Drug UsageCOOPNCT02379455
Cooperation for Improved Pharmacotherapy in Home-dwelling Elderly People Receiving Polypharmacy - The COOP Study
A study testing Comprehensive drug review in people with Drug Usage, run by Oslo University Hospital at 1 site in Norway.
Trial summary
Polypharmacy increases the risk of adverse drug effects, interactions and other drug-related problems, and several studies indicate that inappropriate drug use is a major reason for poor health and impaired function in the elderly. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Drug Usage
- What is being tested?
- Comprehensive drug review
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2015to 22 Sep 2017
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- The patient must be on the list of one of the family physicians participating in the study
- Home dwelling (not permanently institutionalised)
- Medications administered by the home nursing service
- Polypharmacy defined as the use of at least seven different systemic medications taken regularly
- Informed consent by the patient or a close relative
Who cannot join
- Patient or relative denies inclusion
- The family physician does not want the particular patient to participate
- Moderate/severe dementia (Clinical Dementia Rating Scale score > 1) and contact with the closest proxy less than once every other week.
- The patient does not speak/understand Norwegian
- Expected to become permanently institutionalised within six months
- Life expectancy < six months
Trial locations and contacts
1 site in 1 country.
About this study
Polypharmacy increases the risk of adverse drug effects, interactions and other drug-related problems, and several studies indicate that inappropriate drug use is a major reason for poor health and impaired function in the elderly. A majority of interventions for improvement of drug treatment in the elderly have been evaluated by the use of surrogate outcomes such as drug-related problems, number of prescribed drugs or prevalence of potentially inappropriate prescriptions - and it is so far unclear whether such interventions can result in clinical significant improvements. The primary objective of this trial is therefore to evaluate the effect upon patients, relatives and local health care service of a structured cooperation between a hospital-based geriatrician and family physicians on complex drug regimens in home-dwelling frail elderly patients.
Read the detailed description
This is a 24 weeks cluster randomized, single-blinded, controlled trial. Family physicians will be invited to participate in the project with patients from their lists, and can participate with 1-5 patients each. The investigators will carry out cluster randomization on physician level instead of individual randomization on patient level.
The investigators suppose that such a comprehensive clinical evaluation and drug review that they will test, is most relevant for patients with relatively pronounced polypharmacy. It has previously been shown that conventionally used limits for polypharmacy, e.g. five drugs used regularly, identifies many patients without particular complex health states and without drug related problems. The investigators will therefore limit this project to patients using seven regular drugs or more, in order to increase the likelihood that they may benefit from a drug review.
A major challenge when studying complex interventions is to describe the intervention with sufficient precision as to facilitate replication. Our main strategy for this will be to compensate for the necessary degree of pragmatism in the interventional approach with a detailed description of the interventions that were in fact carried out, in particular changes in the drug regimens of the individual patients.
The intervention will consist of three main parts:
- Geriatric assessment: The patients will be seen by a physician trained in geriatric medicine. The physician will carry out a medical history and a physical examination, and relevant blood analyses and other supplementary test will be ordered if not already available. The geriatric work-up will be aimed at evaluating whether current medications are indicated, whether the relevant conditions are satisfactorily compensated, whether the dosages are appropriate, whether the patient has symptoms that may in reality be adverse drug effects, and whether drug-drug interactions or drug-disease interactions are likely to occur. Published tools like the START (Screening Tool of Older Persons' Prescriptions) criteria, Screening Tool to Alert doctors to Right Treatment (STOPP) criteria and The Norwegian General Practice (NORGEP) criteria will be used.
- Conference with common drug review: The main purpose of this conference is to combine the competence of the geriatrician and that of the family physician in a focused drug review. The two physicians will discuss the patient's drug list systematically. The geriatrician may suggest changes in the drug regimen, but the family physician retains the medical responsibility for the patient and is in charge of all ordinations and medication changes.
- Clinical follow-up: Depending on medication changes that have been done, the two physicians will arrange the necessary follow-up within the project period.
The investigators will assess the outcomes at 16 and 24 weeks, counted from baseline, and will also assess baseline values for the outcomes in order to adjust for potential inequalities.
