MultimorbidityNCT02398812
The Interprofessional Medication Assessment for Older Patients
A study testing Medication assessment and treatment plan based on it in people with Multimorbidity and Polypharmacy, run by East Savo Hospital District at 5 sites in Finland.
Trial summary
The objective of this pragmatic multi-center randomized controlled trial is to test the effectiveness of interprofessional medication assessment in older patients needing home care due to their diseases or decreased functional capacity in primary care. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Multimorbidity, Polypharmacy
- What is being tested?
- Medication assessment and treatment plan based on it
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 514 participants
- Where
- 5 sitesFinland
- Study dates
- Feb 2015to Dec 2018
- 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
- Home dwelling ≥65 years-old persons registered to public home care services and who
- have had dizziness, orthostatic hypotension or have fallen or
- use at least six medicines
Who cannot join
- Home care is not responsible for patient's medication, for example due to severe chronic illness (for example severe renal insufficiency or cancer with active treatment in secondary or tertiary care).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Finland5 sites
Welfare district of Forssa
Forssa, FI 30100
Selänne Basic Health Care District
Haapajärvi, FI 85800
Juva Health Care
Juva, FI-51900
City of Lahti, home care
Lahti, FI-15100
Eastern Savo Hospital District
Savonlinna, FI-57100
About this study
Official title: The Interprofessional Medication Assessment for Older Patients - a Multicenter Randomized Trial in Primary Care Setting
The objective of this pragmatic multi-center randomized controlled trial is to test the effectiveness of interprofessional medication assessment in older patients needing home care due to their diseases or decreased functional capacity in primary care. The main hypothesis is that intervention has a positive impact on functional capacity and for rational and safe use of medicines.
Read the detailed description
Aging increases the risk of adverse effects and interactions caused by medication. Medication reconciliation and medication review are well-known practices to optimize medicines use. Both interventions usually require a team-based approach to be effective. Medication reconciliation is the process of obtaining and documenting a complete and accurate list of current patient medications and comparing this list with medication orders at each point of care transition to identify and rectify any discrepancies before patient harm occurs. Medication review is the process of evaluating current medication treatment to manage the risk and optimize the outcomes of medication treatment by detecting, solving, and preventing medication-related problems. The present study focuses on medication assessment including both medication reconciliation and review combined to clinical assessment of an individual patient.
According to a systematic review there is a need for research focusing on medication management in community settings and especially to assess the impact of medication assessment on clinical outcomes.
- Conditions
- Multimorbidity, Polypharmacy
- Being tested
- Medication assessment and treatment plan based on it
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication assessment and treatment plan based on itOther
Intervention
- Phase I: A medication assessment conducted by an interprofessional team including nurse, pharmacist and physician. The assessment is based on current medication list and basic information cathered by nurse.
- Phase II: This phase is needed if the assessment cannot be conducted safely without physical examination conducted by physician. The comprehensive interprofessional assessment takes place after the clinical examination conducted by home care physician.
| Study group | Role | What they receive |
|---|---|---|
| Active comparator | Active comparator | In addition to usual care, participants allocated to intervention group will receive medication assessment and treatment plan based on it Receives: Other: Medication assessment and treatment plan based on it |
| Usual care | No intervention | Usual care (reference group). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional capacity IADL (Instrumental Activities of Daily Living)
Measured: at 6 months from baseline
Functional capacity ADL (Activities of daily living;KATZ)
Measured: at 6 months from baseline
Functional capacity TUG (Timed up and go)
Measured: at 6 months from baseline
Functional capacity MMSE ( Mini-mental state examination)
Measured: at 6 months from baseline
Functional capacity GDS (Geriatric Depression Scale)-15
Measured: at 6 months from baseline
Secondary outcomes (6)
Use of health care services
visits to physician, hospital days and nursing care at home
Measured: at 6 and 12 months from baseline
Need of services delivered to home
Measured: at 6 and 12 months from baseline
Number of medicines
Measured: at 6 and 12 months from baseline
Quality of medicines
Measured: at 6 and 12 months from baseline
Cost of medicines
Measured: at 6 and 12 months from baseline
Health related quality of life assessed with EQ-5D
Measured: at 6 and 12 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionJun 2016
- Study completionDec 2018 (estimated)
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 MultimorbidityStudies 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
- Masking
- None (open label)
- Enrolment
- 514 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Savo Hospital District
- Sponsor type
- University, hospital or other
- Collaborators
- University of Eastern Finland, Finnish Medicines Agency
- Responsible party
- Sponsor
- Investigators
- Pekka Mäntyselkä, MD, Study chair, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02398812
- Sponsor's protocol ID
- ILMA
- Status last verified
- Jun 2016
- First submitted
- 13 Mar 2015
- Last updated
- 13 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Auvinen K, Voutilainen A, Jyrkka J, Lonnroos E, Mantyselka P. Interprofessional medication assessment among home care patients: any impact on functioning? Results from a randomised controlled trial. BMC Geriatr. 2020 Oct 6;20(1):390. doi: 10.1186/s12877-020-01796-1.
