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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03383848
Recruitment Status : Completed
First Posted : December 26, 2017
Last Update Posted : December 17, 2020
Sponsor:
Information provided by (Responsible Party):
Michael Lanham, University of Michigan

Brief 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.

Condition or disease Intervention/treatment Phase
Infertility Device: Medication Management Software Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 164 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of Patient Experience and Quality of Life During In Vitro Fertilization Treatment
Actual Study Start Date : January 10, 2018
Actual Primary Completion Date : October 31, 2020
Actual Study Completion Date : October 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental Software Group
Subjects in the experimental group will be provided with free access to the medication management software online, which will be able to be accessed on the SmartPhone/SmartDevice and home tablet(s) or computer(s) of their choice, through any browser. They will also be provided with links to the surveys to be filled out in the REDCap secure web application throughout the study.
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.

No Intervention: Control Group
Subjects in the control group will receive standard of care, and will receive emails with links to the surveys to be filled out in the REDCap secure web application throughout the study.



Primary Outcome Measures :
  1. Documented Medication Errors [ Time Frame: End of treatment cycle, between day 9 and day 15 ]
    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.


Secondary Outcome Measures :
  1. Number of Phone and Patient Portal Messages to Infertility Nurses [ Time Frame: End of treatment cycle, between day 9 and day 15 ]
    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.

  2. Quantity of Medication Waste [ Time Frame: End of treatment cycle, between day 9 and day 15 ]
    Amount of medication patient has left at the end of the IVF cycle, as an indication of medication tracking errors.

  3. Stress Level [ Time Frame: Baseline, between stimulation days 6 and 8, and on the day prior to egg retrieval (between day 9 and day 15 of treatment cycle) ]
    Change in stress levels as measured by CART (Concerns of Women Undergoing Assisted Reproductive Technologies) survey.

  4. Anxiety Level [ Time Frame: Baseline, between stimulation days 6 and 8, and on the day prior to egg retrieval (between day 9 and day 15 of treatment cycle) ]
    Change in state anxiety score as measured by Spielberger's State-Trait Anxiety Inventory survey.

  5. Quality of Life [ Time Frame: Baseline, between stimulation days 6 and 8, and on the day prior to egg retrieval (between day 9 and day 15 of treatment cycle) ]
    Change in quality of life assessment as measured by FertiQoL (Fertility Patient Quality of Life) questionnaire.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03383848


Locations
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United States, Michigan
Center for Reproductive Medicine, University of Michigan
Ann Arbor, Michigan, United States, 48108
Northville Health Center
Northville, Michigan, United States, 48168
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Michael Lanham, MD University of Michigan
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Michael Lanham, Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT03383848    
Other Study ID Numbers: HUM00121481
First Posted: December 26, 2017    Key Record Dates
Last Update Posted: December 17, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infertility