Condition category
Not Applicable
Date applied
03/01/2018
Date assigned
11/01/2018
Last edited
12/01/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims:
Elderly patients suffering from multiple diseases often have to take a large variety of different drugs. Unfortunately and even though every individual drug might have its justification and benefits, long and complicated medication lists bring along a considerable risk of unwanted drug effects. These might be due to unforeseen interactions of the many preparations or due to the increasing probability of prescription or intake errors. During a hospital stay, the number of prescribed medicines often rises once more. On the other hand, follow-up general practitioners or the patients themselves show a tendency not to maintain the changes introduced in the hospital after discharge, but to switch back to the usual drug regimens that they are already familiar with. The purpose of the present study is to examine whether a systematic discharge procedure coupled with better communication among hospital physicians, the patients and their general practitioners can help to improve the patients’ medication at discharge. We expect that the successful study will promote shortening of overly long medication lists by “deprescribing” inappropriate drugs. Ultimately, this study will help to extend the time until the next hospital admission and thus lead to a higher quality of life after discharge.

Who can participate?
Senior hospital physicians of participating hospitals in the German-speaking part of Switzerland with their subordinate assistant physicians and their in-hospital patients of at least 60 years of age and with 5 or more drugs prescribed.

What does the study involve?
The senior hospital physicians are assigned by chance to either the intervention or the control arm of the study. The senior hospital physicians are then be instructed by the study center about their respective discharge and communication strategy and in turn teach their assistant physicians how to apply it to the patients to be discharged. Over a period of up to 4 months, the hospital physicians apply the assigned discharge strategy to about 50 suitable patients per senior hospital physician. In particular, the medication lists and quality of life scores of these patients are recorded at the time of leaving the hospital. Subsequently, after 1, 3 and 6 months, more data is collected from the patients on their number of drugs, quality of life and doctor contacts, hospital readmissions or deaths. In case of incomplete responses from the patients themselves, the study team tries to collect the missing data from relatives, general practitioners or health insurance companies.

What are the possible benefits and risks of participating?
Study participants may benefit directly from the favorable effects of an optimized medication list and an improved information flow at discharge. However, changing their medication lists might also lead to undesirable consequences. Therefore, the general practitioners will be infomred about their patients’ participation in the study and will be asked to pay particular attention to possible side effects. Moreover, should previously well-controlled symptoms of illnesses appear more frequently or in higher intensity after a change of drugs, then that same change can be reversed immediately at any time.

Where is the study conducted?
Institute of Primary Care of the University of Zurich, Switzerland

When is the study starting and how long is it expected to run for?
January 2017 to December 2020

How long will the trial be recruiting participants for?
May 2018 to December 2018

Who is funding the study?
1. National Research Programme “Smarter Health Care” (NRP 74), Swiss National Science Foundation (Switzerland)
2. Institute of Primary Care, UniversityHospital Zurich (Switzerland)

Who is the main contact?
Dr. med. Stefan Neuner-Jehle MPH (Scientific)
stefan.neuner-jehle@usz.ch

Trial website

http://www.nfp74.ch/en/projects/healthcare-across-sectors/project-neuner-jehle

Contact information

Type

Scientific

Primary contact

Dr Stefan Neuner-Jehle

ORCID ID

Contact details

Institute of Primary Care
UniversityHospital Zurich
Pestalozzistrasse 24
Zurich
CH-8091
Switzerland
+41 44 255 98 55
stefan.neuner-jehle@usz.ch

Type

Public

Additional contact

Dr Thomas Grischott

ORCID ID

http://orcid.org/0000-0002-1564-5296

Contact details

Institute of Primary Care
UniversityHospital Zurich
Pestalozzistrasse 24
Zurich
CH-8091
Switzerland
+41 44 255 98 55
thomas.grischott@usz.ch

Type

Public

Additional contact

Dr Stefan Zechmann

ORCID ID

http://orcid.org/0000-0001-5012-0068

Contact details

Institute of Primary Care
UniversityHospital Zurich
Pestalozzistrasse 24
Zurich
CH-8091
Switzerland
+41 44 255 98 55
stefan.zechmann@usz.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Improving inappropriate medication and information transfer at hospital discharge: A cluster-RCT

Acronym

HDS

Study hypothesis

A simple medication review tool in combination with a defined communication strategy at hospital discharge leads to longer hospital readmission times compared to usual care at discharge, and has the potential to improve the patients' health outcomes and quality of life.

Ethics approval

Not provided at time of registration.

Study design

Single-center double-blind cluster-randomized parallel-controlled clinical trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Discharge of multimorbid elderly hospital patients

Intervention

Randomisation on the level of senior hospital physicians (= clusters) is done using a software random number generator. A minimization approach is used to restrict potential imbalance between the two study arms in terms of cluster covariates.

