Drug UsageNCT06020391
Cooperation for Better Treatment of Polypharmacy in the Community
A study testing Collaborative drug review in people with Drug Usage, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The elderly population today relies heavily on medication consumption. While there are cases where using multiple medications is necessary and reasonable, it also increases the risk of inappropriate treatment and adverse drug effects. 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?
- Collaborative drug review
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 1 siteNorway
- Study dates
- 6 Sep 2023to 22 Oct 2024
- 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
- Age 70+
- Admitted to the MipAC unit
- Use of at least six different systemic medications taken regularly
- Informed consent by the patient
Who cannot join
- Previously included in the study
- Not speaking or understanding Norwegian
- Residing outside of the municipality of Oslo
- Planned discharge within 24 hours
- Isolated for infection control reasons
- Considered too ill to approach or life expectancy judged to be less than six months
- Personnel at the MipAC unit discourage participation (in case of important reasons not covered by the other exclusion criteria)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cooperation Across Healthcare Service Levels for Medication Reviews in Older People with Polypharmacy Admitted to a Municipal In-patient Acute Care Unit (The COOP II Study): a Randomized Controlled Trial
The elderly population today relies heavily on medication consumption. While there are cases where using multiple medications is necessary and reasonable, it also increases the risk of inappropriate treatment and adverse drug effects. This randomized, controlled trial aims to examine the effectiveness of incorporating drug reviews as an integral part of clinical practice for older patients admitted to a Municipal in-patient acute care (MipAC) unit in Oslo, Norway. The intervention involves a clinical drug review conducted by a MipAC physician under the guidance of a geriatrician, followed by a telephone consultation between the MipAC physician and the patient's family physician (FP). The primary outcome measure is health-related quality of life, while secondary outcome measures include physical and cognitive function, dry mouth, hospital admissions, and survival. The environmental impact of the study intervention will also be assessed and compared to usual care.
Read the detailed description
The aim of this study is to evaluate the effect of collaborative drug reviews by MipAC physicians, supervised by geriatricians, and FPs on clinically relevant outcome measures in the MipAC patient population aged 70+. The investigators will also assess the environmental impact of the study intervention and compare it to usual care.
The study is a randomized, single-blind, controlled trial with 16 weeks follow-up. In addition, we plan to acquire registry data on MipAC readmissions, hospital admissions, and mortality after one year.
The investigators will recruit 1-4 MipAC physicians to take part in the study. The project physicians will be responsible for the patient's general medical treatment, but will also perform a structured, clinical drug review that goes beyond what is considered usual care. The project physicians will provide necessary information on the patient's medical history and drug use from the medical records, carry out a medical history from the patient, and a physical examination. Relevant blood analyses and other supplementary tests will be ordered if not already available. The clinical drug review will be aimed at evaluating whether current medications are indicated, whether the patient's medical conditions are satisfactorily compensated, whether dosages are appropriate, whether the patient has adverse drug effects, and whether drug-drug or drug-disease interactions are present or likely to occur. The investigators will develop a structured framework for the drug reviews, and the MipAC physicians will receive clinical supervision from a consultant in geriatric medicine.
After performing the clinical drug review, the MipAC physician will offer the patient's FP a telephone based or digital meeting with the purpose of combining the assessments of the MipAC physician and the competence of the FP in a common drug review. The two physicians will review the patient's drug list systematically and discuss if any adjustments should be done, as well as the patient's need for further follow-up.
- Conditions
- Drug Usage
- Being tested
- Collaborative drug review
- Keywords
- Polypharmacy, Geriatrics, Drug review, Medication review, Elderly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collaborative drug reviewOther
- Structured, clinical drug review including medical history, physical examination, and supplementary tests. The work-up will be aimed at evaluating whether current medications are indicated, whether the patient's medical conditions are satisfactorily compensated, whether dosages are appropriate, whether the patient has adverse drug effects, and whether drug-drug or drug-disease interactions are present or likely to occur. The MipAC physicians will receive clinical supervision from a consultant in geriatric medicine.
- The MipAC physician will offer the patient's FP a telephone meeting with the purpose of combining the assessments of the MipAC physician and the competence of the FP in a common drug review. The two physicians will review the patient's drug list systematically and discuss if any adjustments should be done, as well as the patient's need for further follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Collaborative drug review. Receives: Other: Collaborative drug review |
| Control group | No intervention | Usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related quality of life (HRQoL)
HRQoL assessed with the 15-dimensional instrument 15D. 15D is a generic, 15-dimensional instrument concerning different aspects of HRQoL. The dimensions are mobility, vision, hearing, breathing, sleeping, eating, speech, elimination, usual activities, mental function, discomfort and symptoms, depression, distress, vitality, and sexual activity. Each dimension is rated on an ordinal scale with five levels, and the respondent chooses the level best describing his/her present health status. Single index scores are calculated by population-based utility weights, and range from 0 to 1, with higher scores indicating better HRQoL.
Measured: 16 weeks
Secondary outcomes (11)
Handgrip strength
Handgrip strength measured with a standard dynamometer, with three attempts on each hand. The highest value of all six attempts will be reported, measured in kilograms.
