Evaluation of Patient Experience and Quality of Life During In Vitro Fertilization Treatment

Infertility Clinical Trial

Official title:

Evaluation of Patient Experience and Quality of Life During In Vitro Fertilization Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03383848
• Other study ID #: HUM00121481
• Status: Completed
• Phase: N/A
• 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
• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: October 31, 2020
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Women undergoing IVF cycle (planning egg retrieval) at University of Michigan, for any indication (infertility, fertility preservation, or genetic disorder planning preimplantation genetic screening or diagnosis)

• English as primary language

• Owns a smartphone

• Owns a non-smartphone device with access to the internet at home (tablet, laptop computer, or desktop computer)

• Has internet access at home

Exclusion Criteria:

• Non-English speaker as primary language

• Previous participant in same study

• Not undergoing IVF fertility treatment

• Does not own a smartphone

• Does not own a tablet, laptop computer, or desktop computer

• Does not have internet access at home

Related Conditions & MeSH terms

• Infertility

Intervention

Device:
• Medication Management Software
The OnTrack Medication Management Software allows patients to track the amount of fertility medication they have at home. When they check off their "to do" list of medications, it decrements the amount they have at home. It allows them to see when they will run out of medication depending on their current doses (which can change daily). Daily use of the software will be 5-10 minutes daily for approximately 21 days.

Locations

Country	Name	City	State
United States	Center for Reproductive Medicine, University of Michigan	Ann Arbor	Michigan
United States	Northville Health Center	Northville	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Documented Medication Errors	Common medication errors such as wrong dose, missed dose, or running out of medication, as captured through the software and/or reported by the patient to the clinical team caring for them during their IVF cycle.	End of treatment cycle, between day 9 and day 15
Secondary	Number of Phone and Patient Portal Messages to Infertility Nurses	Number of phone and patient portal (electronic health record) messages to infertility nurses from patients using the software as compared to those using standard pencil/paper or homegrown methods to track medication inventory.	End of treatment cycle, between day 9 and day 15
Secondary	Quantity of Medication Waste	Amount of medication patient has left at the end of the IVF cycle, as an indication of medication tracking errors.	End of treatment cycle, between day 9 and day 15
Secondary	Stress Level	Change in stress levels as measured by CART (Concerns of Women Undergoing Assisted Reproductive Technologies) survey.	Baseline, between stimulation days 6 and 8, and on the day prior to egg retrieval (between day 9 and day 15 of treatment cycle)
Secondary	Anxiety Level	Change in state anxiety score as measured by Spielberger's State-Trait Anxiety Inventory survey.	Baseline, between stimulation days 6 and 8, and on the day prior to egg retrieval (between day 9 and day 15 of treatment cycle)
Secondary	Quality of Life	Change in quality of life assessment as measured by FertiQoL (Fertility Patient Quality of Life) questionnaire.	Baseline, between stimulation days 6 and 8, and on the day prior to egg retrieval (between day 9 and day 15 of treatment cycle)