AgingMODIFYNCT05705284
MODIFY or Medication Review in Primary Care Study
A study testing Structured multidisciplinary medication review in people with Aging, run by University of Southampton at 1 site in United Kingdom.
Trial summary
A third of older people take five or more regular medications (polypharmacy) potentially increasing the risk of side-effects, hospital admission and death, with higher risk among people living with frailty. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Aging
- What is being tested?
- Structured multidisciplinary medication review
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2022to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Aged 65 and over
- Frail, (as judged by their health care professional, if applicable)
- Prescribed multiple medications (10+), as determined by their health care professional
- Able to give informed consent
- An informal carer/ relative of a frail patient (aged 65 and over) who is taking multiple medications, as identified by a health care professional
- An informal carer/ relative of a patient (aged 65 and over) living with severe dementia who is taking multiple medications, as identified by a health care professional
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- Able to consent
- Health care professional eligibility criteria
- A health care professional based in GP surgeries in Wessex (eg. GPs, practice-pharmacists, advanced nurse prescriber (ANPs) who works with older people living with frailty, who are prescribed multiple medications.
Who cannot join
- Aged under 65
- Severe cognitive impairment, as judged by their health care professional
- Informal carers/ relatives eligibility criteria
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Clinical Research Network in Primary Care
Southampton
Eloise Radcliff, PhD
Kinda Ibrahim, PhD
About this study
Official title: The Development and iMplementation Of a Multidisciplinary Medication Review and Deprescribing Intervention Among Frail Older People in primarY Care (MODIFY Study)
A third of older people take five or more regular medications (polypharmacy) potentially increasing the risk of side-effects, hospital admission and death, with higher risk among people living with frailty. National recommendations suggest that medications taken by frail older people should be reviewed annually by GPs to identify and reduce/ stop inappropriate medications (deprescribing). Yet this does not happen routinely due to GPs' lack of time, increased workloads and worries about stopping medicines. Recent recommendations suggest involving other non-medical prescribers such as practice-pharmacists and advanced nurse practitioners (ANPs) in reviewing medications. However, it is unknown how staff could work together most effectively and whether they have any training needs.
This research will investigate how practice-pharmacists, ANPs and GPs could best work together with patients living with frailty to perform regular medication reviews. There are four work packages (WPs).
- Review literature to identify what makes a successful medication review and how to safely deprescribe.
- Interviews with GPs, practice-pharmacists, ANPs, frail older patients and carers will investigate where medication review should take place, the role of involved parties, type of medications that could be deprescribed, staff training needs, barriers and facilitators for implementation, and strategies to address them.
- Information from WP1\&2 will be used to develop the intervention: a structured medication review process using pharmacists, ANPs and GPs and involving frail patients and their families in decisions about medications. This will be refined through workshops with service users, clinicians and commissioners. A training programme to implement the intervention and increase staff confidence in deprescribing will be developed alongside the intervention.
- Feasibility study for staff in four GP practices to be trained and to implement the intervention.(this will be subject to further amendment).
Read the detailed description
Background A third of older people take five or more regular medications (polypharmacy) potentially increasing the risk of side-effects, hospital admission and death. These effects are higher among people living with frailty who lose their in-built reserves and become vulnerable to changes triggered by small events such as a change in medication. National recommendations suggest that medications taken by frail older people should be reviewed annually by their GPs to identify and reduce/ stop inappropriate medications (deprescribing). Yet this does not happen routinely due to GPs' lack of time, increased workloads and worries about stopping medicines.
Recent recommendations suggest involving other non-medical prescribers such as practice-pharmacists and advanced nurse practitioners (ANPs) in reviewing medications. However, it is unknown how staff could work together most effectively and whether they have any training needs.
Aim This research will investigate how practice-pharmacists, ANPs and GPs could best work together with patients living with frailty to perform regular medication review.
Methods The study involves four work packages (WPs). The research team will review previous literature to identify what makes a successful medication review and how to safely reduce/ stop inappropriate medications (WP1).
