PolypharmacyNCT01732302
Educational Intervention to Reduce Drug-related Hospitalizations in Elderly Primary Health Care Patients
A study testing Educational intervention in people with Polypharmacy and Adverse Drug Reaction, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The purpose of this study is to determine whether an educational intervention given towards health care providers working in primary health care centers can reduce inappropriate prescribing in the elderly patient and thus reduce number and length of drug-related hospitalizations as well as number of emergency… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Polypharmacy, Adverse Drug Reaction
- What is being tested?
- Educational intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2012to Sep 2013
- 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
- primary health care center in Stockholm County
- authorized by Stockholm County Council since at least 3 years
- at least 5% of patients attributed to primary health care center are 65 years and older
- primary health care center takes care of at least 10 home care patients
Who cannot join
- less than 3000 patients listed in primary health care center
- primary health care centers where researchers carrying out the present study work
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Centre for Family Medicine, Dept of Neurobiology, Care sciences and Society, Karolinska Institutet
Huddinge, 14183
About this study
Official title: Educational Intervention to Reduce Drug-related Hospitalizations and Visits in Emergency Departments in Elderly Primary Health Care Patients - a Cluster-randomized Controlled Trial
The purpose of this study is to determine whether an educational intervention given towards health care providers working in primary health care centers can reduce inappropriate prescribing in the elderly patient and thus reduce number and length of drug-related hospitalizations as well as number of emergency department visits in this patient group.
Read the detailed description
Inappropriate medication in the elderly patient leads to substantial morbidity, possibly causing up to 20% of hospitalizations in this patient group (1). To improve prescribing and thus reduce undesired drug effects is a great challenge for doctors and nurses in primary health care.
Performance of drug utilization reviews is recommended in order to reduce the negative impact of inappropriate prescribing in the elderly. However, scientific evidence on their efficacy is lacking, especially regarding patient-related health outcomes (2,3). Most studies are carried out in inpatient care, making it difficult to draw conclusions regarding primary health care (2). Moreover, studies in this scientific field diverge regarding the content and structure of drug utilization reviews, which implies that comparison between studies becomes challenging, if not impossible.
This trial aims at educating health care providers in how to perform drug utilization reviews, and to help them implement theory into practice.
- Conditions
- Polypharmacy, Adverse Drug Reaction
- Being tested
- Educational intervention
- Keywords
- Drug Utilization Review, Aged, Aged, 80 and over, Primary Health Care
- Medical subject headings
- 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.
Educational interventionOther
Primary health care centers (PHCC) in the intervention group will be visited twice by a pharmacist within a period of three months. At the first visit, an educational intervention will focus on two properties: on the one hand, feed-back of actual patient data of the PHCC illustrating the primary-health-care-specific characteristics of inappropriate prescribing in the elderly patient will be given. Education of relevant subjects will be given in relation to detected problems. On the other hand, a clinical routine regarding the performance of drug utilization reviews will be developed in cooperation with the health care providers. At the second visit 3 months later, the developed concept will be critically reviewed and eventually developed further.
| Study group | Role | What they receive |
|---|---|---|
| Educational intervention | Experimental | Primary health care centers (PHCC) in the intervention group will be visited twice by a pharmacist within a period of three months. At the first visit, an educational intervention will focus on two properties: on the one hand, feed-back of actual patient data of the PHCC illustrating the primary-health-care-specific characteristics of inappropriate prescribing in the elderly patient will be given. Education of relevant subjects will be given in relation to detected problems. On the other hand, a clinical routine regarding the performance of drug utilization reviews will be developed in cooperation with the health care providers. At the second visit 3 months later, the developed concept will be critically reviewed and eventually developed further. Receives: Other: Educational intervention |
| Delayed educational intervention | No intervention | Primary health care centers in the delayed intervention group will receive the same intervention as described above with 9 months delay. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite outcome: Unplanned hospitalisation or emergency department visit
Measured: 9 months
Secondary outcomes (10)
Unplanned hospitalisation
Measured: 9 months
Emergency department visit
Measured: 9 months
Length of hospital stay
Measured: 9 months
All cause mortality
Measured: 9 months
Number of drug utilization reviews
Measured: 9 months
Number of patients with polypharmacy
polypharmacy: 5-9 drugs/patient excessive polypharmacy: 10 and more drugs/patient
Measured: 9 months
Inappropriate drug use according to national guidelines
see link
Measured: 9 months
Number of patients with contraindicated drugs regarding renal function
Measured: 9 months
Number of drugs with inappropriate drug dose regarding renal function
Measured: 9 months
Number of drug interactions
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PolypharmacyStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Principal investigator, Lars Agreus, Karolinska Institutet
- Investigators
- Jan Hasselström, MD, PhD, Principal investigator, Centre for Family Medicine, Dept of Neurobiology, Care sciences and Society, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01732302
- Sponsor's protocol ID
- 2012 1266-31
- Status last verified
- Oct 2013
- First submitted
- 19 Nov 2012
- Last updated
- 21 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Beijer HJ, de Blaey CJ. Hospitalisations caused by adverse drug reactions (ADR): a meta-analysis of observational studies. Pharm World Sci. 2002 Apr;24(2):46-54. doi: 10.1023/a:1015570104121.
PubMed 12061133Spinewine A, Schmader KE, Barber N, Hughes C, Lapane KL, Swine C, Hanlon JT. Appropriate prescribing in elderly people: how well can it be measured and optimised? Lancet. 2007 Jul 14;370(9582):173-184. doi: 10.1016/S0140-6736(07)61091-5.
