Initiating Contraception After Emergency Contraception From Pharmacy
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Purpose
Pharmacists do not provide immediate contraception to women after emergency contraception (EC); they can only give advice on local contraceptive services.
We 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.
We also wish to (iii) explore pharmacists views on the interventions
Data from this pilot will enable us 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.
| Condition | Intervention |
|---|---|
|
Emergency Contraception |
Other: rapid access to contraceptive service Other: one month progestogen only pill |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Pharmacy Based Interventions for Initiating Effective Contraception Following the Use of Emergency Contraception : a Feasibility Study |
- self-reported uptake of effective ongoing contraception (not condoms) [ Time Frame: 6-8 weeks after EC ] [ Designated as safety issue: No ]
- pharmacy recruitment rates [ Time Frame: 8 months ] [ Designated as safety issue: No ]
- completeness (quality) of data recorded by pharmacists (numbers of women attending for EC,demographics of all attendees- age, ethnicity etc) [ Time Frame: 8 months ] [ Designated as safety issue: No ]
- proportion of women who agree to participate who can be successfully contacted [ Time Frame: 8 months ] [ Designated as safety issue: No ]
- qualitative outcomes : women's views on different measures to determine validity of self-reported data on contraceptive use , determined by in depth interviews. [ Time Frame: 8 months ] [ Designated as safety issue: No ]
- qualitative outcomes : pharmacist's views on interventions and any study difficulties [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 90 |
| Study Start Date: | April 2012 |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
control (standard care)
standard verbal and written advice on contraception from pharmacy
|
|
|
rapid access
rapid access to family planning service
|
Other: rapid access to contraceptive service |
|
progestogen only pill
one month progestogen only pill
|
Other: one month progestogen only pill |
Detailed Description:
We 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).
Eligibility| Ages Eligible for Study: | 16 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
women attending community pharmacies requesting emergency contraception
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
Contacts and Locations| Contact: lucy michie, MB CHB | 0044131536 1070 ext 2091 | lucy.michie@ed.ac.uk |
| Contact: sharon Cameron, MD | 00 221315361070 | sharon.cameron@ed.ac.uk |
| United Kingdom | |
| Chalmers sexual and reproductive health service | Recruiting |
| Edinburgh, Lothian, United Kingdom, EH39ES | |
| Contact: Sharon Cameron, MD sharon.cameron@ed.ac.uk | |
| Principal Investigator: Sharon Cameron, MD | |
More Information
No publications provided
| Responsible Party: | University of Edinburgh |
| ClinicalTrials.gov Identifier: | NCT01738971 History of Changes |
| Other Study ID Numbers: | Protocol ECfe03, 182. |
| Study First Received: | November 28, 2012 |
| Last Updated: | November 29, 2012 |
| Health Authority: | United Kingdom: National Health Service United Kingdom: Research Ethics Committee |
Keywords provided by University of Edinburgh:
|
emergency contraception community pharmacy |
Additional relevant MeSH terms:
|
Emergencies Disease Attributes Pathologic Processes Contraceptive Agents Progestins Reproductive Control Agents |
Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |
ClinicalTrials.gov processed this record on May 22, 2013