Potentially Inappropriate MedicationsPro-MNCT05756478
Appropriate Prescribing for Older Adults With Multimorbidity (Pro-M)
A study testing Medication review in people with Potentially Inappropriate Medications and Multimorbidity, run by Geriatric Education and Research Institute at 2 sites in Singapore.
Trial summary
This is a two-site feasibility study to test implementation of an intervention that aims to reduce inappropriate prescribing for older adults with multimorbidity in geriatric medicine specialist clinics at public hospitals in Singapore. The specific aims are: 1. Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Potentially Inappropriate Medications, Multimorbidity, Polypharmacy
- What is being tested?
- Medication review
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesSingapore
- Study dates
- 1 Feb 2023to 16 Oct 2023
- 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 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older adults age 65 and above
- Currently attending Geriatric Medicine Clinic
- on at least 5 medications.
- Doctors and pharmacists
- who are involved in the delivery or support of the intervention during the implementation period.
Who cannot join
- Those younger than 65
- Not a Geriatric Medicine outpatient clinic patient
- On fewer than 5 medications
- Currently receiving other pharmacist-related services such as medication therapy management.
- Non-English, non-Chinese, and non-Malay speaking patients.
- Patient or caregiver who declines any of the study procedure required within the intervention framework.
- Those who are not involved in the implementation of the study.
- Those who are not involved in the delivery of the intervention.
Trial locations and contacts
2 sites in 1 country.
Singapore2 sites
Changi General Hospital
Singapore, Sinagpore, 529889
Tan Tock Seng Hospital
Singapore, 308440
About this study
Official title: Appropriate Prescribing for Older Adults With Multimorbidity (Pro-M): A Feasibility Study
This is a two-site feasibility study to test implementation of an intervention that aims to reduce inappropriate prescribing for older adults with multimorbidity in geriatric medicine specialist clinics at public hospitals in Singapore. The specific aims are:
- To assess the implementation outcomes: Appropriateness, Penetration/Reach, Acceptability, Feasibility, Sustainability (primary)
- To collect data on recruitment and pre-post data on prevalence of potentially inappropriate prescribing (PIP) for the purpose of determining sample size for a scale up next phase study (secondary).
- To conduct cost analysis of the intervention (secondary).
Read the detailed description
The Appropriate prescribing for older adults with multi-morbidity (Pro-M) study aims to assess the feasibility of implementing routine medication review using prescribing criteria for older adults with multi-morbidity at the Geriatric Medicine outpatient clinics at 2 public hospitals in Singapore. The study will consist of a recruitment and implementation period and an evaluation period at the end.
Flow of the intervention (6 months):
- Eligible patients with multimorbidity and are taking at least 5 medications daily will be identified and invited by the doctor to undergo medication review (MR).
- Patients will undergo medication reviews with a pharmacist, involving the use of specific prescribing criteria and tools (e.g. STOPP/START, Beers Criteria), as determined by the sites.
- Medication review findings will be documented in the electronic medical records and shared with the doctor, who will review the findings and make necessary changes to patients' prescriptions during consultations with the patients.
- The Doctors will document the review outcome and prescribing decisions in the electronic medical records and communicate the changes (if any) to other relevant prescribers.
- Patients will be invited to do a short survey on their experiences of the intervention at the end to assess implementation outcomes.
The intervention will be compared to 'usual care', where medication review is only done in an ad-hoc and informal basis. Patients' last consultation prior to the intervention period would be used as the point to measure 'usual care'.
Evaluation(3 months):
Doctors and pharmacists who implemented the study (delivery or support) will be invited to a survey and selected in-depth interviews to assess implementation outcomes.
- Being tested
- Medication review
- Keywords
- Inappropriate prescribing, Feasibility study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication reviewOther
This is a feasibility study of implementing a pharmacist-led medication review using prescribing tools (e.g. STOPP/START, Beers Criteria)
| Study group | Role | What they receive |
|---|---|---|
| Medication Review | Other | This is a feasibility study of implementing a pharmacist-led medication review using prescribing tools (e.g. STOPP/START, Beers Criteria) . Receives: Other: Medication review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients' attitudes towards acceptance of the intervention (Penetration/Reach)
The survey consists of 11 items, and each item is on a 5-point Likert scale (level of agreement). This is a mixed method implementation study that is focused on investigating the feasibility of implementing medication reviews as routine care for older adults with multimorbidity in the outpatient clinics. The first 6 months will be the implementation period, followed by a 3-month evaluation period that consists of a first survey of the implementers (doctors and pharmacists), then an in-depth interview with selected implementers.
Measured: A single-time-point survey to be administered immediately after the intervention
Implementers' attitudes towards the appropriateness of the intervention
The survey consists of 25 items, and each item is measured on a 5-point Likert (level of agreement).
This is a mixed method implementation study that is focused on investigating the feasibility of implementing medication reviews as routine care for older adults with multimorbidity in the outpatient clinics. The first 6 months will be the implementation period, followed by a 3-month evaluation period that consists of a survey of the implementers (doctors and pharmacists), then an in-depth interview with selected implementers.
Measured: 3-month Evaluation period: A single-time-point survey to be conducted immediately after the 6-month implementation period. Selected in-depth interviews will follow to provide a qualitative context to the survey results.
Implementers' attitudes towards the acceptability of the intervention
The survey consists of 25 items, and each item is measured on a 5-point Likert (level of agreement).
This is a mixed method implementation study that is focused on investigating the feasibility of implementing medication reviews as routine care for older adults with multimorbidity in the outpatient clinics. The first 6 months will be the implementation period, followed by a 3-month evaluation period that consists of a survey of the implementers (doctors and pharmacists), then an in-depth interview with selected implementers.
Measured: 3-month Evaluation period: A single-time-point survey to be conducted immediately after the 6-month implementation period. Selected in-depth interviews will follow to provide a qualitative context to the survey results.
Implementers' attitudes towards the feasibility of the intervention.
The survey consists of 25 items, and each item is measured on a 5-point Likert (level of agreement).
This is a mixed method implementation study that is focused on investigating the feasibility of implementing medication reviews as routine care for older adults with multimorbidity in the outpatient clinics. The first 6 months will be the implementation period, followed by a 3-month evaluation period that consists of a survey of the implementers (doctors and pharmacists), then an in-depth interview with selected implementers.
Measured: 3-month Evaluation period: A single-time-point survey to be conducted immediately after the 6-month implementation period. Selected in-depth interviews will follow to provide a qualitative context to the survey results.
Implementers' attitudes towards the sustainability of the intervention.
The survey consists of 25 items, and each item is measured on a 5-point Likert (level of agreement).
This is a mixed method implementation study that is focused on investigating the feasibility of implementing medication reviews as routine care for older adults with multimorbidity in the outpatient clinics. The first 6 months will be the implementation period, followed by a 3-month evaluation period that consists of a survey of the implementers (doctors and pharmacists), then an in-depth interview with selected implementers.
Measured: 3-month Evaluation period: A single-time-point survey to be conducted immediately after the 6-month implementation period. Selected in-depth interviews will follow to provide a qualitative context to the survey results.
Implementers' views on the fidelity of the intervention.
The survey consists of 25 items, and each item is measured on a 5-point Likert (level of agreement).
This is a mixed method implementation study that is focused on investigating the feasibility of implementing medication reviews as routine care for older adults with multimorbidity in the outpatient clinics. The first 6 months will be the implementation period, followed by a 3-month evaluation period that consists of a survey of the implementers (doctors and pharmacists), then an in-depth interview with selected implementers.
Measured: :3-month Evaluation period: A single-time-point survey to be conducted immediately after the 6-month implementation period. Selected in-depth interviews will follow to provide a qualitative context to the survey results.
Secondary outcomes (5)
Recruitment rate
The rate will be measured by the number of participants enrolled in the intervention divided by the number of patients pre-screened as being eligible for the intervention. This information will inform sample size calculation for the next phase scale-up study.
- Percentage of patients with at least one potentially inappropriate medication (PIM) before and after intervention
- Percentage of patients with other medication issues identified before and after intervention.
