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Trial registered on ANZCTR


Registration number
ACTRN12611001262998
Ethics application status
Approved
Date submitted
8/12/2011
Date registered
9/12/2011
Date last updated
14/06/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study to assess the feasibility of a prospective randomised controlled trial of a patient-centred medicines management approach to reduce the burden of iatrogenic symptoms in palliative care
Scientific title
A pilot study to assess the feasibility of a prospective randomised controlled trial of a patient-centred medicines management approach to reduce the burden of iatrogenic symptoms in palliative care
Secondary ID [1] 273562 0
Nil
Universal Trial Number (UTN)
U1111-1126-3156
Trial acronym
Medicines Management
Linked study record

Health condition
Health condition(s) or problem(s) studied:
All patients referred to pallaitive care, irrespective of underlying diagnosis. 279361 0
Condition category
Condition code
Other 285548 285548 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients will be interviewed at the time the patient is first seen by the palliative care service to document a detailed medication history, including medicine use, adherence to medicines, previous adverse drug reactions and any recently ceased or changed medications. The National Medication Management Plan (MMP) will be used as a standard form for recording medication histories and reconciling medicines. Information regarding any symptoms patients are experiencing, the functional consequences of these symptoms, managing their affairs and their beliefs about medicines will also be collected.

For those in this intervention arm, a detailed medication review incorporating medication reconciliation and a structured approach utilising the six open questions from the Prescribing Optimising Method (POM) will be used to inform the medication management plan developed following consultation with the treating medical team and other members of the palliative care team as appropriate. A medication management review and reconciliation will be undertaken within 48 hours of referral to the palliative care service and an agreed medicines management plan will be implemented within 5 days. The medication plan will highlight risk factors for adverse events and adverse drug reactions and relevant monitoring to reduce the likelihood and severity. The medication management plan will be reviewed regularly in accordance with medicine changes and the clinical condition of the patient. When there is a change in performance status of Australian-modified Karnofsky Performance Status score of 20 points consultation will take place with the treating medical team to review and revise the medication management plan. All patients will be asked to keep a medication and symptom diary and will be followed at weekly intervals until death or the end of the study.
Intervention code [1] 283866 0
Treatment: Other
Comparator / control treatment
All patients will be interviewed at the time the patient is first seen by the palliative care service to document a detailed medication history, including medicine use, adherence to medicines, previous adverse drug reactions and any recently ceased or changed medications. The National Medication Management Plan (MMP) will be used as a standard form for recording medication histories and reconciling medicines (Australian Commission on Safety and Quality in Health Care, 2010). Information regarding any symptoms patients are experiencing, the functional consequences of these symptoms, managing their affairs and their beliefs about medicines will also be collected.

This control group will receive usual care.
Control group
Active

Outcomes
Primary outcome [1] 286111 0
The total number of patient defined adverse events between enrolment in the study and either loss of cognition or death.
Timepoint [1] 286111 0
Loss of cognition, death or study end, whichever is first.
Secondary outcome [1] 295167 0
To describe how adverse events impact on patients wellbeing and ability to manage their affairs using a symptom assessment and impact tool.
Timepoint [1] 295167 0
Baseline and weekly until end of study, change to cognition, or death.
Secondary outcome [2] 295168 0
To describe the patients beliefs about the necessity of the prescribed medication for managing their symptoms and co-morbid conditions and concerns about the potential adverse effects of taking the medicine using the Beliefs about Medicines Questionnaire.
Timepoint [2] 295168 0
Baseline and week one only.
Secondary outcome [3] 295169 0
To characterize the burden of adverse events in this setting of multiple concomitant medications and the risk for the prescribing cascade to manage adverse drug events. Medication histories from the patient who consent to interview will be utilized.
Timepoint [3] 295169 0
Baseline
Secondary outcome [4] 295170 0
Where the participant is cared for over the length of the study using weekly follow-up reviews.
Timepoint [4] 295170 0
Baseline and weekly until end of study, change to cognition, or death.
Secondary outcome [5] 295171 0
Change in number of medications total, symptom control and medications for co-morbid disease; change in dose of medications; medicines ceased or substituted and the number with a palliative care action plan for managing anticipated symptoms. A medication plan will record the data.
Timepoint [5] 295171 0
Baseline and weekly until end of study, change to cognition, or death.
Secondary outcome [6] 295172 0
Evaluate changes made as a result of (a) level of prevention; (b) likely or actual drug/drug interaction; (c) actual or likely drug/host interaction (d) medication concordance (e) other medication related problem. These changes will be assessed and recorded by the pharmacist for those int he intervention arm and through record follow-up for ht econtrol gorup.
Timepoint [6] 295172 0
Baseline and weekly until end of study, change to cognition, or death.
Secondary outcome [7] 295173 0
Survival in days from referral to palliative care, area under the curve from time of referral and first AKPS contrasting both groups.
Timepoint [7] 295173 0
Date of death.

