coordination nurses who Support Transitions and Referrals for the participants.

When participants are identified as ‘high-risk of readmission, the STARnurses will use the following assessment tools to assess the patients’ transition needs: General Nursing Assessment, Barthel Index, Edmonton Frailty scale, ESAS-r assessment, K10 Kessler, MUST scale and GSE.

Phase 2: In-hospital patient baseline assessment, more detailed risk of readmission assessment and collaborative development of a Transition Action Plan;

Based on the needs identified from the detailed assessment a template transition action plan has been developed that the STAR nurse will complete with and for all participants. The GP will be contacted prior to the patient’s discharge and the transition action plan communicated to them on the patients discharge.

Phase 3: Post-discharge from hospital, participants will receive transitional care coordination, with phone calls or telehealth follow up in the first 48 hours following discharge, and then weekly and fortnightly. The purpose of the phone calls will be to monitor participants’ stability ad progress. If the person deteriorates, a pathway has been established to recall the patient to an urgent/immediate care centre for further assessment and management and prevent a hospital admission. The patient has been previously instructed to call the STARnurse if they are feeling unwell, or not progressing (in addition to the routine phone calls).

Phase 4: Discharge from the transition service and handover to the general practitioner and practice nurse (primary health care setting). This would require a conversation with the patient and discussion with the Multi-D team to ensure patient is stable in the community and if not stable – follow up care required by GP or others. A phone call and letter to the GP/Practice will summarise the participants’ transition admission, discharge and follow up care required.

Usual care is defined as the ‘usual follow up services’ planned whilst the patient is in hospital, prior to discharge. Follow up is not implemented at all post-discharge from the hospital (usual care). However, some services are planned or initiated whilst the participant is in hospital in preparation for post-discharge, but provision of these services is not followed up. These services would include ‘hospital in the home,’ RDNS, rehabilitation or respite services.
Intervention code [1] 323072 0
Treatment: Other
Comparator / control treatment
Usual care is defined as the ‘usual follow up services’ planned whilst the patient is in hospital, prior to discharge. Follow up is not implemented at all post-discharge from the hospital (usual care). However, some services are planned or initiated whilst the participant is in hospital in preparation for post-discharge, but provision of these services is not followed up. These services would include ‘hospital in the home,’ RDNS, rehabilitation or respite services.
Control group
Active

Outcomes
Primary outcome [1] 330703 0
Rate of representation to hospital (emergency department or hospital admission) within 1 month of discharge from index admission
Timepoint [1] 330703 0
Within 1 month of discharge from index admission
Secondary outcome [1] 431076 0
Evaluate the patient experience with continuity of care and the transition service (Patient Continuity of Care Questionnaire, PCCQ)
Timepoint [1] 431076 0
3 months from index admission
Secondary outcome [2] 431077 0
Assess patients’ symptom burden pre and post transitional support service intervention
Timepoint [2] 431077 0
Baseline (index admission),
6-8 weeks post index admission
12 months post index admission
Secondary outcome [3] 431078 0
Evaluate patients’ quality of life, self-efficacy, and symptom management, pre and post intervention
Timepoint [3] 431078 0
Baseline (index admission),
6-8 weeks post index admission
12 months post index admission
Secondary outcome [4] 431079 0
Calculate a cost/benefit analysis on the transitional service model of care
Timepoint [4] 431079 0
On research completion (12 - 18 months from enrolment of first participant).

Eligibility
Key inclusion criteria
• Inpatients (ward or emergency department)
• Sufficient cognitive function and English language skills to provide informed consent and complete assessments
• Ability to engage in telehealth
• A history of either diabetes with cardiovascular disease, or comorbidity in at least 3 of the following illness domains:
o Diabetes: type 1 or type 2
o Cardiovascular disease: symptomatic atherosclerotic disease (ischemic heart disease, cerebrovascular disease, peripheral vascular disease, symptomatic valvular heart disease or atrial fibrillation
o Chronic cardiac failure
o Psychiatric illness including mood or anxiety disorders
o Respiratory disease including chronic obstructive airways disease, asthma, or interstitial lung disease
o Kidney disease resulting in chronic renal impairment with creatinine clearance <30 ml/min
o Current active malignancy.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients living in or likely to be discharged to high level residential aged care facility
• Patients enrolled in a comprehensive management program on discharge, e.g., formal rehabilitation program, rehabilitation in the home, heart failure outreach service, COPD pulmonary rehabilitation, hospital in the home, or receiving disability or community psychiatric services including care coordination
• Patients followed up through other local health network (LHN) services providing community outreach such as patients who are homeless
• Patients with a current history of illicit drug or alcohol dependence which may interfere with ability to engage with the program
• Patients with palliative intent and likely to have a life expectancy of less than 6 months
• Patients due for elective readmission within 2 weeks of current hospital discharge
• Insufficient cognitive function or English language skills to provide informed consent and complete assessments.

