Telemedicine early medical abortion at home: evaluation

Summary

Background

This report presents the findings and recommendations from an evaluation of the current approach to early medical abortion at home in Scotland, as adopted since March 2020.

In Scotland, the great majority of abortions are performed using two medications, called mifepristone and misoprostol, to end the pregnancy. Prior to the pandemic, prescription of both medicines required an in-person clinic visit with the mifepristone taken in the clinic and an ultrasound scan administered routinely in every case. Since late 2017, a Ministerial approval had already permitted patients to take the second medication, misoprostol, at home up to ten weeks’ gestation. This change had already been shown to be working effectively and welcomed by patients.

Public Health Scotland data shows that the vast majority of abortions are conducted at an early stage of pregnancy (less than 12 weeks’ gestation) – and that has remained the case during the pandemic. Most patients pass the pregnancy at home rather than in a hospital or clinic in a process called early medical abortion at home (EMAH).

At the start of the COVID-19 pandemic, changes were introduced to EMAH so that patients could continue to access abortion care without the need for an in-person visit. As part of these changes, the Scottish Government issued a Ministerial approval to allow the first medication, mifepristone, also to be taken at home. This was accompanied by policy changes and changes to clinical protocols (in Scottish Abortion Care Providers (SACP) guidelines) that recommended:

• consultations could take place by telephone or video call
• medications could be delivered to the patient’s home
• an ultrasound scan was only necessary before an abortion if clinically required (such as uncertainty over stage of pregnancy or pain or bleeding)

The Scottish Government undertook a public consultation exercise from September 2020 to January 2021 on whether the changes to abortion care that were introduced during COVID-19 should remain in place. The consultation exercise revealed a range of strongly held views on future arrangements for EMAH, with many welcoming the new arrangements, but many others raising concerns around perceived risks. As an outcome of this exercise, the Scottish Government commissioned this evaluation of the COVID-19-related arrangements for provision of EMAH. This was to ensure that Ministers had sufficiently robust evidence available in relation to patient safety and experiences in Scotland to enable them to make decisions about the future approach, and to identify examples of good practice or areas for improvement of service delivery around the country.

Aims

The aims of this evaluation were:

1) To determine whether the delivery of EMAH in Scotland, without any in-person appointment, is a safe and effective means of providing abortion treatment, both in terms of evidence of clinical risk and of patient experience.

2) To evaluate the comparative effectiveness of the differing approaches used by NHS Boards since March 2020 to deliver early medical abortion at home (in terms of patient safety, patient experience and wider sexual health service provision for patients having abortions).

The key research questions to be considered by the evaluation to answer the above were:

1. What are the clinical benefits and risks of delivery of early medical abortion at home in Scotland without an in-person appointment?

2. What are the advantages and disadvantages for patients of the current approach to early medical abortion at home versus the pre-March 2020 approach?

3. To what extent have different groups of patients been impacted in different ways by the delivery of early medical abortion at home in Scotland without an in-person appointment, how and why?

4. In comparison with the pre-March 2020 approach, how effective are the different approaches adopted to delivery of early medical abortion at home in different NHS Health Boards in terms of:

• Patient safety
• Patient experience
• Access to and uptake of wider sexual health service provision

What are the advantages and disadvantages of each differing approach?

Methods

The evaluation consisted of four work packages (WPs):

• (WP1) Review of the effectiveness of EMAH and serious complications (haemorrhage, severe infection) and adverse outcomes (inadvertent treatment after 12 weeks, ectopic pregnancy diagnosed after treatment) associated with it across Scottish Health Boards in the 6 months before and 12 months after the changes were introduced using data provided by eight of the eleven mainland NHS Health Board areas;
• (WP2) Mapping of patient pathways for EMAH at each Health Board to provide clarity about the different approaches used. A questionnaire was sent to each Board for completion and draft maps subsequently verified by participating Boards for accuracy;
• (WP3) Online survey of the experiences of 327 patients of EMAH following introduction of the changes to care; and
• (WP4) Qualitative interviews with 27 abortion care staff delivering EMAH across nine Scottish NHS territorial Health Board areas to assess abortion care providers’ perspectives on what constitutes safe, high-quality abortion care in Scotland, and gain insight into approaches used to inform service improvements in abortion care^[1].

Findings

1. What are the clinical benefits and risks of delivery of early medical abortion at home in Scotland without an in-person appointment?

Benefits

WP1 showed that there was no change to the high success rate of EMAH (over 98%). There were also no indications of marked change in the low rate of serious complications before and after the introduction of changes to EMAH.

WP3 showed that the great majority of patients responding to the survey valued the greater flexibility and choice associated with the current approach. Patients valued the option of a telephone consultation and over 90% felt that option should continue to be available. Almost all (97%) of survey respondents felt that the option of taking both abortion medication pills at home should continue.

