ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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

ACTRN12617000114347p

Ethics application status

Not yet submitted

Date submitted

19/01/2017

Date registered

23/01/2017

Date last updated

23/01/2017

Type of registration

Prospectively registered

Titles & IDs

Public title

A prospective cohort study evaluating the incidence of and outcomes associated with dose reductions of diabetic medications in a population of older inpatients discharged to a nursing home

Scientific title

A prospective cohort study evaluating the incidence of and outcomes associated with dose reductions of diabetic medications in a population of older inpatients discharged to a nursing home

Secondary ID [1]

nil known

Universal Trial Number (UTN)

U1111-1191-3355

Trial acronym

Linked study record

ACTRN12616001336471

Health condition

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

Diabetes

Condition category

Condition code

Metabolic and Endocrine

Diabetes

Intervention/exposure

Study type

Observational

Patient registry

True

Target follow-up duration

Target follow-up type

Months

Description of intervention(s) / exposure

This is a prospective observational study design of a minimum number of 60 hospitalised, older patients discharged to Residential Care Facility (RCFs). As part of usual care, treating clinicians routinely assess the appropriateness of continuing each of the antidiabetic medications (oral and/or injectable) and at what dose. Glycohaemoglobin (HbA1c), as a marker of glycaemic control, is a blood test routinely done when a patient with diabetes is admitted to hospital. Older patients (>75 years) with type 2 Diabetes (DM) treated with antidiabetic medication (oral +/- injectable agents) being discharged to a nursing home will be identified by clinical pharmacists on the Acute Medical Unit (AMU) or longer stay medical wards. The clinical pharmacists will ask the patient and/or carers if the research team can approach them to discuss the project. Patients and/or their carers will then be approached by the researchers (not involved in the patient’s care) and asked if they are interested in participating.

Patients enrolled in the study will act as their own control. Rates of emergency presentations and admissions in the 6 months prior to admission will be compared to those in 6 months after discharge (followed prospectively for 6 months) in both patients who had a diabetes medication deprescribed (Group A) and those who did not (Group B). Routine HbA1c at admission (as a marker of glycaemic control in the preceding 3 months) will be compared to a repeat HbA1c 3 months after enrollment (a routine blood test to be performed by the GP)..
Quality of life outcomes at 30 and 90 days will be via phone contact with participants / next of kin/or RCF.
Deprescribing is defined as a drug dose reduction or cessation. Insulin adjustments are common in hospital and a dose reduction in insulin will not be considered deprescribing, however, cessation of a particular insulin dose or type of insulin will be considered deprescribing.

Intervention code [1]

Not applicable

Comparator / control treatment

Patients enrolled in the study will act as their own control. Rates of emergency presentations and admissions in the 6 months prior to admission will be compared to those in 6 months after discharge (followed prospectively for 6 months) in both patients who had a diabetes medication deprescribed (Group A) and those who did not (Group B). .

Control group

Active

Outcomes

Primary outcome [1]

Rate of deprescribing of antidiabetic medication in patients discharged to RCF - information from hospital and GP records and medication charts review

Timepoint [1]

6 months

Secondary outcome [1]

Rates of re-prescribing of antidiabetic medication that was ceased in hospital
Collected via medication chart review and GP records

Timepoint [1]

30 days, 90 days and 6 months

Secondary outcome [2]

HbA1c at 3 months to ascertain glycaemic control.
Information recorded from hospital and GP records

Timepoint [2]

3 months

Secondary outcome [3]

Comparison of the Emergency department presentation or readmission (to a South Australian Public Teaching Hospital) or unplanned GP assessments.
Assessed by hospital records and phone calls to Residential Care Facility at the prescribed time-points

Timepoint [3]

30 days, 90 days, 6 months

Secondary outcome [4]

mortality
Information gathered from hospital records, follow-up contacts.

Timepoint [4]

30 days, 90 days, 6 months

Secondary outcome [5]

Rates of re-admissions related specifically to diabetes treatment, i.e. hypoglycemia, hyperglycemia or hyperglycaemic hyperosmolar syndrome as primary reason for admission.
Information from hospital records

Timepoint [5]

30 days, 90 days, 6 months

Secondary outcome [6]

Patient Quality of life - administration of Short Form 8 questionnaire (SF-8)

Timepoint [6]

30 days, 90 days

Eligibility

Key inclusion criteria

(1) Type 2 Diabetes aged >75
(2) Medical inpatient within the Southern Adelaide Local Health Network- with a length of stay greater than 48 hours (to signify a significant hospital admission where a medication review will have occurred by the treating team)
(3) Discharge destination RCF
(4) HbA1C <8% (64mmol/mol) during current admission
(5) Currently managed with antidiabetic medication (oral and/or injectable)

Minimum age

75 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

(1) Current Hospital admission directly related to diabetes blood glucose management, i.e. cause of admission due to hypoglycaemia or hyperglycaemic hyperosmolar syndrome
(2) Patients determine to be terminally ill
(3) Patients not discharged to a Residential Care Facility

Study design

Purpose

Natural history

Duration

Longitudinal

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

The analysis will be primarily descriptive. The primary variable of interest is the incidence of deprescribing of antidiabetic medications, and the potential scope for further deprescribing.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/03/2017

Actual

Date of last participant enrolment

Anticipated

1/03/2018

Actual

Date of last data collection

Anticipated

1/09/2018

Actual

Sample size

Target

100

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Flinders Medical Centre - Bedford Park

Recruitment hospital [2]

The Royal Adelaide Hospital - Adelaide

Recruitment hospital [3]

Noarlunga Health Service - Noarlunga Centre

Recruitment hospital [4]

Repatriation Hospital - Daw Park

Recruitment postcode(s) [1]

5042 - Bedford Park

Recruitment postcode(s) [2]

5000 - Adelaide

Recruitment postcode(s) [3]

5168 - Noarlunga Centre

Recruitment postcode(s) [4]

5041 - Daw Park

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Royal Adelaide Hopsital - Elders Research Cooperative

Address [1]

North Terrace
Adelaide
South Australia 5000

Country [1]

Australia

Primary sponsor type

Hospital

Name

Flinders Medical Centre

Address

Flinders Drive
Bedford Park SA 5042

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Southern Adelaide Clinical Human Research Ethics Committee

Ethics committee address [1]

Flinders Medical Centre
Flinders Drive
Bedford Park SA 5042

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

23/01/2017

Approval date [1]

Ethics approval number [1]

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 when medication can and should be ceased, especially in older patients with diabetes.  We know that often medications are ceased while a patient is in hospital; sometimes medications are not ceased.  We want to collect data about those patients who had medications for diabetes stopped and those who did not, and compare the two groups later to look for any differences.
Many older 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 understand 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 you, only observe whether or not it does happen for you and call you after discharge to find out how you are feeling. Nothing about your hospital care will be different.  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; sometimes a medicine is stopped because it is no longer beneficial. And sometimes no medications need to be stopped.  These measures are all part of routine hospital care.  We simply want to check on you after your hospital stay to see how you are feeling.  We will also ask your nursing home for information about falls and General Practitioner (GP) call-outs to see you and any changes to your medication since discharge. 
With your permission we will also contact your GP and ask them to perform a routine diabetes blood test 3 months after you are discharged. This is called a “HbA1c” and it is a blood test that looks at your diabetes control in the last 3 months. Your GP would probably be doing this blood test anyway and we will ask him or her for the result.
We will document your age and information such as your list of medications at the time of admission as well as discharge, the reason for your hospitalisation, what over medical conditions you have, whether or not you required another presentation or admission to hospital in the 6 months prior to and after this admission; your glucose (sugar) control before and after the first hospitalisation; the reason for admission if you do require readmission; which medications you are taking at 30 days and 3 months after discharge, to determine if any medications have been restarted that were ceased while you were in hospital the first time and the reason why a medication was restarted; and lastly, how you rate your quality of life.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Tilenka Thynne

Address

Department of Clinical Pharmacology
Flinders Medical Centre and Flinders University
Flinders Drive
Bedford Park
South Australia 5042

Country

Australia

Phone

+61 8 8204 5202

Fax

+61 8 8204 5114

Tilenka.thynne@sa.gov.au

Contact person for public queries

Name

Tilenka Thynne

Address

Department of Clinical Pharmacology
Flinders Medical Centre and Flinders University
Flinders Drive
Bedford Park
South Australia 5042

Country

Australia

Phone

+61 8 8204 5202

Fax

+61 8 8204 5114

Tilenka.thynne@sa.gov.au

Contact person for scientific queries

Name

Tilenka Thynne

Address

Department of Clinical Pharmacology
Flinders Medical Centre and Flinders University
Flinders Drive
Bedford Park
South Australia 5042

Country

Australia

Phone

+61 8 8204 5202

Fax

+61 8 8204 5114

tilenka.thynne@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

No additional documents have been identified.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically