AgingNCT05297461
Impact of Medication Review by Community Pharmacists
A study testing Medication review in people with Aging, run by Monash University Malaysia at 1 site in Malaysia.
Trial summary
The aging population size has been enlarging globally. A higher number of older adults means a higher number of medication use. It is estimated that older adults are the largest medication consumers.That would result in various medication use problems which provide a link between polypharmacy, inappropriate… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Medication review
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteMalaysia
- Study dates
- 30 Jun 2022to 30 Jan 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients above 60 years old Patients who have chronic disease ie diabetes, hypertension, cardiovascular
- Patients who have been patronizing the pharmacy for the purchase of at least one prescription medication for the past three months.
- Patients be able to converse, read and understand the Malay language or English language.
- Access to a telephone or mobile phone or internet
- The patients must understand the study process, agree to participate in this study, and sign the informed consent
Who cannot join
- Patient who are unable to converse, read and understand Malay or English language
- Patients who unable to give their consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Community Pharmacists' Medication Review on Medication Use Related Problems Among Older Adults in Penang: A Pilot Randomised Controlled Study
The aging population size has been enlarging globally. A higher number of older adults means a higher number of medication use. It is estimated that older adults are the largest medication consumers.That would result in various medication use problems which provide a link between polypharmacy, inappropriate medication, and deprescribing.[2] Primary health care providers especially community pharmacists are often the first point of healthcare towards older adults.[3] Various interventions are being carried out by community pharmacies to determine an optimal outcome on medication usage.
Medication review intervention is a clinical process where a pharmacist reviews a patient's medication, identifies any drug-related problems and suggests strategies to reduce the medication use problems. Medication review is being utilized in various countries especially in Organisation for Economic Co-operation and Development (OECD )regions ie Australia, New Zealand, the United Kingdom, and the United States of America, and the pharmacist were remunerated for the service. Although medication review is widely searched intervention globally, the scope for intervention is lacking in low and middle-income countries.
Read more
Community pharmacy is regarded as the first point of care of primary health care in a community for older adults. A systemic review search on community pharmacist-led intervention among the aging population has demonstrated medication adherence improvement outcomes. Consequently, community pharmacists can reduce medication use problems in different settings in the community in various ways and contribute to the patients' overall well-being and health-related quality of life.
There is a lack of information in Malaysia due to the fragmented health care system where there is no continuity of care between the public and private sectors. During this pandemic outbreak, when most countries suffer critical health care points, much effort and pharmaceutical care should be delivered towards older adults to reduce the current burden. This study assesses the feasibility of medication review for older adults at the community pharmacy level and identifies any medication-related problems in Penang state. The significance of this study is improving medication use among older adults at a primary care level and will probably upgrade the quality of the Malaysian health care system by providing some program and policy level solutions towards the problems.
Read the detailed description
- Before the initiation of the study, the community pharmacy involved or volunteered from intervention groups in Penang, Malaysia will undergo half-day training on a structured medication review plan and the study process.
- Control groups pharmacies will undergo a briefing of the study process only.
- A validated survey MedUseQ questionnaire will be administered to each respondent from both intervention and control groups prior to the intervention.
- Medication review intervention will then be performed only for the intervention group.
- A pharmacist will review the medications of those in the intervention group and tried to resolve any drug-related problems encountered by the participants. In addition, the pharmacist will conduct a question-answer session with the participants to enhance older adults' knowledge and awareness of their medications.
- Immediate post-intervention knowledge questions related to their medications name and dose, timing and interval of dose, medication indication, and possible side effects.
- Intervention groups will be followed up at two months and four months through a phone call or face to face. Follow-up will include detecting any medication-related problems among participants, updating their current medication regime, and to further clarifying any query from them.
- Meanwhile, the control group will not be going under follow-up. Only the number of drug related problems will be recorded
- All participants will then be followed six months of post-intervention and will be given again the MedUseQ survey to compare the difference between baseline and post-intervention.
- Data collection will be conducted at baseline and six months after the intervention.