In the intervention group, the senior hospital physicians takes part in a teaching session of two hours duration about how to integrate a structured medication review and specific elements of communication into the daily discharge routine. The senior physicians are responsible for instructing their assistant physicians in patient recruitment and carrying out the correct discharge procedure.

The assistant physicians critically review their patients’ medication lists, discuss the results of these reviews and their suggestions with the patients and compile revised medication lists which they then communicate to the patients’ general practitioners with an invitation for discussion.

The senior hospital physicians in the control group undergo a two hour instructiont addressing multimorbidity, patient in- and exclusion and the handling of the different data collection forms. Their assistant physicians will follow the “usual” discharge routine of their clinics.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. Time (in days) without readmission to hospital is collected using Patient records (patient questionnaires and/or calls, general practitioner records, hospital records, health insurance company records) and consecutive calculation, within 6 months after discharge

Secondary outcome measures

1. Readmission rates are collected using patient records (patient questionnaires and/or calls, general practitioner records, hospital records, health insurance company records) within 1, 3 and 6 months after discharge
2. Numbers of emergency department visits or general practitioner encounters are measured using patient records (questionnaires and/or calls, general practitioner records, hospital/emergency department records, health insurance company records) within 1, 3 and 6 months after discharge
3. Deaths during follow-up of 6 months are measured using patient records (general practitioner records, hospital records, health insurance company records)
4. Reasons for hospital readmission (when applicable), emergency department visits, general practitioner encounters or death are measured using patient records (questionnaires and/or calls, general practitioner records, hospital/emergency department records, health insurance company records)
5. Numbers of drugs at discharge and at 1, 3 and 6 months after discharge are measured using hospital records at discharge and patient records and/or calls (general practitioner records, health insurance company records)
6. Anatomical therapeutic chemical classes (ATC-codes) of the drugs prescribed/de-prescribed at discharge and at 1, 3, and 6 months after discharge are measured using hospital records at discharge and patient records and/or calls (general practitioner records, health insurance company records) and consecutive classification at study center
7. Proportions of potentially inappropriate medications (PIMs) at discharge and at 1, 3 and 6 months after discharge are measured using hospital records at discharge and patient records and/or calls (general practitioner records, health insurance company records) and consecutive classification at study center based on updated Beers criteria (2012) and PRISCUS list
8. Patients’ quality of life at discharge and at 1, 3 and 6 months after discharge is measured using patient questionnaire (EQ-5D-3L-scale)

Descriptors of clusters (hospital types, type and size (number of beds) of clinics) and of individual participants (sex, age) will be collected and treated as covariates. Additionally, the following indicators of process quality will be collected: Hospital physician-general practitioner contacts with regard to the impending discharge, frequency of general practitioners’ utilization of communication offer by hospital physicians, ratings of feasibility/acceptance among hospital physicians, barriers and enablers of deprescribing, dropout rates of hospital physicians, general practitioners and patients.

Overall trial start date

01/01/2017

Overall trial end date

31/12/2020

Reason abandoned

Eligibility

Participant inclusion criteria

1. In-hospital patient at the time of inclusion
2. Male or female of 60 years or older with 5 or more drugs prescribed
3. Signed informed consent or – in case of a patient incapable of judgement – written consent of a representative according to the Swiss law (fulfillment of the criteria laid down in HFG Art. 24, 1a.-c. with a legal representative according to ZGB Art. 378)

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

42 senior hospital physicians (clusters) and 2100 patients (target cluster size is about 50)

Participant exclusion criteria

1. End-stage disease with a life expectancy below three months
2. Cognitive inability to follow study procedures neither independently nor with assistance
3. Hospitals who took part in the Swiss national pilot project “progress! Sichere Medikation an Schnittstellen” will not be considered for participation in the trial (but may be involved in the pilot phase of the study).

Recruitment start date

01/05/2018

Recruitment end date

31/12/2018

Locations

Countries of recruitment

Switzerland

Trial participating centre

Institute of Primary Care
UniversityHospital Zurich Pestalozzistrasse 24
Zurich
CH-8091
Switzerland

Sponsor information

Organisation

Institute of Primary Care

Sponsor details

Dr. med. Stefan Neuner-Jehle MPH
University Hospital Zurich
Pestalozzistrasse 24
Zurich
CH-8091
Switzerland
+41 44 255 98 55
stefan.neuner-jehle@usz.ch

Sponsor type

University/education

Website

http://www.hausarztmedizin.uzh.ch/de.html

Funders

Funder type

University/education

Funder name

National Research Programme “Smarter Health Care” (NRP 74), Swiss National Science Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Institute of Primary Care of the University of Zurich

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The study protocol will be submitted for publication in the BioMed Central journal “Implementation Science” before completion of patient recruitment. Full study results are intended to be published in an international scientific journal in 2020.

All study data will be archived at the study center (Institute of Primary Care, UniversityHospital Zurich) for a minimum of 10 years after completion or premature termination of the clinical trial.

IPD sharing statement:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/10/2020

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes