Initiating Contraception After Emergency Contraception From Pharmacy

Study Overview
=================
Brief Summary
-----------------
Pharmacists do not provide immediate contraception to women after emergency contraception (EC); they can only give advice on local contraceptive services. The investigators wish to establish the following 2 pharmacy- based interventions in NHS Lothian, designed to increase uptake of effective contraception as soon as possible, after EC Pharmacists would provide one packet of progestogen-only pills, giving women one month to arrange an appointment with contraceptive services. Rapid access to a family planning clinic upon presentation of the empty EC packet. Women would be seen as a 'walk-in' and contraception provided. If feasible, these interventions could reduce unintended pregnancies. Participating pharmacies will be randomised to provide one of the interventions, or standard care (verbal/written advice on local contraceptive services). Women requesting EC from study pharmacies will be recruited by the research nurse/doctor to participate in the study that will involve them consenting to contact by telephone 6-8 weeks after EC by the researcher, to evaluate the interventions in terms of : (i) determine women's experiences/ views of the interventions and control. (ii) determine if women have commenced effective contraception and if not , reasons why. A subset of 12 women will also be invited for in-depth interview to collect more detailed qualitative data on their EC experience. The investigators also wish to (iii) explore pharmacists views on the interventions Data from this pilot will enable the investigators to determine whether a larger multisite study is feasible. The aims of a larger study being to determine if either of the two interventions being tested result in an increased proportion of women using effective ongoing contraception compared to the control.

Detailed Description
-----------------
The investigators propose to test 2 pharmacy based interventions to increase uptake of effective contraception after EC: Pharmacists would provide one packet of progestogen-only pills to women, so that they would have 28 days to arrange an appointment with contraceptive services to get a supply of ongoing contraception. Rapid access to a family planning clinic upon presentation of their empty(used) packet of EC. Women would be seen as a 'walk-in' (without appointment) and ongoing contraception discussed and provided. These interventions would be compared with the status quo, i.e. pharmacists give verbal advice and written information on local contraceptive services where ongoing contraception can be accessed. The interventions that we are testing are low cost i.e one packet of progestogen-only pills (£3 for most costly brand) plus additional consultation time with the pharmacist (estimated 20 mins@ £1 per minute), versus the staff consultation time in a family planning clinic. In the family planning clinic, women would be seen as a 'walk-in' and so this may not add costs, since staff are already present.These interventions could, if shown to be effective, offer huge costs savings to the NHS, by reducing the costs of unintended pregnancies (abortion, miscarriage, birth).

Official Title
-----------------
Pharmacy Based Interventions for Initiating Effective Contraception Following the Use of Emergency Contraception : a Feasibility Study

Conditions
-----------------
Contraceptive Use After Emergency Contraception

Intervention / Treatment
-----------------
* Other: rapid access
* Other: one month progestogen only pill


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age >= 16 yrs requesting emergency contraception eligible for emergency contraception written , informed consent Exclusion Criteria: age < 16 yrs not able to give written , informed consent

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control (standard care)<br>standard verbal and written advice on contraception from pharmacy | |
| Experimental: rapid access<br>rapid access to family planning service | Other: rapid access<br>* Provision of box which the participant can take to local family planning clinic (contraceptive service) allowing rapid access (i.e. will be seen by a health professional for a consultation regarding contraception there and then).<br>|
| Experimental: progestogen only pill<br>one month progestogen only pill | Other: one month progestogen only pill<br>* Provision of 1 month supply of a progestogen only pill (levonorgestrel 35mcg - Norgeston, Bayer, UK)<br>* Other names: Norgeston (Bayer, UK);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported Uptake of Effective Ongoing Contraception (Not Condoms) | Outcome measure identified when participants conducted for agreed telephone interview 6-8 weeks following recruitment to study. Participants asked via telephone what method of contraception, if any, there were currently using. | 6-8 weeks after EC | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacy Recruitment Rates | Proportion of participants that pharmacists were successful in recruiting during the specified 8 month recruitment time period. Initial target set to recruit 60 participants to each arm/group. | 8 months | 
| Completeness (Quality) of Data Recorded by Pharmacists (Numbers of Women Attending for EC,Demographics of All Attendees- Age, Ethnicity Etc) |  | 8 months | 
| Proportion of Women Who Agree to Participate Who Can be Successfully Contacted |  | 8 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
emergency contraception, community pharmacy