Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000580279
Ethics application status
Approved
Date submitted
3/04/2018
Date registered
16/04/2018
Date last updated
16/04/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A trial of a specialist pharmacist review of medications for people moving to residential care for the first time
Scientific title
Feasibility study of medication review by a specialist pharmacist and guided by a prognostic indicator for older people entering Aged Residential Care
Secondary ID [1] 294458 0
Nil known
Universal Trial Number (UTN)
U1111-1187-5247
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Polypharmacy 307213 0
Frailty 307214 0
Condition category
Condition code
Public Health 306325 306325 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Older people entering long-term Aged Residential Care (ARC) for the first time will be recruited. Written and verbal explanations of the study will be provided by a trained research assistant. If the person agrees to participate in the study written consent will be obtained. The research assistant will record a quality-of-life score.
Participants will go through a Medicines Therapy Assessment (MTA) conducted by an accredited pharmacist. This involves the pharmacist reviewing medication records, meeting with the participant (and family or other caregiver when appropriate) and discussing their priorities for care and their medications. The assessment will take 45-60 minutes. It will occur as a one-off intervention.
The Changes in Health, End-Stage Symptoms and Signs (CHESS) scale is routinely collected as part of the ARC admission process in all older people in New Zealand. This is a prognostic indicator with scores from 0-5, higher scores indicating poorer prognosis. The pharmacist will also consider this score. The pharmacist will then develop individualised recommendations based on admission medications, participants priorities and potential prognosis. Detailed recommendations will be provided to the participants regular GP, by personal visit, phone call, email or letter as preferred by the GP. The GP will be responsible for making any medication changes. There will be no additional follow-up with the GP after the initial assessment and recommendations are made.
After 3 and 6 months the research assistant will review number and classes of medications and repeat the quality-of-life scale again.
Intervention code [1] 300752 0
Treatment: Other
Comparator / control treatment
For the control facilities the initial approach will be made by ARC staff. If the person agrees to meet the research team, the research assistant will visit and gain consent to access the person's medical/ ARC records for information on medications and outcomes. Other than gaining consent there will be no intervention, their GP will provide the best standard of usual care. This will be individualised care based on the older person's medical history and current active conditions.
Control group
Active

Outcomes
Primary outcome [1] 305333 0
Acceptability of intervention to older people.
This will be assessed by collecting the number of eligible patients offered a medication review at the time of admission to ARC, and the number of these people who accept the offer of a review.
Timepoint [1] 305333 0
Baseline
Primary outcome [2] 305334 0
Acceptability of intervention to GPs
This will be assessed by identifying GPs who provide services to the intervention ARC facilities. They will be provided with information about the proposed intervention, and provided with a form indicating if they will be willing for their patients to have a medication review.
Timepoint [2] 305334 0
Baseline
Primary outcome [3] 305335 0
Number of pharmacist recommendation taken up by GPs.
Number and classes of medications will be recorded at the time of admission to ARC, before the pharmacist review. They will then be recorded again 3 and 6 months after the review. Changes will be matched with pharmacist recommendations, and the number of recommendations which are followed will be recorded.
Timepoint [3] 305335 0
3 (primary time point) and 6 months
Secondary outcome [1] 344879 0
Quality of Life
This will be assessed by the EuroQOL Quality of Life scale. This is a validated scale widely used in older people, both for research and clinical management.
Timepoint [1] 344879 0
Baseline, 3 and 6 months

