ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12616001336471

Ethics application status

Approved

Date submitted

22/09/2016

Date registered

26/09/2016

Date last updated

28/04/2017

Type of registration

Retrospectively registered

Titles & IDs

Public title

A prospective cohort study of the effect of deprescribing on mortality and readmission in a population of elderly inpatients discharged to a nursing home.

Scientific title

A prospective cohort study of the effect of deprescribing on mortality and readmission in a population of elderly inpatients discharged to a nursing home.

Secondary ID [1]

nil known

Universal Trial Number (UTN)

U1111-1187-3281

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

polypharmacy

Condition category

Condition code

Public Health

Health service research

Intervention/exposure

Study type

Observational

Patient registry

True

Target follow-up duration

Target follow-up type

Years

Description of intervention(s) / exposure

We hope to enrol any medical inpatient greater than age 75 who is prescribed five or more regularly scheduled medications at the time of admission and who will be discharged to a residential care facility. This could potentially include patients who were admitted from home but for whom a return to home is no longer feasible. the follow-up period is for one year and id comprised of a 30 day, 90 day and 12 month follow-ups. The 30 day and 90 day follow-ups include phone calls to either the participant, the next of kin, GP, or staff at the residential care facility to obtain outcome information. The 12 month follow-up will involve hospital records and may involve contact with the residential care facility or GP.

Intervention code [1]

Not applicable

Comparator / control treatment

no control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

mortality

Timepoint [1]

30 day, 90-day and 12 month mortality from date of enrollment.

Secondary outcome [1]

Readmission to hospital after enrollment.
This outcome is assessed via the 30 and 90 day follow-up phone calls and review of hospital records.

Timepoint [1]

30 day, 90 days and 12 month readmission after enrollment

Secondary outcome [2]

Compliance with medication discontinuation.
This outcome is assessed via the 30 and 90 day follow-up phone calls and review of hospital records.

Timepoint [2]

30 days, 90 days, and 12 months after enrollment.

Secondary outcome [3]

determination and rationale of restarting medications, if the information is available through the General Practitioner or Residential Care Facility’s records.

Timepoint [3]

30 day, 90 day and 12 month s from enrollment

Secondary outcome [4]

Principal diagnosis at index admission as well as readmission principal diagnosis to ascertain incidence of adverse drug reaction (ADR) or recurrence of disease related to drug withdrawal.

Timepoint [4]

30 day, 90 day and 12 months from enrollment

Secondary outcome [5]

Patient quality of life measured by Short Form-8

Timepoint [5]

30 and 90 days from enrollment

Secondary outcome [6]

Prognostication at the time of deprescribing using the Burden of Illness Score for Elderly Persons.

Timepoint [6]

12 months after enrollment

Eligibility

Key inclusion criteria

Medical inpatient older than age 75
1. Prescribed five or more regularly scheduled medications
2. Discharge destination is a residential care facility
3. In-hospital length of stay greater than 48 hours

Minimum age

75 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

terminally ill patient whose death is expected within 30 days;
1. A patient less than 75 years of age;
2. Any patient not being discharged to residential care;
3. Any patient deemed inappropriate for enrolment by the attending medical team;
4. Patients with length of stay less than 48 hours (to avoid the bias of the patient not acutely unwell; e.g. sent to the Emergency Department to have a chronic indwelling catheter changed).

Study design

Purpose

Natural history

Duration

Longitudinal

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

The primary aim of this study is to assess feasibility of enrollment and likely recruitment rates for an RCT to be performed next. Analysis will therefore be primarily descriptive. We will also gather sufficient data to allow an estimate of the effect size on mortality and readmission at 30 and 90 days.

Our research hypothesis is that there will be no difference in mortality and re-admissions at 30 and 90 days between patients for whom medications are ceased and those for whom medications remain unchanged. The usual mortality rate at one year for this population of elderly patients is variable, but is anticipated to lie between 20% and 50%. The usual 30-day readmission rate for this patient group is approximately 10%.

We intend to enrol a total of 200 patients from the seven public acute care hospitals in Adelaide. This number will enable us to make an estimate of the sample size needed to measure mortality and read-mission rates for the larger RCT.

Although we anticipate no changes in mortality or readmission rates, we anticipate that quality of life may improve with reduced medication amongst this population. Therefore, we will also assess the feasibility of measuring quality of life using the Short Form-8 with a phone call to either the participant or the available next of kin at 30 and 90 days. This questionnaire consists of eight questions and takes only minutes to complete.

If the enrollment rate is not as high as we anticipate then results will still be broadly generalisable provided that there is no bias in outcomes due to subject self-selection. We do not anticipate this will be the case given that subjects are not being requested to perform any active intervention i.e. they will be provided with standard of care treatment.

