Initiating Contraception After Emergency Contraception From Pharmacy

• Sponsor: University of Edinburgh (Other)
• Overall Status: Completed
• CT.gov ID: NCT01738971
• Collaborator: NHS Lothian (Other), London School of Hygiene and Tropical Medicine (Other)
• Enrollment: 168
• Location: 1
• Arms: 3
• Duration (Months): 8
• Patients Per Site Per Month: 21

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Contraceptive Use After Emergency Contraception	Other: rapid access; Other: one month progestogen only pill	N/A

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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 168 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Pharmacy Based Interventions for Initiating Effective Contraception Following the Use of Emergency Contraception : a Feasibility Study
• Study Start Date: Apr 1, 2012
• Actual Primary Completion Date: Dec 1, 2012
• Actual Study Completion Date: Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: control (standard care) standard verbal and written advice on contraception from pharmacy
Experimental: rapid access rapid access to family planning service	Other: rapid 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).
Experimental: progestogen only pill one month progestogen only pill	Other: one month progestogen only pill; Provision of 1 month supply of a progestogen only pill (levonorgestrel 35mcg - Norgeston, Bayer, UK); Other Names: Norgeston (Bayer, UK)

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. Completeness (Quality) of Data Recorded by Pharmacists (Numbers of Women Attending for EC,Demographics of All Attendees- Age, Ethnicity Etc) [8 months]

3. Proportion of Women Who Agree to Participate Who Can be Successfully Contacted [8 months]

Other Outcome Measures

1. 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]

2. Qualitative Outcomes : Pharmacist's Views on Interventions and Any Study Difficulties [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chalmers sexual and reproductive health service	Edinburgh	Lothian	United Kingdom	EH39ES

Sponsors and Collaborators

• University of Edinburgh
• NHS Lothian
• London School of Hygiene and Tropical Medicine

Investigators

• Principal Investigator: Sharon T Cameron, MBChB, University of Edinburgh

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Edinburgh
• ClinicalTrials.gov Identifier: NCT01738971
• Other Study ID Numbers: Protocol ECfe03; 182.
• First Posted: Nov 30, 2012
• Last Update Posted: Aug 18, 2014
• Last Verified: Aug 1, 2014

• Keywords provided by University of Edinburgh: emergency contraception; community pharmacy
• Additional relevant MeSH terms: Emergencies; Progestins

Study Results

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.

Arm/Group Title	Control (Standard Care)	Rapid Access	Progestogen Only Pill
Arm/Group Description	standard verbal and written advice on contraception from pharmacy	rapid access to family planning service rapid access to contraceptive service	one month progestogen only pill one month progestogen only pill
Period Title: Overall Study
STARTED	54	58	56
COMPLETED	35	28	39
NOT COMPLETED	19	30	17

Baseline Characteristics

Arm/Group Title	Control (Standard Care)	Rapid Access	Progestogen Only Pill	Total
Arm/Group Description	standard verbal and written advice on contraception from pharmacy	rapid access to family planning service rapid access to contraceptive service	one month progestogen only pill one month progestogen only pill	Total of all reporting groups
Overall Participants	35	28	39	102
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	23 (4.5)	25 (5.6)	22 (5.2)	23 (5.2)
Sex: Female, Male (Count of Participants)
Female	35 100%	28 100%	39 100%	102 100%
Male	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United Kingdom	35 100%	28 100%	39 100%	102 100%
Contraception use at time of enrollment (participants) [Number]
None	12 34.3%	8 28.6%	13 33.3%	33 32.4%
Condoms	19 54.3%	17 60.7%	26 66.7%	62 60.8%
Other method	4 11.4%	3 10.7%	0 0%	7 6.9%

Outcome Measures

1. Primary Outcome

Title	Self-reported Uptake of Effective Ongoing Contraception (Not Condoms)
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Control (Standard Care)	Rapid Access	Progestogen Only Pill
Arm/Group Description	standard verbal and written advice on contraception from pharmacy	rapid access to family planning service rapid access to contraceptive service	one month progestogen only pill one month progestogen only pill
Measure Participants	31	25	39
Effective contraception	5 14.3%	13 46.4%	22 56.4%
Long acting contraception	0 0%	5 17.9%	3 7.7%
No contraception / barrier method	26 74.3%	12 42.9%	17 43.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control (Standard Care), Progestogen Only Pill
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments	see above description of analysis taking into account cluster randomisation
Method of Estimation	Estimation Parameter	relative probability
	Estimated Value	3.13
	Confidence Interval	() 95%; 1.90 to 5.13
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Control (Standard Care), Rapid Access
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.006
	Comments	see above comments regarding analysis taking cluster randomised account into consideration
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	relative probability
	Estimated Value	2.57
	Confidence Interval	() 95%; 1.55 to 4.27
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Pharmacy Recruitment Rates
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control (Standard Care)	Rapid Access	Progestogen Only Pill
Arm/Group Description	standard verbal and written advice on contraception from pharmacy	rapid access to family planning service rapid access to contraceptive service	one month progestogen only pill one month progestogen only pill
Measure Participants	60	60	60
Recruited	54 154.3%	58 207.1%	56 143.6%
Not recruited from target figure	6 17.1%	2 7.1%	4 10.3%

3. Secondary Outcome

Title	Completeness (Quality) of Data Recorded by Pharmacists (Numbers of Women Attending for EC,Demographics of All Attendees- Age, Ethnicity Etc)
Time Frame	8 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Proportion of Women Who Agree to Participate Who Can be Successfully Contacted
Time Frame	8 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control (Standard Care)	Rapid Access	Progestogen Only Pill
Arm/Group Description	standard verbal and written advice on contraception from pharmacy	rapid access to family planning service rapid access to contraceptive service	one month progestogen only pill one month progestogen only pill
Measure Participants	54	58	56
Women successfully contacted for follow-up	35 100%	28 100%	39 100%
Not contacted / lost to follow-up	19 54.3%	30 107.1%	17 43.6%

5. Other Pre-specified Outcome

Title	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

6. Other Pre-specified Outcome

Title	Qualitative Outcomes : Pharmacist's Views on Interventions and Any Study Difficulties
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	14 months
Arm/Group Title	Control (Standard Care)		Rapid Access		Progestogen Only Pill
Arm/Group Description	standard verbal and written advice on contraception from pharmacy		rapid access to family planning service rapid access to contraceptive service		one month progestogen only pill one month progestogen only pill
All Cause Mortality
	Control (Standard Care)		Rapid Access		Progestogen Only Pill
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Control (Standard Care)		Rapid Access		Progestogen Only Pill
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/54 (0%)		0/58 (0%)		0/56 (0%)
Other (Not Including Serious) Adverse Events
	Control (Standard Care)		Rapid Access		Progestogen Only Pill
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/54 (0%)		0/58 (0%)		0/56 (0%)

Limitations/Caveats

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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.