Drug-Related ProblemsNCT00661310
Optimizing Drug-Therapy in Patients 80 Years and Older
A study testing Drug review 80+ -To reduce usage of hospital care in people with Drug-Related Problems, run by Uppsala University Hospital at 1 site in Sweden.
Trial summary
The purpose of this study is to measure the effects of an enhanced service where a pharmacists is part of the healthcare team on the ward (focusing on drug-related problems and transferring information between primary and secondary care). Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- Drug-Related Problems
- What is being tested?
- Drug review 80+ -To reduce usage of hospital care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2005to Jun 2007
- 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 80 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 80 years and older
- Acute admission to study ward
Who cannot join
- <80 years
- Scheduled admission
- Previously admitted to studyward during study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimizing Drug-Therapy in Patients, 80 Years and Older, in Order to Reduce Drug-Related Morbidity and Usage of Secondary Care - a Randomized Controlled Trial
The purpose of this study is to measure the effects of an enhanced service where a pharmacists is part of the healthcare team on the ward (focusing on drug-related problems and transferring information between primary and secondary care). Primary outcome measure is visits to hospital during a 12-month follow-up period, and the population is patients 80 years and older.
Read the detailed description
Optimising drug-therapy for patients, 80 years and older, to reduce hospital visits
Background and Objective:
Results from a pilot-study performed in 2004 at the Academic Hospital, Uppsala, including 214 consecutive patients (80 years old or older) showed that 9.4%-13.6% of the patients were acutely admitted to hospital due to a drug related problem1. Other similar international studies show that the frequency of drug-related hospital admissions stands for at least 14% of the acute admissions (14%-30.4%). Of these admissions it was estimated that 32%-69% were preventable 2,3,4.
A study from Antrim Hospital, Northern Ireland, showed that pharmacists´ involvement in the health care team can reduce the number of acute hospital admissions and improve quality of drug use5.
In view of these findings this study was initiated in 2005 with fundings from the Drug and Therapeutics committee, the County Council of Uppsala, the Division of Acute-Medicine and the Pharmacy Department at the Academic Hospital in Uppsala
Aim and objectives:
The Study Aim was to optimize drug-prescribing and drug use for patients 80 years and older.
The main objective was to reduce the number of hospital visits for patients 80-years old or older.
Design:
A randomized, controlled trial including 400 patients (200+200). Patients in the intervention group (I) received a patient interview on admission, drug counseling on discharge and a drug review - all performed by a clinical pharmacist. Patients in the control group (C) received standard care, without pharmacists´ involvement.
Patients were included between Oct 2005 and June 2006.
Setting:
Two wards at the Division of Acute-Medicine at Uppsala University Hospital, Sweden
Main Outcome Measures:
- Frequency of hospital visits 12 months after (last included patient) discharge from hospital for (I) and (C).
- Conditions
- Drug-Related Problems
- Being tested
- Drug review 80+ -To reduce usage of hospital care
- Keywords
- re-admissions, medicines, management, patients, 80 years and older, acute, admissions, hospital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug review 80+ -To reduce usage of hospital careOther
drug review performed by multiprofessional team, including clinical pharmacist, in order to optimize drug therapy and reduce usage of hospital care. Also patient education and follow-up
| Study group | Role | What they receive |
|---|---|---|
| I | Experimental | Intervention by team consisting of Doctor, pharmacist and nurse Receives: Other: Drug review 80+ -To reduce usage of hospital care |
| C | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects on hospital visits
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2008 (estimated)
- Study startSep 2005
- Primary completionJun 2006
- Study completionJun 2007
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 Drug-Related ProblemsStudies 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
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University
- Investigators
- Henrik Toss, MD PhD, Principal investigator, Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00661310
- Sponsor's protocol ID
- Uppsala80
- Status last verified
- Oct 2008
- First submitted
- 14 Apr 2008
- Last updated
- 5 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Gillespie U, Alassaad A, Henrohn D, Garmo H, Hammarlund-Udenaes M, Toss H, Kettis-Lindblad A, Melhus H, Morlin C. A comprehensive pharmacist intervention to reduce morbidity in patients 80 years or older: a randomized controlled trial. Arch Intern Med. 2009 May 11;169(9):894-900. doi: 10.1001/archinternmed.2009.71.
