The Interprofessional Medication Assessment for Older Patients

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.

Study Overview

• Status: Unknown
• Conditions: Multimorbidity; Polypharmacy
• Intervention / Treatment: Other: Medication assessment and treatment plan based on it

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 Type: Interventional
• Enrollment (Actual): 514
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Forssa, Finland, FI 30100
    • Welfare district of Forssa
  • Haapajärvi, Finland, FI 85800
    • Selänne Basic Health Care District
  • Juva, Finland, FI-51900
    • Juva Health Care
  • Lahti, Finland, FI-15100
    • City of Lahti, home care
  • Savonlinna, Finland, FI-57100
    • Eastern Savo Hospital District

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active comparator; In addition to usual care, participants allocated to intervention group will receive medication assessment and treatment plan based on it	Other: 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; Usual care (reference group).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Functional capacity IADL (Instrumental Activities of Daily Living)	at 6 months from baseline
Functional capacity ADL (Activities of daily living;KATZ)	at 6 months from baseline
Functional capacity TUG (Timed up and go)	at 6 months from baseline
Functional capacity MMSE ( Mini-mental state examination)	at 6 months from baseline
Functional capacity GDS (Geriatric Depression Scale)-15	at 6 months from baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Use of health care services	visits to physician, hospital days and nursing care at home	at 6 and 12 months from baseline
Need of services delivered to home		at 6 and 12 months from baseline
Number of medicines		at 6 and 12 months from baseline
Quality of medicines		at 6 and 12 months from baseline
Cost of medicines		at 6 and 12 months from baseline
Health related quality of life assessed with EQ-5D		at 6 and 12 months from baseline

Collaborators and Investigators

• Sponsor: East Savo Hospital District
• Collaborators: University of Eastern Finland; Finnish Medicines Agency
• Investigators: Study Chair: Pekka Mäntyselkä, MD, PROFESSOR

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): June 1, 2016
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: March 13, 2015
• First Submitted That Met QC Criteria: March 20, 2015
• First Posted (Estimate): March 26, 2015

Study Record Updates

• Last Update Posted (Estimate): June 13, 2016
• Last Update Submitted That Met QC Criteria: June 10, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: ILMA