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

Primary Purpose

Adverse Drug Event, Readmission, Patient Compliance

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
HomeCoMe-program
Sponsored by
H.T. Ensing, PharmD, MSc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Adverse Drug Event focused on measuring continuity of care, medicines management, home visit, drug-related problems

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zorgapotheken Flevoland

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HomeCoMe-program group

Arm Description

the arm receiving the pharmacist home visit

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
July 2, 2013
Last Updated
February 22, 2016
Sponsor
H.T. Ensing, PharmD, MSc
Collaborators
Zorggroep Almere, Flevoziekenhuis
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1. Study Identification

Unique Protocol Identification Number
NCT01897870
Brief Title
The Effect of a Pharmacist Home Visit on Drug-related Problems Post-discharge.
Acronym
HomeCoMe
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 Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
H.T. Ensing, PharmD, MSc
Collaborators
Zorggroep Almere, Flevoziekenhuis

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adverse Drug Event, Readmission, Patient Compliance
Keywords
continuity of care, medicines management, home visit, drug-related problems

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HomeCoMe-program group
Arm Type
Experimental
Arm Description
the arm receiving the pharmacist home visit
Intervention Type
Behavioral
Intervention Name(s)
HomeCoMe-program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Identifying and solving adverse drug events (ADEs) and other drug-related problems (DRPs) post-discharge
Description
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
Secondary Outcome Measure Information:
Title
Improvement of adherence to medication at hospital discharge
Description
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
Title
Patient assessment of medication knowledge at time of home visit
Description
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
Title
Types of interventions made at the pharmacist home visit
Description
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
Title
Patient satisfaction with the pharmacist home visit
Description
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
Title
Assessment of patient reported health rating
Description
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
Title
General practitioners satisfaction with the pharmacist home visit
Description
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
Title
Assessment of patient reported health rating
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcel L Bouvy, Prof, PharmD, PhD
Organizational Affiliation
UIPS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zorgapotheken Flevoland
City
Almere
State/Province
Flevoland
ZIP/Postal Code
1315RA
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
16534045
Citation
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.
Results Reference
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PubMed Identifier
12492615
Citation
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.
Results Reference
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PubMed Identifier
22861493
Citation
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.
Results Reference
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The Effect of a Pharmacist Home Visit on Drug-related Problems Post-discharge.

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