MTO: Improving Medication Therapy Through a Digital Interdisciplinary Model

Sponsor

Umeå University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05629936

Collaborator

Region Västerbotten (Other)

100

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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	N/A

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

Study Type:

Interventional

Anticipated 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

Anticipated Study Start Date :

Nov 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Dec 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Other: 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

Arm

Intervention/Treatment

Other: 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

Primary Outcome Measures

Change in self-reported health state: EuroQol-5 dimension-5 level questionnaire (EQ-5D-5L) [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.
Change in self-reported adherence: Medication Adherence Report Scale-5 (MARS-5) [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.
Change in self-reported beliefs about medicines in general: The Beliefs about Medicines Questionnaire - general (BMQ-general) [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

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

No locations specified.

Sponsors and Collaborators

Umeå University
Region Västerbotten

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Maria Gustafsson, Principal investigator, Umeå University

ClinicalTrials.gov Identifier:

NCT05629936

Other Study ID Numbers:

UMU-MTO-2022

First Posted:

Nov 29, 2022

Last Update Posted:

Nov 29, 2022

Last Verified:

Nov 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Maria Gustafsson, Principal investigator, Umeå University

Telemedicine

Medication reconciliation

Clinical pharmacist

Elderly

Adherence

Drug-related problems

Study Results

No Results Posted as of Nov 29, 2022