Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000261718
Ethics application status
Approved
Date submitted
20/12/2021
Date registered
14/02/2022
Date last updated
14/02/2022
Date data sharing statement initially provided
14/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of an intervention comprising a coordinated and integrated medicine management service (Home Medicines Review (HMR)) provided for patients in primary care with osteoporosis (OP) and Minimal Trauma Fracture (MTF)
Scientific title
The effect of an integrated medicine management service on the risk of falls and refractures in patients with osteoporosis and minimal trauma fracture (#STOP).
Secondary ID [1] 305831 0
Commonwealth Government of Australia - MRFQ1000064
Universal Trial Number (UTN)
U1111-1272-1211
Trial acronym
#STOP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoporosis. 324426 0
Minimal Trauma Fracture. 324427 0
Polypharmacy 324428 0
Falls 324893 0
Condition category
Condition code
Musculoskeletal 321922 321922 0 0
Osteoporosis
Musculoskeletal 321923 321923 0 0
Other muscular and skeletal disorders
Injuries and Accidents 321924 321924 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a coordinated and integrated medication management service (Home Medicines Review (HMR)).

The HMR is an existing clinical medication review service that is provided by Accredited Pharmacists and generally takes 1 hour for the initial consultation. Recently, revised program rules permit specialist physicians to generate an HMR referral for their patient and provide for two follow-up services at 3- and 6-months (these follow-up services generally take 30mins for each consultation) .

The HMR service is delivered face to face, on a one-on-one basis in the participant's home. Where this is not possible the HMR Service will be conducted by internet or telephone.

The HMR considers the participant's medicines and health so as to support the quality use of medicines, assist minimising adverse medicine events and to help people better understand and manage their medicines. Medication recommendations resulting from the HMR could include the deprescribing of inappropriate medicines that may cause falls, such as sedatives/hypnotics. In addition, recommendations could also pertain to the prescription of appropriate anti-osteoporosis medicines and adjustment of other regular medication doses.

HMR Intervention Pathway:
STAGE 1. Referral
Participant seen by ORP clinicians (ORP Clinic visit - baseline)
• HMR referral provided by ORP clinician with reasons for referral including: “Review falls risk increasing medicines and identify adherence to anti-osteoporosis medicine barriers and provide solutions”.
• The referring ORP clinician may include the participant’s clinical details in the referral e.g., any available laboratory results, height, weight, age, and gender, blood pressure and the results of any other tests or investigations available (such as Bone Mineral Density (BMD)).
STAGE 2. Home Service (within 1 week of referral)
Accredited HMR pharmacist:
• Contacts participant to arrange time and location (preferably the participant’s home) for the review.
• Conducts the review, at which all medicines are collected and recorded, and the participant interviewed. The interview consists of the participant's experiences using their medicines, such as administration and perceived effectiveness with a special focus on FRIDs and anti-OP medicine adherence. (Approx 1 hour)
• Addresses urgent medication related problems.
STAGE 3. Report (within 1 week of HMR consultation)
After the review the Accredited HMR pharmacist:
• Reconciles medical conditions with medicines, identifies any medicine-related problems, and writes a report recommending solutions for consideration by the participant's General Practitioner. (e.g. cease benzodiazapines)
• Shares the report with the ORP clinician for endorsement prior to a copy being shared with the participant’s GP and community pharmacist and a lay copy provided to the participant and/or their caregiver.
STAGE 4. MMP (as soon as possible post HMR report - preferably within 1 week)
Participant:
• Visits GP and discusses the HMR report.
• A Medication Management plan (MMP) should be formulated.
STAGE 5. Follow-up (3 and 6 months post 1st HMR consultation)
Accredited HMR Pharmacist:
• Arranges for a follow-up service at 3- and 6- months to review medication changes, any medication related problems and discuss anti-OP adherence. (Approx. 30mins for each consultation)
STAGE 6 (12 months - NB not part of HMR intervention)
Follow-up phone calls (15 mins) to all participants to collect participant data (Falls, hospitalization, self-reported questionnaires) (End of trial)

