Medication Adherence Clinical Trial
Official title:
Self-administration of Patients Own Drugs During Hospital Stay - Patient Involvement, Medication Errors and Health Economics
Background Medication administration errors occur in around 20% of administrations. Patient
involvement (PI) is recommended and self-management support e.g. as self-administration of
patient's own drugs during hospital stay is a central component of practising PI.
Aim To investigate whether PI in administering drugs in hospital affects the number of
medication errors, medication adherence and patient satisfaction and whether it is
economically advantageously.
Materials and methods The PhD Study is performed at the Department of Cardiology, Randers
Regional Hospital.
The study design is "complex intervention" and the PhD study therefore consists of three
studies. In study 1 the intervention is developed, investigated for feasibility and
pilot-tested in small scale. In study 2 and 3 the intervention is evaluated within a RCT with
outcomes as medication errors, medication adherence, patient satisfaction and
cost-effectiveness.
Background When patients are admitted to Danish hospitals, the responsibility for their
medication is taken over by the hospital staff.
Medication administration errors occur in approximately 20% of the total opportunities for
error.
Patient involvement (PI) is recommended and self-management support is a central component of
PI aiming to improve patients' knowledge, skills and confidence into managing their health
condition. "Self-administration of patient's own drugs" during hospital stay is considered a
central part of self-management support.
Self-administration of patient's own drugs has been tested in the Capital Region of Denmark.
Conclusions were that self-administration increase PI, prepare patients to manage their
medication after discharge and release resources within the care group. The occurrence of
medication errors compared to traditional medication system was not investigated.
Aim The aim is to investigate whether PI in administering drugs during hospital stay affects
the number of medication errors, medication adherence and patient satisfaction and whether it
is economically advantageously.
Materials and methods The study design is "complex intervention" and a stepwise process is
recommended by the UK Medical Research Council. In study 1 the intervention will therefore be
developed, investigated for feasibility and pilot-tested in small scale. In study 2 and 3 the
intervention will be evaluated within a RCT.
Intervention If the patient is assessed able to self-administer own drugs at admission, the
patient will be asked if he has brought (or can get someone to bring) his usual drugs to
hospital. The drugs and an updated medication list will be placed in a lockable bedside
table. During hospitalization the patient is responsible for taking his own medication. If a
new drug is prescribed, the patient will be involved and instructed about it. Furthermore the
smallest package will be delivered so that the patient can begin self-administration of the
new drug during hospitalization. After discharge, the patient can bring the package and an
updated medication list back home to ensure continuity in the medical treatment.
Study 1: Feasibility and pilot study The PhD study is performed at the Department of
Cardiology, Randers Regional Hospital. By visits in the department it is assessed how many
eligible patients there are, how many patients change ability to self-administer own drugs
during hospital stay (risk of withdrawal), how many drugs do they receive and how many
opportunities for error are there? These numbers will be used to assess the inclusion period
and to calculate the sample size for the RCT. The intervention and workflows will be
developed in collaboration with nurses, physicians and patients to ensure acceptability,
feasibility and high patient safety.
In the pilot study the intervention and tools for study 2 is tested.
Study 2: RCT The study is a randomized controlled trial where patients are randomized for
either intervention or control. The intervention group consists of patients who
self-administer own drugs at home and are able to self-administer own drugs during hospital
stay. The control group consists of patients who self-administer own drugs at home, who is
able to self-administer own drugs during hospital stay, but where standard care is used (not
self-administration).
Study 3: Health economic evaluation The cost effectiveness of the intervention is assessed
from the perspectives of the hospital and the health system. Relevant resource use will be
identified and detailed in study 1 and measured alongside the RCT.
The costs incurred in the intervention group will be compared to the control group based on
an intention to treat principle. If the intervention costs in the intervention group exceed
those in the control group, the costs will be related to an effect measure such as number of
medication errors avoided.
Perspectives When the patient plays an active role in their own medication, it is expected
that they will have a more comprehensive and adequate understanding of their situation and
will be better to manage their own medication. The number of medication errors during the
processes of dispensing and administering drugs at the wards is expected to decrease when
patients administers their own drugs. PI and the use of patient's own drugs during admission
are expected to contribute to a better utilization of the resources of the Health Care
System.
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