ANZCTR - Registration

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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]

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.

Condition category

Condition code

Other

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]

Treatment: Other

Comparator / control treatment

Control group

Active

Outcomes

Primary outcome [1]

The total number of patient defined adverse events between enrolment in the study and either loss of cognition or death.

Timepoint [1]

Loss of cognition, death or study end, whichever is first.

Secondary outcome [1]

To describe how adverse events impact on patients wellbeing and ability to manage their affairs using a symptom assessment and impact tool.

Timepoint [1]

Baseline and weekly until end of study, change to cognition, or death.

Secondary outcome [2]

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]

Baseline and week one only.

Secondary outcome [3]

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]

Baseline

Secondary outcome [4]

Where the participant is cared for over the length of the study using weekly follow-up reviews.

Timepoint [4]

Baseline and weekly until end of study, change to cognition, or death.

Secondary outcome [5]

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]

Baseline and weekly until end of study, change to cognition, or death.

Secondary outcome [6]

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]

Baseline and weekly until end of study, change to cognition, or death.

Secondary outcome [7]

Survival in days from referral to palliative care, area under the curve from time of referral and first AKPS contrasting both groups.

Timepoint [7]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW,SA

Recruitment postcode(s) [1]

5041

Recruitment postcode(s) [2]

2176

Funding & Sponsors

Funding source category [1]

University

Name [1]

Flinders University

Address [1]

Palliative and Supportive Services
700 Goodwood Road
Daw Park
SA 5041

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Southern Adelaide Clinical Research Ethics Committee

Ethics committee address [1]

Human Research Ethics Room 2A 221 Flinders Medical Centre Level 2, Flinders Medical Centre BEDFORD PARK SA 5042

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

28/10/2011

Approval date [1]

23/11/2011

Ethics approval number [1]

EC00188

Ethics committee name [2]

Cancer Institute NSW Clinical Research Ethics Committee

Ethics committee address [2]

Ethics Coordinator Cancer Institute NSW PO Box 41 ALEXANDRIA NSW 1435

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

28/10/2011

Approval date [2]

Ethics approval number [2]

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

Ms Debra Rowett

Address

Information Service (DATIS) Service
Repatriation General Hospital
700 Goodwood Road
Daw Park SA 5041

Country

Australia

Phone

+61 8 8275 1179

Fax

Debra.Rowett@health.sa.gov.au

Contact person for public queries

Name

Belinda Fazekas

Address

Palliative Care Clinical Studies Collaborative
700 Goodwood Road
Daw Park
SA 5041

Country

Australia

Phone

+61 8 8275 1396

Fax

belinda.fazekas@health.sa.gov.au

Contact person for scientific queries

Name

Prof David Currow

Address

Palliative Care Clinical Studies Collaborative
700 Goodwood Road
Daw Park
SA 5041

Country

Australia

Phone

+61 8 7221 8235

Fax

david.currow@flinders.edu.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

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Documents added automatically

No additional documents have been identified.

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