NCT06451692

Brief Summary

To examine the effect of a cross-sectoral medication review intervention to admitted multi-morbid, polypharmacy patients aged 65+ at SHS in two settings; an acute admission unit (typical admission time \< 48 hours) and a medical outpatient setting (patients routinely visits for follow-up, diagnosis or treatment, but do require a bed or overnight care).

Trial Health

77
On Track

Trial Health Score

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

Enrollment
800

participants targeted

Target at P75+ for not_applicable

Timeline
13mo left

Started Jun 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress64%
Jun 2024Jun 2027

First Submitted

Initial submission to the registry

May 28, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 11, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

June 17, 2024

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

April 13, 2026

Status Verified

March 1, 2026

Enrollment Period

2.5 years

First QC Date

May 28, 2024

Last Update Submit

April 8, 2026

Conditions

Medication ReviewPolypharmacyGeneral PractitionersInterdisciplinary CommunicationClinical Pharmacy

Keywords

Multi-morbidityMedication reviewDementiaClinical Fragility scaleHospital to home transitionPolypharmacy

Outcome Measures

Primary Outcomes (1)

  • Readmission and emergency department rate.

    The number of acute readmissions and emergency department visits between 4 hours and 30 days after discharge from the index hospital stay in the intervention group compared with the control group. As a "yes" or "no" and a time-to-event. Potential readmissions are assessed through the electronic patient journal.

    Up to thirty days after discharge

Secondary Outcomes (5)

  • Acute admission

    Up to 90 days after discharge

  • Mortality

    30 and 90 days after discharge

  • GP contacts

    Up to 90 days after discharge

  • Implementation rate

    Up to 90 days after discharge

  • Compliance with medical treatment

    Up to 90 days after discharge

Other Outcomes (2)

  • Patient satisfaction with the intervention

    7 to 10 days after discharge

  • Evaluation of the collaboration among clinical pharmacists, medical specialists, and GPs

    10 months after the randomization of the first participant in each setting an online survey link will be sent clinical pharmacists, medical specialists, and GPs

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

The clinical pharmacist will assess the patient's medication, and perform interviews with the patient and/or the patient's attorney-in-fact. Potential medical recommendations will be discussed with the treating hospital clinician and the clinical pharmacist, and a medication plan will be developed together with the patient or the patient's attorney-in-fact. The GPs will be informed through optimized discharge summaries.

Other: Clinical pharmacist

Control group

NO INTERVENTION

Patients in the control group receive standard care without a clinical pharmacist involved in the healthcare team at ward level. Standard care consists of usual treatment from a team of hospital physicians, nurses, nurse assistants, and as needed occupational therapists, physiotherapist, and clinical dieticians. Hospital physicians and/or nurses might perform patient counselling about medication treatment during hospitalization

Interventions

Clinical pharmacistOTHER

The clinical pharmacist calls the patients' GP 90 days after discharge for follow-up

Intervention group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • all hospitalized patients who are prescribed at least seven medications specified in the Electronic Patient Journal (EPJ) at admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sygehus Sønderjylland

Aabenraa, Southern Denmark, 6200, Denmark

RECRUITING

MeSH Terms

Conditions

Dementia

Interventions

Pharmacists

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Health PersonnelHealth Care Facilities Workforce and Services

Central Study Contacts

Joo Hanne Poulsen Revell

CONTACT

+45 79974906Joo.Hanne.Poulsen.Revell@rsyd.dk

Lene Juel Kjeldsen

CONTACT

+45 79974932Lene.Juel.Kjeldsen@rsyd.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2024

First Posted

June 11, 2024

Study Start

June 17, 2024

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

April 13, 2026

Record last verified: 2026-03

Locations

DK(1)