Measured: 6 months during implementation period
Effectiveness of the intervention: Percentage of patients with at least one PIM before and after intervention.
The rate will be measured by the number of patients prescribed with at least 1 PIM at the start of the intervention divided by total number of patients enrolled. It will then be compared to the rate of patients prescribed with at least 1 PIM after they had completed the intervention. This information will inform sample size calculation for the next phase scale-up study.
- Cost of medications identified before and after medication review: cost of PIM and/or other medications issues identified will be collected during the implementation period.
Measured: 6 months during implementation period
Effectiveness of the intervention: Percentage of patients with other medication issues identified before and after intervention.
The rate will be measured by the number of patients prescribed with at least 1 other medication issues at the start of the intervention divided by total number of patients enrolled. It will then be compared to the rate of patients prescribed with at least 1 other medication issues after they had completed the intervention. This information will inform sample size calculation for the next phase scale-up study.
Measured: 6 months during implementation period
Manpower cost to conduct medication review
The cost would be measured by the estimated number of manpower hours needed to deliver the intervention multiplied by the manpower norm costs. This information will be utilized to calculate cost of implementing the intervention.
Measured: 6 months during implementation period
Cost of PIM and other medications with issues identified before and after medication review.
The cost would be measured by calculating the subsidized cost of the identified medications (PIM and other medications with issues) prescribed to the enrolled patients. This information will be utilized to calculate cost of implementing the intervention.
Measured: 6 months during implementation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start1 Feb 2023
- Primary completion16 Oct 2023
- Study completion16 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Potentially Inappropriate MedicationsStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- In order to investigate if implementing routine pharmacist-led medication reviews in the outpatient clinics of public hospitals for older adults with multi-morbidity, we are conducting a single-arm study at 2 sites to understand how the implementation strategies could be best carried out to facilitate the aim to reduce inappropriate prescribing. Pre- and post-medication review data on potentially inappropriate medications and other issues flagged will also be collected for a future scale up study. Each site is expected to recruit 30 patients. An evaluation will also be conducted with the doctors and pharmacists delivering and implementing the study.
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geriatric Education and Research Institute
- Sponsor type
- Other government
- Collaborators
- Tan Tock Seng Hospital, Changi General Hospital
- Responsible party
- Sponsor
- Investigators
- Penny Lun, M.A., Principal investigator, Geriatric Education and Research Institute, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05756478
- Sponsor's protocol ID
- GERI1630
- Acronym
- Pro-M
- Status last verified
- Feb 2024
- First submitted
- 30 Jan 2023
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tang JY, Teng PHJ, Chen CY, Tan KT, Ang W, Lau S, Ang AGC, Kyaw KK, Tay XY, Lim WMS, Espeleta WDV, Lin H, Ding YY, Lun P. Appropriate Prescribing for older adults with Multimorbidity (Pro-M): protocol for a feasibility study. Arch Public Health. 2024 Mar 18;82(1):37. doi: 10.1186/s13690-024-01264-x.
PubMed 38500190
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Appropriate Prescribing for Older Adults With Multimorbidity (Pro-M): A Feasibility Study
- ClinicalTrials.gov ID
- NCT05756478
- Acronym / sponsor ID
- Pro-M / GERI1630
- Keywords
- Inappropriate prescribing, Feasibility study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Geriatric Education and Research InstituteOther government
- Collaborators
- Tan Tock Seng Hospital, Changi General Hospital
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 16 Oct 2023 (actual)
- Study completion
- 16 Oct 2023 (actual)
- First posted
- 6 Mar 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.
This is a two-site feasibility study to test implementation of an intervention that aims to reduce inappropriate prescribing for older adults with multimorbidity in geriatric medicine specialist clinics at public hospitals in Singapore. The specific aims are:
- To assess the implementation outcomes: Appropriateness, Penetration/Reach, Acceptability, Feasibility, Sustainability (primary)
- To collect data on recruitment and pre-post data on prevalence of potentially inappropriate prescribing (PIP) for the purpose of determining sample size for a scale up next phase study (secondary).