- Conditions
- Drug Usage
- Being tested
- Comprehensive drug review
- Keywords
- Polypharmacy, Geriatrics, Elderly, Drug review
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive drug reviewOther
- Geriatric assessment including medical history, physical examination, supplementary tests. The geriatric work-up will be aimed at evaluating whether current medications are indicated, whether the relevant conditions are satisfactorily compensated, whether the dosages are appropriate, whether the patient has symptoms that may in reality be adverse drug effects, and whether drug-drug interactions or drug-disease interactions are likely to occur. 2) Conference with common drug review. The project physician and the family physician will discuss the patient's drug list systematically. 3) Individualized clinical follow-up depending on the medication changes that have been done.
| Study group | Role | What they receive |
|---|---|---|
| Comprehensive drug review | Experimental | Not described Receives: Other: Comprehensive drug review |
| Control group | No intervention | Follow-up by family physician "as usual". |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related quality of life as measured with 15D
Measured: 16 weeks
Secondary outcomes (37)
Short Physical Performance Battery (SPPB)
Measured: 16 weeks
Short Physical Performance Battery (SPPB)
Measured: 24 weeks
Gait speed
Measured: 16 weeks
Gait speed
Measured: 24 weeks
Hand grip strength
Measured: 16 weeks
Hand grip strength
Measured: 24 weeks
Functional Independence Measure (FIM)
Measured: 16 weeks
Functional Independence Measure (FIM)
Measured: 24 weeks
Trail making test A and B
Measured: 16 weeks
Trail making test A and B
Measured: 24 weeks
Digit Span
Measured: 16 weeks
Digit Span
Measured: 24 weeks
Five Digits Test
Measured: 16 weeks
Five Digits Test
Measured: 24 weeks
Medication Appropriateness Index (MAI)
Measured: 16 weeks
Medication Appropriateness Index (MAI)
Measured: 24 weeks
Assessment of Underutilization (AOU)
Measured: 16 weeks
Assessment of Underutilization (AOU)
Measured: 24 weeks
Number of falls
Recorded with the aid of diaries kept by patients/caregivers
Measured: During the first 16 weeks after baseline
Number of falls
Recorded with the aid of diaries kept by patients/caregivers
Measured: During the first 24 weeks after baseline
Orthostatic blood pressure
Measured: 16 weeks
Orthostatic blood pressure
Measured: 24 weeks
Changes in body weight
Measured: 16 weeks
Changes in body weight
Measured: 24 weeks
Relative Stress Scale
Measured: 16 weeks
Relative Stress Scale
Measured: 24 weeks
Number of hospital admissions (with reasons)
Measured: During the first 16 weeks from baseline
Number of hospital admissions (with reasons)
Measured: During the first 24 weeks from baseline
Number of days in own home (in contrast to being in hospital or nursing home)
Measured: During the first 16 weeks from baseline
Number of days in own home (in contrast to being in hospital or nursing home)
Measured: During the first 24 weeks from baseline
Admission to permanent institutional care
Measured: 16 weeks
Admission to permanent institutional care
Measured: 24 weeks
Current use of home nursing service
Measured: 16 weeks
Current use of home nursing service
Measured: 24 weeks
Mortality
Measured: 16 weeks
Mortality
Measured: 24 weeks
Health-related quality of life as measured with 15D
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionAug 2017
- Study completion22 Sep 2017
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 Drug UsageStudies of the same condition, open and under way.
- More trials run by Oslo 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Research Council of Norway, University of Oslo
- Responsible party
- Principal investigator, Torgeir Bruun Wyller, Oslo University Hospital
- Investigators
- Torgeir B Wyller, MD PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02379455
- Sponsor's protocol ID
- 222033/H10
- Acronym
- COOP
- Status last verified
- Jan 2018
- First submitted
- 27 Feb 2015
- Last updated
- 26 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Veddeng S, Madland H, Molden E, Wyller TB, Romskaug R. Association between statin use and physical performance in home-dwelling older patients receiving polypharmacy: cross-sectional study. BMC Geriatr. 2022 Mar 23;22(1):242. doi: 10.1186/s12877-022-02942-7.
PubMed 35321652Romskaug R, Skovlund E, Straand J, Molden E, Kersten H, Pitkala KH, Lundqvist C, Wyller TB. Effect of Clinical Geriatric Assessments and Collaborative Medication Reviews by Geriatrician and Family Physician for Improving Health-Related Quality of Life in Home-Dwelling Older Patients Receiving Polypharmacy: A Cluster Randomized Clinical Trial. JAMA Intern Med. 2020 Feb 1;180(2):181-189. doi: 10.1001/jamainternmed.2019.5096.
PubMed 31617562Romskaug R, Molden E, Straand J, Kersten H, Skovlund E, Pitkala KH, Wyller TB. Cooperation between geriatricians and general practitioners for improved pharmacotherapy in home-dwelling elderly people receiving polypharmacy - the COOP Study: study protocol for a cluster randomised controlled trial. Trials. 2017 Apr 4;18(1):158. doi: 10.1186/s13063-017-1900-0.
PubMed 28372591
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cooperation for Improved Pharmacotherapy in Home-dwelling Elderly People Receiving Polypharmacy - The COOP Study
- ClinicalTrials.gov ID
- NCT02379455
- Acronym / sponsor ID
- COOP / 222033/H10
- Conditions
- Drug Usage
- Keywords
- Polypharmacy, Geriatrics, Elderly, Drug review
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- The Research Council of Norway, University of Oslo
- Study start
- Mar 2015 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- 22 Sep 2017 (actual)
- First posted
- 5 Mar 2015 (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.
Polypharmacy increases the risk of adverse drug effects, interactions and other drug-related problems, and several studies indicate that inappropriate drug use is a major reason for poor health and impaired function in the elderly. A majority of interventions for improvement of drug treatment in the elderly have been evaluated by the use of surrogate outcomes such as drug-related problems, number of prescribed drugs or prevalence of potentially inappropriate prescriptions - and it is so far unclear whether such interventions can result in clinical significant improvements. The primary objective of this trial is therefore to evaluate the effect upon patients, relatives and local health care service of a structured cooperation between a hospital-based geriatrician and family physicians on complex drug regimens in home-dwelling frail elderly patients.
Detailed description
This is a 24 weeks cluster randomized, single-blinded, controlled trial. Family physicians will be invited to participate in the project with patients from their lists, and can participate with 1-5 patients each. The investigators will carry out cluster randomization on physician level instead of individual randomization on patient level.
The investigators suppose that such a comprehensive clinical evaluation and drug review that they will test, is most relevant for patients with relatively pronounced polypharmacy. It has previously been shown that conventionally used limits for polypharmacy, e.g. five drugs used regularly, identifies many patients without particular complex health states and without drug related problems. The investigators will therefore limit this project to patients using seven regular drugs or more, in order to increase the likelihood that they may benefit from a drug review.
A major challenge when studying complex interventions is to describe the intervention with sufficient precision as to facilitate replication. Our main strategy for this will be to compensate for the necessary degree of pragmatism in the interventional approach with a detailed description of the interventions that were in fact carried out, in particular changes in the drug regimens of the individual patients.
The intervention will consist of three main parts:
- Geriatric assessment: The patients will be seen by a physician trained in geriatric medicine. The physician will carry out a medical history and a physical examination, and relevant blood analyses and other supplementary test will be ordered if not already available. The geriatric work-up will be aimed at evaluating whether current medications are indicated, whether the relevant conditions are satisfactorily compensated, whether the dosages are appropriate, whether the patient has symptoms that may in reality be adverse drug effects, and whether drug-drug interactions or drug-disease interactions are likely to occur. Published tools like the START (Screening Tool of Older Persons' Prescriptions) criteria, Screening Tool to Alert doctors to Right Treatment (STOPP) criteria and The Norwegian General Practice (NORGEP) criteria will be used.
- Conference with common drug review: The main purpose of this conference is to combine the competence of the geriatrician and that of the family physician in a focused drug review. The two physicians will discuss the patient's drug list systematically. The geriatrician may suggest changes in the drug regimen, but the family physician retains the medical responsibility for the patient and is in charge of all ordinations and medication changes.
- Clinical follow-up: Depending on medication changes that have been done, the two physicians will arrange the necessary follow-up within the project period.
The investigators will assess the outcomes at 16 and 24 weeks, counted from baseline, and will also assess baseline values for the outcomes in order to adjust for potential inequalities.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comprehensive drug review | Experimental | Other: Comprehensive drug review |
| Control group | No intervention | –Follow-up by family physician "as usual". |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- The patient must be on the list of one of the family physicians participating in the study
- Home dwelling (not permanently institutionalised)
- Medications administered by the home nursing service
- Polypharmacy defined as the use of at least seven different systemic medications taken regularly
- Informed consent by the patient or a close relative
Key exclusion criteria (6 listed)
- Patient or relative denies inclusion
- The family physician does not want the particular patient to participate
- Moderate/severe dementia (Clinical Dementia Rating Scale score > 1) and contact with the closest proxy less than once every other week.
