An interventional study of HomeCoMe-program in Adverse Drug Event, Readmission and Patient Compliance, sponsored by H.T. Ensing, PharmD, MSc. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-02-23.
Sponsored by H.T. Ensing, PharmD, MSc · Not applicable, Interventional, and Supportive care
the purpose of this study is to determine the the effect of a home-based medication management program on drug-related problems post-discharge.
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.
445 studies on the registry are indexed under Drug-Related Side Effects and Adverse Reactions; 77 are open to participants now.
This study's enrollment of 150 is above the median of 103 across 260 interventional studies indexed under Drug-Related Side Effects and Adverse Reactions.
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Exclusion Criteria:
the arm receiving the pharmacist home visit
Behavioral: HomeCoMe-program
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.
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.
Time frame: within 7 days post-discharge
Improvement of adherence to medication at hospital 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.
Time frame: up to 6 months after discharge
Patient assessment of medication knowledge at time of home visit
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.
Time frame: within 7 days after discharge
Types of interventions made at the pharmacist home visit
The types of intervention the pharmacist works on during the 7 day follow-up home visit are assessed.
Time frame: within 7 days after discharge
Patient satisfaction with the pharmacist 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.
Time frame: Immediately after receiving the home visit
Assessment of patient reported health rating
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.
Time frame: at 14 days after discharge
General practitioners satisfaction with the pharmacist 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.
Time frame: Immediately after the home visit is executed
Assessment of patient reported health rating
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.
Time frame: at 42 days after discharge
The record gives a start of Nov 2013, a primary completion of Feb 2016 and a completion of Feb 2016. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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