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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Behavioral: Educational training


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>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<br>* 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.<br>|
| No Intervention: Control group<br>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?
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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 |