- To conduct cost analysis of the intervention (secondary).
Detailed description
The Appropriate prescribing for older adults with multi-morbidity (Pro-M) study aims to assess the feasibility of implementing routine medication review using prescribing criteria for older adults with multi-morbidity at the Geriatric Medicine outpatient clinics at 2 public hospitals in Singapore. The study will consist of a recruitment and implementation period and an evaluation period at the end.
Flow of the intervention (6 months):
- Eligible patients with multimorbidity and are taking at least 5 medications daily will be identified and invited by the doctor to undergo medication review (MR).
- Patients will undergo medication reviews with a pharmacist, involving the use of specific prescribing criteria and tools (e.g. STOPP/START, Beers Criteria), as determined by the sites.
- Medication review findings will be documented in the electronic medical records and shared with the doctor, who will review the findings and make necessary changes to patients' prescriptions during consultations with the patients.
- The Doctors will document the review outcome and prescribing decisions in the electronic medical records and communicate the changes (if any) to other relevant prescribers.
- Patients will be invited to do a short survey on their experiences of the intervention at the end to assess implementation outcomes.
The intervention will be compared to 'usual care', where medication review is only done in an ad-hoc and informal basis. Patients' last consultation prior to the intervention period would be used as the point to measure 'usual care'.
Evaluation(3 months):
Doctors and pharmacists who implemented the study (delivery or support) will be invited to a survey and selected in-depth interviews to assess implementation outcomes.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- In order to investigate if implementing routine pharmacist-led medication reviews in the outpatient clinics of public hospitals for older adults with multi-morbidity, we are conducting a single-arm study at 2 sites to understand how the implementation strategies could be best carried out to facilitate the aim to reduce inappropriate prescribing. Pre- and post-medication review data on potentially inappropriate medications and other issues flagged will also be collected for a future scale up study. Each site is expected to recruit 30 patients. An evaluation will also be conducted with the doctors and pharmacists delivering and implementing the study.
| Arm | Type | Receives |
|---|---|---|
| Medication Review | Other | Other: Medication reviewThis is a feasibility study of implementing a pharmacist-led medication review using prescribing tools (e.g. STOPP/START, Beers Criteria) . |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Older adults age 65 and above
- Currently attending Geriatric Medicine Clinic
- on at least 5 medications.
- Doctors and pharmacists
- who are involved in the delivery or support of the intervention during the implementation period.
Key exclusion criteria (8 listed)
- Those younger than 65
- Not a Geriatric Medicine outpatient clinic patient
- On fewer than 5 medications
- Currently receiving other pharmacist-related services such as medication therapy management.
- Non-English, non-Chinese, and non-Malay speaking patients.
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 |
|---|---|---|
| Medication reviewThis is a feasibility study of implementing a pharmacist-led medication review using prescribing tools (e.g. STOPP/START, Beers Criteria) | Other | Medication Review |
Primary outcome
Patients' attitudes towards acceptance of the intervention (Penetration/Reach)
Time frame: A single-time-point survey to be administered immediately after the intervention
The survey consists of 11 items, and each item is on a 5-point Likert scale (level of agreement). This is a mixed method implementation study that is focused on investigating the feasibility of implementing medication reviews as routine care for older adults with multimorbidity in the outpatient clinics. The first 6 months will be the implementation period, followed by a 3-month evaluation period that consists of a first survey of the implementers (doctors and pharmacists), then an in-depth interview with selected implementers.
Implementers' attitudes towards the appropriateness of the intervention
Time frame: 3-month Evaluation period: A single-time-point survey to be conducted immediately after the 6-month implementation period. Selected in-depth interviews will follow to provide a qualitative context to the survey results.
The survey consists of 25 items, and each item is measured on a 5-point Likert (level of agreement). This is a mixed method implementation study that is focused on investigating the feasibility of implementing medication reviews as routine care for older adults with multimorbidity in the outpatient clinics. The first 6 months will be the implementation period, followed by a 3-month evaluation period that consists of a survey of the implementers (doctors and pharmacists), then an in-depth interview with selected implementers.
