Clinical trial NCT05719870: A Multidisciplinary Approach to Improve Adherence to Medical Recommendations in Older Adults
Official title: A Multidisciplinary Approach to Improve Adherence to Medical Recommendations in Older Adults at Hospital Discharge
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Medication Adherence
Aging
Multidisciplinary Communication
Fall
Hospital Discharge
Lead sponsor: University Hospital of Ferrara
Sponsor class: OTHER
Collaborators: name: University of Padova
First posted: 2023-02-09
Enrollment: 360
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to the 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.

Over 30 and 90 days from discharge, data on falls, rehospitalizations and vital status will be collected through hospital records.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Comprehension of medical recommendation at hospital discharge
timeFrame: At baseline (corresponding to hospital discharge)
measure: Adherence to medical recommendations given at hospital discharge
timeFrame: 7 days after hospital discharge
measure: Adherence to the recommendations provided by the occupational therapist at hospital discharge
timeFrame: 7 days after hospital discharge
Secondary outcomes:
measure: Mortality
timeFrame: 7, 30 and 90 days after hospital discharge
measure: Number of falls
timeFrame: 30 and 90 days after hospital discharge
measure: Number of emergency department visits
timeFrame: 30 and 90 days after hospital discharge
measure: Number of rehospitalizations
timeFrame: 30 and 90 days after hospital discharge
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: Geriatric Unit of Ferrara Hospital
city: Padova
country: Italy
facility: Geriatric Unit of the Padua Central Hospital
Study officials:
affiliation: Università degli Studi di Ferrara
name: Cateriina Trevisan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: