Medication Dispensing System to Support Medication Adherence for Individuals Living at Home With Chronic Conditions: A Randomized Controlled Trial

Purpose: It is estimated by 2045, one in five Albertans in Canada will be 65 or older. Medication compliance in the senior population is a significant challenge for optimizing patient outcomes. This has significant implications when nearly 69% of medication related hospitalizations are attributed to non-adherence and the estimated cost to the Canadian Health care system is $7-$9 billion. The factors that contribute to poor medication adherence are multifactorial. For example, multiple medications within a treatment regimen, increased frequency of medication intake and a prolonged course of drug therapy all contribute to decreased medication adherence. Almost 2/3 of those aged 65 and over take five or more prescription drugs thus increasing the risk of adherence issues.

Therefore, therapeutic management of multiple chronic diseases can only be realized when the individual is adherent to their prescribed pharmacological regimen. Age-related innovations provide an enormous opportunity to enhance the quality of life for seniors and reduce healthcare cost related to medication adherence issues. The spencer medication dispensing device is a new integrated technology that improves medication compliance and offers independence to seniors at home while providing real-time pharmacist and caregiver support. Alberta Health Services (AHS) is committed to supporting and strengthening community care by adopting age-related innovations. Hence, the aim of study is to evaluate user benefits and effectiveness of the device for improving medication compliance in older adults and seniors population.

Primary Research Question: Does the spencer system improve medication adherence in individuals 50 year or older living in the community taking five plus medications?

Study Design: This Randomized Controlled Trial (RCT) with the spencer device will be conducted from March 2019 to June 2020 in Calgary, Alberta. The data will be collected over a six-month period, the spencer deployment will begin in April 2019 and will continue till September 2019. This is a proof of concept study for which no formal sample size calculation is required. A total of 100 study participants will be recruited in the study (50 intervention group and 50 in the control group). The investigators will randomly place a participant in either the intervention group to use spencer or into the control group to continue the using their current method of management.

Randomization: The investigators will be using block randomization which is the recommended method for sample sizes of 50 or less in each group to balance the groups in terms of the number of subjects they contain, and in the distribution of potential confounding variables. The study is not blinded so the blocks will vary in sizes (10, 12, 14) to reduce the predictability of the intervention assignment. A project assistant (a contracted staff which will not be involved in data collection or analysis activities) will produce computer-generated sets of random allocations in advance of the study and then sealed in consecutively numbered opaque envelopes. Once the participants has given consent to be included in the study, he/she will then be irreversibly randomized by opening the next sealed envelope containing his/her assignment.