Overview

This trial is active, not recruiting.

Conditions multimorbidity, polypharmacy
Treatment medication assessment and treatment plan based on it
Sponsor East Savo Hospital District
Collaborator University of Eastern Finland
Start date February 2015
End date June 2016
Trial size 514 participants
Trial identifier NCT02398812, ILMA

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Active Comparator)
In addition to usual care, participants allocated to intervention group will receive medication assessment and treatment plan based on it
medication assessment and treatment plan based on it
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.
(No Intervention)
Usual care (reference group).

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 65 years old.

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).

Additional Information

Official title The Interprofessional Medication Assessment for Older Patients - a Multicenter Randomized Trial in Primary Care Setting
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by East Savo Hospital District.