- Conditions
- Aging
- Being tested
- Medication review
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication reviewOther
Community pharmacy benchmarking guideline Pharmaceutical Services Division provides guidelines for medication review in community pharmacy settings in Malaysia
| Study group | Role | What they receive |
|---|---|---|
| Medication Review | Experimental | The intervention group will receive medication review intervention which includes reviewing older adults' medications and identifying any drug-related problems. Receives: Other: Medication review |
| Standard Care | No intervention | The standard care includes the current existing care provided to patients in the community pharmacy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing feasibility: intervention time
Length of intervention (minutes)
Measured: 6 months
Assessing feasibility: Number of staffs
Number of staffs
Measured: 6 months
Assessing feasibility: Access to prescribers
Number of prescribers contacted
Measured: 6 months
Type and number medication-related problem
- Number of inappropriate medications (Based on Beer's criteria)
- Number of medications
- Adverse drug reactions detected
- Drug-drug interaction
- Improper medication administration
- Incorrect dose and frequency of medications
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start30 Jun 2022
- Primary completion30 Nov 2022
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Monash University Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina Christopher, Monash University Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05297461
- Sponsor's protocol ID
- MedRev
- Status last verified
- Oct 2023
- First submitted
- 17 Mar 2022
- Last updated
- 31 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Marek KD, Antle L. Medication Management of the Community-Dwelling Older Adult. In: Hughes RG, editor. Patient Safety and Quality: An Evidence-Based Handbook for Nurses. Rockville (MD): Agency for Healthcare Research and Quality (US); 2008 Apr. Chapter 18. Available from http://www.ncbi.nlm.nih.gov/books/NBK2670/
PubMed 21328769Mangin D, Garfinkel D. Foreword to the first special collection: Addressing the invisible iatrogenic epidemic: the role of deprescribing in polypharmacy and inappropriate medication use. Ther Adv Drug Saf. 2019 Oct 21;10:2042098619883156. doi: 10.1177/2042098619883156. eCollection 2019. No abstract available.
PubMed 31673327Ramli A, Taher S. Managing chronic diseases in the malaysian primary health care - a need for change. Malays Fam Physician. 2008 Apr 30;3(1):7-13. eCollection 2008.
PubMed 25606105Blenkinsopp A, Bond C, Raynor DK. Medication reviews. Br J Clin Pharmacol. 2012 Oct;74(4):573-80. doi: 10.1111/j.1365-2125.2012.04331.x.
PubMed 22607195Lee E, Braund R, Tordoff J. Examining the first year of Medicines Use Review services provided by pharmacists in New Zealand: 2008. N Z Med J. 2009 Apr 24;122(1293):3566.
PubMed 19448788Ramalho de Oliveira D, Brummel AR, Miller DB. Medication therapy management: 10 years of experience in a large integrated health care system. J Manag Care Pharm. 2010 Apr;16(3):185-95. doi: 10.18553/jmcp.2010.16.3.185.
PubMed 20331323Benrimoj SI, Roberts AS. Providing patient care in community pharmacies in Australia. Ann Pharmacother. 2005 Nov;39(11):1911-7. doi: 10.1345/aph.1G165. Epub 2005 Oct 11.
PubMed 16219897Beuscart JB, Petit S, Gautier S, Wierre P, Balcaen T, Lefebvre JM, Kambia N, Bertoux E, Mascaut D, Barthelemy C, Cuny D, Puisieux F, Decaudin B. Polypharmacy in older patients: identifying the need for support by a community pharmacist. BMC Geriatr. 2019 Oct 21;19(1):277. doi: 10.1186/s12877-019-1276-y.
PubMed 31638909Christopher CM, Blebil AQ, Bhuvan KC, Alex D, Ibrahim MIM, Ismail N, Cheong MWL. Assessing feasibility of conducting medication review with follow-up among older adults at community pharmacy: a pilot randomised controlled trial. Int J Clin Pharm. 2024 Aug;46(4):843-853. doi: 10.1007/s11096-024-01711-3. Epub 2024 Apr 18.
PubMed 38635115
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Community Pharmacists' Medication Review on Medication Use Related Problems Among Older Adults in Penang: A Pilot Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT05297461
- Acronym / sponsor ID
- MedRev
- Conditions
- Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Monash University MalaysiaUniversity, hospital or other
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 28 Mar 2022 (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.
The aging population size has been enlarging globally. A higher number of older adults means a higher number of medication use. It is estimated that older adults are the largest medication consumers.That would result in various medication use problems which provide a link between polypharmacy, inappropriate medication, and deprescribing.[2] Primary health care providers especially community pharmacists are often the first point of healthcare towards older adults.[3] Various interventions are being carried out by community pharmacies to determine an optimal outcome on medication usage.
Medication review intervention is a clinical process where a pharmacist reviews a patient's medication, identifies any drug-related problems and suggests strategies to reduce the medication use problems. Medication review is being utilized in various countries especially in Organisation for Economic Co-operation and Development (OECD )regions ie Australia, New Zealand, the United Kingdom, and the United States of America, and the pharmacist were remunerated for the service. Although medication review is widely searched intervention globally, the scope for intervention is lacking in low and middle-income countries.
Community pharmacy is regarded as the first point of care of primary health care in a community for older adults. A systemic review search on community pharmacist-led intervention among the aging population has demonstrated medication adherence improvement outcomes. Consequently, community pharmacists can reduce medication use problems in different settings in the community in various ways and contribute to the patients' overall well-being and health-related quality of life.
There is a lack of information in Malaysia due to the fragmented health care system where there is no continuity of care between the public and private sectors. During this pandemic outbreak, when most countries suffer critical health care points, much effort and pharmaceutical care should be delivered towards older adults to reduce the current burden. This study assesses the feasibility of medication review for older adults at the community pharmacy level and identifies any medication-related problems in Penang state. The significance of this study is improving medication use among older adults at a primary care level and will probably upgrade the quality of the Malaysian health care system by providing some program and policy level solutions towards the problems.
Detailed description
- Before the initiation of the study, the community pharmacy involved or volunteered from intervention groups in Penang, Malaysia will undergo half-day training on a structured medication review plan and the study process.
- Control groups pharmacies will undergo a briefing of the study process only.
- A validated survey MedUseQ questionnaire will be administered to each respondent from both intervention and control groups prior to the intervention.
- Medication review intervention will then be performed only for the intervention group.
- A pharmacist will review the medications of those in the intervention group and tried to resolve any drug-related problems encountered by the participants. In addition, the pharmacist will conduct a question-answer session with the participants to enhance older adults' knowledge and awareness of their medications.
- Immediate post-intervention knowledge questions related to their medications name and dose, timing and interval of dose, medication indication, and possible side effects.
- Intervention groups will be followed up at two months and four months through a phone call or face to face. Follow-up will include detecting any medication-related problems among participants, updating their current medication regime, and to further clarifying any query from them.
- Meanwhile, the control group will not be going under follow-up. Only the number of drug related problems will be recorded
- All participants will then be followed six months of post-intervention and will be given again the MedUseQ survey to compare the difference between baseline and post-intervention.
- Data collection will be conducted at baseline and six months after the intervention.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medication Review | Experimental | Other: Medication reviewThe intervention group will receive medication review intervention which includes reviewing older adults' medications and identifying any drug-related problems. |
| Standard Care | No intervention | –The standard care includes the current existing care provided to patients in the community pharmacy. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients above 60 years old Patients who have chronic disease ie diabetes, hypertension, cardiovascular
- Patients who have been patronizing the pharmacy for the purchase of at least one prescription medication for the past three months.
- Patients be able to converse, read and understand the Malay language or English language.
- Access to a telephone or mobile phone or internet
- The patients must understand the study process, agree to participate in this study, and sign the informed consent
Key exclusion criteria (2 listed)
- Patient who are unable to converse, read and understand Malay or English language
- Patients who unable to give their consent
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 reviewCommunity pharmacy benchmarking guideline Pharmaceutical Services Division provides guidelines for medication review in community pharmacy settings in Malaysia | Other | Medication Review |
Primary outcome
Assessing feasibility: intervention time
Time frame: 6 months
Length of intervention (minutes)
Assessing feasibility: Number of staffs
Time frame: 6 months
Number of staffs
Assessing feasibility: Access to prescribers
Time frame: 6 months
Number of prescribers contacted
Type and number medication-related problem
Time frame: 6 months
1. Number of inappropriate medications (Based on Beer's criteria) 2. Number of medications 3. Adverse drug reactions detected 4. Drug-drug interaction 5. Improper medication administration 6. Incorrect dose and frequency of medications
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 31 Oct 2023.
- Background: PubMed 21328769Marek KD, Antle L. Medication Management of the Community-Dwelling Older Adult. In: Hughes RG, editor. Patient Safety and Quality: An Evidence-Based Handbook for Nurses. Rockville (MD): Agency for Healthcare Research and Quality (US); 2008 Apr. Chapter 18. Available from http://www.ncbi.nlm.nih.gov/books/NBK2670/
- Background: PubMed 31673327Mangin D, Garfinkel D. Foreword to the first special collection: Addressing the invisible iatrogenic epidemic: the role of deprescribing in polypharmacy and inappropriate medication use. Ther Adv Drug Saf. 2019 Oct 21;10:2042098619883156. doi: 10.1177/2042098619883156. eCollection 2019. No abstract available.
- Background: PubMed 25606105Ramli A, Taher S. Managing chronic diseases in the malaysian primary health care - a need for change. Malays Fam Physician. 2008 Apr 30;3(1):7-13. eCollection 2008.
- Background: PubMed 22607195Blenkinsopp A, Bond C, Raynor DK. Medication reviews. Br J Clin Pharmacol. 2012 Oct;74(4):573-80. doi: 10.1111/j.1365-2125.2012.04331.x.
- Background: PubMed 19448788Lee E, Braund R, Tordoff J. Examining the first year of Medicines Use Review services provided by pharmacists in New Zealand: 2008. N Z Med J. 2009 Apr 24;122(1293):3566.
- Background: PubMed 20331323Ramalho de Oliveira D, Brummel AR, Miller DB. Medication therapy management: 10 years of experience in a large integrated health care system. J Manag Care Pharm. 2010 Apr;16(3):185-95. doi: 10.18553/jmcp.2010.16.3.185.
- Background: PubMed 16219897Benrimoj SI, Roberts AS. Providing patient care in community pharmacies in Australia. Ann Pharmacother. 2005 Nov;39(11):1911-7. doi: 10.1345/aph.1G165. Epub 2005 Oct 11.
- Background: PubMed 31638909Beuscart JB, Petit S, Gautier S, Wierre P, Balcaen T, Lefebvre JM, Kambia N, Bertoux E, Mascaut D, Barthelemy C, Cuny D, Puisieux F, Decaudin B. Polypharmacy in older patients: identifying the need for support by a community pharmacist. BMC Geriatr. 2019 Oct 21;19(1):277. doi: 10.1186/s12877-019-1276-y.
- Derived from this study: PubMed 38635115Christopher CM, Blebil AQ, Bhuvan KC, Alex D, Ibrahim MIM, Ismail N, Cheong MWL. Assessing feasibility of conducting medication review with follow-up among older adults at community pharmacy: a pilot randomised controlled trial. Int J Clin Pharm. 2024 Aug;46(4):843-853. doi: 10.1007/s11096-024-01711-3. Epub 2024 Apr 18.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 Aging, run by Monash University Malaysia at 1 site in Malaysia.
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 2 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 31 Oct 2023. 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 Malaysia. 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?
Assessing feasibility: intervention time (time frame: 6 months). The study lists 4 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 NCT05297461, which also lists 9 linked publications.
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 31 Oct 2023.