In addition, the NHS staff interviewed (WP4) identified enduring benefits of changes to the provision of EMAH, such as: improved access to care for patients; overcoming geographic barriers to timely care; reducing the need for patient travel; reducing need for multiple appointments and associated time required for these. Staff also noted that they believed the new model of EMAH enhanced patients’ control and autonomy over the abortion process.

Staff interviewed (WP4) reported that their confidence with conducting safeguarding assessments by phone grew over time. Staff felt able to determine which patients may have issues and need to make an in-person visit.

Risks

This evaluation considered a number of risks. In relation to safety, two main risks of patients not all having an in-person appointment and therefore not all routinely having an ultrasound scan were considered. Firstly, the risk of an ectopic pregnancy not being diagnosed was reviewed and, secondly, the risk of the patient being at a later gestation (over 12 weeks) than had been estimated when having their abortion treatment. It is important to note that given such complications or adverse events were very rare, the number of cases reviewed was not sufficient to confirm whether or not the change in approach led to any changes in relation to the safety of EMAH.

However, while the sample size was not big enough to draw robust conclusions on rare forms of complications, it is sufficiently clear that there are no indications of concerning increases in serious complications or of significant numbers of patients accessing the medications at home at later gestations. This finding broadly mirrors that from a study carried out by providers in England, which was able to consider data regarding a larger number of abortions^[2]. Additionally, the numbers show that ectopic pregnancy was a complication before and after the changes, which is consistent with previous studies showing that even routine ultrasound in all patients can sometimes miss pregnancy of unknown location/ectopic pregnancies.

Another potential risk of shifting to a telephone consultation (where there is no subsequent in person appointment) is that staff may miss visual cues that could alert them to safeguarding issues. Conversely, for some individuals telephone consultations may help them disclose safeguarding matters as they might find that they are able to talk more freely and able to divulge details of abuse.

2. What are the advantages and disadvantages for patients of the current approach to early medical abortion at home versus the pre-March 2020 approach?

Staff (WP4) considered that the changes had been generally positive, resulting in improved access and more patient-centred care, and giving patients more autonomy over the process. They noted that the new model resulted in fewer clinic appointments for patients and less time off work, reducing the need to arrange childcare or carer duties. They also noted that the telemedicine appointment may offer less ‘visibility’ for those patients who may be concerned about maintaining privacy and confidentiality of their care. Staff also noted that using telemedicine had helped to reduce waiting times for patients.

The patient survey (WP3) provides strong support from patients for keeping the current approach to EMAH. Indeed, most survey respondents were either very satisfied or slightly satisfied with the care they had received from the abortion service. They expressed support for retaining the options of: a telemedicine consultation; administering both abortion medications at home; and having medications delivered to home or collected from clinics or a community pharmacy. Findings from the staff interviews (WP4) also provided support for keeping the new models of EMAH care.

3. To what extent have different groups of patients been impacted in different ways by the delivery of early medical abortion at home in Scotland without an in-person appointment, how and why?

Staff (WP4) reported that the new model of care offered advantages that may particularly benefit certain groups such as those facing geographic barriers to care, as well as those on low incomes and carers, as it was associated with fewer visits, less travel and time off work or reduced need to make arrangements for those who were carers for others. Staff noted that this way of delivering care was especially important in rural and remote areas because it enabled them to provide high-quality care via phone/video, even when in a different geographic location.

The patient survey (WP3) showed support for continuing flexibility in the models of care from the great majority of respondents. Whilst most respondents were from the two largest Health Boards, it did have respondents from across Scotland. In addition, just under one half of all respondents were from the most deprived postcode areas, showing that support for the new ways of delivering EMAH care are supported by patients from both deprived and affluent backgrounds. Unfortunately there were not sufficient numbers of respondents either from minority ethnic groups or who declared that they had a disability to allow for any comment on whether any of these groups’ views differed in any way from the overall responses.

Mapping of the EMAH pathways across Scotland (WP2) revealed some variations in EMAH service delivery by different Health Boards, most notably in whether all or only a minority of patients (who met certain criteria) had an ultrasound scan; whether patients were given options in how they could access their abortion medications; and access to a comprehensive range of ongoing contraception. In addition, not all Health Boards provided EMAH up to 12 weeks of pregnancy as per WHO recommendations and in line with what is permitted under the Scottish Abortion Care Providers guidelines of March 2020^[3]. See the service summary chart on page 24.

4. In comparison with the pre-March 2020 approach, how effective are the different approaches adopted to delivery of early medical abortion at home in different NHS Health Boards in terms of:

• Patient safety
• Patient experience
• Access to and uptake of wider sexual health service provision

What are the advantages and disadvantages of each differing approach?

Given the high safety in both time periods, and extremely small numbers of any adverse outcomes, any meaningful comparison in complication rates between Health Boards was not possible.

