Clinical trial NCT05629936: Improving Medication Therapy Through a Digital Interdisciplinary Medicine Therapy Optimisation Model
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Drug Use
Keywords: Telemedicine
Medication reconciliation
Clinical pharmacist
Elderly
Adherence
Drug-related problems
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: Region Västerbotten
First posted: 2022-11-29
Enrollment: 8
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study investigates if a digital interdisciplinary medicine therapy optimisation (MTO) model in primary care can improve medication therapy, quality of life, medication adherence, and beliefs about medicines, among patients \>65 years living in sparsely populated areas. The intervention includes digital medication interviews, comprehensive medication reviews, interdisciplinary patient-centred discussions, and follow-ups.

Detailed description: Initially, a pilot study will be conducted to evaluate the feasibility of the method and to make appropriate adjustments to the study design before starting the main study. Patients that meet the inclusion criteria will be invited to participate in the study via letter. The patients will also receive three validated questionnaires; Medication Adherence Report Scale-5 (MARS-5), EuroQol-5 Dimension-5 Level questionnaire (EQ-5D-5L) and The Beliefs about Medicines Questionnaire (BMQ) to fill in prior to initiation of the study, to collect baseline data. The intervention consists of several steps and all meetings are digital. At first, the patient will have a medication interview with a clinical pharmacist, Next, the clinical pharmacist conducts a comprehensive medication review based on information from the interview and the participant's medical records and laboratory values. The clinical pharmacist and the participant's primary care physician will then have a joint discussion regarding preliminary medication management proposals and therapy management plans. The patient will be informed by their physician if any medication changes have been made. Digital follow-up meetings with the patient and the clinical pharmacist will take place 1-2, 4 and 12 weeks after the baseline consultation, and additionally if requested by the patient or if the pharmacist consider it necessary. The clinical pharmacist will also conduct repeated medical record reviews every second week during the 12-week intervention period. 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 one more time.

Eligibility criteria: Inclusion Criteria:

* Using 5 or more medications or recommended by the primary care physician (e.g. according to the use of certain medicines or conditions such as chronic kidney disease)
* Living at home (i.e not in a nursing home)
* Registered at certain primary healthcare centres in the rural areas of Västerbotten

Exclusion Criteria:

* Do not speak Swedish or unable to communicate
* Has home care services
* Has a confirmed major neurocognitive disorder
* Receives palliative care

Primary outcomes:
measure: Identification and resolution of drug-related problems
timeFrame: The 12-week intervention period
measure: Change in self-reported medication adherence: Medication Adherence Report Scale-5 (MARS-5)
timeFrame: Baseline and 12 weeks
measure: Change in self-reported health-related quality of life: EuroQol-5 Dimension-5 Level questionnaire (EQ-5D-5L)
timeFrame: Baseline and 12 weeks
measure: Change in self-reported beliefs about medicines: The Beliefs about Medicines Questionnaire (BMQ)
timeFrame: Baseline and 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Storuman
country: Sweden
facility: Storuman healthcare centre
Study officials:
affiliation: Department of Medical and Translational Biology, Umeå University
name: Maria Gustafsson, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: