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A Multidisciplinary Approach to Improve Adherence to Medical Recommendations in Older Adults

A Multidisciplinary Approach to Improve Adherence to Medical Recommendations in Older Adults at Hospital Discharge

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05719870
Acronym
APPROACH
Enrollment
360
Registered
2023-02-09
Start date
2022-03-01
Completion date
2023-02-28
Last updated
2023-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Medication Adherence, Aging, Multidisciplinary Communication, Fall, Hospital Discharge

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.

Interventions

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.

Sponsors

University of Padova
CollaboratorOTHER
University Hospital of Ferrara
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

Inclusion 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.

Design outcomes

Primary

MeasureTime frameDescription
Comprehension of medical recommendation at hospital dischargeAt baseline (corresponding to hospital discharge)number of mistakes in recalling the prescribed therapy
Adherence to medical recommendations given at hospital discharge7 days after hospital dischargenumber of discrepancies in taking the prescribed therapy
Adherence to the recommendations provided by the occupational therapist at hospital discharge7 days after hospital dischargenumber of days per week of recommendations' adherence

Secondary

MeasureTime frameDescription
Mortality7, 30 and 90 days after hospital dischargeAssessment of vital status through hospital records and telephone interviews
Number of rehospitalizations30 and 90 days after hospital dischargeEvaluation through structured telephone interviews
Number of falls30 and 90 days after hospital dischargeEvaluation through structured telephone interviews
Number of emergency department visits30 and 90 days after hospital dischargeEvaluation through structured telephone interviews

Countries

Italy

Contacts

Primary ContactGiuseppe Sergi, MD, PhD
giuseppe.sergi@unipd.it0498218492
Backup ContactCaterina Trevisan, MD, PhD
caterina.trevisan@unife.it0532239572

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026