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Improving Medication Therapy Through a Digital Interdisciplinary Model (MTO)

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ClinicalTrials.gov Identifier: NCT05629936
Recruitment Status : Not yet recruiting
First Posted : November 29, 2022
Last Update Posted : November 29, 2022
Sponsor:
Collaborator:
Region Västerbotten
Information provided by (Responsible Party):
Maria Gustafsson, Umeå University

Study Description
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Brief Summary:
This study investigates if a digital interdisciplinary medicine therapy optimization (MTO) model in primary care can improve medication therapy, quality of life and adherence among patients >65 years living in sparsley populated areas. The intervention includes digital medication interviews, comprehensive medication reviews, team based patient discussions and follow-ups.

Condition or disease Intervention/treatment Phase
Drug Use Other: digital interdisciplinary intervention Not Applicable

Detailed Description:
A pilot study to develop the MTO-model including 10-15 patients, will be carried out and appropriate adjustments to the model will be made before starting the main study. Patients meeting the inclusion criteria will be invited to participate in the study and sent three questionnaires, MARS-5, EQ-5D-5L and BMQ-general, to fill in before starting the intervention. Baseline in this digital intervention is a medication interview with a clinical pharmacist. Based on the information from this interview, journal- and laboratory data, a comprehensive medication review will be conducted and a preliminary proposal discussed in a digital interdisciplinary meeting resulting in a final MTO-plan. The patients will be informed by their physician if any medication changes have been made and follow-up meetings with a pharmacist will take place 1-2,4 and 12 weeks after baseline and in addition of requested by the patients or if the pharmacist consider it necessary. In addition to the prescheduled meetings with the patient, the intervention includes repeated medical journal reviews every second week during the 12-weeks intervention. After the last follow-up at 12 weeks, the patient will be asked to fill in the three questionnaires; MARS-5, EQ-5D-5L and BMQ-general.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Improving Medication Therapy and Patient Involvement Through a Digital Interdisciplinary Model Among Old People in Primary Care Living in Sparsely Populated Regions in Sweden
Estimated Study Start Date : November 2022
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines

Arms and Interventions
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Arm Intervention/treatment
digital intervention
Digital intervention
 Other: digital interdisciplinary intervention
Digital medication interview, comprehensive medication review, interdisciplinary patient team discussion followed by a MTO-plan, follow-ups


Outcome Measures
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Primary Outcome Measures :
  1. Change in self-reported health state: EuroQol-5 dimension-5 level questionnaire (EQ-5D-5L) [ Time Frame: Change in self-reported health state between baseline and 12 weeks ]
    Assessing health-related quality of life through the EQ-5D-5L-questionnaire. EQ VAS score ranging between 0 and 100, with higher score indicating a higher overall self-rated health status.

  2. Change in self-reported adherence: Medication Adherence Report Scale-5 (MARS-5) [ Time Frame: Change in self-reported adherence between baseline and 12 weeks ]
    Assessing medication adherence through MARS-5 questionnaire. Total score ranging between 5 and 25, with higher scores indicating a higher level of adherence.

  3. Change in self-reported beliefs about medicines in general: The Beliefs about Medicines Questionnaire - general (BMQ-general) [ Time Frame: Change in self-reported beliefs about medicines between baseline and 12 weeks ]
    Assessing beliefs about medicines in general through BMQ-general questionnaire. BMQ-general consists of three different subscales (overuse, harm and benefit) with a total score ranging between 4-20 for each subscale. In two of the subscales (overuse and harm) higher scores indicates a more negative orientation towards medicines in general and in the subscale benefit a higher score indicates a more positive orientation towards medicines.


Eligibility Criteria
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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:   Yes
Criteria

Inclusion Criteria:

  • 5 or more medications or recommended by their physician
  • Living at home (i.e not in nursing home)
  • Registered at one of seven specified primary care centers

Exclusion Criteria:

  • Do not speak Swedish or unable to communicate
  • Home care services
  • Confirmed major NCD
  • Scheduled for palliative care
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: Maria Gustafsson, Principal investigator, Umeå University
ClinicalTrials.gov Identifier: NCT05629936    
Other Study ID Numbers: UMU-MTO-2022
First Posted: November 29, 2022    Key Record Dates
Last Update Posted: November 29, 2022
Last Verified: November 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maria Gustafsson, Umeå University:
Telemedicine
Medication reconciliation
Clinical pharmacist
 Elderly
Adherence
Drug-related problems