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)
randomisation table
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Pragmatic RCT
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Listed below: Sample size per group by baseline readmission rate and absolute reduction in readmission with 80% power and a=0.05

Baseline readmission rate in
control group at 3 months

Absolute reduction in readmission rate 35%, 40%, 45%
in intervention group,

15%, 136, 150, 160
20%, 70, 79, 86
25%, 40, 47, 52

Statistical methods to be undertaken
An intent-to-treat approach will be used. Linear regression analyses will be conducted to estimate effects of the intervention on primary and secondary outcomes. A hospital fixed effects model will be used to account for stratification at the hospital level. Sensitivity analyses will be performed to assess the robustness of the findings.
Sample size estimation & justification
The main aim of a sample size calculation will be to determine the number of participants needed to detect a clinically relevant effect of the transitions service intervention. (Charan and Biswas 2013) . As discussed above the patient population has been selected to have a high baseline readmission rate, and these patients are known to have a high proportion of preventable readmissions attributed to poor care coordination. Our previous data has demonstrated that a similar group of patients (those with diabetes and cardiovascular disease (HREC/18/CALHN/120)) have a 25-30% representation rate within 28 days of discharge. As this intervention is anticipated to be up to 6 weeks, and the effect is expected to help prevent representations beyond this time, our primary endpoint will be to evaluate representation to the emergency department or readmission within 3 months.
Our previous study demonstrated that approximately 40% of patients had a representation by 3 months. The readmission rate in this study may be higher due to enrolment of patients with greater multimorbidity, and the exclusion of patients already receiving other CALHN services.
We anticipate that the enrolment of approximately 200 patients over 18 months will be feasible and provide us with sufficient sample size to achieve the primary outcome with the likely baseline readmission rate in the control group and absolute reduction in the intervention group (Above). Given that the primary endpoint will be derived from SA health information systems, and the study has an intention-to-treat approach, there will be need to consider a larger sample size for consideration of withdrawals, drop-outs, or loss to follow up.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
8/11/2023
Date of last participant enrolment
Anticipated
9/11/2024
Actual
Date of last data collection
Anticipated
22/04/2025
Actual
Sample size
Target
200
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 21962 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [2] 21963 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 37056 0
5011 - Woodville
Recruitment postcode(s) [2] 37057 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 310962 0
Hospital
Name [1] 310962 0
Hospital Research Foundation
Country [1] 310962 0
Australia
Funding source category [2] 311000 0
University
Name [2] 311000 0
The University of South Australia
Country [2] 311000 0
Australia
Primary sponsor type
University
Name
The University of Adelaide
Address
115 Grenfell Street Adelaide, SA 5005 Australia
Country
Australia
Secondary sponsor category [1] 312311 0
University
Name [1] 312311 0
The University of South Australia
Address [1] 312311 0
Located in: University of South Australia, City East CampusAddress: 101 Currie St, Adelaide SA 5001
Country [1] 312311 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310521 0
Central Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 310521 0
Ethics committee country [1] 310521 0
Australia
Date submitted for ethics approval [1] 310521 0
30/03/2022
Approval date [1] 310521 0
29/06/2023
Ethics approval number [1] 310521 0
CALHN Reference Number: 17554

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

Contacts
Principal investigator
Name 117942 0
Prof Sepehr SHAKIB
Address 117942 0
Professor, Discipline of Pharmacology, Adelaide Medical School, University of Adelaide, Royal Adelaide Hospital, North Terrace, Adelaide, 5000 South Australia, Australia.
Country 117942 0
Australia
Phone 117942 0
+61 411 100 278
Fax 117942 0
Email 117942 0
sepehr.shakib@sa.gov.au
Contact person for public queries
Name 117943 0
Kate Davis
Address 117943 0
UniSA Clinical & Health SciencesUniversity of South AustraliaCity East Campus | Playford Building P4-27 | North Terrace, ADELAIDE SA 5000
Country 117943 0
Australia
Phone 117943 0
+61 417893274
Fax 117943 0
Email 117943 0
kate.davis@unisa.edu.au
Contact person for scientific queries
Name 117944 0
Sepehr SHAKIB
Address 117944 0
Professor, Discipline of Pharmacology, Adelaide Medical School, University of Adelaide, Royal Adelaide Hospital, North Terrace, Adelaide, 5000 South Australia, Australia.
Country 117944 0
Australia
Phone 117944 0
+61 411 100 278
Fax 117944 0
Email 117944 0
sepehr.shakib@sa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified patient data
When will data be available (start and end dates)?
The data will initially be available from August 2025 and then stored for ongoing availability for a minimum of 15 years post publication of findings. Therefore data availability is anticipated to end in 2040.This is consistent with national guidelines and UniSA policy and procedures guidelines for general research.
Available to whom?
Other researchers for sound research purposes
Available for what types of analyses?
IPD Meta-analysis
How or where can data be obtained?
Via Chief Investigator, Professor Sepehr Shakib, sepehr.shakib@adelaide.edu.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17837Study protocol  kate.davis@unisa.edu.au Uploaded 383721-(Uploaded-29-01-2024-17-51-56)-Study-related document.pdf
17838Informed consent form  kate.davis@unisa.edu.au Uploaded 383721-(Uploaded-29-01-2024-17-53-58)-Study-related document.docx
21148Ethical approval  kate.davis@unisa.edu.au Uploaded 383721-(Uploaded-29-01-2024-17-55-37)-Study-related document.pdf
21521Other  kate.davis@unisa.edu.au 'Participant information sheet' (provided and disc... [More Details] 383721-(Uploaded-29-01-2024-17-58-04)-Study-related document.docx



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.