Measured: 16 weeks
Digit span forward
Results will be reported as the maximum digit span completed.
Measured: 16 weeks
Digit span backwards
Results will be reported as the maximum digit span completed.
Measured: 16 weeks
Unstimulated whole saliva flow
Unstimulated whole saliva flow will be measured by the spitting method by weighing plastic cups before and after a collection period of 3 minutes. Results will be reported as milliliters/minute.
Measured: 16 weeks
The Shortened Xerostomia Inventory (SXI)
The Shortened Xerostomia Inventory (SXI) is a five-item summated rating scale which combines the responses to five individual items into a single sum score. The sum score can range from 5 to 15, with higher values representing more severe xerostomia.
Measured: 16 weeks
The eight-item Visual Analog Scale xerostomia questionnaire
This is a Visual Analog Scale with eight questions related to xerostomia where participants will be asked to mark their response to each item by placing a vertical line on the 100 millimeter horizontal scale. Results will be reported as millimeters.
Measured: 16 weeks
Oral pain/discomfort
The patients will be asked if they have experienced any oral pain/discomfort since the KAD stay. Responses will be given on a five-category rating scale ranging from "never" (0), "hardly ever" (1), "occasionally" (2), "often" (3), to "very often" (4).
Measured: 16 weeks
Orthostatic blood pressure
Supine blood pressure and pulse rate will be measured after a minimum of five minutes of rest. The patient will then stand up, and measurements will be repeated after one and three minutes. Orthostatic hypotension will be defined as a fall in systolic blood pressure of at least 20 mmHg or a fall in diastolic blood pressure of at least 10 mmHg after one and/or three minutes in standing position.
Measured: 16 weeks
Falls
Number of falls.
Measured: 16 weeks
Admissions to health institutions
The combined number of hospital admissions and MipAC readmissions in the period from baseline to week 16. We also plan to acquire these data after one year.
Measured: 16 weeks and 1 year
Mortality
Mortality in the period from baseline to week 16. We also plan to assess mortality after one year.
Measured: 16 weeks and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start6 Sep 2023
- Primary completion22 Oct 2024
- Study completion22 Oct 2024
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 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
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo, South-Eastern Norway Regional Health Authority, City of Oslo
- Responsible party
- Principal investigator, Rita Romskaug, Oslo University Hospital
- Investigators
- Rita Romskaug, MD, PhD, Principal investigator, Dept. of Geriatric Medicine, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06020391
- Sponsor's protocol ID
- 2022066
- Status last verified
- Feb 2025
- First submitted
- 22 Aug 2023
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share all individual participant data collected during the trial, after deidentification.
Publications
Santervas LR, Wyller TB, Skovlund E, Jensen JL, Fjeld KG, Hove LH, Ringstad IB, Nordberg LB, Mellingen KM, Kristoffersen ES, Romskaug R. Cooperation across healthcare service levels for medication reviews in older people with polypharmacy admitted to a municipal in-patient acute care unit (The COOP II Study): study protocol for a randomized controlled trial. Trials. 2024 Sep 13;25(1):612. doi: 10.1186/s13063-024-08442-w.
PubMed 39272164
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cooperation Across Healthcare Service Levels for Medication Reviews in Older People with Polypharmacy Admitted to a Municipal In-patient Acute Care Unit (The COOP II Study): a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06020391
- Acronym / sponsor ID
- 2022066
- Conditions
- Drug Usage
- Keywords
- Polypharmacy, Geriatrics, Drug review, Medication review, Elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University of Oslo, South-Eastern Norway Regional Health Authority, City of Oslo
- Study start
- 6 Sep 2023 (actual)
- Primary completion
- 22 Oct 2024 (actual)
- Study completion
- 22 Oct 2024 (actual)
- First posted
- 31 Aug 2023 (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 elderly population today relies heavily on medication consumption. While there are cases where using multiple medications is necessary and reasonable, it also increases the risk of inappropriate treatment and adverse drug effects. This randomized, controlled trial aims to examine the effectiveness of incorporating drug reviews as an integral part of clinical practice for older patients admitted to a Municipal in-patient acute care (MipAC) unit in Oslo, Norway. The intervention involves a clinical drug review conducted by a MipAC physician under the guidance of a geriatrician, followed by a telephone consultation between the MipAC physician and the patient's family physician (FP). The primary outcome measure is health-related quality of life, while secondary outcome measures include physical and cognitive function, dry mouth, hospital admissions, and survival. The environmental impact of the study intervention will also be assessed and compared to usual care.
Detailed description
The aim of this study is to evaluate the effect of collaborative drug reviews by MipAC physicians, supervised by geriatricians, and FPs on clinically relevant outcome measures in the MipAC patient population aged 70+. The investigators will also assess the environmental impact of the study intervention and compare it to usual care.
The study is a randomized, single-blind, controlled trial with 16 weeks follow-up. In addition, we plan to acquire registry data on MipAC readmissions, hospital admissions, and mortality after one year.
