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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Medication Adherence; Aging; Fall; Multidisciplinary Communication; Hospital Discharge
• Intervention / Treatment: Behavioral: Educational training

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.

• Study Type: Interventional
• Enrollment (Anticipated): 360
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Giuseppe Sergi, MD, PhD; Phone Number: 0498218492; Email: giuseppe.sergi@unipd.it
• Study Contact Backup: Name: Caterina Trevisan, MD, PhD; Phone Number: 0532239572; Email: caterina.trevisan@unife.it

Study Locations

• Italy
  • Ferrara, Italy, 44126
    • Recruiting
    • Geriatric Unit of Ferrara Hospital
    • Contact: Caterina Trevisan; Phone Number: 0532239572; Email: caterina.trevisan@unife.it
    • Principal Investigator: Stefano Volpato
    • Principal Investigator: Amedeo Zurlo
    • Principal Investigator: Francesca Remelli
  • Padova, Italy, 35128
    • Recruiting
    • Geriatric Unit of the Padua Central Hospital
    • Contact: Giuseppe Sergi; Phone Number: 0498218492; Email: giuseppe.sergi@unipd.it
    • Principal Investigator: Bruno Micael Zanforlini
    • Principal Investigator: Fabrizia Miotto
    • Principal Investigator: Andrea Cignarella
    • Principal Investigator: Sara Sambo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention group; 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.	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.
NO_INTERVENTION: Control group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comprehension of medical recommendation at hospital discharge	number of mistakes in recalling the prescribed therapy	At baseline (corresponding to hospital discharge)
Adherence to medical recommendations given at hospital discharge	number of discrepancies in taking the prescribed therapy	7 days after hospital discharge
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Assessment of vital status through hospital records and telephone interviews	7, 30 and 90 days after hospital discharge
Number of falls	Evaluation through structured telephone interviews	30 and 90 days after hospital discharge
Number of emergency department visits	Evaluation through structured telephone interviews	30 and 90 days after hospital discharge
Number of rehospitalizations	Evaluation through structured telephone interviews	30 and 90 days after hospital discharge

Collaborators and Investigators

• Sponsor: University Hospital of Ferrara
• Collaborators: University of Padova
• Investigators: Principal Investigator: Cateriina Trevisan, MD, PhD, Università degli Studi di Ferrara

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2022
• Primary Completion (ANTICIPATED): February 28, 2023
• Study Completion (ANTICIPATED): February 28, 2023

Study Registration Dates

• First Submitted: November 2, 2022
• First Submitted That Met QC Criteria: January 30, 2023
• First Posted (ESTIMATE): February 9, 2023

Study Record Updates

• Last Update Posted (ESTIMATE): February 9, 2023
• Last Update Submitted That Met QC Criteria: January 30, 2023
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 947/2021/SPER/AOUFe

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No