Clinicians in the ORP clinic will refer intervention arm participants for an HMR by an Accredited HMR Pharmacist, citing reasons for the review such as to: “review falls risk increasing medicines” and “identify adherence to anti-osteoporosis medicine barriers and provide solutions”. The Accredited HMR Pharmacist will arrange a convenient time to conduct the review in accordance with the guidelines. (within 1 week of the ORP Clinic Visit)
Following the completion of the review, the accredited pharmacist will share the report with the ORP clinician for discussion and endorsement, prior to a copy being shared with the participant’s GP and community pharmacist. A summary provided to the patient themselves will include key findings and recommendations in lay language for the patient to discuss with their primary healthcare clinicians such as the GP and community pharmacist. A 15 minute phone call from the accredited pharmacist will occur within a week of the HMR to ensure that the patient understands and agrees with the points raised. The patient will be encouraged to make an appointment with their GP as soon as possible and the accredited pharmacist will offer to assist with this appointment as required (e.g. this could involve being available to take a doctor’s call during the patient’s visit if needed).
Follow-up 30 minute services by the Accredited HMR Pharmacist will also occur at 3- and 6- months to review any existing or new medication related problems and to discuss adherence.

To ensure fidelity of the HMR intervention across all reviews, all Accredited HMR Pharmacists will undertake specific training prior to starting in the form of a training package. The intervention procedure will be monitored by the University of Sydney Research Team to ensure it is carried out consistently across each review and follow up service. Furthermore, one to one, qualitative interviews with all stakeholders will be conducted to assure adherence to the intervention process throughout the trial period (formative and summative). These interviews will be led by Prof Lin Perry (CI), face to face or via video-conference/telephone. Interviews are anticipated to take 30 mins and data will be collected until thematic saturation is achieved (anticipated to be approx 50 interviews across all stakeholders).

Extra support will be offered to participant’s GPs in the form of 3x20min CPD accredited training modules specially designed for this study. These CPD modules are based on a training package developed by MedCast. They will include 1 module on de-prescribing, 1 on osteoporosis and 1 on adherence. Each module has been designed to take approximately 20mins duration. They are to be completed at the discretion of each of the GPs with no time limits.
Intervention code [1] 322275 0
Prevention
Comparator / control treatment
At baseline, participants in the control arm will complete a brief interview with the site RA that includes initial data collection-details of regular community pharmacy and GP, medication history and self-reported measures. The participant will then complete their standard ORP clinic procedures.
The control arm participant will receive usual care at each clinic site and outside the clinic, which may include, but is not limited to; medication prescription and dispensing via usual channels e.g., GPs and other Clinicians, Community Pharmacists.
Participants in the control study arms will receive a follow up phone call from a member of the University of Sydney research team at 12 months post recruitment to follow up on self-reported data.
Control group
Active

Outcomes
Primary outcome [1] 329676 0
Change in participant’s Drug Burden Index (DBI).

The drug burden is a measure of burden obtained from anticholinergic and sedative medicine load calculated via participant medication lists collected via community pharmacy records and validated through PBS records (obtained via linked data - NSW Centre for Health Record Linkage (CHEREL) and the Centre for Victorian Data Linkage (CVDL).
Timepoint [1] 329676 0
DBI will be calculated at baseline, 3 months, and 12 months (primary time-point) post recruitment via retrospectively received medication-list data.
Secondary outcome [1] 403418 0
Adherence with anti-osteoporosis medications assessed as a composite of pharmacy refill records, and PBS records.
Timepoint [1] 403418 0
Adherence will be measured at baseline, and 12 months post-recruitment (with prescription/PBS records obtained at 18 months post-recruitment for retrospective analyses).
Secondary outcome [2] 403419 0
Self reported adherence assessed using the MARs-5 scale.
Timepoint [2] 403419 0
At baseline and 12 months post recruitment.
Secondary outcome [3] 403420 0
Number of self-reported falls, using a Falls Diary.
Timepoint [3] 403420 0
At 12-months post recruitment.
Secondary outcome [4] 403421 0
Self reported quality of life measured using the EuroQol 5-Dimenison 5-Level (EQ-5D-5L) tool.
Timepoint [4] 403421 0
At baseline and 12-months post recruitment.
Secondary outcome [5] 404863 0
Self reported re-fracture collected from falls diary
Timepoint [5] 404863 0
12 months post recruitment
Secondary outcome [6] 404864 0
Self-reported hospitalisations from falls diary
Timepoint [6] 404864 0
12 months post recruitment
Secondary outcome [7] 404865 0
Self reported Beliefs about Medicines measured via the Beliefs about Medicines Questionnaire (BMQ) tool.
Timepoint [7] 404865 0
Baseline and 12 months post recruitment.
Secondary outcome [8] 404866 0
Mortality gathered through linked data (e.g. NSW Centre for Health Record Linkage (CHEREL) and the Centre for Victorian Data Linkage (CVDL)).
Timepoint [8] 404866 0
12 months post recruitment
Secondary outcome [9] 404867 0
Re-hospitalizations gathered through linked data (e.g.CHEREL)
Timepoint [9] 404867 0
12 months post recruitment

