Clinical trial NCT01897870: The Effect of a Pharmacist Home Visit on Drug-related Problems Post-discharge.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adverse Drug Event
Readmission
Patient Compliance
Keywords: continuity of care
medicines management
home visit
drug-related problems
Lead sponsor: Zorggroep Almere
Sponsor class: OTHER
Collaborators: name: Zorggroep Almere
name: Flevoziekenhuis
First posted: 2013-07-12
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Identifying and solving adverse drug events (ADEs) and other drug-related problems (DRPs) post-discharge
timeFrame: within 7 days post-discharge
Secondary outcomes:
measure: Improvement of adherence to medication at hospital discharge
timeFrame: up to 6 months after discharge
measure: Patient assessment of medication knowledge at time of home visit
timeFrame: within 7 days after discharge
measure: Types of interventions made at the pharmacist home visit
timeFrame: within 7 days after discharge
measure: Patient satisfaction with the pharmacist home visit
timeFrame: Immediately after receiving the home visit
measure: Assessment of patient reported health rating
timeFrame: at 14 days after discharge
measure: General practitioners satisfaction with the pharmacist home visit
timeFrame: Immediately after the home visit is executed
measure: Assessment of patient reported health rating
timeFrame: at 42 days after discharge
Other outcomes:
Locations:
city: Almere
country: Netherlands
facility: Zorgapotheken Flevoland
state: Flevoland
Study officials:
affiliation: UIPS
name: Marcel L Bouvy, Prof, PharmD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schnipper JL, Kirwin JL, Cotugno MC, Wahlstrom SA, Brown BA, Tarvin E, Kachalia A, Horng M, Roy CL, McKean SC, Bates DW. Role of pharmacist counseling in preventing adverse drug events after hospitalization. Arch Intern Med. 2006 Mar 13;166(5):565-71. doi: 10.1001/archinte.166.5.565.
citation: Al-Rashed SA, Wright DJ, Roebuck N, Sunter W, Chrystyn H. The value of inpatient pharmaceutical counselling to elderly patients prior to discharge. Br J Clin Pharmacol. 2002 Dec;54(6):657-64. doi: 10.1046/j.1365-2125.2002.01707.x.
citation: Kwint HF, Faber A, Gussekloo J, Bouvy ML. The contribution of patient interviews to the identification of drug-related problems in home medication review. J Clin Pharm Ther. 2012 Dec;37(6):674-80. doi: 10.1111/j.1365-2710.2012.01370.x. Epub 2012 Aug 3.