PubMed 33023497
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Interprofessional Medication Assessment for Older Patients - a Multicenter Randomized Trial in Primary Care Setting
- ClinicalTrials.gov ID
- NCT02398812
- Acronym / sponsor ID
- ILMA
- Conditions
- Multimorbidity, Polypharmacy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 514 participants (actual)
- Lead sponsor
- East Savo Hospital DistrictUniversity, hospital or other
- Collaborators
- University of Eastern Finland, Finnish Medicines Agency
- Study start
- Feb 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Dec 2018 (estimated)
- First posted
- 26 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.
The objective of this pragmatic multi-center randomized controlled trial is to test the effectiveness of interprofessional medication assessment in older patients needing home care due to their diseases or decreased functional capacity in primary care. The main hypothesis is that intervention has a positive impact on functional capacity and for rational and safe use of medicines.
Detailed description
Aging increases the risk of adverse effects and interactions caused by medication. Medication reconciliation and medication review are well-known practices to optimize medicines use. Both interventions usually require a team-based approach to be effective. Medication reconciliation is the process of obtaining and documenting a complete and accurate list of current patient medications and comparing this list with medication orders at each point of care transition to identify and rectify any discrepancies before patient harm occurs. Medication review is the process of evaluating current medication treatment to manage the risk and optimize the outcomes of medication treatment by detecting, solving, and preventing medication-related problems. The present study focuses on medication assessment including both medication reconciliation and review combined to clinical assessment of an individual patient.
According to a systematic review there is a need for research focusing on medication management in community settings and especially to assess the impact of medication assessment on clinical outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active comparator | Active comparator | Other: Medication assessment and treatment plan based on itIn addition to usual care, participants allocated to intervention group will receive medication assessment and treatment plan based on it |
| Usual care | No intervention | –Usual care (reference group). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Home dwelling ≥65 years-old persons registered to public home care services and who
- have had dizziness, orthostatic hypotension or have fallen or
- use at least six medicines
Key exclusion criteria (1 listed)
- Home care is not responsible for patient's medication, for example due to severe chronic illness (for example severe renal insufficiency or cancer with active treatment in secondary or tertiary care).
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 assessment and treatment plan based on itIntervention * Phase I: A medication assessment conducted by an interprofessional team including nurse, pharmacist and physician. The assessment is based on current medication list and basic information cathered by nurse. * Phase II: This phase is needed if the assessment cannot be conducted safely without physical examination conducted by physician. The comprehensive interprofessional assessment takes place after the clinical examination conducted by home care physician. | Other | Active comparator |
Primary outcome
Functional capacity IADL (Instrumental Activities of Daily Living)
Time frame: at 6 months from baseline
Functional capacity ADL (Activities of daily living;KATZ)
Time frame: at 6 months from baseline
Functional capacity TUG (Timed up and go)
Time frame: at 6 months from baseline
Functional capacity MMSE ( Mini-mental state examination)
Time frame: at 6 months from baseline
Functional capacity GDS (Geriatric Depression Scale)-15
Time frame: at 6 months from baseline
6 secondary outcomes
Use of health care services
Time frame: at 6 and 12 months from baseline
Need of services delivered to home
Time frame: at 6 and 12 months from baseline
Number of medicines
Time frame: at 6 and 12 months from baseline
Quality of medicines
Time frame: at 6 and 12 months from baseline
Cost of medicines
Time frame: at 6 and 12 months from baseline
Health related quality of life assessed with EQ-5D
Time frame: at 6 and 12 months from baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2016.
- Derived from this study: PubMed 33023497Auvinen K, Voutilainen A, Jyrkka J, Lonnroos E, Mantyselka P. Interprofessional medication assessment among home care patients: any impact on functioning? Results from a randomised controlled trial. BMC Geriatr. 2020 Oct 6;20(1):390. doi: 10.1186/s12877-020-01796-1.
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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.
Pekka Mäntyselkä, MD study chair
Professor
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medication assessment and treatment plan based on it in people with Multimorbidity and Polypharmacy, run by East Savo Hospital District at 5 sites in Finland.
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 3 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: status not confirmed, as of the sponsor's last update on 13 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Finland. 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?
Results are not available in the source record.
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?
Functional capacity IADL (Instrumental Activities of Daily Living) (time frame: at 6 months from baseline). The study lists 5 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 NCT02398812, 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 13 Jun 2016.