Eligibility
Key inclusion criteria
Patients over 65 years, taking more than 5 medicines with a history of OP who have had a MTF and reside in a domiciliary dwelling.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients that are unable to consent or are receiving treatment for palliative care.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created
by computer software (i.e. computerised sequence
generation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
When participants enroll in the study both the participant and their Osteoporosis Re-fracture Prevention (ORP) clinician will be blinded to the study arm allocation until the initial consultation has been completed. At the completion of the clinician consultation, clinicians will become un-blinded to the participants trial arm when they are required to make the referral for a Home Medicines Review Service. It is also at this time that the study arm the participant has been randomized into will be revealed.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Assuming that Drug Burden Index (DBI) would be reduced by 20% after medication review, based on these data, we estimate that 546 participants/group is needed to have 90% power to detect 20% reduction in DBI score in the intervention group. This sample allows for up to a 20% loss to follow-up.

The statistical analyses of data will be conducted according to a pre-specified statistical analysis plan with an intention-to-treat approach. Baseline characteristics will be descriptively analysed. Both unadjusted and adjusted analyses will be carried out to assess the effectiveness of the intervention; and conclusions about the effect of intervention will be drawn from the adjusted results. The primary analyses will make adjustment for stratification factors, such as centres, genders and types of OP medication, and the baseline value (for continuous outcomes). Exploratory analysis will make additional adjustments for any important baseline predictors identified during the analysis which show evidence of substantial imbalance between the study groups. Continuous outcomes will be analysed using linear regression, and mean difference and corresponding 95% confidence interval will be reported. We analyse binary and count outcomes using log binomial and Poisson regression, respectively. Relative risk (95% CI) will be reported for binary outcomes, and ratio of means (95% CI) for count outcomes. A sensitivity per-protocol analysis will be conducted based on the intervention the participants receive. Interim analysis will only be done on the intervention group. Statistical significance will be assessed at the 0.05 level using a two-sided comparative test.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2022
Actual
Date of last participant enrolment
Anticipated
30/06/2023
Actual
Date of last data collection
Anticipated
30/12/2024
Actual
Sample size
Target
1092
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 21201 0
Prince of Wales Hospital - Randwick
Recruitment hospital [2] 21203 0
GenesisCare - St. Vincent's Sydney - Darlinghurst
Recruitment hospital [3] 21204 0
Genea Liverpool - Liverpool
Recruitment hospital [4] 21205 0
John Hunter Hospital - New Lambton
Recruitment hospital [5] 21206 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [6] 21208 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [7] 21263 0
Sunshine Hospital - St Albans
Recruitment postcode(s) [1] 36070 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 36068 0
2031 - Randwick
Recruitment postcode(s) [3] 36071 0
2170 - Liverpool
Recruitment postcode(s) [4] 36072 0
2305 - New Lambton
Recruitment postcode(s) [5] 36134 0
3021 - St Albans
Recruitment postcode(s) [6] 36073 0
3050 - Parkville
Recruitment postcode(s) [7] 36075 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 310184 0
Government body
Name [1] 310184 0
Commonwealth Government - Health Department
Country [1] 310184 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Level 3, Administration Building (F23), Corner of Eastern Avenue and City Road, University of Sydney, Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 311336 0
None
Name [1] 311336 0
Address [1] 311336 0
Country [1] 311336 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309867 0
South Eastern Sydney Local Health District (SESLHD) Ethics Review Committee (POW Zone)
Ethics committee address [1] 309867 0
District Executive Unit, Level4
The Sutherland Hospital & Community Health Service
Cnr The Kingsway & Kareena Road
Caringbah, NSW, 2229
Ethics committee country [1] 309867 0
Australia
Date submitted for ethics approval [1] 309867 0
02/11/2021
Approval date [1] 309867 0
23/12/2021
Ethics approval number [1] 309867 0
2021/ETH12003

