OPTImization of Medication by Transdisciplinary Assessment of Drug Treatment in Elderly Hospitalized Patients

NCT05387096 | Active Not Recruiting

• 1 other identifier: DIFA-2020-024
• Study Type: interventional
• Target: 642
• Locations: 2 countries
• Sites: 3

Brief Summary

This study is being done to find out if a multi-faceted intervention designed to optimize medication in hospitalized older people with multiple chronic medical conditions exposed to multiple medications can reduce unplanned hospital readmission and emergency department attendance compared to current usual medication management. The study intervention aims to minimize potentially inappropriate medications in a structured way and involves follow up with patients and GPs. Patients will be allocated equally to (i) standard medication management (control arm) or (ii) trained physician-delivered intervention or (iii) clinical pharmacist-delivered intervention.

Conditions

Multimorbidity; Polypharmacy

Keywords

inappropriate prescribing; multimorbidity; polypharmacy; hospital admission; older people; frail elderly; medication therapy management; STOPP/START

Outcome Measures

Primary Outcomes (6)

• Unscheduled readmission to hospital.

  All-cause re-hospitalization in multi-morbid older people exposed to polypharmacy. Computerized hospital admission records will be inspected. If hospital readmission has occurred dates of admission and discharge will be recorded in the electronic case report form.

  At day 30 post-discharge.

• Emergency Department attendance.

  Unscheduled emergency department attendance at in multi-morbid older people exposed to polypharmacy. Computerized hospital emergency department attendance records will be inspected. The primary researcher will record on the electronic case report form whether there has there been an unscheduled emergency department attendance since the first follow-up post discharge.

  At day 30 post-discharge.

• Composite endpoint 1

  Composite endpoint of readmission to hospital or emergency department attendance within 30 days of discharge from the index admission.

  At day 30 post-discharge.

• Unscheduled readmission to hospital.

  Unscheduled readmission at 180 days post-discharge in multi-morbid older people exposed to polypharmacy. This will be ascertained during the follow-up interview within 180 (+/-14) days post-discharge. Computerized hospital emergency department attendance records will be inspected. The primary researcher will record on the electronic case report form whether there has there been an unscheduled readmission at 180 days since discharge from the index hospital admission.

  At between days 90 and 180 post-discharge.

• Emergency Department attendance.

  Unscheduled emergency department attendance at in multi-morbid older people exposed to polypharmacy. This will be ascertained during the follow-up interview within 180 (+/-14) days post-discharge. Computerized hospital emergency department attendance records will be inspected. The primary researcher will record on the electronic case report form whether there has there been an unscheduled emergency department attendance at 180 days since discharge from the index hospital admission.

  At between days 90 and 180 post-discharge.

• Composite endpoint 2

  Composite endpoint of readmission to hospital or emergency department attendance within 180 days of discharge from the index admission.

  At between days 90 and 180 post-discharge.

Secondary Outcomes (6)

• Quality of life measured by EuroQol quality of life 5 dimensional 5 level instrument (incorporating pain control)

  At day 30 post-discharge.

• Quality of life measured by EuroQol quality of life 5 dimensional 5 level instrument

  At between days 90 and 180 post-discharge.

• All-cause mortality

  At day 30 post-discharge.

• All-cause mortality

  At between days 90 and 180 post-discharge.

• Occurrence of first admission to residential care facility for long-term nursing care

  At day 30 post-discharge.

Other Outcomes (5)

• Quality Life Adjusted Year (QALY)

  At between days 90 and 180 post-discharge.

• Cost per hospital readmission avoided

  At between days 90 and 180 post-discharge.

• Cost per ED attendance avoided

  At between days 90 and 180 post-discharge.

Study Arms (3)

Control: standard pharmaceutical care

SHAM COMPARATOR

Patients in the control arm (standard pharmaceutical care) will receive a sham intervention in the form of the modified Medication Adherence Rating Scale (MARS) questionnaire

Other: Sham Intervention

trained physician-implemented intervention

ACTIVE COMPARATOR

The definitive multi-faceted intervention delivered by a trained physician.

Other: Definitive multi-faceted intervention consisting of several components

clinical pharmacist-implemented intervention

ACTIVE COMPARATOR

The definitive multi-faceted intervention delivered by a trained pharmacist.

Other: Definitive multi-faceted intervention consisting of several components

Interventions

Definitive multi-faceted intervention consisting of several components OTHER

The definitive intervention will consist of the following components: structured history of medication (SHiM), Screening Tool of Older Persons' Prescriptions (STOPP) and Screening Tool to Alert to Right Treatment (START) screening for PIMs and PPOs, drug-drug and drug-disease interactions screening, face-to-face consultation with attending hospital physicians to discuss PIMs, PPOs, interactions and other issues, pre-discharge medication review and adjustment, detailed medication adjustment discharge report to patients' general practitioners (GPs), post-discharge follow-up contact with patients' GPs and community pharmacists at 1 week, 1 month and 3-6 months post -discharge. The interventions will be applied by a trained physician or pharmacist.

Also known as: STOPP/START criteria, Face to face consultation with attending physician, medication adjustment report to patient's general practitioner, post discharge follow up with GP and community pharmacist, follow up with patient at 30 and 90-180 days post discharge, the Structured History of Medication (SHiM) questionnaire, Stockley's Drug Interaction Checker

clinical pharmacist-implemented intervention; trained physician-implemented intervention

Sham Intervention OTHER

Sham intervention in the form of the modified Medication Adherence Rating Scale (MARS) questionnaire in addition to standard care.

Also known as: Control

Control: standard pharmaceutical care

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥ 70years
• or more chronic conditions.
• ≥ 5 daily medications pre-admission, all medications taken for at least 4 weeks continuously.
• Can speak and understand English (in the two Irish medical centres), and Dutch or French in Ghent University Hospital (Ghent is predominantly Dutch-speaking).
• Can give informed consent or give witnessed verbal consent or have a suitable proxy who can give informed assent on the patient's behalf.
• Agrees to follow-up contact post-discharge up to 180 days post-randomization.
• Agrees to primary researcher contacting the GP and community pharmacist post-discharge.

You may not qualify if:

• Terminal illness.
• Severe dementia and clearly unable to understand the purpose of the trial or give consent to participation.
• Severe communication disorder, making informed consent impossible.
• Likely to be discharged from hospital within 48 hours of arrival.
• Intensive Care Unit (ICU) admission.
• Primary psychiatric presenting illness.
• Unavailable for post-discharge follow-up for any reason.
• Non-accidental poisoning.
• Previous participation in medication optimization trials.
• Active participation in another clinical trial
• Infectious illness requiring strict isolation (including COVID-19 infection) blocking access of the primary researcher to the patient for enrolment.
• End-stage renal, liver or lung disease requiring organ replacement therapy.
• Admitted under the care of specialists in Clinical Pharmacology, Palliative Medicine, Clinical Oncology or Haematology.
• Admitted under the care of specialists in Geriatric Medicine in Ghent University Hospital.
• Trial participation refusal.

Sponsors & Collaborators

• University College Cork: lead
• University Hospital, Ghent: collaborator
• University Hospital Waterford: collaborator

Study Sites (3)

Ghent University Hospital

Ghent, 9000, Belgium

Location

Cork University Hospital

Cork, Ireland

Location

University Hospital Waterford

Waterford, Ireland

Location

Related Publications (26)

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Related Links

• Drug-drug interaction tool

MeSH Terms

Interventions

Potentially Inappropriate Medication List; Pharmacists; methyl 3-mercaptopropionimidate; Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Health Personnel; Health Care Facilities Workforce and Services; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Study Officials

• Denis O'Mahony, Professor

  University College Cork

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: To mimic the intervention for blinding purposes of the participants, both control and intervention arm patients will receive a sham intervention.While the intervention will be known to clinical staff, the trial statistician will remain blinded until the results are finalized.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A randomized controlled clinical trial is proposed in which it is anticipated to randomize 3 x 463 patients to one of 3 groups: (a) standard pharmaceutical care, or (b) trained physician-implemented DI, or (c) clinical pharmacist-implemented DI.

Study Record Dates

• First Submitted: April 9, 2022
• First Posted: May 24, 2022
• Study Start: January 17, 2023
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: July 10, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be made available six months after publication.
• Access Criteria: Open access

Locations

IE (2); BE (1)