ElderlyNCT00738816
Effect of Systematic Medication Review in Elderly Patients Admitted to an Orthopedic Department
A study testing Systematic medication review and advisory notes in people with Elderly, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
Elderly patients have a higher risk of experiencing adverse drug events due to an age related increase in morbidity and medication use. Inappropriate or wrong medication use among elderly patients acutely admitted to hospitals is assumed to result in earlier contact to general practitioner, emergency departments and… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Elderly
- What is being tested?
- Systematic medication review and advisory notes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2009to Apr 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 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- age 65 years or older
- expected admission time of more than 24 hours
- acute admission
Who cannot join
- Psychotic patients
- Moribund patients
- Suicidal patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Systematic Medication Review in Elderly Patients Admitted to an Orthopedic Department.
Elderly patients have a higher risk of experiencing adverse drug events due to an age related increase in morbidity and medication use. Inappropriate or wrong medication use among elderly patients acutely admitted to hospitals is assumed to result in earlier contact to general practitioner, emergency departments and re-admissions if not corrected during hospital admission. It is therefore our hypothesis that a systematic medication review conducted by pharmacists and physicians specialized in pharmacology will increase time to first unscheduled physician contact (general practitioner, emergency departments, ambulatory care and re-admissions) after discharge from hospital from an average of 21days to 25 days. Further, the following secondary outcome parameters will be measured at discharge and within 3-month follow-up:
- length of in-hospital stay
- number of contacts to general practitioner 30 days after discharge, that resulted in medication changes
- number of re-admissions at 3-month
- number of death at 3-month
- number of contact to primary health care at 3-month
- patients self-experienced quality of health(EQ-5D) 3-month
- Conditions
- Elderly
- Being tested
- Systematic medication review and advisory notes
- Keywords
- Medication review, Patient, Safety, Drug, Prescriptions, Drug-use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systematic medication review and advisory notesOther
Within 24 hours of admission a pharmacist retrieve medication histories from patients included in the intervention group. Medication histories will be obtained from - medical records, medication charts, patients electronical medication profile, interview with patients and if necessary contact to the patients general practitioner. The obtained medication history will be discussed with a physician specialized in pharmacology and an advisory note with suggested changes to the patients medication is added to the medical record. The orthopedic physicians are not obliged to follow the suggested changes
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | Systematic medication review Receives: Other: Systematic medication review and advisory notes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first unscheduled physician contact(general practitioner,emergency department, ambulatory care or re-admission to hospital) after discharge from the Orthopaedic Department
Measured: January 2010
Secondary outcomes (1)
Admission time
Measured: October 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2008 (estimated)
- Study startApr 2009
- Primary completionFeb 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ElderlyStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Nielsen Lars Peter, Assoc. Prof., Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00738816
- Sponsor's protocol ID
- Klinfarm
- Status last verified
- Dec 2010
- First submitted
- 20 Aug 2008
- Last updated
- 14 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Holland R, Desborough J, Goodyer L, Hall S, Wright D, Loke YK. Does pharmacist-led medication review help to reduce hospital admissions and deaths in older people? A systematic review and meta-analysis. Br J Clin Pharmacol. 2008 Mar;65(3):303-16. doi: 10.1111/j.1365-2125.2007.03071.x. Epub 2007 Dec 17.
PubMed 18093253Lau HS, Florax C, Porsius AJ, De Boer A. The completeness of medication histories in hospital medical records of patients admitted to general internal medicine wards. Br J Clin Pharmacol. 2000 Jun;49(6):597-603. doi: 10.1046/j.1365-2125.2000.00204.x.
PubMed 10848724Glintborg B, Andersen SE, Dalhoff K. Drug-drug interactions among recently hospitalised patients--frequent but mostly clinically insignificant. Eur J Clin Pharmacol. 2005 Oct;61(9):675-81. doi: 10.1007/s00228-005-0978-6. Epub 2005 Oct 19.
PubMed 16047138Page RL 2nd, Ruscin JM. The risk of adverse drug events and hospital-related morbidity and mortality among older adults with potentially inappropriate medication use. Am J Geriatr Pharmacother. 2006 Dec;4(4):297-305. doi: 10.1016/j.amjopharm.2006.12.008.
PubMed 17296535Vira T, Colquhoun M, Etchells E. Reconcilable differences: correcting medication errors at hospital admission and discharge. Qual Saf Health Care. 2006 Apr;15(2):122-6. doi: 10.1136/qshc.2005.015347.