PubMed 19433702
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Drug-Therapy in Patients, 80 Years and Older, in Order to Reduce Drug-Related Morbidity and Usage of Secondary Care - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00661310
- Acronym / sponsor ID
- Uppsala80
- Conditions
- Drug-Related Problems
- Keywords
- re-admissions, medicines, management, patients, 80 years and older, acute, admissions, hospital
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Uppsala University HospitalUniversity, hospital or other
- Collaborators
- Uppsala University
- Study start
- Sep 2005
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 18 Apr 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.
The purpose of this study is to measure the effects of an enhanced service where a pharmacists is part of the healthcare team on the ward (focusing on drug-related problems and transferring information between primary and secondary care). Primary outcome measure is visits to hospital during a 12-month follow-up period, and the population is patients 80 years and older.
Detailed description
Optimising drug-therapy for patients, 80 years and older, to reduce hospital visits
Background and Objective:
Results from a pilot-study performed in 2004 at the Academic Hospital, Uppsala, including 214 consecutive patients (80 years old or older) showed that 9.4%-13.6% of the patients were acutely admitted to hospital due to a drug related problem1. Other similar international studies show that the frequency of drug-related hospital admissions stands for at least 14% of the acute admissions (14%-30.4%). Of these admissions it was estimated that 32%-69% were preventable 2,3,4.
A study from Antrim Hospital, Northern Ireland, showed that pharmacists´ involvement in the health care team can reduce the number of acute hospital admissions and improve quality of drug use5.
In view of these findings this study was initiated in 2005 with fundings from the Drug and Therapeutics committee, the County Council of Uppsala, the Division of Acute-Medicine and the Pharmacy Department at the Academic Hospital in Uppsala
Aim and objectives:
The Study Aim was to optimize drug-prescribing and drug use for patients 80 years and older.
The main objective was to reduce the number of hospital visits for patients 80-years old or older.
Design:
A randomized, controlled trial including 400 patients (200+200). Patients in the intervention group (I) received a patient interview on admission, drug counseling on discharge and a drug review - all performed by a clinical pharmacist. Patients in the control group (C) received standard care, without pharmacists´ involvement.
Patients were included between Oct 2005 and June 2006.
Setting:
Two wards at the Division of Acute-Medicine at Uppsala University Hospital, Sweden
Main Outcome Measures:
- Frequency of hospital visits 12 months after (last included patient) discharge from hospital for (I) and (C).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Other: Drug review 80+ -To reduce usage of hospital careIntervention by team consisting of Doctor, pharmacist and nurse |
| C | No intervention | – |
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 80 years and older
- Acute admission to study ward
Key exclusion criteria (3 listed)
- <80 years
- Scheduled admission
- Previously admitted to studyward during study period
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 |
|---|---|---|
| Drug review 80+ -To reduce usage of hospital caredrug review performed by multiprofessional team, including clinical pharmacist, in order to optimize drug therapy and reduce usage of hospital care. Also patient education and follow-up | Other | I |
Primary outcome
Effects on hospital visits
Time frame: 1 year
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 5 Dec 2008.
- Derived from this study: PubMed 19433702Gillespie U, Alassaad A, Henrohn D, Garmo H, Hammarlund-Udenaes M, Toss H, Kettis-Lindblad A, Melhus H, Morlin C. A comprehensive pharmacist intervention to reduce morbidity in patients 80 years or older: a randomized controlled trial. Arch Intern Med. 2009 May 11;169(9):894-900. doi: 10.1001/archinternmed.2009.71.
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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.
Henrik Toss, MD PhD principal investigator
Uppsala 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 Drug review 80+ -To reduce usage of hospital care in people with Drug-Related Problems, run by Uppsala University Hospital at 1 site in Sweden.
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: finished, as of the sponsor's last update on 5 Dec 2008. 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 Sweden. 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?
Effects on hospital visits (time frame: 1 year). 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 NCT00661310, 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 5 Dec 2008.