Interviews with GPs, practice-pharmacists, ANPs, frail older patients and carers will be conducted (WP2). These will discover views about where medication review should take place, the role of each of the involved parties in the process, type of medications that could be deprescribed, staff development and training needs, barriers and facilitators for implementation, and strategies to address these barriers.
Information gathered from WP1\&2 will be used to develop the intervention: a structured medication review process using pharmacists, ANPs and GPs most effectively and involving frail patients and their families in decisions about medications (WP3). The intervention will be refined further through a series of workshops with service users, clinicians and commissioners. A training programme to implement the intervention and increase staff confidence in reducing/ stopping medications safely will be developed and delivered to GPs, practice-pharmacists and ANPs based on the Polypharmacy Action Learning Sets approach adopted by the Wessex Academic Health Science Network (AHSN) .
Finally, the feasibility and acceptability of the intervention to staff and patients in four GP practices will be assessed (WP4).
Patient and Public Involvement (PPI) Three PPI members have been involved in protocol development and refinement and will continue to contribute to the research study by for example being involved in developing research instruments and monitoring recruitment.
Dissemination and impact Working with colleagues in the Wessex AHSN and local clinical commissioners, the research team will be able to share our findings and training programme to the wider research and clinical community in Wessex and potentially influence practices and policies both locally and nationally.
- Conditions
- Aging
- Being tested
- Structured multidisciplinary medication review
- Keywords
- polypharmacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured multidisciplinary medication reviewOther
Multidisciplinary process for medication review/deprescribing: The intervention will be a structured process for performing a shared-decision, person-centred medication review among those living with frailty involving GPs, PCN-pharmacist and ANPs.
| Study group | Role | What they receive |
|---|---|---|
| Patients participating in structured multidisciplinary medication review | Experimental | Patients participating in structured multidisciplinary medication review Receives: Other: Structured multidisciplinary medication review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of recruitment
proportion of staff recruited and trained in each GP practice
Measured: Baseline
Number of medications
Total number of medications taken by each patient
Measured: change in scores between baseline and 3 months follow up
Rates of adverse events
rates of adverse drug events due to deprescribing (including self-reported dizziness, falls, drowsiness, confusion, hallucinations, blurred vision, constipation, diarrhoea, dry mouth or other) during 3 months follow up.
Measured: at 3 months
Rates of hospitalisation
rates of hospitalisation 3 months post intervention
Measured: 3 months
Mortality rates
mortality rates 3 months post intervention
Measured: 3 months
frailty status
Frailty score using the electronic frailty index (e-FI)
Measured: changes between baseline and 3 months
rates of falls
number of falls reported and proportion of fallers (self-reported)
Measured: changes between baseline and 3 months
Rates of fractures
number of fractures and proportion of people sustained fractures (self-reported)
Measured: changes between baseline and 3 months
function
Activity of daily living using Barthel
Measured: changes between baseline and 3 months
cognition
- cognition using the abbreviated mental test (AMT)
Measured: changes between baseline and 3 months
depression
- depression using the geriatric depression scale (GDS)
Measured: changes between baseline and 3 months
healthcare utilisation
number of visits to GP/specialists and number of unplanned hospitalisations
Measured: at 3 months follow up
Acceptability
Interviews or focus groups will be conducted at the end of the feasibility study with a purposive sample of (n=6-8) GPs, pharmacists, ANPs in the four GP practices who received the training and implemented the intervention, and 8-10 patients and carers who received the intervention
Measured: at 3 months follow up
Feasibility of deprescribing
number of recommendations in the medication reviews made to each patient (stop, reduce, switch or start).
Measured: 3 months follow up
number of potentially inappropriate medications
total number of potentially inappropriate medications months using the STOPP/START criteria.
