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Trial registered on ANZCTR


Registration number
ACTRN12621000456853p
Ethics application status
Not yet submitted
Date submitted
15/03/2021
Date registered
19/04/2021
Date last updated
19/04/2021
Date data sharing statement initially provided
19/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Forget-me-not: engaging patients, carers and General Practitioners to review antipsychotics used for delirium, dementia and other related conditions after hospital discharge
Scientific title
Forget-me-not: evaluating the effect of an interdisciplinary, patient, carer and General Practitioner-inclusive interventions on antipsychotic de-prescription after discharge from hospital in patients with delirium, acute behavioural and psychological symptoms of dementia, and other related conditions
Secondary ID [1] 303692 0
Nil known
Universal Trial Number (UTN)
U1111-1266-1223
Trial acronym
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
dementia 321094 0
delirium 321095 0
Condition category
Condition code
Neurological 318896 318896 0 0
Dementias
Neurological 318897 318897 0 0
Alzheimer's disease
Neurological 319284 319284 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a pre-post study involving 2 cohort of patients recruited during two separate 12week periods. The 'pre' phase is the control group, and the 'post' phase is the intervention group.

Participant allocation and recruitment:
All patients meeting the study selection criteria for each phase of the study will be invited to participate. Eligibility will be monitored by researchers to who have access to daily hospital patient lists and clinical information which will assist with flagging eligible patients for recruitment by pharmacists providing direct patient care.

The 'control' group will receive standard usual care provided at this hospital:
*provision of general verbal information to patients/carers from clinical pharmacists about antipsychotics prescribed at discharge. This is currently without emphasis on recommended duration of treatment.
* provision of written information in the form of a Consumer Medicines Information sheet (TGA approved)
* provision of a pharmacy generated "medication list" which lists all prescribed medicines at discharge. This list provides information on dosage and general indication for a medicine but for antipsychotics, does not specify details on recommended duration of treatment
* medical teams do not routinely contact GP to discuss anti-psychotic prescribing and management plans

For intervention phase patients, a suite of interventions in addition to standard clinical care will be provided. These are:

At the time of hospital discharge, a clinical pharmacist will provide patients and/or their carers
* increased and specific verbal information on the risk/benefits of antipsychotic use in dementia, post delirium and other related conditions, including best practice guidelines on the recommended duration of use.
* written information from an established, reputable national (Australian) consumer focused organisation for Dementia (namely Dementia Australia but may include others), to support pharmacist provided information. Written information provided will come from material already available in the public domain
* adjustment to Pharmacy Department generated "medication list" used as part of standard care, to re-iterate the added verbal and written information provided regarding antipsychotic use. Explicit recommendations for review of antipsychotics used beyond 12 weeks will be added to this list.

After hospital discharge:
A hospital medical officer (Senior Medical Registrar) will telephone the participants primary care physician (General Practitioner) within 1 week of hospital discharge to discuss participant's specific anti-psychotic treatment, hospital medical team’s prescribing and management intention (where initiated in hospital). Where deemed clinically appropriate for the patient, the hospital medical officer will provide a dose reduction or deprescribing plan to the GP for consideration and action. The dose reduction plan will be jointly generated by hospital medical officer and pharmacist, using a purposely designed de-prescribing template based on a peer reviewed algorithm (www.deprescribing.org). The GP will discuss and action the plan with the patient as part of ongoing primary care.

Strategies to monitor adherence to the intervention will include:
* a centralised database of all patients consented to the study
* clinical documentation of telephone calls and transmission of deprescribing plan (via email or fax) to GP by the Senior Medical Registrar into the patients hospital medical records
* documentation in the centralised study database when intervention is delivered and if attempts to contact GP fail, documentation of date(s) and follow up plan
Intervention code [1] 319987 0
Behaviour
Intervention code [2] 319988 0
Treatment: Other
Intervention code [3] 320249 0
Prevention
Comparator / control treatment
Control participants will receive standard usual clinical care during the study's 'pre-implementation' phase (12 week period).
Standard usual care provided at this hospital is:
* provision of general verbal information to patients/carers from clinical pharmacists about antipsychotics prescribed at discharge. This is currently without emphasis on recommended duration of treatment.
* provision of written information in the form of a Consumer Medicines Information sheet (TGA approved)
* provision of a pharmacy generated "medication list" which lists all prescribed medicines at discharge. This list provides information on dosage and general indication for a medicine but for antipsychotics, does not specify details on recommended duration of treatment
* medical teams do not routinely contact GP to discuss anti-psychotic prescribing and management plans

A clinical pharmacist will obtain participant consent during usual interaction when patient is discharged from hospital. Participants will receive 2 telephone calls (week 1 and week 12-14 after discharge) from the research team to assess study outcome measures
Control group
Historical

Outcomes
Primary outcome [1] 326832 0
Comparative prevalence of complete de-prescribing of anti-psychotic treatment.

This will be assessed by self reporting during a telephone call with the patient/carer at 12-14weeks. Supporting information (where consent provided) to verify information reported by patient/carer includes contacting the participants GP, Community Pharmacy, aged care facility or viewing the My Health Record.
Timepoint [1] 326832 0
12 weeks after hospital discharge
Secondary outcome [1] 392834 0
Comparative prevalence of dose reduction in anti-psychotic treatment (total daily dose of single antipsychotic)
Timepoint [1] 392834 0
12 weeks after hospital discharge.

The method of assessment is hospital prescription record (for baseline dose) and patient/carer reported (for dose at 12 weeks). Where consent provided, information reported by patient/carer will be verified by contacting the participants GP, Community Pharmacy, aged care facility or viewing the My Health Record.
Secondary outcome [2] 392835 0
Comparative prevalence of dose reduction in anti-psychotic treatment (number of anti-psychotic agents)
Timepoint [2] 392835 0
12 weeks after hospital discharge.

The method of assessment is hospital prescription record (for baseline number of antipsychotics prescribed) and patient/carer reported (number of antipsychotics prescribed at 12 weeks). Where consent provided, information reported by patient/carer will be verified by contacting the participants GP, Community Pharmacy, aged care facility or viewing the My Health Record.
Secondary outcome [3] 394016 0
Quality of life measured using the Dementia Quality of Life (DEMQOL) instrument (for participants with dementia diagnosis only]
Timepoint [3] 394016 0
The DEMQOL instrument will be administered by telephone to participants with dementia diagnosis at 12-14wks after hospital discharge by a trained member of the research team.
Secondary outcome [4] 394017 0
Quality of life measured using the Dementia Quality of Life (DEMQOL-Proxy) instrument (for carers of participants with dementia diagnosis only]
Timepoint [4] 394017 0
The DEMQOL-Proxy instrument will be administered by telephone to carers of participants with dementia diagnosis at 12-14wks after hospital discharge by a trained member of the research team.

Eligibility
Key inclusion criteria
• Patients discharging from an inpatient admission under a General Medicine Unit (of the study organisation) to any address in the state of Victoria, Australia
•Patients discharged with prescription of at least 1 oral antipsychotic (including ‘prn’- when required treatments)
•Patient able to give informed consent OR consent provided by medical treatment decision maker
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients with the following ICD-10 Classification of Mental and Behavioural Disorders:
o F20-F29 - schizophrenia, schizotypal states and delusional disorders
o F30-31 – manic episode, bipolar affective disorder
o F40-F48 - Neurotic, stress-related and somatoform disorders
o F02.3 - Dementia in Parkinson’s Disease

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Other
Other design features
This is a pre-post study, where all patients during a specified 12 week period will be in the 'pre' or controlled group followed by another 12 weeks where patients will be allocated to the 'post' or intervention group.

Participants will only be allocated to one arm of the study. Any patients recruited to the ‘pre-intervention’ phase are ineligible for the ‘intervention’ phase. This is to address the common occurrence of hospital readmissions.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculation is based on hypothesis that the study intervention will have an effect size of 25% reduction in prevalence of anti-psychotic prescribing at 12 weeks. We estimate that 80% of patients remain on antipsychotic at 12 weeks without any intervention. The sample size therefore to show a 25% reduction (p value = 0.05, power =80%) is calculated to be 81 patients in each study phase. The final sample size for the intervention phase can be more accurately determined with prevalence data from the pre-intervention phase is obtained.

Data analysis

Demographic details of study participants will be reported using descriptive statistics. Categorical outcome variables will be tested for significance using a Chi-Square test. Means of continuous variables (e.g. % dose reduction of anti-psychotic) will be tested for significance using Mann-Whitney U test or t-tests. Statistical analysis will be conducted using appropriate statistical analysis software e.g. Jamovi® (Version 1.6.15 Solid for Windows).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/05/2021
Actual
Date of last participant enrolment
Anticipated
26/11/2021
Actual
Date of last data collection
Anticipated
21/02/2022
Actual
Sample size
Target
162
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 18902 0
Box Hill Hospital - Box Hill
Recruitment hospital [2] 18903 0
Angliss Hospital - Upper Ferntree Gully
Recruitment hospital [3] 18904 0
Maroondah Hospital - Ringwood East
Recruitment postcode(s) [1] 33409 0
3128 - Box Hill
Recruitment postcode(s) [2] 33410 0
3156 - Upper Ferntree Gully
Recruitment postcode(s) [3] 33411 0
3135 - Ringwood East

Funding & Sponsors
Funding source category [1] 308107 0
Charities/Societies/Foundations
Name [1] 308107 0
Eastern Health Foundation
Country [1] 308107 0
Australia
Primary sponsor type
Other
Name
Eastern Health
Address
5 Arnold St
Box Hill, Vic 3128
Country
Australia
Secondary sponsor category [1] 308856 0
None
Name [1] 308856 0
Address [1] 308856 0
Country [1] 308856 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 308092 0
Eastern Health Human Research Ethics Committee (HREC),
Ethics committee address [1] 308092 0
Ethics committee country [1] 308092 0
Australia
Date submitted for ethics approval [1] 308092 0
30/04/2021
Approval date [1] 308092 0
Ethics approval number [1] 308092 0

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

Contacts
Principal investigator
Name 109506 0
Ms Cathy Ngo
Address 109506 0
C/O Pharmacy Department
Box Hill Hospital
8 Arnold Street, Box Hill Vic 3128
Country 109506 0
Australia
Phone 109506 0
+61433063009
Fax 109506 0
Email 109506 0
cathy.ngo@easternhealth.org.au
Contact person for public queries
Name 109507 0
Cathy Ngo
Address 109507 0
C/O Pharmacy Department
Box Hill Hospital
8 Arnold Street, Box Hill Vic 3128
Country 109507 0
Australia
Phone 109507 0
+61433063009
Fax 109507 0
Email 109507 0
cathy.ngo@easternhealth.org.au
Contact person for scientific queries
Name 109508 0
Cathy Ngo
Address 109508 0
C/O Pharmacy Department
Box Hill Hospital
8 Arnold Street, Box Hill Vic 3128
Country 109508 0
Australia
Phone 109508 0
+61433063009
Fax 109508 0
Email 109508 0
cathy.ngo@easternhealth.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The data collected is and will remain the property of the hospital organisation. We have not applied for Ethics approval for (de-identified) sharing of IPD as much relates to a participants clinical care and not appropriate for access outside of the organisation.


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
No additional documents have been identified.