NCT05719870

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 2, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 9, 2023

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

February 9, 2023

Status Verified

June 1, 2022

Enrollment Period

12 months

First QC Date

November 2, 2022

Last Update Submit

January 30, 2023

Conditions

Medication AdherenceAgingMultidisciplinary CommunicationFallHospital Discharge

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (4)

  • Mortality

    7, 30 and 90 days after hospital discharge

  • Number of falls

    30 and 90 days after hospital discharge

  • Number of emergency department visits

    30 and 90 days after hospital discharge

  • Number of rehospitalizations

    30 and 90 days after hospital discharge

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

Educational trainingBEHAVIORAL

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.

Intervention group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Geriatric Unit of Ferrara Hospital

Ferrara, 44126, Italy

RECRUITING

Geriatric Unit of the Padua Central Hospital

Padua, 35128, Italy

RECRUITING

Related Publications (1)

  • Zanforlini BM, Sambo S, Devita M, Cignarella A, Vezzali F, Sturani S, Grandieri A, Noale M, Siviero P, Limongi F, Volpato S, Sergi G, Trevisan C; APPROACH working group. A multidisciplinary approach to improve adherence to medical recommendations in older adults at hospital discharge: The APPROACH study protocol. PLoS One. 2024 Apr 30;19(4):e0297238. doi: 10.1371/journal.pone.0297238. eCollection 2024.

    PMID: 38687693DERIVED

MeSH Terms

Conditions

Medication Adherence

Interventions

Training Support

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Financial SupportEconomicsHealth Care Economics and Organizations

Study Officials

  • Cateriina Trevisan, MD, PhD

    Università degli Studi di Ferrara

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Giuseppe Sergi, MD, PhD

CONTACT

0498218492giuseppe.sergi@unipd.it

Caterina Trevisan, MD, PhD

CONTACT

0532239572caterina.trevisan@unife.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2022

First Posted

February 9, 2023

Study Start

March 1, 2022

Primary Completion

February 28, 2023

Study Completion

February 28, 2023

Last Updated

February 9, 2023

Record last verified: 2022-06

Locations

IT(2)