HomeCoMe: The Effect of a Pharmacist Home Visit on Drug-related Problems Post-discharge.

Sponsor
H.T. Ensing, PharmD, MSc (Other)
Overall Status
Completed
CT.gov ID
NCT01897870
Collaborator
Zorggroep Almere (Other), Flevoziekenhuis (Other)
150
1
1
27
5.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: HomeCoMe-program
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
150 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
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 Start Date :
Nov 1, 2013
Actual Primary Completion Date :
Feb 1, 2016
Actual Study Completion Date :
Feb 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: HomeCoMe-program group

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.

Outcome Measures

Primary Outcome Measures

  1. Identifying and solving adverse drug events (ADEs) and other drug-related problems (DRPs) post-discharge [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 Outcome Measures

  1. Improvement of adherence to medication at hospital discharge [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.

  2. Patient assessment of medication knowledge at time of home visit [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.

  3. Types of interventions made at the pharmacist home visit [within 7 days after discharge]

    The types of intervention the pharmacist works on during the 7 day follow-up home visit are assessed.

  4. Patient satisfaction with the pharmacist home visit [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.

  5. Assessment of patient reported health rating [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.

  6. General practitioners satisfaction with the pharmacist home visit [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.

  7. Assessment of patient reported health rating [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zorgapotheken Flevoland Almere Flevoland Netherlands 1315RA

Sponsors and Collaborators

  • H.T. Ensing, PharmD, MSc
  • Zorggroep Almere
  • Flevoziekenhuis

Investigators

  • Principal Investigator: Marcel L Bouvy, Prof, PharmD, PhD, UIPS

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
H.T. Ensing, PharmD, MSc, PharmD, MSc, Zorggroep Almere
ClinicalTrials.gov Identifier:
NCT01897870
Other Study ID Numbers:
  • ZGA-1
First Posted:
Jul 12, 2013
Last Update Posted:
Feb 23, 2016
Last Verified:
Feb 1, 2016
Keywords provided by H.T. Ensing, PharmD, MSc, PharmD, MSc, Zorggroep Almere
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 23, 2016