Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03383848 |
Other study ID # |
HUM00121481 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 10, 2018 |
Est. completion date |
October 31, 2020 |
Study information
Verified date |
December 2020 |
Source |
University of Michigan |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
This study will evaluate if an electronic medication management software solution can improve
outcomes for patients undergoing in vitro fertilization (IVF) treatment. Participants will be
randomized equally into two groups: half will use the management software, while the other
half will act as a control group.
Description:
In the United States, individuals suffering from infertility pursued approximately 190,000
cycles of in vitro fertilization (IVF) in 2014, with approximately 1.5 million cycles
performed internationally. Without insurance coverage, each cycle can cost between $15,000
and $25,000 for medications and procedures. The goal of an IVF cycle is a healthy baby, but
to achieve this goal, patients and their partners are asked to manage administration and
inventory of between 6 and 12 medications with doses and routes that can change daily. Due to
the complexity of the treatment and the fact that the medications are expensive and ordered
by patients incrementally to reduce large amounts of waste, medication errors (wrong dose;
missed dose; running out of medication) are common (3-15% of patients).
The current standard is that patients manage this process of medication inventory,
administration, and refills on their own with their own systems, using paper calendars
provided by a clinic (which are immediately inaccurate once the cycle starts),
paper-and-pencil lists, electronic lists, or generic medication-tracking applications,
combined with verbal and written reminders from their clinic. Not having the right medication
at the right time is the most critical error, and with the current methods, the patient often
does not realize this fact while there is sufficient time to rectify the inventory problem,
and the clinic has no way to catch at-risk patients proactively. For these patients, this
error can mean a sub-optimal response with a lower chance of pregnancy that particular month
(as low as 0%, depending on the error). Of the patients undergoing IVF with perfect
adherence, only about 50% achieve the goal of a healthy baby. For the remainder, there will
always be the concern that perhaps they could have had a different outcome, and for those
with a medication error, they will never know whether the outcome could have been different
if that error had not occurred.
This study will determine if patients using medication management software will have lower
numbers of documented medication errors (as captured through the software and/or reported by
the patient to the clinical team caring for them during their IVF cycle) compared to patients
who use standard paper/pencil or home-grown methods to track their medication inventory.