Please be advised that due to the high volume of submissions, the ANZCTR is currently experiencing delays in processing submissions from those outside of Australia and New Zealand. As the ANZCTR is funded by Australia and New Zealand, we must prioritise submissions from these countries first. International submissions should allow additional time for registration. Apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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] 290103 0
nil known
Universal Trial Number (UTN)
U1111-1187-3281
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
polypharmacy 300195 0
Condition category
Condition code
Public Health 300080 300080 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
1
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] 295857 0
Not applicable
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299564 0
mortality
Timepoint [1] 299564 0
30 day, 90-day and 12 month mortality from date of enrollment.
Secondary outcome [1] 327519 0
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] 327519 0
30 day, 90 days and 12 month readmission after enrollment
Secondary outcome [2] 327520 0
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] 327520 0
30 days, 90 days, and 12 months after enrollment.
Secondary outcome [3] 327521 0
determination and rationale of restarting medications, if the information is available through the General Practitioner or Residential Care Facility’s records.
Timepoint [3] 327521 0
30 day, 90 day and 12 month s from enrollment
Secondary outcome [4] 327522 0
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] 327522 0
30 day, 90 day and 12 months from enrollment
Secondary outcome [5] 327523 0
Patient quality of life measured by Short Form-8
Timepoint [5] 327523 0
30 and 90 days from enrollment
Secondary outcome [6] 327524 0
Prognostication at the time of deprescribing using the Burden of Illness Score for Elderly Persons.
Timepoint [6] 327524 0
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
Gender
Both males and females
Can healthy volunteers participate?
No
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 6623 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 6624 0
Noarlunga Health Service - Noarlunga Centre
Recruitment hospital [3] 6625 0
Repatriation Hospital - Daw Park
Recruitment hospital [4] 6626 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [5] 6627 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [6] 6628 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [7] 6629 0
Modbury Hospital - Modbury
Recruitment postcode(s) [1] 14244 0
5000 - Adelaide
Recruitment postcode(s) [2] 14245 0
5168 - Noarlunga Centre
Recruitment postcode(s) [3] 14246 0
5041 - Daw Park
Recruitment postcode(s) [4] 14247 0
5011 - Woodville
Recruitment postcode(s) [5] 14248 0
5042 - Bedford Park
Recruitment postcode(s) [6] 14249 0
5112 - Elizabeth Vale
Recruitment postcode(s) [7] 14250 0
5092 - Modbury

Funding & Sponsors
Funding source category [1] 294477 0
Hospital
Name [1] 294477 0
Royal Adelaide Hospital - Research Fund
Address [1] 294477 0
North Terrace
Adelaide
South Australia 5000
Country [1] 294477 0
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] 293347 0
None
Name [1] 293347 0
Address [1] 293347 0
Country [1] 293347 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295915 0
Royal Adelaide Hospital
Ethics committee address [1] 295915 0
North Terrace
Adelaide
South Australia 5000
Ethics committee country [1] 295915 0
Australia
Date submitted for ethics approval [1] 295915 0
23/07/2015
Approval date [1] 295915 0
28/08/2015
Ethics approval number [1] 295915 0
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 68870 0
Dr Patrick Russell
Address 68870 0
Royal Adelaide Hospital
General Medicine, Level 7
North Terrace
Adelaide, South Australia 5000
Country 68870 0
Australia
Phone 68870 0
+61 8 82224651
Fax 68870 0
+61 8 8222 2697
Email 68870 0
patrick.russell@sa.gov.au
Contact person for public queries
Name 68871 0
Mrs Sara Laubscher
Address 68871 0
Royal Adelaide Hospital
General Medicine, Level 7
North Terrace
Adelaide, South Australia 5000
Country 68871 0
Australia
Phone 68871 0
+61 8 82224651
Fax 68871 0
+61 8 8222 2697
Email 68871 0
sara.laubscher@sa.gov.au
Contact person for scientific queries
Name 68872 0
Dr Patrick Russell
Address 68872 0
Royal Adelaide Hospital
General Medicine, Level 7
North Terrace
Adelaide, South Australia 5000
Country 68872 0
Australia
Phone 68872 0
+61 8 82224651
Fax 68872 0
+61 8 8222 2697
Email 68872 0
patrick.russell@sa.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary