- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01897870
The Effect of a Pharmacist Home Visit on Drug-related Problems Post-discharge. (HomeCoMe)
February 22, 2016 updated by: H.T. Ensing, PharmD, MSc
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.
the purpose of this study is to determine the the effect of a home-based medication management program on drug-related problems post-discharge.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Flevoland
-
Almere, Flevoland, Netherlands, 1315RA
- Zorgapotheken Flevoland
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HomeCoMe-program group
the arm receiving the pharmacist home visit
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
within 7 days post-discharge
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement of adherence to medication at hospital discharge
Time Frame: up to 6 months after discharge
|
The "medication possession ratio" will be calculated retrospectively from pharmacy dispensing data after 6 months to investigate patient's adherence and compared between the intervention and control group.
|
up to 6 months after discharge
|
Patient assessment of medication knowledge at time of home visit
Time Frame: within 7 days after discharge
|
At time of the home visit patients are asked about their knowledge (e.g.
indication, dose regime, etc) regarding the medication they are taking.
Knowledge is scored and lack of knowledge is solved by teaching the patient.
|
within 7 days after discharge
|
Types of interventions made at the pharmacist home visit
Time Frame: within 7 days after discharge
|
The types of intervention the pharmacist works on during the 7 day follow-up home visit are assessed.
|
within 7 days after discharge
|
Patient satisfaction with the pharmacist home visit
Time Frame: Immediately after receiving the home visit
|
The satisfaction survey consists of 13 interview questions, where the subject subjectively scores each question on a four-point scale, developed specifically for this study.
|
Immediately after receiving the home visit
|
Assessment of patient reported health rating
Time Frame: at 14 days after discharge
|
Patient are asked by telephone to report their health on a scale from 1 (worst imaginable health) to 10 (best imaginable health).
Number are compared between the intervention and control group.
|
at 14 days after discharge
|
General practitioners satisfaction with the pharmacist home visit
Time Frame: Immediately after the home visit is executed
|
The satisfaction survey consists of 13 interview questions, where the subject subjectively scores each question on a four-point scale, developed specifically for this study.
|
Immediately after the home visit is executed
|
Assessment of patient reported health rating
Time Frame: at 42 days after discharge
|
Patient are asked by telephone to report their health on a scale from 1 (worst imaginable health) to 10 (best imaginable health).
Number are compared between the intervention and control group.
|
at 42 days after discharge
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Marcel L Bouvy, Prof, PharmD, PhD, UIPS
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2013
Primary Completion (Actual)
February 1, 2016
Study Completion (Actual)
February 1, 2016
Study Registration Dates
First Submitted
July 2, 2013
First Submitted That Met QC Criteria
July 9, 2013
First Posted (Estimate)
July 12, 2013
Study Record Updates
Last Update Posted (Estimate)
February 23, 2016
Last Update Submitted That Met QC Criteria
February 22, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZGA-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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