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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]

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

Anxiety

Sleep disorders

Condition category

Condition code

Neurological

Dementias

Mental Health

Anxiety

Mental Health

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]

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]

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]

Baseline and 4 months post commencement of the RedUSe project intervention

Primary outcome [2]

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]

Baseline and 4 months post commencement of the RedUSe project intervention

Primary outcome [3]

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]

Baseline and 4 months post commencement of the RedUSe project intervention

Secondary outcome [1]

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]

Monthly (for 4 months from baseline to 4 months after commencement of the RedUSe project intervention)

Secondary outcome [2]

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]

Baseline and 4 months post commencement of the RedUSe project intervention

Secondary outcome [3]

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]

Baseline and 4 months post commencement of the RedUSe project intervention

Secondary outcome [4]

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]

Baseline and 4 months post commencement of the RedUSe project intervention

Secondary outcome [5]

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]

Monthly (for 4 months from baseline to 4 months after commencement of the RedUSe project intervention)

Secondary outcome [6]

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]

Monthly (for 4 months from baseline to 4 months after commencement of the RedUSe project intervention)

Secondary outcome [7]

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]

Monthly (for 4 months from baseline to 4 months after commencement of the RedUSe project intervention)

Secondary outcome [8]

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]

Baseline and 4 months post commencement of the RedUSe project intervention

Secondary outcome [9]

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]

Baseline and 4 months post commencement of the RedUSe project intervention

Secondary outcome [10]

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]

Monthly (for 4 months from baseline to 4 months after commencement of the RedUSe project intervention)

Secondary outcome [11]

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]

Baseline and 4 months post commencement of the RedUSe project intervention

Secondary outcome [12]

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]

Baseline and 4 months post commencement of the RedUSe project intervention

Secondary outcome [13]

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]

Monthly (for 4 months from baseline to 4 months after commencement of the RedUSe project intervention)

Secondary outcome [14]

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]

Monthly (for 4 months from baseline to 4 months after commencement of the RedUSe project intervention)

Secondary outcome [15]

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]

Monthly (for 4 months from baseline to 4 months after commencement of the RedUSe project intervention)

Secondary outcome [16]

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]

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?

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]

7005 - Sandy Bay

Recruitment postcode(s) [2]

7004 - South Hobart

Recruitment postcode(s) [3]

5037 - North Plympton

Recruitment postcode(s) [4]

5214 - Goolwa

Recruitment postcode(s) [5]

5097 - St Agnes

Recruitment postcode(s) [6]

5085 - Northgate

Recruitment postcode(s) [7]

5052 - Belair

Recruitment postcode(s) [8]

5118 - Gawler

Recruitment postcode(s) [9]

5171 - Mclaren Vale

Recruitment postcode(s) [10]

4021 - Kippa-Ring

Recruitment postcode(s) [11]

4551 - Caloundra

Recruitment postcode(s) [12]

4350 - Toowoomba

Recruitment postcode(s) [13]

2190 - Greenacre

Recruitment postcode(s) [14]

2035 - Maroubra

Recruitment postcode(s) [15]

2232 - Sutherland

Recruitment postcode(s) [16]

3082 - Mill Park

Recruitment postcode(s) [17]

3034 - Avondale Heights

Recruitment postcode(s) [18]

3196 - Bonbeach

Recruitment postcode(s) [19]

5065 - Toorak Gardens

Recruitment postcode(s) [20]

3196 - Chelsea

Recruitment postcode(s) [21]

5045 - Glenelg

Recruitment postcode(s) [22]

5074 - Campbelltown

Recruitment postcode(s) [23]

5011 - Woodville

Recruitment postcode(s) [24]

5167 - Port Noarlunga

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Department of Social Services

Address [1]

Tuggeranong Office Park, Soward Way and Athllon Drive, Greenway ACT 2900

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Tasmanian Health and Medical Human Research Ethics Committee

Ethics committee address [1]

Office of Research Services
University of Tasmania
Private Bag 01
Hobart TAS 7001

Ethics committee country [1]

Date submitted for ethics approval [1]

17/04/2014

Approval date [1]

26/05/2014

Ethics approval number [1]

H0013999

Summary

Brief summary

A multifaceted program (the Reducing the Use of Sedatives; RedUSe project) was implemented across 150 Australian residential aged care facilities (RACFs). 
The RedUSe project consisted of educational sessions supported by auditing and benchmarking of sedative prescribing. There was 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 antipsychotics and benzodiazepines). 
We aimed to review the clinical outcomes of the residents and nursing home staff, and economic outcomes for the health care system resulting from this intervention. 
We hypothesised that reduced use of antipsychotics and/or benzodiazepines, as a result of this project, will:
- Not negatively affect behavioural and psychological symptoms
- Improve resident quality of life
- Decrease the rate of resident falls
- Increase activities of daily living
- Decrease general practitioner visits
- Decrease hospitalisations
- Decrease caregiver burden
- Increase the job satisfaction of nursing staff
- Be associated with lower costs to the health care system than 'usual' practice. 

Nursing staff were interviewed with validated questionnaires to assess behavioural and psychological symptoms, social engagement, activities of daily living, and caregiver burden at the start and four months of RedUSe. 
Additionally, nursing staff were required to record the number of falls, challenging episodes, hospitalisations, and general practitioner consultations the residents had each month for the same four month period (a minor addendum to their existing recording activities). 
To asses job satisfaction, an anonymous survey was made available at the start and four months of RedUSe.

Trial website

Trial related presentations / publications

Hoyle, D and Westbury, J and Bindoff, I and Clinnick, L and Peterson, G, “Impact of sedative reduction, via a multifaceted intervention, on long-term care facility residents”, International Psychogeriatric Association Annual Congress 2016, 6-9 September, San Francisco, USA, pp. 41-42. (2016) [Conference Extract]

Hoyle, D and Westbury, JL and Bindoff, IK and Clinnick, L* and Peterson, GM, “The impact of psycholeptic reduction in residential aged care facilities: Preliminary findings”, 29 November - 2 December, 2015, Hobart, Tasmania (2015) [Conference Extract] 

Hoyle, D and Westbury, JL and Bindoff, IK and Clinnick, L*, “The impact of psychotropic reduction within aged care facilities”, 4-6 November, 2015, Alice Springs, Australia (2015) [Conference Extract]

Hoyle, D and Westbury, JL and Bindoff, IK and Peterson, GM, “The impact of reducing sedatives on residents: the rationale for translating sedative reduction into clinical outcomes”, 29 November - 2 December, 2015, Hobart, Tasmania (2015) [Conference Extract]

Hoyle, D and Westbury, J and Bindoff, I and Clinnick, L and Peterson, G, “The impact of sedative reduction on agitation and falls in aged care facilities: preliminary findings”, Bringing Research to Life: 14th National Conference of Emerging Researchers in Ageing Program and Proceedings, 7-8 December 2015, Melbourne, Australia, pp. 63-66. (2015) [Refereed Conference Paper]

Hoyle, D and Westbury, JL and Bindoff, IK and Peterson, GM, “Why 'RedUSe'? Rationale for studying the clinical outcomes of sedative reduction in the residential aged care setting”, 24-25 September 2014, Adelaide, Australia, pp. 42. (2015) [Conference Extract]

Hoyle, D and Westbury, JL and Bindoff, IK and Peterson, GM, “Clinical outcomes of reducing the use of sedatives in residents of aged care facilities”, 2014, Hobart, Tasmania (2014) [Conference Extract]

Hoyle, D and Westbury, J and Bindoff, I and Peterson, G, “Why 'RedUSe'? Rationale for studying the clinical outcomes of sedative reduction in the residential aged care setting”, Making Research Matter: Proceedings of the 13th National Conference of Emerging Researchers in Ageing, 24-25 November 2014, Adelaide, Australia, pp. 84-87. (2014) [Refereed Conference Paper]

Public notes

Contacts

Principal investigator

Name

Mr Daniel Hoyle

Address

School of Medicine (Pharmacy)
University of Tasmania
Private Bag 26
Hobart, TAS 7001

Country

Australia

Phone

+61362261529

Fax

+61362267627

Daniel.Hoyle@utas.edu.au

Contact person for public queries

Name

Daniel Hoyle

Address

School of Medicine (Pharmacy)
University of Tasmania
Private Bag 26
Hobart, TAS 7001

Country

Australia

Phone

+61362261529

Fax

+61362267627

Daniel.Hoyle@utas.edu.au

Contact person for scientific queries

Name

Daniel Hoyle

Address

School of Medicine (Pharmacy)
University of Tasmania
Private Bag 26
Hobart, TAS 7001

Country

Australia

Phone

+61362261529

Fax

+61362267627

Daniel.Hoyle@utas.edu.au

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