The investigators will recruit 1-4 MipAC physicians to take part in the study. The project physicians will be responsible for the patient's general medical treatment, but will also perform a structured, clinical drug review that goes beyond what is considered usual care. The project physicians will provide necessary information on the patient's medical history and drug use from the medical records, carry out a medical history from the patient, and a physical examination. Relevant blood analyses and other supplementary tests will be ordered if not already available. The clinical drug review will be aimed at evaluating whether current medications are indicated, whether the patient's medical conditions are satisfactorily compensated, whether dosages are appropriate, whether the patient has adverse drug effects, and whether drug-drug or drug-disease interactions are present or likely to occur. The investigators will develop a structured framework for the drug reviews, and the MipAC physicians will receive clinical supervision from a consultant in geriatric medicine.
After performing the clinical drug review, the MipAC physician will offer the patient's FP a telephone based or digital meeting with the purpose of combining the assessments of the MipAC physician and the competence of the FP in a common drug review. The two physicians will review the patient's drug list systematically and discuss if any adjustments should be done, as well as the patient's need for further follow-up.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Collaborative drug reviewCollaborative drug review. |
| Control group | No intervention | –Usual care. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age 70+
- Admitted to the MipAC unit
- Use of at least six different systemic medications taken regularly
- Informed consent by the patient
Key exclusion criteria (7 listed)
- Previously included in the study
- Not speaking or understanding Norwegian
- Residing outside of the municipality of Oslo
- Planned discharge within 24 hours
- Isolated for infection control reasons
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 |
|---|---|---|
| Collaborative drug review1. Structured, clinical drug review including medical history, physical examination, and supplementary tests. The work-up will be aimed at evaluating whether current medications are indicated, whether the patient's medical conditions are satisfactorily compensated, whether dosages are appropriate, whether the patient has adverse drug effects, and whether drug-drug or drug-disease interactions are present or likely to occur. The MipAC physicians will receive clinical supervision from a consultant in geriatric medicine. 2. The MipAC physician will offer the patient's FP a telephone meeting with the purpose of combining the assessments of the MipAC physician and the competence of the FP in a common drug review. The two physicians will review the patient's drug list systematically and discuss if any adjustments should be done, as well as the patient's need for further follow-up. | Other | Intervention group |
Primary outcome
Health-related quality of life (HRQoL)
Time frame: 16 weeks
HRQoL assessed with the 15-dimensional instrument 15D. 15D is a generic, 15-dimensional instrument concerning different aspects of HRQoL. The dimensions are mobility, vision, hearing, breathing, sleeping, eating, speech, elimination, usual activities, mental function, discomfort and symptoms, depression, distress, vitality, and sexual activity. Each dimension is rated on an ordinal scale with five levels, and the respondent chooses the level best describing his/her present health status. Single index scores are calculated by population-based utility weights, and range from 0 to 1, with higher scores indicating better HRQoL.
11 secondary outcomes
Handgrip strength
Time frame: 16 weeks
Digit span forward
Time frame: 16 weeks
Digit span backwards
Time frame: 16 weeks
Unstimulated whole saliva flow
Time frame: 16 weeks
The Shortened Xerostomia Inventory (SXI)
Time frame: 16 weeks
The eight-item Visual Analog Scale xerostomia questionnaire
Time frame: 16 weeks
Oral pain/discomfort
Time frame: 16 weeks
Orthostatic blood pressure
Time frame: 16 weeks
Falls
Time frame: 16 weeks
Admissions to health institutions
Time frame: 16 weeks and 1 year
Mortality
Time frame: 16 weeks and 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 28 Feb 2025.
- Derived from this study: PubMed 39272164Santervas LR, Wyller TB, Skovlund E, Jensen JL, Fjeld KG, Hove LH, Ringstad IB, Nordberg LB, Mellingen KM, Kristoffersen ES, Romskaug R. Cooperation across healthcare service levels for medication reviews in older people with polypharmacy admitted to a municipal in-patient acute care unit (The COOP II Study): study protocol for a randomized controlled trial. Trials. 2024 Sep 13;25(1):612. doi: 10.1186/s13063-024-08442-w.
- Individual participant dataSharing planned: Yes. We plan to share all individual participant data collected during the trial, after deidentification.
Related trials for Drug Usage
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
RecruitingObservational study
National Pregnancy Registry for Psychiatric Medications
Pregnant Women, Psychotropic Drugs
Not yet recruiting
HIV/STI/HCV Testing and Overdose Prevention Among Survivors of Sex Trafficking
HIV Testing, STI
RecruitingObservational study
An Observational Study Called FINEROD to Learn More About the Use of the Treatment Finerenone Including How Safe it is and How Well it Works Under Real-world Conditions
Chronic Kidney Disease, Type 2 Diabetes Mellitus
RecruitingObservational study
A Study of LIVTENCITY (Maribavir) in Adults With Cytomegalovirus (CMV) Infection After Transplantation in South Korea
Cytomegalovirus (CMV)
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.
Rita Romskaug, MD, PhD principal investigator
Dept. of Geriatric Medicine, 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 Collaborative 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 4 inclusion and 7 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 28 Feb 2025. 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 (HRQoL) (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 NCT06020391, 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 28 Feb 2025.