Abortion Early, Pregnancy Related
Conditions
Brief summary
This study aims to evaluate the feasibility, acceptability, and effectiveness of dispensing mifepristone via a mail-order pharmacy. The investigators will recruit patients at up to 10 primary care and internal medicines sites not currently providing abortion services around the country, as well as abortion clinic sites. Patients will go through routine in clinic visits to determine eligibility and then will receive the medications in the mail at their preferred address. The investigators will survey patients 3 and 14 days after the initial clinic visit and interview providers at the end of the study.
Detailed description
This is a prospective cohort study of patients obtaining medication abortion via mifepristone dispensed from an online mail order pharmacy. After an initial pilot test with 25 patients, the investigators will identify 10 clinics to participate in the study. The study team will train primary care providers not currently providing abortion to provide medication abortion with the medications dispensed via mail order pharmacy. The investigators aim to recruit up to 650 patients for this study across all the sites. Patients will come in for an initial consult visit at the study site and then receive their medications at a preferred address within 3 days of the initial visit. Study participants will fill out surveys about their experience and feedback about the acceptability of the process; this will occur at 3 and 14 days after the initial recruitment visit. The investigators will also collect clinic data from patients and clinic sites to track clinical outcomes. And the investigators will interview providers at the end of the study to better understand their experiences prescribing mifepristone via mail-order.
Interventions
DRUGMifepristone
Patients will have MifeprexⓇ (mifepristone) shipped to a preferred address via an online mail order pharmacy rather than standard care at clinic visit.
Sponsors
Daniel Grossman, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Prospective Cohort
Eligibility
Sex/Gender
FEMALE
Age
15 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Women seeking medication abortion through 63 days gestation * Eligible for MifeprexⓇ at a study site * English or Spanish speaking * Willing and able to participate in the study, including willing and able to receive medications at home or other preferred address within 3 days of initial medication abortion visit
Exclusion criteria
* Not pregnant * Not seeking medication abortion * under the age of 15 * Over 63 days gestation * Contraindicated for medication abortion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability: Satisfaction With Mail-Order Dispensing of Medication Abortion | Day 14 following initial medication abortion visit | Percentage of participants reporting whether they were satisfied with receiving the medications by mail, by abortion instance. |
| Acceptability: Would Use Mail-Order Dispensing Again | Day 14 following initial medication abortion visit | Percentage of participants reporting they would prefer to receive medications by mail for future medication abortion, by abortion instance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Effectiveness of Mail-Order Medication Abortion | Up to 6 weeks after initial medication abortion visit. | Percentage of participants who experienced a complete medication abortion, by abortion instance. |
| Feasibility: Proportion of Patients Who Receive Medications by Day 2 and Day 3 | Day 3 following initial medication abortion visit | Percentage of participants who received the medications by mail-order pharmacy by Day 2 and Day 3, by abortion instance. |
| Provider Acceptability of Mail-Order Dispensing of Medication Abortion | Up to 3 months after data collection completed. | Provider acceptability will be assessed qualitatively through open-ended interviews with providers and staff involved in the study. |
| Clinical Safety of Mail-Order Medication Abortion | Up to 6 weeks after initial medication abortion visit. | Percentage of participants who experience adverse events related to the abortion, by abortion instance. |
| Feasibility: Confidentiality Maintained When Receiving Medications by Mail | Day 3 following initial medication abortion visit | Percentage of participants who reported that confidentiality was maintained when they received the medications by mail-order pharmacy, by abortion instance. |
Countries
United States
Participant flow
Pre-assignment details
536 patients were consented and enrolled as part of this study. Four participants enrolled twice and were analyzed based on their abortion instance, leading to 540 abortions analyzed as part of this study.
Participants by arm
| Arm | Count |
|---|---|
| Medication Abortion Patients Oral Mifepristone 200 mg, followed by misoprostol 800 mcg administered buccally (at 24-48 hours following mifepristone)
Mifepristone: Patients will have MifeprexⓇ (mifepristone) shipped to a preferred address via an online mail order pharmacy rather than standard care at clinic visit. | 506 |
| Total | 506 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did Not Take Mifepristone or Misoprostol | 8 |
| Overall Study | Lost to Follow-up | 20 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Medication Abortion Patients |
|---|---|
| Age, Continuous | 27 years |
| Age, Customized Age, Categorical 15-19 years | 30 Participants |
| Age, Customized Age, Categorical 20-24 years | 144 Participants |
| Age, Customized Age, Categorical 25-29 years | 161 Participants |
| Age, Customized Age, Categorical Greater than or equal to 30 years | 171 Participants |
| Educational level College or advanced degree | 112 Participants |
| Educational level High school or less | 170 Participants |
| Educational level Missing data | 18 Participants |
| Educational level Some college or professional school | 206 Participants |
| Parity Nulliparous | 189 Participants |
| Parity Parous | 317 Participants |
| Prior abortion experience Medication abortion | 149 Participants |
| Prior abortion experience Missing data | 15 Participants |
| Prior abortion experience None | 249 Participants |
| Prior abortion experience Procedural abortion only | 93 Participants |
| Race/Ethnicity, Customized Race and ethnicity Black | 194 Participants |
| Race/Ethnicity, Customized Race and ethnicity Hispanic | 88 Participants |
| Race/Ethnicity, Customized Race and ethnicity Missing data | 38 Participants |
| Race/Ethnicity, Customized Race and ethnicity Multiracial/other race | 45 Participants |
| Race/Ethnicity, Customized Race and ethnicity White | 141 Participants |
| Region of Enrollment United States | 506 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 510 |
| other Total, other adverse events | 21 / 510 |
| serious Total, serious adverse events | 3 / 510 |
Outcome results
Primary
Acceptability: Satisfaction With Mail-Order Dispensing of Medication Abortion
Percentage of participants reporting whether they were satisfied with receiving the medications by mail, by abortion instance.
