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

Aging Clinical Trial

— APPROACH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05719870
• Other study ID #: 947/2021/SPER/AOUFe
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: February 28, 2023

Study information

• Verified date: June 2022
• Source: University Hospital of Ferrara
• Contact: Giuseppe Sergi, MD, PhD
• Phone: 0498218492
• Email: giuseppe.sergi[@]unipd.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Educational training
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.

Locations

Country	Name	City	State
Italy	Geriatric Unit of Ferrara Hospital	Ferrara
Italy	Geriatric Unit of the Padua Central Hospital	Padova

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital of Ferrara	University of Padova

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comprehension of medical recommendation at hospital discharge	number of mistakes in recalling the prescribed therapy	At baseline (corresponding to hospital discharge)
Primary	Adherence to medical recommendations given at hospital discharge	number of discrepancies in taking the prescribed therapy	7 days after hospital discharge
Primary	Adherence to the recommendations provided by the occupational therapist at hospital discharge	number of days per week of recommendations' adherence	7 days after hospital discharge
Secondary	Mortality	Assessment of vital status through hospital records and telephone interviews	7, 30 and 90 days after hospital discharge
Secondary	Number of falls	Evaluation through structured telephone interviews	30 and 90 days after hospital discharge
Secondary	Number of emergency department visits	Evaluation through structured telephone interviews	30 and 90 days after hospital discharge
Secondary	Number of rehospitalizations	Evaluation through structured telephone interviews	30 and 90 days after hospital discharge