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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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12611001262998
Acronym
Medicines Management
Enrollment
40
Registered
2011-12-09
Start date
2012-01-06
Completion date
2012-03-14
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 consequenc

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.

Sponsors

Flinders University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026