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| ID | Type | Description | Link |
|---|---|---|---|
| 182. | Other Identifier | Edinburgh and Lothians Health Foundation |
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| Name | Class |
|---|---|
| NHS Lothian | OTHER_GOV |
| London School of Hygiene and Tropical Medicine | OTHER |
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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
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.
The investigators propose to test 2 pharmacy based interventions to increase uptake of effective contraception after EC:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control (standard care) | No Intervention | standard verbal and written advice on contraception from pharmacy | |
| rapid access | Experimental | rapid access to family planning service |
|
| progestogen only pill | Experimental | one month progestogen only pill |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rapid access | Other | 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). |
| 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 |
| 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) |
| Measure | Description | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sharon T Cameron, MBChB | University of Edinburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chalmers sexual and reproductive health service | Edinburgh | Lothian | EH39ES | United Kingdom |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control (Standard Care) | standard verbal and written advice on contraception from pharmacy |
| FG001 | Rapid Access | rapid access to family planning service rapid access to contraceptive service |
| FG002 | Progestogen Only Pill | one month progestogen only pill one month progestogen only pill |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline analysis conducted on all participants successfully contacted for telephone follow-up at 6-8weeks post enrollment to study. no baseline analysis possible on those recruited in pharmacy but lost to follow-up.
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| ID | Title | Description |
|---|---|---|
| BG000 | Control (Standard Care) | standard verbal and written advice on contraception from pharmacy |
| BG001 | Rapid Access | rapid access to family planning service rapid access to contraceptive service |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Number | participants | 6-8 weeks after EC |
|
14 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control (Standard Care) | standard verbal and written advice on contraception from pharmacy |
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Loss to follow-up relatively high. Self-reporting of primary outcome measure (contraceptive method at time of follow-up). Would have been preferable to be able to validate this.
Pharmacists unable to record demographic data of those not recruited.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Lucy Michie | University of Edinburgh | 0131 5361542 | michieluc@yahoo.co.uk |
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| ID | Term |
|---|---|
| D016912 | Levonorgestrel |
| ID | Term |
|---|---|
| D009644 | Norgestrel |
| D009652 | Norpregnenes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 |
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| one month progestogen only pill | Other | Provision of 1 month supply of a progestogen only pill (levonorgestrel 35mcg - Norgeston, Bayer, UK) |
|
|
| 8 months |
| Proportion of Women Who Agree to Participate Who Can be Successfully Contacted | 8 months |
| BG002 | Progestogen Only Pill | one month progestogen only pill one month progestogen only pill |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Contraception use at time of enrollment | Number | participants |
|
| Rapid Access |
rapid access to family planning service rapid access to contraceptive service |
| OG002 | Progestogen Only Pill | one month progestogen only pill one month progestogen only pill |
|
|
|
| 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. | Posted | Number | participants | 8 months |
|
|
|
| Secondary | Completeness (Quality) of Data Recorded by Pharmacists (Numbers of Women Attending for EC,Demographics of All Attendees- Age, Ethnicity Etc) | Not Posted | 8 months |
| Secondary | Proportion of Women Who Agree to Participate Who Can be Successfully Contacted | Posted | Number | participants | 8 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. | Not Posted | 8 months |
| Other Pre-specified | Qualitative Outcomes : Pharmacist's Views on Interventions and Any Study Difficulties | Not Posted | 12 months |
| 0 |
| 54 |
| 0 |
| 54 |
| EG001 | Rapid Access | rapid access to family planning service rapid access to contraceptive service | 0 | 58 | 0 | 58 |
| EG002 | Progestogen Only Pill | one month progestogen only pill one month progestogen only pill | 0 | 56 | 0 | 56 |
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| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
|
|