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Adverse Drug EventHomeCoMeNCT01897870

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

A study testing HomeCoMe-program in people with Adverse Drug Event and Readmission, run by H.T. Ensing, PharmD, MSc at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
HomeCoMe-program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteNetherlands
Study dates
Nov 2013to Feb 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Zorgapotheken Flevoland

    Almere Stad, Flevoland, 1315RA

Other trials in Netherlands

About this study

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.

the purpose of this study is to determine the the effect of a home-based medication management program on drug-related problems post-discharge.

Read the 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.

Being tested
HomeCoMe-program
Keywords
continuity of care, medicines management, home visit, drug-related problems
Medical subject headings
Drug-Related Side Effects and Adverse Reactions, Patient Compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HomeCoMe-programBehavioural

    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.

Study groups in NCT01897870
Study groupRoleWhat they receive
HomeCoMe-program groupExperimentalthe arm receiving the pharmacist home visit
Receives: Behavioral: HomeCoMe-program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: within 7 days post-discharge

Secondary outcomes (7)

  1. 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.

    Measured: up to 6 months after discharge

  2. 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.

    Measured: within 7 days after discharge

  3. 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.

    Measured: within 7 days after discharge

  4. 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.

    Measured: Immediately after receiving the home visit

  5. 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.

    Measured: at 14 days after discharge

  6. 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.

    Measured: Immediately after the home visit is executed

  7. 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.

    Measured: at 42 days after discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2013 (estimated)
  2. Study startNov 2013
  3. Primary completionFeb 2016
  4. Study completionFeb 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01897870
Sponsor's protocol ID
ZGA-1
Acronym
HomeCoMe
Status last verified
Feb 2016
First submitted
2 Jul 2013
Last updated
23 Feb 2016
Results posted
No
Data monitoring committee
No

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.

    PubMed 16534045

  • 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.

    PubMed 12492615

  • 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.

    PubMed 22861493

Questions about this trial

What is this clinical trial studying?

A study testing HomeCoMe-program in people with Adverse Drug Event and Readmission, run by H.T. Ensing, PharmD, MSc at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Identifying and solving adverse drug events (ADEs) and other drug-related problems (DRPs) post-discharge (time frame: within 7 days post-discharge). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01897870, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2016.

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