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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Zorggroep Almere
Sponsor:
Collaborators:
Zorggroep Almere
Flevoziekenhuis, Almere
Information provided by (Responsible Party):
H.T. Ensing, PharmD, MSc, Zorggroep Almere
ClinicalTrials.gov Identifier:
NCT01897870
First received: July 2, 2013
Last updated: March 11, 2014
Last verified: March 2014
  Purpose

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 Intervention
Adverse Drug Event
Patient Readmission
Patient Compliance
Behavioral: HomeCoMe-program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Zorggroep Almere:

Primary Outcome Measures:
  • Identifying and solving adverse drug events (ADEs) and other drug-related problems (DRPs) post-discharge [ Time Frame: within 7 days post-discharge ] [ Designated as safety issue: No ]

    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:
  • Improvement of adherence to medication at hospital discharge [ Time Frame: up to 6 months after discharge ] [ Designated as safety issue: No ]
    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.

  • Patient assessment of medication knowledge at time of home visit [ Time Frame: within 7 days after discharge ] [ Designated as safety issue: No ]
    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.

  • Types of interventions made at the pharmacist home visit [ Time Frame: within 7 days after discharge ] [ Designated as safety issue: No ]
    The types of intervention the pharmacist works on during the 7 day follow-up home visit are assessed.

  • Patient satisfaction with the pharmacist home visit [ Time Frame: Immediately after receiving the home visit ] [ Designated as safety issue: No ]
    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.

  • Assessment of patient reported health rating [ Time Frame: at 14 days after discharge ] [ Designated as safety issue: No ]
    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.

  • General practitioners satisfaction with the pharmacist home visit [ Time Frame: Immediately after the home visit is executed ] [ Designated as safety issue: No ]
    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.

  • Assessment of patient reported health rating [ Time Frame: at 42 days after discharge ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 675
Study Start Date: November 2013
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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) actual use of the prescribed medication regimen, (2) possible ADEs and other DRPs, (3) adherence issues, to embed the patient's new medication situation in his or her life, by (a) assessing patient's needs, beliefs and wishes around his pharmacotherapy, (b) identifying and solving obstacles for medicines intake, (c) checking on the need for a compliance aid, coming to an agreement with the patient on introduction (if needed), (d) collecting spare medication with a check on dispensation date, expiration date and cause for discontinuation (e.g. due to a side effect being not reported to the prescriber) and finally (4) knowledge on medication use, when to take which medicine and why, and medication changes made during the hospitalisation.
No Intervention: Usual care group
the arm receiving usual pharmacy care

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01897870

Contacts
Contact: Hendrik T Ensing, PharmD, MSc +31365454378 rensing@zorggroep-almere.nl

Locations
Netherlands
Zorgapotheken Flevoland Recruiting
Almere, Flevoland, Netherlands, 1315RA
Contact: Hendrik T Ensing, PharmD, MSc    +31365454378    rensing@zorggroep-almere.nl   
Principal Investigator: Hendrik T Ensing, PharmD, MSc         
Sponsors and Collaborators
H.T. Ensing, PharmD, MSc
Zorggroep Almere
Flevoziekenhuis, Almere
Investigators
Principal Investigator: Marcel L Bouvy, Prof, PharmD, PhD UIPS
  More Information

Publications:
Responsible Party: H.T. Ensing, PharmD, MSc, PharmD, MSc, Zorggroep Almere
ClinicalTrials.gov Identifier: NCT01897870     History of Changes
Other Study ID Numbers: ZGA-1
Study First Received: July 2, 2013
Last Updated: March 11, 2014
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Zorggroep Almere:
continuity of care
medicines management
home visit
drug-related problems

ClinicalTrials.gov processed this record on September 16, 2014