Recruitment

Recruitment status

Stopped early

Data analysis

Data collected is being analysed

Reason for early stopping/withdrawal

Lack of funding/staff/facilities
Other reasons/comments

Other reasons

As above, lack of funding to complete follow-up visits if recruiting not ceased early.

Date of first participant enrolment

Anticipated

Actual

23/03/2016

Date of last participant enrolment

Anticipated

30/12/2016

Actual

2/11/2016

Date of last data collection

Anticipated

2/11/2017

Actual

Sample size

Target

200

Accrual to date

Final

106

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

The Royal Adelaide Hospital - Adelaide

Recruitment hospital [2]

Noarlunga Health Service - Noarlunga Centre

Recruitment hospital [3]

Repatriation Hospital - Daw Park

Recruitment hospital [4]

The Queen Elizabeth Hospital - Woodville

Recruitment hospital [5]

Flinders Medical Centre - Bedford Park

Recruitment hospital [6]

Lyell McEwin Hospital - Elizabeth Vale

Recruitment hospital [7]

Modbury Hospital - Modbury

Recruitment postcode(s) [1]

5000 - Adelaide

Recruitment postcode(s) [2]

5168 - Noarlunga Centre

Recruitment postcode(s) [3]

5041 - Daw Park

Recruitment postcode(s) [4]

5011 - Woodville

Recruitment postcode(s) [5]

5042 - Bedford Park

Recruitment postcode(s) [6]

5112 - Elizabeth Vale

Recruitment postcode(s) [7]

5092 - Modbury

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Royal Adelaide Hospital - Research Fund

Address [1]

North Terrace
Adelaide
South Australia 5000

Country [1]

Australia

Primary sponsor type

Hospital

Name

Royal Adelaide Hospital

Address

Royal Adelaide Hospital
North Terrace, Adelaide,
South Australia 5000

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Adelaide Hospital

Ethics committee address [1]

North Terrace
Adelaide
South Australia 5000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

23/07/2015

Approval date [1]

28/08/2015

Ethics approval number [1]

HREC/15/RAH/302

Summary

Brief summary

Modern medical care can provide many medications for problems, whether simply short-term medications like antibiotics or longer-term medications like those used to treat high blood pressure. But we do not know enough about ceasing medications, especially in elderly patients. We know that often medications are ceased while a patient is hospitalised; sometimes medications are not ceased. We want to collect data about those patients who had medications stopped and those who did not, and compare the two groups later to look for any differences.
Many elderly people complain about being on too many medications. People on lots of medications might wonder what would happen if one or more of their regular medications was ceased. Our purpose is to understand better any benefits for older people to be on fewer regular medications and any unforeseen risks of stopping regular medications in older people. Hospital doctors often cease a regular medication. We will not influence when and how that happens for your loved one, only observe whether or not it does happen, and call you after discharge to find out how he or she is feeling.
What does participation in this research involve? Nothing about their hospital care will be different. The patient will be treated just like any other patient. Sometimes a patient is hospitalised as a result of a side effect of a medication which is then stopped. Sometimes a patient is admitted to hospital for a different reason but a medicine needs to be stopped in hospital. And sometimes no medications need to be stopped. These measures are all part of routine hospital care. We simply want to check on your loved one after his or her hospital stay to see how he or she is feeling. 
What are the possible benefits of taking part? After discharge, the patient will be given extra attention in the form of a follow-up phone call, either to you, the patient, or the patient’s General Practitioner. If, during this phone call, it becomes evident that the patient needs urgent or semi-urgent attention, the re-search assistant will immediately contact the Chief Investigator, who will then contact either the Residential Care Facility where the patient lives, the next of kin (or person responsible), or the General Practitioner to develop a plan to address the patient’s needs. 
What are the possible risks and disadvantages of taking part? 
The only burden to you might be a follow-up phone call. If, during this phone call, you seem anxious or distress because of the questions, the interview will be stopped.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Patrick Russell

Address

Royal Adelaide Hospital
General Medicine, Level 7
North Terrace
Adelaide, South Australia 5000

Country

Australia

Phone

+61 8 82224651

Fax

+61 8 8222 2697

patrick.russell@sa.gov.au

Contact person for public queries

Name

Sara Laubscher

Address

Royal Adelaide Hospital
General Medicine, Level 7
North Terrace
Adelaide, South Australia 5000

Country

Australia

Phone

+61 8 82224651

Fax

+61 8 8222 2697

sara.laubscher@sa.gov.au

Contact person for scientific queries

Name

Patrick Russell

Address

Royal Adelaide Hospital
General Medicine, Level 7
North Terrace
Adelaide, South Australia 5000

Country

Australia

Phone

+61 8 82224651

Fax

+61 8 8222 2697

patrick.russell@sa.gov.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Prospective cohort study of nonspecific deprescribing in older medical inpatients being discharged to a nursing home.	2021	https://dx.doi.org/10.1177/20420986211052344

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically