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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] 290839 0
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 301515 0
Condition category
Condition code
Metabolic and Endocrine 301233 301233 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
6
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] 296769 0
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] 300649 0
Rate of deprescribing of antidiabetic medication in patients discharged to RCF - information from hospital and GP records and medication charts review
Timepoint [1] 300649 0
6 months
Secondary outcome [1] 330504 0
Rates of re-prescribing of antidiabetic medication that was ceased in hospital
Collected via medication chart review and GP records
Timepoint [1] 330504 0
30 days, 90 days and 6 months
Secondary outcome [2] 330505 0
HbA1c at 3 months to ascertain glycaemic control.
Information recorded from hospital and GP records
Timepoint [2] 330505 0
3 months
Secondary outcome [3] 330506 0
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] 330506 0
30 days, 90 days, 6 months
Secondary outcome [4] 330507 0
mortality
Information gathered from hospital records, follow-up contacts.
Timepoint [4] 330507 0
30 days, 90 days, 6 months
Secondary outcome [5] 330508 0
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] 330508 0
30 days, 90 days, 6 months
Secondary outcome [6] 330509 0
Patient Quality of life - administration of Short Form 8 questionnaire (SF-8)
Timepoint [6] 330509 0
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?
No
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)
SA
Recruitment hospital [1] 7216 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [2] 7217 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [3] 7272 0
Noarlunga Health Service - Noarlunga Centre
Recruitment hospital [4] 7273 0
Repatriation Hospital - Daw Park
Recruitment postcode(s) [1] 14981 0
5042 - Bedford Park
Recruitment postcode(s) [2] 14982 0
5000 - Adelaide
Recruitment postcode(s) [3] 15038 0
5168 - Noarlunga Centre
Recruitment postcode(s) [4] 15039 0
5041 - Daw Park

Funding & Sponsors
Funding source category [1] 295273 0
Hospital
Name [1] 295273 0
Royal Adelaide Hopsital - Elders Research Cooperative
Country [1] 295273 0
Australia
Primary sponsor type
Hospital
Name
Flinders Medical Centre
Address
Flinders Drive
Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 294097 0
None
Name [1] 294097 0
Address [1] 294097 0
Country [1] 294097 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 296608 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 296608 0
Flinders Medical Centre
Flinders Drive
Bedford Park SA 5042
Ethics committee country [1] 296608 0
Australia
Date submitted for ethics approval [1] 296608 0
23/01/2017
Approval date [1] 296608 0
Ethics approval number [1] 296608 0

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 71458 0
Dr Tilenka Thynne
Address 71458 0
Department of Clinical Pharmacology
Flinders Medical Centre and Flinders University
Flinders Drive
Bedford Park
South Australia 5042
Country 71458 0
Australia
Phone 71458 0
+61 8 8204 5202
Fax 71458 0
+61 8 8204 5114
Email 71458 0
[email protected]
Contact person for public queries
Name 71459 0
Dr Tilenka Thynne
Address 71459 0
Department of Clinical Pharmacology
Flinders Medical Centre and Flinders University
Flinders Drive
Bedford Park
South Australia 5042
Country 71459 0
Australia
Phone 71459 0
+61 8 8204 5202
Fax 71459 0
+61 8 8204 5114
Email 71459 0
[email protected]
Contact person for scientific queries
Name 71460 0
Dr Tilenka Thynne
Address 71460 0
Department of Clinical Pharmacology
Flinders Medical Centre and Flinders University
Flinders Drive
Bedford Park
South Australia 5042
Country 71460 0
Australia
Phone 71460 0
+61 8 8204 5202
Fax 71460 0
+61 8 8204 5114
Email 71460 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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