Eligibility
Key inclusion criteria
Aged over 65 years (55 y for Maori).
Moving to long-term Aged Residential Care for the first time.
On four or more medications.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Palliative or terminal care
On three or less medications
In ARC for short stay respite or rehabilitation and expected to return to their own home.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Intervention will be determined at the facility level.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
For the statistical analysis participant characteristics (demographics, medication use, and clinical characteristics) will be summarised by group using simple descriptive statistics, numbers and percentages for categorical data and means and standard deviations or medians and interquartile ranges for descriptive statistics.
Feasibility outcomes will be summarised descriptively. Specifically the number and percentage of those approached of older people/ caregivers who consent to take part in the study and the number of GPs who consent to take part in the study, and the level of missingness in the data collected.
Participant outcomes (medication use at the different time points, clinical events and QoL) will be summarised descriptively by group. In particular the type of medications prescribed (ie preventative versus symptomatic treatments) will be described. Differences for those receiving the intervention and those who received usual care will be explored using regression models.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/04/2018
Actual
Date of last participant enrolment
Anticipated
17/10/2019
Actual
Date of last data collection
Anticipated
17/04/2020
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment outside Australia
Country [1] 10243 0
New Zealand
State/province [1] 10243 0
Canterbury

Funding & Sponsors
Funding source category [1] 299082 0
Government body
Name [1] 299082 0
Health Research Council
Country [1] 299082 0
New Zealand
Primary sponsor type
Individual
Name
Claire Heppenstall
Address
Portacom A, Burwood Hospital,
Private Bag 4708,
Christchurch 8140
Country
New Zealand
Secondary sponsor category [1] 298325 0
University
Name [1] 298325 0
University of Otago
Address [1] 298325 0
PO Box 4345,
Christchurch 8140
Country [1] 298325 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300019 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 300019 0
Ministry of Health,
Health and Disability Ethics Committees,
PO Box 5013,
Wellington 6140.
Ethics committee country [1] 300019 0
New Zealand
Date submitted for ethics approval [1] 300019 0
28/03/2018
Approval date [1] 300019 0
10/04/2018
Ethics approval number [1] 300019 0
18/sth/76

Summary
Brief summary
Introduction: Older people in Aged Residential Care (ARC) usually have multiple complex, physical, mental and social needs. Most are on multiple medications (polypharmacy). This is associated with adverse outcomes including falls, fractures, cognitive decline, incontinence and hospital admissions. This study will examine the intervention of a pharmacist-led medication review, guided by a routinely collected prognostic scale, and a frailty score.
Methods and analysis: This is a feasibility study. Study population: Participants will be new admissions to long-term residential care in Christchurch. There will be 8 intervention facilities and 4 control facilities. Participants will be approached in the first month after they enter ARC. Intervention: A specialist pharmacist will review medications, guided by patient’s treatment priorities, a prognostic scale (InterRAI CHESS scale) and a frailty index (Reported Edmonton Frailty Score, REFS). Recommendations will be made to GPs, who will make final decisions on any medication changes. Primary outcomes: Number of older people and GPs accepting a medication review. Number of pharmacist recommendation adopted by GPs (measured by number and classes of medications) after three and six months. Secondary outcomes: quality of life at baseline, three and six months. Hospital admissions after 3 and 6 months. Increased level of care after three and six months.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2566 2566 0 0
/AnzctrAttachments/374805-full protocol.docx (Protocol)
Attachments [2] 2567 2567 0 0
/AnzctrAttachments/374805-patient information sheet.docx (Participant information/consent)

Contacts
Principal investigator
Name 82278 0
Dr Claire Heppenstall
Address 82278 0
University of Otago, Department of Medicine,
Portacom A, Burwood Hospital,
Private Bag 4708,
Christchurch 8140.
Country 82278 0
New Zealand
Phone 82278 0
+64 27 349 4703
Fax 82278 0
Email 82278 0
[email protected]
Contact person for public queries
Name 82279 0
Claire Heppenstall
Address 82279 0
University of Otago, Department of Medicine,
Portacom A, Burwood Hospital,
Private Bag 4708,
Christchurch 8140.
Country 82279 0
New Zealand
Phone 82279 0
+64 27 349 4703
Fax 82279 0
Email 82279 0
[email protected]
Contact person for scientific queries
Name 82280 0
Claire Heppenstall
Address 82280 0
University of Otago, Department of Medicine,
Portacom A, Burwood Hospital,
Private Bag 4708,
Christchurch 8140.
Country 82280 0
New Zealand
Phone 82280 0
+64 27 349 4703
Fax 82280 0
Email 82280 0
[email protected]

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No Supporting Document Provided



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