Contraceptive Use After Emergency Contraception
Conditions
Keywords
emergency contraception, community pharmacy
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 1. Pharmacists would provide one packet of progestogen-only pills, giving women one month to arrange an appointment with contraceptive services. 2. 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: 1. 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. 2. 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).
Interventions
OTHERrapid access
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).
OTHERone month progestogen only pill
Provision of 1 month supply of a progestogen only pill (levonorgestrel 35mcg - Norgeston, Bayer, UK)
Sponsors
NHS Lothian
London School of Hygiene and Tropical Medicine
University of Edinburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported Uptake of Effective Ongoing Contraception (Not Condoms) | 6-8 weeks after EC | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacy Recruitment Rates | 8 months | 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. |
| 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 | — |
Other
| Measure | Time frame |
|---|---|
| Qualitative Outcomes : Women's Views on Different Measures to Determine Validity of Self-reported Data on Contraceptive Use , Determined by in Depth Interviews. | 8 months |
| Qualitative Outcomes : Pharmacist's Views on Interventions and Any Study Difficulties | 12 months |
Countries
United Kingdom
Participant flow
Recruitment details
Recruitment from end April 2012 - end December 2012 (8 month period). Recruitment of participants by community pharmacists within 11 community pharmacies in Edinburgh. All participating pharmacists trained by the research team prior to commencing recruitment of participants.
Participants by arm
| Arm | Count |
|---|---|
| Control (Standard Care) standard verbal and written advice on contraception from pharmacy | 35 |
| Rapid Access rapid access to family planning service
rapid access to contraceptive service | 28 |
| Progestogen Only Pill one month progestogen only pill
one month progestogen only pill | 39 |
| Total | 102 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 19 | 30 | 17 |
Baseline characteristics
| Characteristic | Control (Standard Care) | Rapid Access | Progestogen Only Pill | Total |
|---|---|---|---|---|
| Age, Continuous | 23 years STANDARD_DEVIATION 4.5 | 25 years STANDARD_DEVIATION 5.6 | 22 years STANDARD_DEVIATION 5.2 | 23 years STANDARD_DEVIATION 5.2 |
| Contraception use at time of enrollment Condoms | 19 participants | 17 participants | 26 participants | 62 participants |
| Contraception use at time of enrollment None | 12 participants | 8 participants | 13 participants | 33 participants |
| Contraception use at time of enrollment Other method | 4 participants | 3 participants | 0 participants | 7 participants |
| Region of Enrollment United Kingdom | 35 participants | 28 participants | 39 participants | 102 participants |
| Sex: Female, Male Female | 35 Participants | 28 Participants | 39 Participants | 102 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 54 | 0 / 58 | 0 / 56 |
| serious Total, serious adverse events | 0 / 54 | 0 / 58 | 0 / 56 |
Outcome results
Primary
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.
Time frame: 6-8 weeks after EC
Population: A small number of participants were identified who had been recruited to the study although were already using an effective method of contraception (i.e. using a contraceptive pill but had forgot to take), and continued to use the same method at follow-up. These participants were excluded from analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control (Standard Care) | Self-reported Uptake of Effective Ongoing Contraception (Not Condoms) | Long acting contraception | 0 participants |
| Control (Standard Care) | Self-reported Uptake of Effective Ongoing Contraception (Not Condoms) | Effective contraception | 5 participants |
| Control (Standard Care) | Self-reported Uptake of Effective Ongoing Contraception (Not Condoms) | No contraception / barrier method | 26 participants |
| Rapid Access | Self-reported Uptake of Effective Ongoing Contraception (Not Condoms) | Long acting contraception | 5 participants |
| Rapid Access | Self-reported Uptake of Effective Ongoing Contraception (Not Condoms) | Effective contraception | 13 participants |
| Rapid Access | Self-reported Uptake of Effective Ongoing Contraception (Not Condoms) | No contraception / barrier method | 12 participants |
| Progestogen Only Pill | Self-reported Uptake of Effective Ongoing Contraception (Not Condoms) | Effective contraception | 22 participants |
| Progestogen Only Pill | Self-reported Uptake of Effective Ongoing Contraception (Not Condoms) | No contraception / barrier method | 17 participants |
| Progestogen Only Pill | Self-reported Uptake of Effective Ongoing Contraception (Not Condoms) | Long acting contraception | 3 participants |
Comparison: Cluster randomised study design - statisitical analysis takes this into account. Analaysis was conducted at a cluster level and the proportions in each cluster using effective contraception were compared between groups by 2-sample t tests, weighted by the different number of patients in each cluster.~Comparison of number of women using effective contraception at 6-8 weeks in progestogen only pill group compared to control.p-value: <0.00195% CI: [1.9, 5.13]t-test, 2 sided
Comparison: Cluster randomised study design - statisitical analysis takes this into account. Analaysis was conducted at a cluster level and the proportions in each cluster using effective contraception were compared between groups by 2-sample t tests, weighted by the different number of patients in each cluster.~Comparison of number of women using effective contraception at 6-8 weeks in rapid access group compared to control.p-value: 0.00695% CI: [1.55, 4.27]t-test, 2 sided
Secondary
Completeness (Quality) of Data Recorded by Pharmacists (Numbers of Women Attending for EC,Demographics of All Attendees- Age, Ethnicity Etc)
Time frame: 8 months
Secondary
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.
Time frame: 8 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control (Standard Care) | Pharmacy Recruitment Rates | Recruited | 54 participants |
| Control (Standard Care) | Pharmacy Recruitment Rates | Not recruited from target figure | 6 participants |
| Rapid Access | Pharmacy Recruitment Rates | Recruited | 58 participants |
| Rapid Access | Pharmacy Recruitment Rates | Not recruited from target figure | 2 participants |
| Progestogen Only Pill | Pharmacy Recruitment Rates | Recruited | 56 participants |
| Progestogen Only Pill | Pharmacy Recruitment Rates | Not recruited from target figure | 4 participants |
Secondary
Proportion of Women Who Agree to Participate Who Can be Successfully Contacted
Time frame: 8 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control (Standard Care) | Proportion of Women Who Agree to Participate Who Can be Successfully Contacted | Not contacted / lost to follow-up | 19 participants |
| Control (Standard Care) | Proportion of Women Who Agree to Participate Who Can be Successfully Contacted | Women successfully contacted for follow-up | 35 participants |
| Rapid Access | Proportion of Women Who Agree to Participate Who Can be Successfully Contacted | Women successfully contacted for follow-up | 28 participants |
| Rapid Access | Proportion of Women Who Agree to Participate Who Can be Successfully Contacted | Not contacted / lost to follow-up | 30 participants |
| Progestogen Only Pill | Proportion of Women Who Agree to Participate Who Can be Successfully Contacted | Women successfully contacted for follow-up | 39 participants |
| Progestogen Only Pill | Proportion of Women Who Agree to Participate Who Can be Successfully Contacted | Not contacted / lost to follow-up | 17 participants |
Other Pre-specified
Qualitative Outcomes : Pharmacist's Views on Interventions and Any Study Difficulties
Time frame: 12 months
Other Pre-specified
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