Similarly, whilst there were responses from patients in all except two of Scotland’s Health Board areas, many of the Board areas had too few responses to allow for any real comparison of how experiences between patients in different Health Board areas varied.

Findings from the staff interviews (WP4) provided support for keeping the new models of EMAH care from across all the Health Boards who participated. It was recognised that some Health Boards, particularly smaller services, faced greater challenges than others in ensuring flexibility for patients or adapting to changes in Ministerial approvals. Whilst all Health Boards provided some written and/or oral information to patients about the abortion process, it was recognised by some staff that there would be benefits in sharing good practice to ensure consistent, good quality and up to date information was available to patients in all areas.

Although discussions about contraception and testing for sexually transmitted infections (STI) can still take place by telephone, the removal of an in-person visit removes the opportunity to provide some (but not all) methods of contraception at that time and to undertake STI testing at that time. However, the patient pathways (WP2) showed that some Health Boards were still able to provide a wide range of contraceptive methods along with abortion medication and had pathways in place to help the patients that wanted to use a contraceptive implant or intrauterine device to access these as soon as possible. The review of patient pathways (WP2) showed that Health Boards did have pathways in place for STI testing and these included sending self-sampling kits to patients, providing antibiotics to those at highest risk of STI, arranging a clinic visit for testing or signposting them to a local sexual health clinic.

Conclusions

The findings of this evaluation evidence the high effectiveness of EMAH care in Scotland, as well as showing that there are no indications of any concerning changes in the low levels of complications. This, alongside high levels of acceptability to patients and staff support for continuing the new models of care, indicates that the benefits of the current flexible model outweigh any risks associated with not always having in person appointments. There are some variations in EMAH service delivery across the country, which currently result in less choice for patients in some Health Board areas compared to others.

A number of recommendations are set out below. Some of these come directly from the findings of this evaluation in comparing the effectiveness of the current model of EMAH with the model in place until March 2020. Others are more general recommendations, which emerged from the findings of WPs 2, 3 and 4, although they are suggested to address wider challenges associated with abortion care, rather than being due to issues specifically caused by the current approach to EMAH.

Recommendations

1. Continuation of approval for home administration of mifepristone for EMAH.

The evaluation was commissioned to inform this decision and provides evidence to support the effectiveness and acceptability to patients and staff of home use of mifepristone. Whilst there was insufficient data to draw robust conclusions on safety in relation to rare complications, there were conversely no indications of concerning increases in risks of complications. There should therefore be continuing approval for home use of mifepristone as set out in the existing May 2022 Ministerial approval^[4].

2. Develop quality information around abortion care for national use.

All Health Boards provide patient information on EMAH that they have developed locally, but some Health Boards may find it more difficult than better resourced boards to keep this information updated when changes are introduced to models of care. The Health Board pathways and responses to the patient survey suggested some differences in the written and oral information provided about the abortion and other related services. There is an opportunity with the national NHS website NHS Inform to provide standardised, quality information in a range of formats (including audiovisual animations or films) and languages easily accessible to support informed choice and access to telemedicine EMAH across Scotland. This should include clear information on what the procedure involves, including experiential information to better meet patients’ expectations of pain and bleeding as some free text feedback from the patient survey indicated that patients were not all made aware of how painful the process would be.

3. Improve equity of access to telemedicine EMAH across Scotland.

The Health Board pathways showed variations in access to appointments for abortion consultations across Scotland. With availability of telemedicine there is the opportunity to provide consultations more flexibly across the week to improve consistency of the service patients are offered across different Health Boards. Given the challenges faced by smaller Health Boards (such as limited numbers of staff), consideration could also be given to formalising arrangements for one or more Health Boards to work more closely together to bridge gaps in availability of EMAH services.

4. Optimise the patient pathway for EMAH across Scotland with more choice of options around elements of care including a wide choice of post-abortion contraception.

Given variability between Health Boards in the models of EMAH and the patient survey feedback reflecting the desire for choice of options, patient pathways should be optimised across Health Boards to ensure they are patient-centred. Specifically, choices should be offered on: the mode of consultation - in-person or telephone/ video (unless there is a clinical need for an in-person visit); whether to have an ultrasound scan (unless this is clinically indicated); choice to have EMAH up to 12 weeks; choice of how to access medications; wide choice of contraceptive options and availability of options for testing for sexually transmitted infections (such as provision of a self-sampling kit or an appointment at a clinic).

5. Support (funding, training, leadership) for staff of abortion services to help them implement improvements to EMAH care.

This is applicable to abortion services more generally. Through staff interviews in particular it was apparent that because abortion services in Scotland are part of larger services (hospital or sexual and reproductive health), they must compete with funding or staffing in other parts of the service to implement service improvements. Smaller Health Boards with fewer staff may find this most challenging. Continuing to support the abortion care providers’ network across Scotland will provide support for service improvements, including the development of shared national guidelines, opportunities for collaborative research, and peer support.