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The Interprofessional Medication Assessment for Older Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02398812
Recruitment Status : Unknown
Verified June 2016 by East Savo Hospital District.
Recruitment status was:  Active, not recruiting
First Posted : March 26, 2015
Last Update Posted : June 13, 2016
Sponsor:
Collaborators:
University of Eastern Finland
Finnish Medicines Agency
Information provided by (Responsible Party):
East Savo Hospital District

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.

Condition or disease Intervention/treatment Phase
Multimorbidity Polypharmacy Other: Medication assessment and treatment plan based on it Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 514 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Interprofessional Medication Assessment for Older Patients - a Multicenter Randomized Trial in Primary Care Setting
Study Start Date : February 2015
Actual Primary Completion Date : June 2016
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


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).



Primary Outcome Measures :
  1. Functional capacity IADL (Instrumental Activities of Daily Living) [ Time Frame: at 6 months from baseline ]
  2. Functional capacity ADL (Activities of daily living;KATZ) [ Time Frame: at 6 months from baseline ]
  3. Functional capacity TUG (Timed up and go) [ Time Frame: at 6 months from baseline ]
  4. Functional capacity MMSE ( Mini-mental state examination) [ Time Frame: at 6 months from baseline ]
  5. Functional capacity GDS (Geriatric Depression Scale)-15 [ Time Frame: at 6 months from baseline ]

Secondary Outcome Measures :
  1. Use of health care services [ Time Frame: at 6 and 12 months from baseline ]
    visits to physician, hospital days and nursing care at home

  2. Need of services delivered to home [ Time Frame: at 6 and 12 months from baseline ]
  3. Number of medicines [ Time Frame: at 6 and 12 months from baseline ]
  4. Quality of medicines [ Time Frame: at 6 and 12 months from baseline ]
  5. Cost of medicines [ Time Frame: at 6 and 12 months from baseline ]
  6. Health related quality of life assessed with EQ-5D [ Time Frame: at 6 and 12 months from baseline ]


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02398812


Locations
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Finland
Welfare district of Forssa
Forssa, Finland, FI 30100
Selänne Basic Health Care District
Haapajärvi, Finland, FI 85800
Juva Health Care
Juva, Finland, FI-51900
City of Lahti, home care
Lahti, Finland, FI-15100
Eastern Savo Hospital District
Savonlinna, Finland, FI-57100
Sponsors and Collaborators
East Savo Hospital District
University of Eastern Finland
Finnish Medicines Agency
Investigators
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Study Chair: Pekka Mäntyselkä, MD Professor
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: East Savo Hospital District
ClinicalTrials.gov Identifier: NCT02398812    
Other Study ID Numbers: ILMA
First Posted: March 26, 2015    Key Record Dates
Last Update Posted: June 13, 2016
Last Verified: June 2016