InfertilityNCT04803045
Does a Brief Intervention Decrease Patient Drop Out Rates?
An observational study of Infertility, run by Boston IVF at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Follow up email
- How many people
- 647 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2017to 1 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Female patients attending an initial consult at Boston IVF between set dates.
Who may be able to join
- Female patients attending an initial consult with a physician at Boston IVF and were recommended to continue care with the clinic
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Infertility
- Being tested
- Follow up email
- Keywords
- Infertility, IVF, Patient retention
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow up emailOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Follow Up Email | Patients received a follow up email 3 months after an initial consult with a physician but did not return to care. Receives: Other: Follow up email | |
| No follow up | Patients who did not receive any follow up after their initial consult, following clinic standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Return to care behavior
The study will track if the patient return to care rate
Measured: 11 months after initial consult
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start1 Jul 2017
- Primary completion1 Jan 2019
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 647 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston IVF
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alice Domar, PhD, Principal investigator, Boston IVF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04803045
- Sponsor's protocol ID
- DomarRTC
- Status last verified
- Mar 2021
- First submitted
- 15 Mar 2021
- Last updated
- 22 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Brief Intervention on Retention Rates With Patients Who Did Not Return to Care After an Initial Physician Visit
- ClinicalTrials.gov ID
- NCT04803045
- Acronym / sponsor ID
- DomarRTC
- Conditions
- Infertility
- Keywords
- Infertility, IVF, Patient retention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 647 participants (actual)
- Lead sponsor
- Boston IVFUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 17 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Follow Up Email | – | Other: Follow up emailPatients received a follow up email 3 months after an initial consult with a physician but did not return to care. |
| No follow up | – | –Patients who did not receive any follow up after their initial consult, following clinic standard of care. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Female patients attending an initial consult at Boston IVF between set dates.
Key inclusion criteria (1 listed)
- Female patients attending an initial consult with a physician at Boston IVF and were recommended to continue care with the clinic
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Follow up emailPatients 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. | Other | Follow Up Email |
Primary outcome
Return to care behavior
Time frame: 11 months after initial consult
The study will track if the patient return to care rate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alice Domar, PhD principal investigator
Boston IVF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Boston IVF at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Return to care behavior (time frame: 11 months after initial consult). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2021.