Clinical trial NCT03417362: Delivery of Audiovisual Information on Early Medical Abortion
Official title: Delivery of Audiovisual Information on Early Medical Abortion to Women in Europe Via Digital Technology: is it Acceptable and Informative?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abortion Early
Abortion in First Trimester
Keywords: education
audiovisual
information
acceptability
Lead sponsor: NHS Lothian
Sponsor class: OTHER_GOV
First posted: 2018-01-31
Enrollment: 174
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The majority of abortions in the United Kingdom (UK) are performed before 9 weeks (63 days) gestation using a method known as Early Medical Abortion (EMA). EMA involves an assessment visit and provision of two types of medication .

The assessment visit usually involves Ultrasound to confirm gestation, detailed personal history, safeguarding assessment and contraception planning, before arranging treatment and follow up.

The process is long and lots of information is given to women attending the service. In NHS Lothian (National Health Service, Lothian Health Board), the average appointment length for combined assessment and provision of the first part of treatment is 3 hours.

Despite how common abortion is ( 1 in 3), many women presenting for abortion care are not aware of what the procedure will involve. This may in part to the social stigma surrounding abortion and unintended pregnancy in general. This stigma can in turn result in feelings of anxiety and shame about the decision to terminate a pregnancy.

There is evidence that short videos shown to patients prior to abortion or contraception consultations can improve their ability to recall information and can make them feel more confident about the procedure.

Additionally, abortion care providers have found patients who have seen videos to be better prepared and informed and this allows consultations to progress more easily and allow greater time for discussion of contraceptive methods.

We have prepared a video approximately 3 minutes in length to provide information about EMA. It summarises the process described above using simple language and animated characters. The video has been translated into French, Portuguese and Swedish and has been adapted to reflect subtle differences in practice and law in these countries. We have partners in services in these three countries who will be conducting the trial there in accordance with this protocol and their own local ethics and clinical governance requirements.

Detailed description: Despite abortion being a common medical procedure, many women do not have access to good quality, reliable information about it. This may stem from the stigma and shame surrounding the procedure leading to less community knowledge and experience sharing compared to other medical conditions, for example diabetes or heart disease.

Lack of knowledge and understanding about a medical procedure can cause anxiety, distress and confusion when seeing a healthcare professional, which in turn can prolong consultations.

By introducing the short video animation, we are hoping that this will give the women attending the service a basic level of knowledge about Early Medical Abortion, reduce the anxiety and worry they are experiencing by informing them, and make them feel more confident and clear during their consultations.

It has been shown in other studies that short videos in contraception and abortion consultations can have this impact, but a randomised control trial methodology has never been applied to this intervention.

In a standard initial Early Medical Abortion visit a patient will experience the following Patient Journey:

1. Arrival and registration
2. Waiting for appointment in waiting room
3. Ultrasound scan to determine gestation
4. Self taken vulvovaginal swab for Chlamydia and Gonorrhoea screening
5. Blood tests for : HIV, Syphilis, Full Blood Count, Blood Group
6. Return to the waiting room
7. Assessment consultation with healthcare professional (i.e. Specialist Nurse or Doctor)
8. Return to the waiting room
9. Treatment Consultation: to receive 'first part' of treatment i.e. Mifepristone and dates for 'second part' 24-48 hours later.
10. Leave department

In the study, the above will happen, however patients will be given a participant information sheet (at step 1 above )when they arrive in department to register. At Step 6, when the patient has returned to the waiting room, eligible patients will be approached and asked if they would like to participate and if so will be randomised to 'standard of care' or 'intervention' (i.e. the video). They will resume the Patient Journey above and will again be approached at Step 8 or Step 10 to complete the short questionnaire.

For the questionnaire: a single researcher will record, on a standard proforma, what information the subject had taken from the consultation and its accuracy, and the overall acceptability of the consultation using a Likert scale to quantify descriptors such as 'helpful', 'informative', 'understandable', 'impersonal', 'sympathetic' 'unsympathetic' etc.

The number of women declining to participate in the study would be recorded .

Eligibility criteria: Inclusion Criteria:

1. Female
2. Pregnant
3. Presenting for Termination of Pregnancy
4. Aged 16 years or over
5. Able to understand English (the video is in English, and whilst translations are available, their content has been altered to reflect abortion laws in other countries)
6. Gestation of 9 weeks (63 days) or less on ultrasound scan
7. Able to provide consent

Exclusion Criteria:

1. Non pregnant
2. Pregnancy of Unknown Location
3. Uncertain of decision or wishing to continue pregnancy
4. 15 years old or younger
5. Unable to understand English
6. Gestation 9 weeks and 1 day (64 days) or greater on ultrasound scan.
7. Unable to provide consent

Primary outcomes:
measure: Is the recall of key information about EMA similar after watching the video compared to following face to face contact with a clinician?
timeFrame: Immediately during questionnaire
Secondary outcomes:
measure: What place/ role do women who watch the video feel that it has (if any)?
timeFrame: Immediately during questionnaire
measure: Do women find it acceptable to receive information about Early Medical Abortion (EMA) via an animated video?
timeFrame: Immediately during questionnaire
Other outcomes:
Locations:
city: Paris
country: France
facility: Assistance Publique Hopitaux de Paris
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Edinburgh
country: United Kingdom
facility: Chalmers Centre for Sexual and Reproductive Health
Study officials:
affiliation: NHS Lothian
name: Sharon T Cameron, FRCOG
role: STUDY_DIRECTOR
References:
citation: Michie L, Cameron ST, Glasier A, Johnstone A. Giving information about the contraceptive implant using a DVD: is it acceptable and informative? A pilot randomised study. J Fam Plann Reprod Health Care. 2016 Jul;42(3):194-200. doi: 10.1136/jfprhc-2015-101186. Epub 2015 Aug 6.
citation: Powell-Jackson R, Glasier A, Cameron ST. Benefits of using a digital video disk for providing information about abortion to women requesting termination of pregnancy. Contraception. 2010 Jun;81(6):537-41. doi: 10.1016/j.contraception.2010.01.015. Epub 2010 Feb 19.
citation: Reynolds-Wright JJ, Belleuvre F, Daberius A, Faucher P, Gemzell-Danielsson K, Cameron ST. Information on early medical abortion for women using an audiovisual animation vs face-to-face consultation: A consortium randomized and quasi-randomized trial. Acta Obstet Gynecol Scand. 2020 Dec;99(12):1611-1617. doi: 10.1111/aogs.13944. Epub 2020 Jul 12.