A Multidisciplinary Approach to Improve Adherence to Medical Recommendations in Older Adults (APPROACH)

University Hospital of Ferrara

Status: Enrolling

Conditions: Hospital Discharge; Aging; Medication Adherence; Multidisciplinary Communication; Fall

Treatments: Behavioral: Educational training

Study type: Interventional

Funder types: Other

Identifiers

NCT05719870

947/2021/SPER/AOUFe

Details and patient eligibility

About

Background and overall goal: Poor comprehension and medication adherence are common in older people, especially after hospitalizations, in case of changes or prescriptions of new therapeutic regimes. The aim of this project is to evaluate the effectiveness of a multidomain intervention with an integrated care approach, in improving medication adherence in older people after hospital discharge. A secondary aim is investigate the determinants of poor comprehension and medication adherence in such individuals.

Target population: The project will involve older patients hospitalized in a Geriatric Department and discharged at home, and (when present) their caregivers.

Methods and assessments: Upon hospital discharge, data from the comprehensive geriatric assessment and information on the present hospitalization and prescribed therapies will be collected for all participants. The comprehension of medical recommendations reported in the discharge summary will be evaluated for all patients/caregiver before and after the routine explanation by treating physicians. Participants will be then randomized in intervention vs. control group. The intervention will include: first, educational training of patients/caregivers at hospital discharge by a multidisciplinary team; second, after hospital discharge, a phone recall on the prescribed therapies and a one-week phone consultant service managed by a geriatrician, supported by the multidisciplinary team, to address potential concerns on prescribed treatments. Control group will follow usual care. After 7 days medication adherence will be assessed for both study groups through structured phone interviews. At 30 and 90 days from discharge, data on falls, rehospitalizations and vital status will be collected through hospital records.

Full description

Background and overall goal: Poor comprehension and medication adherence are common in older people, especially after hospitalizations, in case of changes or prescriptions of new therapeutic regimes. The aim of this project is to evaluate the effectiveness of a multidomain intervention with an integrated care approach, in improving medication adherence in older people after hospital discharge. Moreover, a secondary aim is to investigate the determinants of poor comprehension and medication adherence in such individuals.

Target population: The project will involve older patients hospitalized in a Geriatric Department and discharged at home, and (when present) their caregivers.

Methods and assessments: Upon hospital discharge, data from the comprehensive geriatric assessment and information on the present hospitalization and prescribed therapies will be collected for all participants. The comprehension of medical recommendations reported in the discharge summary will be evaluated for all patients/caregiver before and after the routine explanation by treating physicians. Participants will be then randomized in intervention vs. control group. The intervention will include: first, educational training of patients/caregivers at hospital discharge by a multidisciplinary team; second, after hospital discharge, a phone recall on the prescribed therapies and a one-week phone consultant service managed by a geriatrician, supported by the multidisciplinary team, to address potential concerns on prescribed treatments. Control group will follow usual care. After 7, 30 and 90 days, data on medication adherence, falls, rehospitalizations and vital status will be assessed for both study groups through structured phone interviews and hospital records.

Enrollment: 360 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For the enrolment of the study participants, we will regularly monitor ward admissions, and potential eligibility of the patients will be evaluated by using the following inclusion criteria:

• Patients hospitalized in the Geriatric Units of the Padua and Ferrara University Hospitals
• Age 60 years or older
• Patients living in the community setting and who will be discharged at home
• Expected survival >7 days

Exclusion criteria:

• Patients discharged in long-term care facilities or other acute or post-acute wards
• No consent to participate in the study.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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360 participants in 2 patient groups

Intervention group

Experimental group

Description:

Patients hospitalized in the Geriatric Unit aged 60 years or older, that living in the community setting and who will be discharged at home and with expected survival \>7 days.

Treatment:

Behavioral: Educational training

Control group

No Intervention group

Description:

Patients hospitalized in the Geriatric Unit aged 60 years or older, that living in the community setting and who will be discharged at home and with expected survival \>7 days. The control group will be discharged following standard care procedures, and will receive only appropriate corrections and clarifications in case mistakes in the comprehension of the medical recommendations.