The Interprofessional Medication Assessment for Older Patients

Polypharmacy Clinical Trial

Official title:

The Interprofessional Medication Assessment for Older Patients - a Multicenter Randomized Trial in Primary Care Setting

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02398812
• Other study ID #: ILMA
• Status: Active, not recruiting
• Phase: N/A
• First received: March 13, 2015
• Last updated: June 10, 2016
• Start date: February 2015
• Est. completion date: December 2018

Study information

• Verified date: June 2016
• Source: East Savo Hospital District
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The main hypothesis is that intervention has a positive impact on functional capacity and for rational and safe use of medicines.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 514
• Est. completion date: December 2018
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Multimorbidity
• Polypharmacy

Intervention

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.

Locations

Country	Name	City	State
Finland	Welfare district of Forssa	Forssa
Finland	Selänne Basic Health Care District	Haapajärvi
Finland	Juva Health Care	Juva
Finland	City of Lahti, home care	Lahti
Finland	Eastern Savo Hospital District	Savonlinna

Sponsors (3)

Lead Sponsor	Collaborator
East Savo Hospital District	Finnish Medicines Agency, University of Eastern Finland

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional capacity IADL (Instrumental Activities of Daily Living)		at 6 months from baseline
Primary	Functional capacity ADL (Activities of daily living;KATZ)		at 6 months from baseline
Primary	Functional capacity TUG (Timed up and go)		at 6 months from baseline
Primary	Functional capacity MMSE ( Mini-mental state examination)		at 6 months from baseline
Primary	Functional capacity GDS (Geriatric Depression Scale)-15		at 6 months from baseline
Secondary	Use of health care services	visits to physician, hospital days and nursing care at home	at 6 and 12 months from baseline
Secondary	Need of services delivered to home		at 6 and 12 months from baseline
Secondary	Number of medicines		at 6 and 12 months from baseline
Secondary	Quality of medicines		at 6 and 12 months from baseline
Secondary	Cost of medicines		at 6 and 12 months from baseline
Secondary	Health related quality of life assessed with EQ-5D		at 6 and 12 months from baseline