- The patient does not speak/understand Norwegian
- Expected to become permanently institutionalised within six months
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 |
|---|---|---|
| Comprehensive drug review1) Geriatric assessment including medical history, physical examination, supplementary tests. The geriatric work-up will be aimed at evaluating whether current medications are indicated, whether the relevant conditions are satisfactorily compensated, whether the dosages are appropriate, whether the patient has symptoms that may in reality be adverse drug effects, and whether drug-drug interactions or drug-disease interactions are likely to occur. 2) Conference with common drug review. The project physician and the family physician will discuss the patient's drug list systematically. 3) Individualized clinical follow-up depending on the medication changes that have been done. | Other | Comprehensive drug review |
Primary outcome
Health-related quality of life as measured with 15D
Time frame: 16 weeks
37 secondary outcomes
Short Physical Performance Battery (SPPB)
Time frame: 16 weeks
Short Physical Performance Battery (SPPB)
Time frame: 24 weeks
Gait speed
Time frame: 16 weeks
Gait speed
Time frame: 24 weeks
Hand grip strength
Time frame: 16 weeks
Hand grip strength
Time frame: 24 weeks
Functional Independence Measure (FIM)
Time frame: 16 weeks
Functional Independence Measure (FIM)
Time frame: 24 weeks
Trail making test A and B
Time frame: 16 weeks
Trail making test A and B
Time frame: 24 weeks
Digit Span
Time frame: 16 weeks
Digit Span
Time frame: 24 weeks
Five Digits Test
Time frame: 16 weeks
Five Digits Test
Time frame: 24 weeks
Medication Appropriateness Index (MAI)
Time frame: 16 weeks
Medication Appropriateness Index (MAI)
Time frame: 24 weeks
Assessment of Underutilization (AOU)
Time frame: 16 weeks
Assessment of Underutilization (AOU)
Time frame: 24 weeks
Number of falls
Time frame: During the first 16 weeks after baseline
Number of falls
Time frame: During the first 24 weeks after baseline
Orthostatic blood pressure
Time frame: 16 weeks
Orthostatic blood pressure
Time frame: 24 weeks
Changes in body weight
Time frame: 16 weeks
Changes in body weight
Time frame: 24 weeks
Relative Stress Scale
Time frame: 16 weeks
Relative Stress Scale
Time frame: 24 weeks
Number of hospital admissions (with reasons)
Time frame: During the first 16 weeks from baseline
Number of hospital admissions (with reasons)
Time frame: During the first 24 weeks from baseline
Number of days in own home (in contrast to being in hospital or nursing home)
Time frame: During the first 16 weeks from baseline
Number of days in own home (in contrast to being in hospital or nursing home)
Time frame: During the first 24 weeks from baseline
Admission to permanent institutional care
Time frame: 16 weeks
Admission to permanent institutional care
Time frame: 24 weeks
Current use of home nursing service
Time frame: 16 weeks
Current use of home nursing service
Time frame: 24 weeks
Mortality
Time frame: 16 weeks
Mortality
Time frame: 24 weeks
Health-related quality of life as measured with 15D
Time frame: 24 weeks
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 26 Jan 2018.
- Derived from this study: PubMed 35321652Veddeng S, Madland H, Molden E, Wyller TB, Romskaug R. Association between statin use and physical performance in home-dwelling older patients receiving polypharmacy: cross-sectional study. BMC Geriatr. 2022 Mar 23;22(1):242. doi: 10.1186/s12877-022-02942-7.
- Derived from this study: PubMed 31617562Romskaug R, Skovlund E, Straand J, Molden E, Kersten H, Pitkala KH, Lundqvist C, Wyller TB. Effect of Clinical Geriatric Assessments and Collaborative Medication Reviews by Geriatrician and Family Physician for Improving Health-Related Quality of Life in Home-Dwelling Older Patients Receiving Polypharmacy: A Cluster Randomized Clinical Trial. JAMA Intern Med. 2020 Feb 1;180(2):181-189. doi: 10.1001/jamainternmed.2019.5096.
- Derived from this study: PubMed 28372591Romskaug R, Molden E, Straand J, Kersten H, Skovlund E, Pitkala KH, Wyller TB. Cooperation between geriatricians and general practitioners for improved pharmacotherapy in home-dwelling elderly people receiving polypharmacy - the COOP Study: study protocol for a cluster randomised controlled trial. Trials. 2017 Apr 4;18(1):158. doi: 10.1186/s13063-017-1900-0.
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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.
Torgeir B Wyller, MD PhD principal investigator
Oslo 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 Comprehensive drug review in people with Drug Usage, run by Oslo University Hospital at 1 site in Norway.
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 5 inclusion and 6 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 26 Jan 2018. 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 Norway. 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?
Health-related quality of life as measured with 15D (time frame: 16 weeks). 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 NCT02379455, 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 26 Jan 2018.