Measured: Change between baseline and 3 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start1 Jan 2022
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Multidisciplinary process for medication review/deprescribing: The intervention will be a structured process for performing a shared-decision, person-centred medication review among those living with frailty involving GPs, PCN-pharmacist and ANPs.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Collaborators
- University of Portsmouth
- Responsible party
- Sponsor
- Investigators
- Kinda Ibrahim, PhD, Principal investigator, University of Southampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05705284
- Sponsor's protocol ID
- ERGO ID 71720
- Acronym
- MODIFY
- Status last verified
- May 2024
- First submitted
- 22 Mar 2022
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development and iMplementation Of a Multidisciplinary Medication Review and Deprescribing Intervention Among Frail Older People in primarY Care (MODIFY Study)
- ClinicalTrials.gov ID
- NCT05705284
- Acronym / sponsor ID
- MODIFY / ERGO ID 71720
- Conditions
- Aging
- Keywords
- polypharmacy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Collaborators
- University of Portsmouth
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 30 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A third of older people take five or more regular medications (polypharmacy) potentially increasing the risk of side-effects, hospital admission and death, with higher risk among people living with frailty. National recommendations suggest that medications taken by frail older people should be reviewed annually by GPs to identify and reduce/ stop inappropriate medications (deprescribing). Yet this does not happen routinely due to GPs' lack of time, increased workloads and worries about stopping medicines. Recent recommendations suggest involving other non-medical prescribers such as practice-pharmacists and advanced nurse practitioners (ANPs) in reviewing medications. However, it is unknown how staff could work together most effectively and whether they have any training needs.
This research will investigate how practice-pharmacists, ANPs and GPs could best work together with patients living with frailty to perform regular medication reviews. There are four work packages (WPs).
- Review literature to identify what makes a successful medication review and how to safely deprescribe.
- Interviews with GPs, practice-pharmacists, ANPs, frail older patients and carers will investigate where medication review should take place, the role of involved parties, type of medications that could be deprescribed, staff training needs, barriers and facilitators for implementation, and strategies to address them.
- Information from WP1\&2 will be used to develop the intervention: a structured medication review process using pharmacists, ANPs and GPs and involving frail patients and their families in decisions about medications. This will be refined through workshops with service users, clinicians and commissioners. A training programme to implement the intervention and increase staff confidence in deprescribing will be developed alongside the intervention.
- Feasibility study for staff in four GP practices to be trained and to implement the intervention.(this will be subject to further amendment).
Detailed description
Background A third of older people take five or more regular medications (polypharmacy) potentially increasing the risk of side-effects, hospital admission and death. These effects are higher among people living with frailty who lose their in-built reserves and become vulnerable to changes triggered by small events such as a change in medication. National recommendations suggest that medications taken by frail older people should be reviewed annually by their GPs to identify and reduce/ stop inappropriate medications (deprescribing). Yet this does not happen routinely due to GPs' lack of time, increased workloads and worries about stopping medicines.
Recent recommendations suggest involving other non-medical prescribers such as practice-pharmacists and advanced nurse practitioners (ANPs) in reviewing medications. However, it is unknown how staff could work together most effectively and whether they have any training needs.
Aim This research will investigate how practice-pharmacists, ANPs and GPs could best work together with patients living with frailty to perform regular medication review.
Methods The study involves four work packages (WPs). The research team will review previous literature to identify what makes a successful medication review and how to safely reduce/ stop inappropriate medications (WP1).
Interviews with GPs, practice-pharmacists, ANPs, frail older patients and carers will be conducted (WP2). These will discover views about where medication review should take place, the role of each of the involved parties in the process, type of medications that could be deprescribed, staff development and training needs, barriers and facilitators for implementation, and strategies to address these barriers.
Information gathered from WP1\&2 will be used to develop the intervention: a structured medication review process using pharmacists, ANPs and GPs most effectively and involving frail patients and their families in decisions about medications (WP3). The intervention will be refined further through a series of workshops with service users, clinicians and commissioners. A training programme to implement the intervention and increase staff confidence in reducing/ stopping medications safely will be developed and delivered to GPs, practice-pharmacists and ANPs based on the Polypharmacy Action Learning Sets approach adopted by the Wessex Academic Health Science Network (AHSN) .
