- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04803045
Does a Brief Intervention Decrease Patient Drop Out Rates?
March 18, 2021 updated by: Boston IVF
The Impact of a Brief Intervention on Retention Rates With Patients Who Did Not Return to Care After an Initial Physician Visit
The goal of this study is to determine a) if a follow-up email to selected patients who had an initial consult with an infertility specialist, but did not return for a second visit, would change return to care behavior and b) why patients had not returned.
Study Overview
Detailed Description
From July 2017 to March 2018 all patients who had attended an initial visit with an infertility specialist at the clinic, but had not returned for at least three months were selected to receive a follow up email.
Those selected for an email excluded patients who the Investigator's knew had achieved a pregnancy, already had a plan for treatment, had visited for an egg freeze and all LGTBQ patients.
The email asked if the patient had any questions about that visit, offered support to the patient and included contact information for the patient liaison sending the email.
The email also asked each participant to indicate why they had not returned and were provided 4 options and an opportunity to write in a response.
From April 2018 to December 2018 no emails were sent to patients.
No other change of patient contact practice was initiated during the trial period.
This study will observe routine to care behavior of these patients after 11 months post initial consult date.
Study Type
Observational
Enrollment (Actual)
647
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Massachusetts
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Waltham, Massachusetts, United States, 02451
- Boston IVF
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Female patients attending an initial consult at Boston IVF between set dates.
Description
Inclusion Criteria:
- Female patients attending an initial consult with a physician at Boston IVF and were recommended to continue care with the clinic
Exclusion Criteria:
- Patients who the Investigators knew had achieved a pregnancy
- Patients who already had a plan for treatment in place after their initial consult
- Patients who had visited for an egg freeze
- LGTBQ patients
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Follow Up Email
Patients received a follow up email 3 months after an initial consult with a physician but did not return to care.
|
Patients received an email 3 months after an initial consult asking why they had not returned to care.
Patients were provided with 4 options and a space to write in comments.
The email asked if the patient had any questions and offered support.
|
|
No follow up
Patients who did not receive any follow up after their initial consult, following clinic standard of care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Return to care behavior
Time Frame: 11 months after initial consult
|
The study will track if the patient return to care rate
|
11 months after initial consult
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Alice Domar, PhD, Boston IVF
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2017
Primary Completion (Actual)
January 1, 2019
Study Completion (Actual)
March 1, 2020
Study Registration Dates
First Submitted
March 15, 2021
First Submitted That Met QC Criteria
March 15, 2021
First Posted (Actual)
March 17, 2021
Study Record Updates
Last Update Posted (Actual)
March 22, 2021
Last Update Submitted That Met QC Criteria
March 18, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DomarRTC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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