NCT01897870

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 12, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

February 23, 2016

Status Verified

February 1, 2016

Enrollment Period

2.3 years

First QC Date

July 2, 2013

Last Update Submit

February 22, 2016

Conditions

Keywords

continuity of caremedicines managementhome visitdrug-related problems

Outcome Measures

Primary Outcomes (1)

  • Identifying and solving adverse drug events (ADEs) and other drug-related problems (DRPs) 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.

    within 7 days post-discharge

Secondary Outcomes (7)

  • 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

  • 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

  • Assessment of patient reported health rating

    at 14 days after discharge

  • +2 more secondary outcomes

Study Arms (1)

HomeCoMe-program group

EXPERIMENTAL

the arm receiving the pharmacist home visit

Behavioral: HomeCoMe-program

Interventions

A home visit by patients own community pharmacist within seven days after hospital discharge. The community pharmacist will perform a semi-structured interview on (1) use of the prescribed medication, (2) ADEs, (3) adherence issues, by (A) assessing patient's needs and concerns around his pharmacotherapy, (B) identifying and solving obstacles for medicines intake, (C) checking on the need for a compliance aid, (D) collecting spare medication and finally (4) knowledge on medication use, when to take which medicine and why, and medication changes made during the hospitalisation.

HomeCoMe-program group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zorgapotheken Flevoland

Almere Stad, Flevoland, 1315RA, Netherlands

Location

Related Publications (3)

  • 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.

    PMID: 16534045BACKGROUND
  • 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.

    PMID: 12492615BACKGROUND
  • 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.

    PMID: 22861493BACKGROUND

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse ReactionsPatient Compliance

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Marcel L Bouvy, Prof, PharmD, PhD

    UIPS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PharmD, MSc

Study Record Dates

First Submitted

July 2, 2013

First Posted

July 12, 2013

Study Start

November 1, 2013

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

February 23, 2016

Record last verified: 2016-02

Locations