Eligibility
Key inclusion criteria
Greater thant 18 years of age
Able to give written informed consent
Able to keep a diary of events
English-speaking and able to read questionnaires
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients unable to give consent or those who are deemed inappropriate to participate in the interview by the palliative care team.
Clinical prediction of survival < 6 weeks.
Australian Karnofsky Performance Status score (AKPS) is = 40 at the time of referral

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be identified by the study staff working with the palliative care service to identify first referrals to the service. Sequential patients referred to the service will be asked to participate and provide informed consent.

Patients will then be randomised to control or intervention. Control arm – usual care (n =20) and Intervention arm – medication management review and plan (n=20). Randomisation will occur at the palliative care service level. All participants in one palliative care service will recevie the medication management plan, all participants in the second palliative care servcice will receive usual care.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
No sequence will be generated.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
None
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/12/2011
Actual
6/01/2012
Date of last participant enrolment
Anticipated
Actual
14/03/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment postcode(s) [1] 4776 0
5041
Recruitment postcode(s) [2] 4777 0
2176

Funding & Sponsors
Funding source category [1] 284348 0
University
Name [1] 284348 0
Flinders University
Country [1] 284348 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Palliative and Supportive Services
700 Goodwood Road
Daw Park
SA 5041
Country
Australia
Secondary sponsor category [1] 283286 0
None
Name [1] 283286 0
Address [1] 283286 0
Country [1] 283286 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286307 0
Southern Adelaide Clinical Research Ethics Committee
Ethics committee address [1] 286307 0
Human Research Ethics Room 2A 221 Flinders Medical Centre Level 2, Flinders Medical Centre BEDFORD PARK SA 5042
Ethics committee country [1] 286307 0
Australia
Date submitted for ethics approval [1] 286307 0
28/10/2011
Approval date [1] 286307 0
23/11/2011
Ethics approval number [1] 286307 0
EC00188
Ethics committee name [2] 286308 0
Cancer Institute NSW Clinical Research Ethics Committee
Ethics committee address [2] 286308 0
Ethics Coordinator Cancer Institute NSW PO Box 41 ALEXANDRIA NSW 1435
Ethics committee country [2] 286308 0
Australia
Date submitted for ethics approval [2] 286308 0
28/10/2011
Approval date [2] 286308 0
Ethics approval number [2] 286308 0
EC00414

Summary
Brief summary
The meticulous management of symptoms is paramount in palliative care to relieve suffering and improve quality of life. The most common therapeutic intervention is the use of medicines. However, there is a limited evidence base to inform decision making with respect to efficacy, effectiveness and harm from medicines in palliative care. Complex clinical decisions have to be made in the face of much uncertainty balancing between efficacy and harms. Prescribing decisions require frequent review and reevaluation as the expected benefits may diminish and the likely harms increase. There is increasing recognition that chronic diseases should be managed differently in the setting of far advanced life limiting illness and that the focus of medicine use should be towards improving quality of life while preventing avoidable harms.

Harm from medicines has been studied extensively in a number of settings but there is very limited research in palliative care. The understanding of prevalence of adverse drug events (ADE) including adverse drug reactions (ADR) and the burden of these events in palliative care is limited. This is despite these patients often being at high risk for adverse events given they are often older with multiple concomitant drug therapies both for symptom control and ongoing medicines for their underlying disease or other chronic conditions. The burden of advancing disease and multimorbidity often results in progressive increases in the number of medicines prescribed and the complexity of the medication regimens (Currow D 2007). This adds to the likelihood of experiencing an adverse event which may have significant functional consequences, the associated burden of managing complex medication regimens and costs for this vulnerable patient group.

While there is uncertainty about the benefits and harms of medicines in the last months of life, it also becomes increasingly difficult to differentiate the pathology of the underlying disease processes from adverse drug reactions. One of the challenges is the recognition and correct attribution of adverse drug reactions by clinicians and patients alike in the presence of increasing symptom burden and progressive disease.

Research is needed to inform a patient-centred approach to medicines management and prescribing for patients with advanced life-limiting illnesses that recognizes the benefits and harms from medicines especially for managing co-morbid illnesses within the specific needs of the patient’s remaining life expectancy. New approaches to medicines management have the potential to decrease iatrogenic burden and unintended functional decline, futile treatments, unnecessary suffering and inappropriate health care utilisation.
Trial website
Trial related presentations / publications
Results have not yet been published
Public notes

Contacts
Principal investigator
Name 33514 0
Ms Debra Rowett
Address 33514 0
Information Service (DATIS) Service
Repatriation General Hospital
700 Goodwood Road
Daw Park SA 5041
Country 33514 0
Australia
Phone 33514 0
+61 8 8275 1179
Fax 33514 0
Email 33514 0
[email protected]
Contact person for public queries
Name 16761 0
Belinda Fazekas
Address 16761 0
Palliative Care Clinical Studies Collaborative
700 Goodwood Road
Daw Park
SA 5041
Country 16761 0
Australia
Phone 16761 0
+61 8 8275 1396
Fax 16761 0
Email 16761 0
[email protected]
Contact person for scientific queries
Name 7689 0
Prof David Currow
Address 7689 0
Palliative Care Clinical Studies Collaborative
700 Goodwood Road
Daw Park
SA 5041
Country 7689 0
Australia
Phone 7689 0
+61 8 7221 8235
Fax 7689 0
Email 7689 0
[email protected]

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

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