Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001262392
Ethics application status
Approved
Date submitted
25/08/2017
Date registered
1/09/2017
Date last updated
1/09/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Clinical and economic outcomes of the Reducing the Use of Sedatives (RedUSe) project in Australian residential aged care facilities
Scientific title
Clinical and economic outcomes of a multifaceted intervention (Reducing the Use of Sedatives; RedUSe project) to reduce the use of psycholeptic medications in residential aged care facilities
Secondary ID [1] 292721 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
ACTRN12608000221358

Health condition
Health condition(s) or problem(s) studied:
Behavioural and psychological symptoms of dementia 304485 0
Anxiety 304486 0
Sleep disorders 304487 0
Condition category
Condition code
Neurological 303821 303821 0 0
Dementias
Mental Health 303877 303877 0 0
Anxiety
Mental Health 303878 303878 0 0
Other mental health disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The research project described is an independent evaluation of the clinical and economic outcomes of an intervention called the "Reducing the Use of Sedatives Project" (RedUSe). The clinical and economic outcomes were assessed between the baseline of the RedUSe project and four months after implementation of the intervention.
The RedUSe project consists of educational sessions supported by auditing and benchmarking of sedative prescribing. There is also a sedative review component where pharmacists, nurses and doctors work together in consultation with the resident and/or relatives to review regularly used sedative medications (predominantly benzodiazepines and antipsychotics).
The educational component includes pharmacist-led sessions with nursing staff at the residential aged care facility at baseline and three months. Prescribers also receive academic detailing at these time points. Within these sessions, the health care providers receive the results of an electronic audit of antipsychotic and benzodiazepine prescribing that takes place at baseline, three and six months of the RedUSe project.
Additionally, residents identified by the audit as receiving regularly charted antipsychotic and/or benzodiazepine medications receive a medication review performed by a nurse, pharmacist and their usual general practitioner at baseline and 3 months of RedUSe.
Intervention code [1] 298966 0
Not applicable
Comparator / control treatment
Residents who do not have their antipsychotic and/or benzodiazepine reduced during the RedUSe project.
Control group
Active

Outcomes
Primary outcome [1] 303196 0
Changes in overall behavioural and psychological symptoms as measured with the Neuropsychiatric Inventory - Nursing Home version (NPI-NH). Assessed through interview with nursing staff member.
(Cummings J. Neuropsychiatric inventory - Nursing home version (NPI-NH) Los Angeles2009 [cited 2017 31/07]. Available from: http://www.dementiamanagementstrategy.com/File.axd?id=c9f7405f-3596-4f5f-9f8d-f322e5188678.)
Timepoint [1] 303196 0
Baseline and 4 months post commencement of the RedUSe project intervention
Primary outcome [2] 303197 0
Changes in resident quality of life as measured with the Assessment of Quality of Life-4 Dimensional tool (AQoL-4D). Assessed through interview with nursing staff member.
(Hawthorne G, Richardson J, Osborne R. The Assessment of Quality of Life (AQoL) instrument: a psychometric measure of Health-Related Quality of Life. Qual Life Res. 1999;8(3):209-24.)
Timepoint [2] 303197 0
Baseline and 4 months post commencement of the RedUSe project intervention
Primary outcome [3] 303198 0
Changes in resident agitation as measured with the Cohen-Mansfield Agitation Inventory (CMAI). Assessed through interview with nursing staff member.
(Cohen-Mansfield J, Marx MS, Rosenthal AS. A description of agitation in a nursing home. J Gerontol. 1989;44(3):M77–M84.)
Timepoint [3] 303198 0
Baseline and 4 months post commencement of the RedUSe project intervention
Secondary outcome [1] 338208 0
Difference in the number of falls.
Defined as an event which results in a person coming to rest inadvertently on the group or floor or other lower level.
The number of falls participating residents have is recorded by the champion nurse (nurse responsible for running the RedUSe project at their residential aged care facility) based on what is observed by that nurse and information within the progress notes.
Timepoint [1] 338208 0
Monthly (for 4 months from baseline to 4 months after commencement of the RedUSe project intervention)
Secondary outcome [2] 338209 0
Cost-effectiveness of the Reducing the Use of Sedatives project.

Cost-effectiveness of the RedUSe project intervention was calculated by estimating the costs to the government (total cost of medicines through the Pharmaceutical Benefits Scheme at baseline and four months, the total estimated hospitalisation cost during the period, the total cost of general practitioner consultations, and costs of the project) versus an approximation of the counterfactual (i.e. what would the cost be if the program was not implemented).
Timepoint [2] 338209 0
Baseline and 4 months post commencement of the RedUSe project intervention
Secondary outcome [3] 338210 0
Changes in nursing staff job satisfaction measured through anonymous completion of the "Adjusted Measure of Job Satisfaction Survey" by care staff (registered and enrolled nurses, and carers).
(Chou SC, Boldy DP, Lee AH. Measuring job satisfaction in residential aged care. International Journal For Quality In Health Care: Journal Of The International Society For Quality In Health Care / Isqua. 2002;14(1):49-54.)
Timepoint [3] 338210 0
Baseline and 4 months post commencement of the RedUSe project intervention
Secondary outcome [4] 338211 0
Changes in nursing staff caregiver burden measured through interviews of the nursing staff with the occupational disruptiveness subscale within the Neuropsychiatric Inventory- Nursing Home version
Timepoint [4] 338211 0
Baseline and 4 months post commencement of the RedUSe project intervention
Secondary outcome [5] 338212 0
The difference in the number of challenging behavioural episodes.
The number of challenging behavioural episodes participating residents have is recorded by the champion nurse (nurse responsible for running the RedUSe project at their residential aged care facility) based on what is observed by that nurse and information within the progress notes.
Timepoint [5] 338212 0
Monthly (for 4 months from baseline to 4 months after commencement of the RedUSe project intervention)
Secondary outcome [6] 338213 0
The difference in the number of general practitioner consultations.
The number of general practitioner consultations that participating residents have is recorded by the champion nurse (nurse responsible for running the RedUSe project at their residential aged care facility) based on what is observed by that nurse and information within the progress notes.
Timepoint [6] 338213 0
Monthly (for 4 months from baseline to 4 months after commencement of the RedUSe project intervention)
Secondary outcome [7] 338214 0
The difference in the number of hospitalisations.
The number of hospitalisations that participating residents have is recorded by the champion nurse (nurse responsible for running the RedUSe project at their residential aged care facility) based on what is observed by that nurse and information within the progress notes.
Timepoint [7] 338214 0
Monthly (for 4 months from baseline to 4 months after commencement of the RedUSe project intervention)
Secondary outcome [8] 338215 0
Change in activities of daily living measured with the Physical Self-Maintenance Scale, Assessed through interview with nursing staff member.
(Lawton MP, Brody EM. Assessment of older people: Self-maintaining and instrumental activities of daily living. Nurs Res. 1970;19(3):278.)
Timepoint [8] 338215 0
Baseline and 4 months post commencement of the RedUSe project intervention
Secondary outcome [9] 338318 0
Changes in resident social engagement measured with the Multidimensional Observational Scale for Elderly Subjects (MOSES) withdrawal subscale.
Assessed through interview with nursing staff member.
(Helmes E, Csapo KG, Short JA. Standardization and validation of the Multidimensional Observation Scale for Elderly Subjects (MOSES). J Gerontol. 1987;42(4):395-405.)
Timepoint [9] 338318 0
Baseline and 4 months post commencement of the RedUSe project intervention
Secondary outcome [10] 338322 0
Severity of falls
The severity of falls indicated by the champion nurse under one of the following three descriptors:
Minor (Minor injury that does not require significant medication intervention (e.g. small skin tear, minor bruise)
Moderate (Injury requiring GP or outpatient management and not resulting in permanent disability)
Severe (Severe injury resulting in hospitalisation and requiring substantial rehabilitation)
Timepoint [10] 338322 0
Monthly (for 4 months from baseline to 4 months after commencement of the RedUSe project intervention)
Secondary outcome [11] 338323 0
Changes in regularly charted antipsychotic daily doses by converting antipsychotic doses to an equivalent daily chlorpromazine dose.
Data obtained from resident medication chart.
Timepoint [11] 338323 0
Baseline and 4 months post commencement of the RedUSe project intervention
Secondary outcome [12] 338324 0
Changes in regularly charted benzodiazepine daily doses by converting benzodiazepine doses to an equivalent daily diazepam dose.
Data obtained from resident medication chart.
Timepoint [12] 338324 0
Baseline and 4 months post commencement of the RedUSe project intervention
Secondary outcome [13] 338326 0
Differences in the severity of challenging episodes.
The severity of challenging episodes indicated by the champion nurse under one of the following four descriptors:
Minor (managed in house- no additional treatment needed (e.g. excessive wandering, calling out).
Moderate (GP needed or treatment started (e.g. Self-harm or struck staff/other residents)
Severe- specialist visit required OR Severe- hospitalisation required
Timepoint [13] 338326 0
Monthly (for 4 months from baseline to 4 months after commencement of the RedUSe project intervention)
Secondary outcome [14] 338327 0
The difference in reasons for general practitioner consultations.

Reasons for general practitioner consultations is recorded by the champion nurse (nurse responsible for running the RedUSe project at their residential aged care facility) based on what is observed by that nurse and information within the progress notes.
Timepoint [14] 338327 0
Monthly (for 4 months from baseline to 4 months after commencement of the RedUSe project intervention)
Secondary outcome [15] 338328 0
The difference in reasons for hospitalisations.

Reasons for hospitalisations is recorded by the champion nurse (nurse responsible for running the RedUSe project at their residential aged care facility) based on what is observed by that nurse and information within the progress notes.
Timepoint [15] 338328 0
Monthly (for 4 months from baseline to 4 months after commencement of the RedUSe project intervention)
Secondary outcome [16] 338329 0
The difference in lengths of hospital admissions.

Length of hospital admissions is recorded by the champion nurse (nurse responsible for running the RedUSe project at their residential aged care facility) based on what is observed by that nurse and information within the progress notes.
Timepoint [16] 338329 0
Monthly (for 4 months from baseline to 4 months after commencement of the RedUSe project intervention)

Eligibility
Key inclusion criteria
Residents: All of the following criteria need to be met for participation:
• Residents must reside at RACFs included in the 2nd, South Australian, 3rd and 4th wave of the RedUSe project.
• Residents must be taking psycholeptic medications (antipsychotics and/or benzodiazepines) at baseline.

Staff: Includes RNs, ENs and carers at RACFs involved in the 2nd, South Australian, 3rd and 4th wave of the RedUSe project.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Residents who have a diagnosed severe mental health condition such as schizophrenia or bipolar disease.
• Residents in respite care
• Residents in final stages of a palliative illness.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Data analysis
Changes in resident psycholeptic medication use between baseline and four months will be used to group residents into clusters representing a decrease or increase/no-change in psycholeptic medication use.
Demographic information will be included as descriptive data for publication. This data will be described in a group format with percent of categorical variation and mean and standard deviation values on numerical data being reported.
Relationships between changes in the Neuropsychiatric Inventory- Nursing Home version (NPI-NH) total scores, Cohen-Mansfield Agitation Inventory total score, Multidimensional Observational Scale for Elderly Subjects-withdrawal subscale score, Assessment of Quality of Life- 4 dimensional total and dimensional scores, number and severity of falls, activities of daily living score, caregiver distress (subscale of NPI-NH), measure of job satisfaction, and psycholeptic medication use will be sought via statistical analysis. This will be done using regression techniques and a possible mediation analysis.
The research team plan to conduct paired t-tests with two categories to assess associations between outcome variables. Analyses will be performed using SPSS version 24 (IBM, Chicago II). All tests will be two-sided and p-values <0.05 will be considered statistically significant.

Economic analysis
The economic analysis will be a cost-utility analysis. The cost of healthcare per resident will be estimated and comparisons will be made between residents whose psycholeptic medications are reduced and residents whose medications are not reduced. Variables (and severity) including falls, challenging (behavioural) events, hospitalisations and general practitioner visits will be accounted for in the cost-benefit assessment.
We will also determine the quality of life (measured with the AQoL-4D tool) of residents in each of these scenarios. This will enable us to calculate quality of life adjusted life years (QALYs) to perform the cost-utility analysis of the project. This economic analysis will ultimately provide policymakers with an Incremental Cost Effectiveness Ratio (ICER) from which they can determine whether it is beneficial to fund similar projects in the future. Due to the inherent uncertainty involved in the cost and quality of life estimates, a sensitivity analysis will also be conducted to determine a range

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
7/01/2015
Date of last participant enrolment
Anticipated
Actual
2/12/2015
Date of last data collection
Anticipated
Actual
11/03/2016
Sample size
Target
200
Accrual to date
Final
206
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC
Recruitment postcode(s) [1] 17095 0
7005 - Sandy Bay
Recruitment postcode(s) [2] 17096 0
7004 - South Hobart
Recruitment postcode(s) [3] 17097 0
5037 - North Plympton
Recruitment postcode(s) [4] 17098 0
5214 - Goolwa
Recruitment postcode(s) [5] 17099 0
5097 - St Agnes
Recruitment postcode(s) [6] 17100 0
5085 - Northgate
Recruitment postcode(s) [7] 17101 0
5052 - Belair
Recruitment postcode(s) [8] 17102 0
5118 - Gawler
Recruitment postcode(s) [9] 17103 0
5171 - Mclaren Vale
Recruitment postcode(s) [10] 17104 0
4021 - Kippa-Ring
Recruitment postcode(s) [11] 17105 0
4551 - Caloundra
Recruitment postcode(s) [12] 17106 0
4350 - Toowoomba
Recruitment postcode(s) [13] 17107 0
2190 - Greenacre
Recruitment postcode(s) [14] 17108 0
2035 - Maroubra
Recruitment postcode(s) [15] 17109 0
2232 - Sutherland
Recruitment postcode(s) [16] 17110 0
3082 - Mill Park
Recruitment postcode(s) [17] 17111 0
3034 - Avondale Heights
Recruitment postcode(s) [18] 17112 0
3196 - Bonbeach
Recruitment postcode(s) [19] 17113 0
5065 - Toorak Gardens
Recruitment postcode(s) [20] 17114 0
3196 - Chelsea
Recruitment postcode(s) [21] 17115 0
5045 - Glenelg
Recruitment postcode(s) [22] 17116 0
5074 - Campbelltown
Recruitment postcode(s) [23] 17117 0
5011 - Woodville
Recruitment postcode(s) [24] 17118 0
5167 - Port Noarlunga

Funding & Sponsors
Funding source category [1] 297362 0
Government body
Name [1] 297362 0
Department of Social Services
Country [1] 297362 0
Australia
Primary sponsor type
Individual
Name
Juanita Westbury
Address
Wicking Dementia Research and Education Centre, Room 421C (Level 4), Medical Science 1, Hobart CBD Campus, 7001
Country
Australia
Secondary sponsor category [1] 296347 0
None
Name [1] 296347 0
Address [1] 296347 0
Country [1] 296347 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298463 0
The Tasmanian Health and Medical Human Research Ethics Committee
Ethics committee address [1] 298463 0
Ethics committee country [1] 298463 0
Date submitted for ethics approval [1] 298463 0
17/04/2014
Approval date [1] 298463 0
26/05/2014
Ethics approval number [1] 298463 0
H0013999

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

Contacts
Principal investigator
Name 77162 0
Mr Daniel Hoyle
Address 77162 0
School of Medicine (Pharmacy)
University of Tasmania
Private Bag 26
Hobart, TAS 7001
Country 77162 0
Australia
Phone 77162 0
+61362261529
Fax 77162 0
+61362267627
Email 77162 0
[email protected]
Contact person for public queries
Name 77163 0
Daniel Hoyle
Address 77163 0
School of Medicine (Pharmacy)
University of Tasmania
Private Bag 26
Hobart, TAS 7001
Country 77163 0
Australia
Phone 77163 0
+61362261529
Fax 77163 0
+61362267627
Email 77163 0
[email protected]
Contact person for scientific queries
Name 77164 0
Daniel Hoyle
Address 77164 0
School of Medicine (Pharmacy)
University of Tasmania
Private Bag 26
Hobart, TAS 7001
Country 77164 0
Australia
Phone 77164 0
+61362261529
Fax 77164 0
+61362267627
Email 77164 0
[email protected]

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