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Clinical Trials/NCT01897870
NCT01897870
Completed
N/A

The Effect of a Home-based Community Pharmacist-led Medication Management Program (HomeCoMe-program) Complementary to an In-hospital Medication Reconciliation Program on Drug-related Problems Post-discharge: A Prospective Cohort Study.

H.T. Ensing, PharmD, MSc1 site in 1 country150 target enrollmentNovember 2013

Overview

Phase
N/A
Intervention
Not specified
Conditions
Adverse Drug Event
Sponsor
H.T. Ensing, PharmD, MSc
Enrollment
150
Locations
1
Primary Endpoint
Identifying and solving adverse drug events (ADEs) and other drug-related problems (DRPs) post-discharge
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

the purpose of this study is to determine the the effect of a home-based medication management program on drug-related problems post-discharge.

Detailed Description

Inaccuracy of medication histories and lack of knowledge on actual medication use results in confusion about medication regimens and medication mismanagement before- during - and after hospital admission. This phenomenon accounts for many readmissions, longer duration of admission and preventable and serious Adverse Drug Events (ADEs) as a result of Drug Related Problems (DRPs). Several studies show that discharge medication reconciliation (MR) and counseling by a pharmacy employee reduces the amount of discrepancies in the discharge prescription lists. Still, no unequivocal effect of MR on the occurrence of DRPs after discharge has been shown. This is due to a shift in underlying potential harmful discrepancies from mainly patient based (unintended nonadherence) to mainly system based (eg dispensing errors) and might be explained by (1) suboptimal transfer of information (2) an overload of information during a stressful situation and (3) difficulty to implement changes in medication at home. Therefore the reduction of DRPs, improvement of patients' medication knowledge and initial adherence can probably most effectively be addressed in a multifaceted integrated transmural intervention. Repetition of important information is the key to success. Moreover, the first weeks following hospital discharge are most crucial in preventing drug-related problems as patients could slip back in old medication schemes, or new problems may arise, such as emerging ADEs due to medication changes made during hospitalization.

Registry
clinicaltrials.gov
Start Date
November 2013
End Date
February 2016
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
H.T. Ensing, PharmD, MSc
Responsible Party
Sponsor Investigator
Principal Investigator

H.T. Ensing, PharmD, MSc

PharmD, MSc

Zorggroep Almere

Eligibility Criteria

Inclusion Criteria

  • patient uses more than three prescribed systemic drugs intended for chronic use at admission and discharge
  • patient has an expected length of stay of 48 hours or longer

Exclusion Criteria

  • Patients admitted for scheduled chemotherapy
  • Patients admitted for radiation therapy
  • Patients admitted for transplantation
  • Patients transferred from another hospital
  • Patients transferred from another non-eligible ward within the same hospital
  • No informed consent signed
  • A live expectancy less than 6 months
  • Inability to be counselled (e.g. cognitive dysfunction, language constraints who cannot be solved with an interpreter)
  • Discharge to a nursing home (presuming dependence on medication administration)
  • If patients' community pharmacy is not participating in this study

Outcomes

Primary Outcomes

Identifying and solving adverse drug events (ADEs) and other drug-related problems (DRPs) post-discharge

Time Frame: within 7 days post-discharge

The total number of assessed and solved ADEs post-discharge will be measured. Assessing and solving ADEs takes place during the pharmacist home visit. Using START-STOPP criteria on patients medication records, ADEs will also be compared between the intervention and usual care group.

Secondary Outcomes

  • Assessment of patient reported health rating(at 42 days after discharge)
  • Types of interventions made at the pharmacist home visit(within 7 days after discharge)
  • Patient satisfaction with the pharmacist home visit(Immediately after receiving the home visit)
  • General practitioners satisfaction with the pharmacist home visit(Immediately after the home visit is executed)
  • Improvement of adherence to medication at hospital discharge(up to 6 months after discharge)
  • Patient assessment of medication knowledge at time of home visit(within 7 days after discharge)

Study Sites (1)

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