Time frame: Day 14 following initial medication abortion visit
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Medication Abortion Patients | Acceptability: Satisfaction With Mail-Order Dispensing of Medication Abortion | Somewhat satisfied | 26 Number of abortions |
| Medication Abortion Patients | Acceptability: Satisfaction With Mail-Order Dispensing of Medication Abortion | Neither satisfied nor dissatisfied | 7 Number of abortions |
| Medication Abortion Patients | Acceptability: Satisfaction With Mail-Order Dispensing of Medication Abortion | Very satisfied | 452 Number of abortions |
| Medication Abortion Patients | Acceptability: Satisfaction With Mail-Order Dispensing of Medication Abortion | Somewhat dissatisfied | 4 Number of abortions |
| Medication Abortion Patients | Acceptability: Satisfaction With Mail-Order Dispensing of Medication Abortion | Very dissatisfied | 6 Number of abortions |
Primary
Acceptability: Would Use Mail-Order Dispensing Again
Percentage of participants reporting they would prefer to receive medications by mail for future medication abortion, by abortion instance.
Time frame: Day 14 following initial medication abortion visit
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Medication Abortion Patients | Acceptability: Would Use Mail-Order Dispensing Again | Yes | 431 Number of abortions |
| Medication Abortion Patients | Acceptability: Would Use Mail-Order Dispensing Again | No | 20 Number of abortions |
| Medication Abortion Patients | Acceptability: Would Use Mail-Order Dispensing Again | Not sure | 26 Number of abortions |
Secondary
Clinical Effectiveness of Mail-Order Medication Abortion
Percentage of participants who experienced a complete medication abortion, by abortion instance.
Time frame: Up to 6 weeks after initial medication abortion visit.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Medication Abortion Patients | Clinical Effectiveness of Mail-Order Medication Abortion | Abortion complete with medications only | 499 Number of abortions |
| Medication Abortion Patients | Clinical Effectiveness of Mail-Order Medication Abortion | Incomplete abortion | 5 Number of abortions |
| Medication Abortion Patients | Clinical Effectiveness of Mail-Order Medication Abortion | Ongoing pregnancy | 6 Number of abortions |
Secondary
Clinical Safety of Mail-Order Medication Abortion
Percentage of participants who experience adverse events related to the abortion, by abortion instance.
Time frame: Up to 6 weeks after initial medication abortion visit.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Medication Abortion Patients | Clinical Safety of Mail-Order Medication Abortion | Adverse Event Related to Medication Abortion | 21 Number of abortions |
| Medication Abortion Patients | Clinical Safety of Mail-Order Medication Abortion | Serious Adverse Event Related to Medication Abortion | 3 Number of abortions |
| Medication Abortion Patients | Clinical Safety of Mail-Order Medication Abortion | Adverse Event Related to Mail-Order Dispensing | 0 Number of abortions |
Secondary
Feasibility: Confidentiality Maintained When Receiving Medications by Mail
Percentage of participants who reported that confidentiality was maintained when they received the medications by mail-order pharmacy, by abortion instance.
Time frame: Day 3 following initial medication abortion visit
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Medication Abortion Patients | Feasibility: Confidentiality Maintained When Receiving Medications by Mail | Yes, confidentiality was maintained | 486 Number of abortions |
| Medication Abortion Patients | Feasibility: Confidentiality Maintained When Receiving Medications by Mail | No, confidentiality was compromised | 8 Number of abortions |
| Medication Abortion Patients | Feasibility: Confidentiality Maintained When Receiving Medications by Mail | Missing data | 1 Number of abortions |
Secondary
Feasibility: Proportion of Patients Who Receive Medications by Day 2 and Day 3
Percentage of participants who received the medications by mail-order pharmacy by Day 2 and Day 3, by abortion instance.
Time frame: Day 3 following initial medication abortion visit
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Medication Abortion Patients | Feasibility: Proportion of Patients Who Receive Medications by Day 2 and Day 3 | Medications delivered by Day 2 | 381 Number of abortions |
| Medication Abortion Patients | Feasibility: Proportion of Patients Who Receive Medications by Day 2 and Day 3 | Medications delivered by Day 3 | 436 Number of abortions |
Secondary
Provider Acceptability of Mail-Order Dispensing of Medication Abortion
Provider acceptability will be assessed qualitatively through open-ended interviews with providers and staff involved in the study.
Time frame: Up to 3 months after data collection completed.
Population: Clinicians and staff involved in implementing a mail-order dispensing model for medication abortion were invited to complete qualitative interviews to share their experiences with non-in-person dispensing of mifepristone. These clinicians and staff were not officially enrolled as participants in the study, but rather contributed perspectives as clinic employees on the feasibility and acceptability of such a model.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Medication Abortion Patients | Provider Acceptability of Mail-Order Dispensing of Medication Abortion | 24 participants |