Summary
Brief summary
To evaluate the effect of an intervention comprising a coordinated and integrated medication management service (Home Medicines Review HMR)) provided for patients in primary Care with Osteoporosis (OP) and Minimal Trauma Fracture (MTF). This intervention aims to improve the medications patients are taking to minimise their risk of falls and improve their bone strength.
Trial website
Trial related presentations / publications
Public notes
For reference, the following is a list of all Chief Investigators (CI) who are involved in the study but who do not provide any financial sponsorship or take on any legal responsibility for the Study:
- CIA: A/Prof Rebekah Moles
- CIB: Dr Stephen Carter
- CIC: Prof Peter Ebeling
- CID: Prof Jacqueline Center
- CIE: Dr Ayano Kelly
- CIF: Prof Lin Perry
- CIG: A/Prof Christopher White
- CIH: Prof Gustavo Duque
- CII: A/Prof Justine Naylor
- CIJ: A/Prof Kathryn Gibson
- CIK: Dr Geraldine Hassett
- CIL: Dr Gabor Major
- CIM: A/Prof Christopher Yates
- CIN: Dr Matthew Jennings
- CIO: Ms Jenny Ly
- CIP: Dr Patrick Bolton
- CIQ: Dr Thach Tran
- CIR: Dr Lei Si
- CIS: Dr Dana Bluic
- CIT: A/Prof Steven Frost
- CIU: Dr Benjamin Basger
- CIY: Dr Mark Kotowicz
- CIW: Kate Luckie

Site Specific Applications (SSAs) for ethics approval will be submitted to all individual hospital
List of participating sites below:
- Liverpool Hospital, NSW
- Prince of Wales Hospital, NSW
- St Vincent’s Hospital, NSW
- John Hunter Hospital, NSW
- Dandenong Hospital, VIC
- Royal Melbourne Hospital, VIC
- Monash Health Centre, Vic

Contacts
Principal investigator
Name 115666 0
A/Prof Rebekah Moles
Address 115666 0
School of Pharmacy Faculty of Medicine and Health, The University of Sydney, A15, Science Rd, Camperdown NSW 2006
Country 115666 0
Australia
Phone 115666 0
+61 02 9351 5968
Fax 115666 0
+61 02 9351 4391
Email 115666 0
rebekah.moles@Sydney.edu.au
Contact person for public queries
Name 115667 0
A/Prof Rebekah Moles
Address 115667 0
School of Pharmacy Faculty of Medicine and Health, The University of Sydney, A15, Science Rd, Camperdown NSW 2006
Country 115667 0
Australia
Phone 115667 0
+61 02 9351 5968
Fax 115667 0
+61 02 9351 4391
Email 115667 0
rebekah.moles@Sydney.edu.au
Contact person for scientific queries
Name 115668 0
A/Prof Rebekah Moles
Address 115668 0
School of Pharmacy Faculty of Medicine and Health, The University of Sydney, A15, Science Rd, Camperdown NSW 2006
Country 115668 0
Australia
Phone 115668 0
+61 02 9351 5968
Fax 115668 0
+61 02 9351 4391
Email 115668 0
rebekah.moles@Sydney.edu.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?
Unidentifiable participant data pertaining to primary and secondary outcomes will be available for future research and maybe shared in publications if required.
When will data be available (start and end dates)?
Data will not be available until the end of the trial, starting from publication in perpetuity.
Available to whom?
Researchers who provide a methodologically sound proposal, on a case-by-case basis at the discretion of Primary Sponsor.
Available for what types of analyses?
Secondary statistical analysis e.g. descriptive.
How or where can data be obtained?
Access will be subject to approvals by Principal Investigator, A/Prof. Rebekah Moles.
rebekah.moles@sydney.edu.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14306Study protocol  rebekah.moles@sydney.edu.au Access will be via by Principal Investigator, A/Pr... [More Details]
14307Statistical analysis plan  rebekah.moles@sydney.edu.au Access will be via by Principal Investigator, A/Pr... [More Details]



Results publications and other study-related documents

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