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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)

The effect of an integrated medicine management service on the risk of falls and refractures in patients with osteoporosis and minimal trauma fracture (#STOP).

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000261718
Acronym
#STOP
Enrollment
315
Registered
2022-02-14
Start date
2023-03-08
Completion date
2024-09-30
Last updated
2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 consultat

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.

Sponsors

University of Sydney
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients over 50 years, taking more than 5 medicines with a history of OP who have had a MTF and reside in a domiciliary dwelling.

Exclusion criteria

Patients that are unable to consent or are receiving treatment for palliative care.

Outcome results

None listed

Source: ANZCTR · Data processed: Jun 21, 2026