Finally, the feasibility and acceptability of the intervention to staff and patients in four GP practices will be assessed (WP4).
Patient and Public Involvement (PPI) Three PPI members have been involved in protocol development and refinement and will continue to contribute to the research study by for example being involved in developing research instruments and monitoring recruitment.
Dissemination and impact Working with colleagues in the Wessex AHSN and local clinical commissioners, the research team will be able to share our findings and training programme to the wider research and clinical community in Wessex and potentially influence practices and policies both locally and nationally.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multidisciplinary process for medication review/deprescribing: The intervention will be a structured process for performing a shared-decision, person-centred medication review among those living with frailty involving GPs, PCN-pharmacist and ANPs.
| Arm | Type | Receives |
|---|---|---|
| Patients participating in structured multidisciplinary medication review | Experimental | Other: Structured multidisciplinary medication reviewPatients participating in structured multidisciplinary medication review |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- Aged 65 and over
- Frail, (as judged by their health care professional, if applicable)
- Prescribed multiple medications (10+), as determined by their health care professional
- Able to give informed consent
- An informal carer/ relative of a frail patient (aged 65 and over) who is taking multiple medications, as identified by a health care professional
Key exclusion criteria (3 listed)
- Aged under 65
- Severe cognitive impairment, as judged by their health care professional
- Informal carers/ relatives eligibility criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured multidisciplinary medication reviewMultidisciplinary process for medication review/deprescribing: The intervention will be a structured process for performing a shared-decision, person-centred medication review among those living with frailty involving GPs, PCN-pharmacist and ANPs. | Other | Patients participating in structured multidisciplinary medication review |
Primary outcome
Feasibility of recruitment
Time frame: Baseline
proportion of staff recruited and trained in each GP practice
Number of medications
Time frame: change in scores between baseline and 3 months follow up
Total number of medications taken by each patient
Rates of adverse events
Time frame: at 3 months
rates of adverse drug events due to deprescribing (including self-reported dizziness, falls, drowsiness, confusion, hallucinations, blurred vision, constipation, diarrhoea, dry mouth or other) during 3 months follow up.
Rates of hospitalisation
Time frame: 3 months
rates of hospitalisation 3 months post intervention
Mortality rates
Time frame: 3 months
mortality rates 3 months post intervention
frailty status
Time frame: changes between baseline and 3 months
Frailty score using the electronic frailty index (e-FI)
rates of falls
Time frame: changes between baseline and 3 months
number of falls reported and proportion of fallers (self-reported)
Rates of fractures
Time frame: changes between baseline and 3 months
number of fractures and proportion of people sustained fractures (self-reported)
function
Time frame: changes between baseline and 3 months
Activity of daily living using Barthel
cognition
Time frame: changes between baseline and 3 months
- cognition using the abbreviated mental test (AMT)
depression
Time frame: changes between baseline and 3 months
- depression using the geriatric depression scale (GDS)
healthcare utilisation
Time frame: at 3 months follow up
number of visits to GP/specialists and number of unplanned hospitalisations
Acceptability
Time frame: at 3 months follow up
Interviews or focus groups will be conducted at the end of the feasibility study with a purposive sample of (n=6-8) GPs, pharmacists, ANPs in the four GP practices who received the training and implemented the intervention, and 8-10 patients and carers who received the intervention
Feasibility of deprescribing
Time frame: 3 months follow up
number of recommendations in the medication reviews made to each patient (stop, reduce, switch or start).
number of potentially inappropriate medications
Time frame: Change between baseline and 3 months follow up
total number of potentially inappropriate medications months using the STOPP/START criteria.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kinda Ibrahim, PhD principal investigator
University of Southampton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured multidisciplinary medication review in people with Aging, run by University of Southampton at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eloise Radcliffe, PhD ((023) 8120 4656, e.radcliffe@soton.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of recruitment (time frame: Baseline). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2024.