Clinical trial NCT02398812: The Interprofessional Medication Assessment for Older Patients
Official title: The Interprofessional Medication Assessment for Older Patients - a Multicenter Randomized Trial in Primary Care Setting
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multimorbidity
Polypharmacy
Lead sponsor: East Savo Hospital District
Sponsor class: OTHER
Collaborators: name: University of Eastern Finland
name: Finnish Medicines Agency
First posted: 2015-03-26
Enrollment: 514
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

Home dwelling ≥65 years-old persons registered to public home care services and who

1. have had dizziness, orthostatic hypotension or have fallen or
2. use at least six medicines

Exclusion Criteria:

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).

Primary outcomes:
measure: Functional capacity IADL (Instrumental Activities of Daily Living)
timeFrame: at 6 months from baseline
measure: Functional capacity ADL (Activities of daily living;KATZ)
timeFrame: at 6 months from baseline
measure: Functional capacity TUG (Timed up and go)
timeFrame: at 6 months from baseline
measure: Functional capacity MMSE ( Mini-mental state examination)
timeFrame: at 6 months from baseline
measure: Functional capacity GDS (Geriatric Depression Scale)-15
timeFrame: at 6 months from baseline
Secondary outcomes:
measure: Use of health care services
timeFrame: at 6 and 12 months from baseline
measure: Need of services delivered to home
timeFrame: at 6 and 12 months from baseline
measure: Number of medicines
timeFrame: at 6 and 12 months from baseline
measure: Quality of medicines
timeFrame: at 6 and 12 months from baseline
measure: Cost of medicines
timeFrame: at 6 and 12 months from baseline
measure: Health related quality of life assessed with EQ-5D
timeFrame: at 6 and 12 months from baseline
Other outcomes:
Locations:
city: Forssa
country: Finland
facility: Welfare district of Forssa
city: Haapajärvi
country: Finland
facility: Selänne Basic Health Care District
city: Juva
country: Finland
facility: Juva Health Care
city: Lahti
country: Finland
facility: City of Lahti, home care
city: Savonlinna
country: Finland
facility: Eastern Savo Hospital District
Study officials:
affiliation: Professor
name: Pekka Mäntyselkä, MD
role: STUDY_CHAIR
References:
citation: 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.