Implementers' attitudes towards the acceptability of the intervention
Time frame: 3-month Evaluation period: A single-time-point survey to be conducted immediately after the 6-month implementation period. Selected in-depth interviews will follow to provide a qualitative context to the survey results.
The survey consists of 25 items, and each item is measured on a 5-point Likert (level of agreement). This is a mixed method implementation study that is focused on investigating the feasibility of implementing medication reviews as routine care for older adults with multimorbidity in the outpatient clinics. The first 6 months will be the implementation period, followed by a 3-month evaluation period that consists of a survey of the implementers (doctors and pharmacists), then an in-depth interview with selected implementers.
Implementers' attitudes towards the feasibility of the intervention.
Time frame: 3-month Evaluation period: A single-time-point survey to be conducted immediately after the 6-month implementation period. Selected in-depth interviews will follow to provide a qualitative context to the survey results.
The survey consists of 25 items, and each item is measured on a 5-point Likert (level of agreement). This is a mixed method implementation study that is focused on investigating the feasibility of implementing medication reviews as routine care for older adults with multimorbidity in the outpatient clinics. The first 6 months will be the implementation period, followed by a 3-month evaluation period that consists of a survey of the implementers (doctors and pharmacists), then an in-depth interview with selected implementers.
Implementers' attitudes towards the sustainability of the intervention.
Time frame: 3-month Evaluation period: A single-time-point survey to be conducted immediately after the 6-month implementation period. Selected in-depth interviews will follow to provide a qualitative context to the survey results.
The survey consists of 25 items, and each item is measured on a 5-point Likert (level of agreement). This is a mixed method implementation study that is focused on investigating the feasibility of implementing medication reviews as routine care for older adults with multimorbidity in the outpatient clinics. The first 6 months will be the implementation period, followed by a 3-month evaluation period that consists of a survey of the implementers (doctors and pharmacists), then an in-depth interview with selected implementers.
Implementers' views on the fidelity of the intervention.
Time frame: :3-month Evaluation period: A single-time-point survey to be conducted immediately after the 6-month implementation period. Selected in-depth interviews will follow to provide a qualitative context to the survey results.
The survey consists of 25 items, and each item is measured on a 5-point Likert (level of agreement). This is a mixed method implementation study that is focused on investigating the feasibility of implementing medication reviews as routine care for older adults with multimorbidity in the outpatient clinics. The first 6 months will be the implementation period, followed by a 3-month evaluation period that consists of a survey of the implementers (doctors and pharmacists), then an in-depth interview with selected implementers.
5 secondary outcomes
Recruitment rate
Time frame: 6 months during implementation period
Effectiveness of the intervention: Percentage of patients with at least one PIM before and after intervention.
Time frame: 6 months during implementation period
Effectiveness of the intervention: Percentage of patients with other medication issues identified before and after intervention.
Time frame: 6 months during implementation period
Manpower cost to conduct medication review
Time frame: 6 months during implementation period
Cost of PIM and other medications with issues identified before and after medication review.
Time frame: 6 months during implementation period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Derived from this study: PubMed 38500190Tang JY, Teng PHJ, Chen CY, Tan KT, Ang W, Lau S, Ang AGC, Kyaw KK, Tay XY, Lim WMS, Espeleta WDV, Lin H, Ding YY, Lun P. Appropriate Prescribing for older adults with Multimorbidity (Pro-M): protocol for a feasibility study. Arch Public Health. 2024 Mar 18;82(1):37. doi: 10.1186/s13690-024-01264-x.
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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.
Penny Lun, M.A. principal investigator
Geriatric Education and Research Institute, Singapore
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medication review in people with Potentially Inappropriate Medications and Multimorbidity, run by Geriatric Education and Research Institute at 2 sites in Singapore.
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 5 inclusion and 8 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: finished, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients' attitudes towards acceptance of the intervention (Penetration/Reach) (time frame: A single-time-point survey to be administered immediately after the intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05756478, which also lists 1 linked publication.
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 9 Feb 2024.