PubMed 16585113
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Systematic Medication Review in Elderly Patients Admitted to an Orthopedic Department.
- ClinicalTrials.gov ID
- NCT00738816
- Acronym / sponsor ID
- Klinfarm
- Conditions
- Elderly
- Keywords
- Medication review, Patient, Safety, Drug, Prescriptions, Drug-use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 21 Aug 2008 (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.
Elderly patients have a higher risk of experiencing adverse drug events due to an age related increase in morbidity and medication use. Inappropriate or wrong medication use among elderly patients acutely admitted to hospitals is assumed to result in earlier contact to general practitioner, emergency departments and re-admissions if not corrected during hospital admission. It is therefore our hypothesis that a systematic medication review conducted by pharmacists and physicians specialized in pharmacology will increase time to first unscheduled physician contact (general practitioner, emergency departments, ambulatory care and re-admissions) after discharge from hospital from an average of 21days to 25 days. Further, the following secondary outcome parameters will be measured at discharge and within 3-month follow-up:
- length of in-hospital stay
- number of contacts to general practitioner 30 days after discharge, that resulted in medication changes
- number of re-admissions at 3-month
- number of death at 3-month
- number of contact to primary health care at 3-month
- patients self-experienced quality of health(EQ-5D) 3-month
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Other: Systematic medication review and advisory notesSystematic medication review |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- age 65 years or older
- expected admission time of more than 24 hours
- acute admission
Key exclusion criteria (3 listed)
- Psychotic patients
- Moribund patients
- Suicidal 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 |
|---|---|---|
| Systematic medication review and advisory notesWithin 24 hours of admission a pharmacist retrieve medication histories from patients included in the intervention group. Medication histories will be obtained from - medical records, medication charts, patients electronical medication profile, interview with patients and if necessary contact to the patients general practitioner. The obtained medication history will be discussed with a physician specialized in pharmacology and an advisory note with suggested changes to the patients medication is added to the medical record. The orthopedic physicians are not obliged to follow the suggested changes | Other | Intervention |
Primary outcome
Time to first unscheduled physician contact(general practitioner,emergency department, ambulatory care or re-admission to hospital) after discharge from the Orthopaedic Department
Time frame: January 2010
1 secondary outcome
Admission time
Time frame: October 2009
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 14 Dec 2010.
- Background: PubMed 18093253Holland R, Desborough J, Goodyer L, Hall S, Wright D, Loke YK. Does pharmacist-led medication review help to reduce hospital admissions and deaths in older people? A systematic review and meta-analysis. Br J Clin Pharmacol. 2008 Mar;65(3):303-16. doi: 10.1111/j.1365-2125.2007.03071.x. Epub 2007 Dec 17.
- Background: PubMed 10848724Lau HS, Florax C, Porsius AJ, De Boer A. The completeness of medication histories in hospital medical records of patients admitted to general internal medicine wards. Br J Clin Pharmacol. 2000 Jun;49(6):597-603. doi: 10.1046/j.1365-2125.2000.00204.x.
- Background: PubMed 16047138Glintborg B, Andersen SE, Dalhoff K. Drug-drug interactions among recently hospitalised patients--frequent but mostly clinically insignificant. Eur J Clin Pharmacol. 2005 Oct;61(9):675-81. doi: 10.1007/s00228-005-0978-6. Epub 2005 Oct 19.
- Background: PubMed 17296535Page RL 2nd, Ruscin JM. The risk of adverse drug events and hospital-related morbidity and mortality among older adults with potentially inappropriate medication use. Am J Geriatr Pharmacother. 2006 Dec;4(4):297-305. doi: 10.1016/j.amjopharm.2006.12.008.
- Background: PubMed 16585113Vira T, Colquhoun M, Etchells E. Reconcilable differences: correcting medication errors at hospital admission and discharge. Qual Saf Health Care. 2006 Apr;15(2):122-6. doi: 10.1136/qshc.2005.015347.
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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.
Nielsen Lars Peter, Assoc. Prof. principal investigator
Aarhus University 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 Systematic medication review and advisory notes in people with Elderly, run by Aarhus University Hospital at 1 site in Denmark.
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 3 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: finished, as of the sponsor's last update on 14 Dec 2010. 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 Denmark. 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?
Time to first unscheduled physician contact(general practitioner,emergency department, ambulatory care or re-admission to hospital) after discharge from the Orthopaedic Department (time frame: January 2010). 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 NCT00738816, which also lists 5 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 14 Dec 2010.