PubMed 17630041Stewart S, Pearson S, Luke CG, Horowitz JD. Effects of home-based intervention on unplanned readmissions and out-of-hospital deaths. J Am Geriatr Soc. 1998 Feb;46(2):174-80. doi: 10.1111/j.1532-5415.1998.tb02535.x.
PubMed 9475445
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Educational Intervention to Reduce Drug-related Hospitalizations and Visits in Emergency Departments in Elderly Primary Health Care Patients - a Cluster-randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01732302
- Acronym / sponsor ID
- 2012 1266-31
- Conditions
- Polypharmacy, Adverse Drug Reaction
- Keywords
- Drug Utilization Review, Aged, Aged, 80 and over, Primary Health Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- Nov 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 22 Nov 2012 (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 determine whether an educational intervention given towards health care providers working in primary health care centers can reduce inappropriate prescribing in the elderly patient and thus reduce number and length of drug-related hospitalizations as well as number of emergency department visits in this patient group.
Detailed description
Inappropriate medication in the elderly patient leads to substantial morbidity, possibly causing up to 20% of hospitalizations in this patient group (1). To improve prescribing and thus reduce undesired drug effects is a great challenge for doctors and nurses in primary health care.
Performance of drug utilization reviews is recommended in order to reduce the negative impact of inappropriate prescribing in the elderly. However, scientific evidence on their efficacy is lacking, especially regarding patient-related health outcomes (2,3). Most studies are carried out in inpatient care, making it difficult to draw conclusions regarding primary health care (2). Moreover, studies in this scientific field diverge regarding the content and structure of drug utilization reviews, which implies that comparison between studies becomes challenging, if not impossible.
This trial aims at educating health care providers in how to perform drug utilization reviews, and to help them implement theory into practice.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational intervention | Experimental | Other: Educational interventionPrimary health care centers (PHCC) in the intervention group will be visited twice by a pharmacist within a period of three months. At the first visit, an educational intervention will focus on two properties: on the one hand, feed-back of actual patient data of the PHCC illustrating the primary-health-care-specific characteristics of inappropriate prescribing in the elderly patient will be given. Education of relevant subjects will be given in relation to detected problems. On the other hand, a clinical routine regarding the performance of drug utilization reviews will be developed in cooperation with the health care providers. At the second visit 3 months later, the developed concept will be critically reviewed and eventually developed further. |
| Delayed educational intervention | No intervention | –Primary health care centers in the delayed intervention group will receive the same intervention as described above with 9 months delay. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- primary health care center in Stockholm County
- authorized by Stockholm County Council since at least 3 years
- at least 5% of patients attributed to primary health care center are 65 years and older
- primary health care center takes care of at least 10 home care patients
Key exclusion criteria (2 listed)
- less than 3000 patients listed in primary health care center
- primary health care centers where researchers carrying out the present study work
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 |
|---|---|---|
| Educational interventionPrimary health care centers (PHCC) in the intervention group will be visited twice by a pharmacist within a period of three months. At the first visit, an educational intervention will focus on two properties: on the one hand, feed-back of actual patient data of the PHCC illustrating the primary-health-care-specific characteristics of inappropriate prescribing in the elderly patient will be given. Education of relevant subjects will be given in relation to detected problems. On the other hand, a clinical routine regarding the performance of drug utilization reviews will be developed in cooperation with the health care providers. At the second visit 3 months later, the developed concept will be critically reviewed and eventually developed further. | Other | Educational intervention |
Primary outcome
Composite outcome: Unplanned hospitalisation or emergency department visit
Time frame: 9 months
10 secondary outcomes
Unplanned hospitalisation
Time frame: 9 months
Emergency department visit
Time frame: 9 months
Length of hospital stay
Time frame: 9 months
All cause mortality
Time frame: 9 months
Number of drug utilization reviews
Time frame: 9 months
Number of patients with polypharmacy
Time frame: 9 months
Inappropriate drug use according to national guidelines
Time frame: 9 months
Number of patients with contraindicated drugs regarding renal function
Time frame: 9 months
Number of drugs with inappropriate drug dose regarding renal function
Time frame: 9 months
Number of drug interactions
Time frame: 9 months
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 21 Oct 2013.
- Background: PubMed 12061133Beijer HJ, de Blaey CJ. Hospitalisations caused by adverse drug reactions (ADR): a meta-analysis of observational studies. Pharm World Sci. 2002 Apr;24(2):46-54. doi: 10.1023/a:1015570104121.
- Background: PubMed 17630041Spinewine A, Schmader KE, Barber N, Hughes C, Lapane KL, Swine C, Hanlon JT. Appropriate prescribing in elderly people: how well can it be measured and optimised? Lancet. 2007 Jul 14;370(9582):173-184. doi: 10.1016/S0140-6736(07)61091-5.
- Background: PubMed 9475445Stewart S, Pearson S, Luke CG, Horowitz JD. Effects of home-based intervention on unplanned readmissions and out-of-hospital deaths. J Am Geriatr Soc. 1998 Feb;46(2):174-80. doi: 10.1111/j.1532-5415.1998.tb02535.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.
Jan Hasselström, MD, PhD principal investigator
Centre for Family Medicine, Dept of Neurobiology, Care sciences and Society, Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational intervention in people with Polypharmacy and Adverse Drug Reaction, run by Karolinska Institutet 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 4 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 21 Oct 2013. 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?
Composite outcome: Unplanned hospitalisation or emergency department visit (time frame: 9 months). 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 NCT01732302, which also lists 3 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 21 Oct 2013.