Condition category
Not Applicable
Date applied
28/08/2017
Date assigned
06/09/2017
Last edited
05/09/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
In today’s complex system of delivering health care with multiple providers, a patient’s long term medication regimen is not re-evaluated as frequently as perhaps it should be. If hospitalized, the care team is often reluctant to change or stop home medications non-contributory to the admission. Alternatively, in the community, the patient’s primary care provider may not have adequate time for re-evaluation. From the published papers on this topic, stopping home medications that are deemed ineffective, redundant, or even harmful will result in fewer adverse drug events such as impaired cognition, falls, hospitalization, and death. This is likely because the number of medications an individual takes has been identified as the single-most important predictor of harm. The aim of this study is to see if daily de-prescribing rounds lead to greater rates of stopping home medication cessation upon hospital discharge.

Who can participate?
Adults aged 19 and older who have been admitted to the participating site and are taking at least one medication prior to admission.

What does the study involve?
Participants are randomly allocated to one of two groups. Participants receive the standard care for despite what group they are allocated to. Those in the first group have their prescribed medications reviewed and have time with the pharmacists to discuss their specific medication needs and what can be discontinued. Those in the second group receive the standard level of care. Participants who have discontinued home medications are followed up after 30 days to see if they continued their discontinuation.

What are the possible benefits and risks of participating?
If a patient had a home medication discontinued they may benefit from reduced pill burden, reduced side effects, and overall increased quality of life. Participants may be at increased risk of symptom recurrence or worsening.

Where is the study run from?
Royal Jubilee Hospital (Canada)

When is the study starting and how long is it expected to run for?
June 2015 to July 2016

Who is funding the study?
Island Health Authority (Canada)

Who is the main contact?
Ms Rachel Edey

Trial website

Contact information

Type

Scientific

Primary contact

Ms Rachel Edey

ORCID ID

http://orcid.org/0000-0002-5277-5030

Contact details

1952 Bay Street
Island Health Authority
Victoria
V8R 1J8
Canada

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

BC2015-097

Study information

Scientific title

Impact of Deprescribing Rounds on Outpatient Prescriptions: An Interventional Trial

Acronym

I DROP IT

Study hypothesis

Daily deprescribing rounds would lead to greater rates of home medication cessation upon hospital discharge.

Ethics approval

Health Ethics Research Board (HREB) for Island Health, 21/10/2015, ref: VIHA File Number: BC2015-097

Study design

Prospective dual-arm unblinded single-centre interventional study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Please use contact details below to request a patient information sheet. Rachel Edey, Primary Investigator Rachel.Edey@viha.ca (250) 886-9321

Condition

Polypharmacy

Intervention

Participants are allocated to one of two arms. Allocation to the intervention arm or control arm is based on which clinical teaching unit (CTU) team the patient was admitted under, which alternated between the two teams on a daily basis. Participants are excluded if they were not taking medications prior to admission or if transferred to another service prior to discharge. The follow-up period was 30 days after discharge.

Patients allocated to the control arm receive standard care.

Patients allocated to the intervention arm undergo a formal review of all prescribed home medications by a clinical pharmacist. A deprescribing guide and standardized medication review is used to identify medications eligible for discontinuation. During daily patient care rounds, dedicated time was given to the clinical pharmacist to discuss patient specific proposed medication changes. Prior to discontinuation of a medication, changes are discussed with the patient to explain the rationale and ensure agreement. On both the intervention and control teams, changes to home medications are communicated to both the patient and outpatient healthcare provider as per standard clinical teaching unit (CTU) discharge documents.

No further follow up is planned. The participants with discontinued home medications had follow up at 30 days after discharge from the CTU service. Follow up was performed through the research site patient management software and through phone calls from study investigators.

Intervention type

Other

Phase

Drug names

Primary outcome measures

The number of home medications discontinued upon hospital discharge is collected from standard CTU discharge documents and were evaluated four week intervals.

Secondary outcome measures

1. Hospital readmission or emergency department visits (to an Island Health facility) within 30 days of discharge was measured using study site patient management software at four week intervals
2. The proportion of medications remaining deprescribed at 30 days after discharge was measured through follow-up phone calls to participants at 30 days post discharge
3. Physician impressions of deprescribing rounds were elucidated through an anonymous, self-administered, web-based questionnaire web-based survey at four week intervals
4. Patient opinion of deprescribed medication/s were determined through follow-up phone questionnaire to participants at 30 days post discharge

Overall trial start date

22/06/2015

Overall trial end date

29/11/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. All males and females admitted under the Royal Jubilee Hospital Clinical Teaching Unit (RJH CTU) service
2. Taking at least 1 medication prior to admission
3. 19 years or older

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

A sample size of at least 64 patients in each study arm was required to detect a 20% difference (α=0.05).

Participant exclusion criteria

1. Not taking any medications prior to admission
2. Under the age of 19 years
3. Foreign language barriers
4. Not discharged from RJH CTU during study period

Recruitment start date

23/11/2015

Recruitment end date

31/07/2016

Locations

Countries of recruitment

Canada

Trial participating centre

Royal Jubilee Hospital
1952 Bay Street
Victoria, British Columbia
V8R 1J8
Canada

Sponsor information

Organisation

Island Health Authority

Sponsor details

Pharmacy Department
1952 Bay Street
Victoria
V8R 1J8
Canada

Sponsor type

Hospital/treatment centre

Website

Organisation

University of British Columbia

Sponsor details

Faculty of Pharmaceutical Sciences
Pharmaceutical Sciences Building
Wesbrook Mall
Vancouver
V6T 1Z3
Canada

Sponsor type

University/education

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Island Health Authority

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The study team has planned for publication in a high-impact peer reviewed journal. We care currently in the submission process to PLOS One for consideration for publication as soon as is possible.

IPD sharing statement:
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. Note that aggregate data would be presented and no patient identifiable information would be released. The participant level dataset was de-identified prior to analysis.

Intention to publish date

12/08/2017

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes