ElderlyNCT00844025
Pharmaceutical Care and Clinical Outcomes for the Elderly Taking Potentially Inappropriate Medication
A study testing Pharmacist intervention in people with Elderly and Chronic Disease, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.
Trial summary
The investigators propose that clinical pharmacist interventions would reduce the rate of adverse drug events in elderly patients taking potentially inappropriate medication. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Elderly, Chronic Disease
- What is being tested?
- Pharmacist intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2009to Feb 2010
- 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 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Hospitalized patients aged at least 65 years
- Taking at least six prescribed medicines regularly, including at least one potential inappropriate medication
Who cannot join
- Patients who refused informed consent
- Discharged before consent could be obtained
- Cognitive impaired
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Shin Kong Wo Ho-Su Memorial Hospital, Department of Pharmacy
Taipei, 111
About this study
Official title: Pharmaceutical Care and Clinical Outcomes for the Elderly Taking Potentially Inappropriate Medication: a Randomized-Controlled Trial
The investigators propose that clinical pharmacist interventions would reduce the rate of adverse drug events in elderly patients taking potentially inappropriate medication.
- Conditions
- Elderly, Chronic Disease
- Being tested
- Pharmacist intervention
- Keywords
- Adverse drug reaction, Inappropriate medication, Pharmacist, Pharmaceutical care
- Medical subject headings
- Chronic Disease, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist interventionBehavioural
Medication review, medication reconciliation, and pharmacotherapy recommendation.
| Study group | Role | What they receive |
|---|---|---|
| Pharmacist intervention | Experimental | Patients in the intervention group will receive pharmaceutical care delivered by clinical pharmacist, which including medication review, medication reconciliation, patient education and recommended actions. Receives: Behavioral: Pharmacist intervention |
| Usual care | No intervention | Patients randomized to usual care group will receive routine review of medication by ward-based pharmacist and nurse. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of unsolved drug-related problems
Measured: 14 days after randomization
Secondary outcomes (2)
Rate of adverse drug event during hospitalization
Measured: 14 days after randomization
Number of potentially inappropriate medication
Measured: 14 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionFeb 2010 (estimated)
- Study completionFeb 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ElderlyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Liu Jen Wei, MS, Principal investigator, Shin Kong Wo Ho-Su Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00844025
- Sponsor's protocol ID
- SKH-8302-98-NDR-05
- Status last verified
- Mar 2009
- First submitted
- 12 Feb 2009
- Last updated
- 31 Mar 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fick DM, Cooper JW, Wade WE, Waller JL, Maclean JR, Beers MH. Updating the Beers criteria for potentially inappropriate medication use in older adults: results of a US consensus panel of experts. Arch Intern Med. 2003 Dec 8-22;163(22):2716-24. doi: 10.1001/archinte.163.22.2716.
PubMed 14662625Gallagher P, O'Mahony D. STOPP (Screening Tool of Older Persons' potentially inappropriate Prescriptions): application to acutely ill elderly patients and comparison with Beers' criteria. Age Ageing. 2008 Nov;37(6):673-9. doi: 10.1093/ageing/afn197. Epub 2008 Oct 1.
PubMed 18829684Krska J, Cromarty JA, Arris F, Jamieson D, Hansford D, Duffus PR, Downie G, Seymour DG. Pharmacist-led medication review in patients over 65: a randomized, controlled trial in primary care. Age Ageing. 2001 May;30(3):205-11. doi: 10.1093/ageing/30.3.205.
PubMed 11443021Laroche ML, Charmes JP, Merle L. Potentially inappropriate medications in the elderly: a French consensus panel list. Eur J Clin Pharmacol. 2007 Aug;63(8):725-31. doi: 10.1007/s00228-007-0324-2. Epub 2007 Jun 7.
PubMed 17554532
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmaceutical Care and Clinical Outcomes for the Elderly Taking Potentially Inappropriate Medication: a Randomized-Controlled Trial
- ClinicalTrials.gov ID
- NCT00844025
- Acronym / sponsor ID
- SKH-8302-98-NDR-05
- Conditions
- Elderly, Chronic Disease
- Keywords
- Adverse drug reaction, Inappropriate medication, Pharmacist, Pharmaceutical care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial HospitalUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Feb 2010 (estimated)
- Study completion
- Feb 2010 (estimated)
- First posted
- 13 Feb 2009 (estimated)
- 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 investigators propose that clinical pharmacist interventions would reduce the rate of adverse drug events in elderly patients taking potentially inappropriate medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmacist intervention | Experimental | Behavioral: Pharmacist interventionPatients in the intervention group will receive pharmaceutical care delivered by clinical pharmacist, which including medication review, medication reconciliation, patient education and recommended actions. |
| Usual care | No intervention | –Patients randomized to usual care group will receive routine review of medication by ward-based pharmacist and nurse. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Hospitalized patients aged at least 65 years
- Taking at least six prescribed medicines regularly, including at least one potential inappropriate medication
Key exclusion criteria (3 listed)
- Patients who refused informed consent
- Discharged before consent could be obtained
- Cognitive impaired
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 |
|---|---|---|
| Pharmacist interventionMedication review, medication reconciliation, and pharmacotherapy recommendation. | Behavioural | Pharmacist intervention |
Primary outcome
Number of unsolved drug-related problems
Time frame: 14 days after randomization
2 secondary outcomes
Rate of adverse drug event during hospitalization
Time frame: 14 days after randomization
Number of potentially inappropriate medication
Time frame: 14 days after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2009.
- Background: PubMed 14662625Fick DM, Cooper JW, Wade WE, Waller JL, Maclean JR, Beers MH. Updating the Beers criteria for potentially inappropriate medication use in older adults: results of a US consensus panel of experts. Arch Intern Med. 2003 Dec 8-22;163(22):2716-24. doi: 10.1001/archinte.163.22.2716.
- Background: PubMed 18829684Gallagher P, O'Mahony D. STOPP (Screening Tool of Older Persons' potentially inappropriate Prescriptions): application to acutely ill elderly patients and comparison with Beers' criteria. Age Ageing. 2008 Nov;37(6):673-9. doi: 10.1093/ageing/afn197. Epub 2008 Oct 1.
- Background: PubMed 11443021Krska J, Cromarty JA, Arris F, Jamieson D, Hansford D, Duffus PR, Downie G, Seymour DG. Pharmacist-led medication review in patients over 65: a randomized, controlled trial in primary care. Age Ageing. 2001 May;30(3):205-11. doi: 10.1093/ageing/30.3.205.
- Background: PubMed 17554532Laroche ML, Charmes JP, Merle L. Potentially inappropriate medications in the elderly: a French consensus panel list. Eur J Clin Pharmacol. 2007 Aug;63(8):725-31. doi: 10.1007/s00228-007-0324-2. Epub 2007 Jun 7.
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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.
Liu Jen Wei, MS principal investigator
Shin Kong Wo Ho-Su Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist intervention in people with Elderly and Chronic Disease, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.
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 2 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 31 Mar 2009. 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 Taiwan. 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?
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?
Number of unsolved drug-related problems (time frame: 14 days after randomization). 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 NCT00844025, which also lists 4 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 Mar 2009.