Drug Utilization ReviewNCT04040855
Medication Reviews in Elderly in Primary Care
A study testing Medication review in people with Drug Utilization Review, run by Region Skane.
Trial summary
The study is a follow-up of a randomized controlled study performed in 2011-2012 with medication reviews in elderly patients in Sweden. Additional data about mortality and hospital admissions have been collected. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Drug Utilization Review
- What is being tested?
- Medication review
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 369 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2011to 31 Mar 2019
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- age>75 years, living in nursing homes or community-dwelling with municipality-provided care, with multi-dose drug dispensing
Who cannot join
- lack of multi-dose drug dispensing, living at home with no municipality-provided care, <75 years old
About this study
Official title: The Impact of Medication Reviews Conducted in Primary Care on Hospital Admissions and Mortality - a Randomized Controlled Trial
The study is a follow-up of a randomized controlled study performed in 2011-2012 with medication reviews in elderly patients in Sweden. Additional data about mortality and hospital admissions have been collected.
Read the detailed description
Background Drug-related problems among the elderly population are common and increasing. Multi-professional medication reviews (MR) have arisen as a method to optimize drug therapy for frail elderly patients. Research has not yet been able to show conclusive evidence of the effect of MRs on mortality or hospital admissions. Aim The aim of this study was to assess the impact of MRs' on hospital admissions and mortality after six and 12 months in a frail population of 369 patients in primary care in a randomized controlled study. Methods Patients were blindly randomized to an intervention group (receiving MRs) and a control group (receiving usual care). Descriptive data on mortality and hospital admissions at six and 12 months were collected. Survival analysis was performed for time to death and time to the first hospital admission within 12 months.
- Conditions
- Drug Utilization Review
- Being tested
- Medication review
- Keywords
- medication reviews, elderly, primary care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication reviewOther
Multi-professional medication review
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patients in the intervention groups received multi-professional medication reviews. A nurse performed a symptom evaluation, a pharmacist assessed the drug list and made adjustment suggestions and finally a physician took action and performed medication changes. Receives: Other: Medication review |
| Control | No intervention | Patients were treated according to the usual routine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
hospital admission
time to the first hospital admission
Measured: six months
hospital admission
time to the first hospital admission
Measured: twelve months
Survival analysis
time to death
Measured: six months
Survival analysis
time to death
Measured: twelve months
Secondary outcomes (4)
number of hospital admissions
number of hospital admissions
Measured: six months
number of hospital admissions
number of hospital admissions
Measured: twelve months
mortality
number of deaths
Measured: six months
mortality
number of deaths
Measured: twelve months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study start1 Sep 2011
- Primary completion31 Dec 2018
- Study completion31 Mar 2019
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 Utilization ReviewStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients were blindly randomized to intervention or control group in 2011. This study is a follow-up with additional data collection for the included patient, a total of 369.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 369 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04040855
- Sponsor's protocol ID
- 2018/8
- Status last verified
- Jul 2019
- First submitted
- 29 Jul 2019
- Last updated
- 1 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Milos Nymberg V, Lenander C, Borgstrom Bolmsjo B. The Impact of Medication Reviews Conducted in Primary Care on Hospital Admissions and Mortality: An Observational Follow-Up of a Randomized Controlled Trial. Drug Healthc Patient Saf. 2021 Jan 27;13:1-9. doi: 10.2147/DHPS.S283708. eCollection 2021.
PubMed 33536791
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Medication Reviews Conducted in Primary Care on Hospital Admissions and Mortality - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04040855
- Acronym / sponsor ID
- 2018/8
- Conditions
- Drug Utilization Review
- Keywords
- medication reviews, elderly, primary care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 369 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 1 Sep 2011 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 1 Aug 2019 (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 study is a follow-up of a randomized controlled study performed in 2011-2012 with medication reviews in elderly patients in Sweden. Additional data about mortality and hospital admissions have been collected.
Detailed description
Background Drug-related problems among the elderly population are common and increasing. Multi-professional medication reviews (MR) have arisen as a method to optimize drug therapy for frail elderly patients. Research has not yet been able to show conclusive evidence of the effect of MRs on mortality or hospital admissions. Aim The aim of this study was to assess the impact of MRs' on hospital admissions and mortality after six and 12 months in a frail population of 369 patients in primary care in a randomized controlled study. Methods Patients were blindly randomized to an intervention group (receiving MRs) and a control group (receiving usual care). Descriptive data on mortality and hospital admissions at six and 12 months were collected. Survival analysis was performed for time to death and time to the first hospital admission within 12 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Patients were blindly randomized to intervention or control group in 2011. This study is a follow-up with additional data collection for the included patient, a total of 369.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Medication reviewPatients in the intervention groups received multi-professional medication reviews. A nurse performed a symptom evaluation, a pharmacist assessed the drug list and made adjustment suggestions and finally a physician took action and performed medication changes. |
| Control | No intervention | –Patients were treated according to the usual routine. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- age>75 years, living in nursing homes or community-dwelling with municipality-provided care, with multi-dose drug dispensing
Key exclusion criteria (1 listed)
- lack of multi-dose drug dispensing, living at home with no municipality-provided care, <75 years old
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 reviewMulti-professional medication review | Other | Intervention |
Primary outcome
hospital admission
Time frame: six months
time to the first hospital admission
hospital admission
Time frame: twelve months
time to the first hospital admission
Survival analysis
Time frame: six months
time to death
Survival analysis
Time frame: twelve months
time to death
4 secondary outcomes
number of hospital admissions
Time frame: six months
number of hospital admissions
Time frame: twelve months
mortality
Time frame: six months
mortality
Time frame: twelve 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 1 Aug 2019.
- Derived from this study: PubMed 33536791Milos Nymberg V, Lenander C, Borgstrom Bolmsjo B. The Impact of Medication Reviews Conducted in Primary Care on Hospital Admissions and Mortality: An Observational Follow-Up of a Randomized Controlled Trial. Drug Healthc Patient Saf. 2021 Jan 27;13:1-9. doi: 10.2147/DHPS.S283708. eCollection 2021.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Medication review in people with Drug Utilization Review, run by Region Skane.
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 1 inclusion and 1 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 1 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
hospital admission (time frame: six 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 NCT04040855, 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 1 Aug 2019.