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Table 1 Summary of research aims and analysis plan sources

From: Pharmacists expand access to reproductive heaLthcare: PEARL study protocol

  Hypothesis Measure Source(s) Outcome Definition
Aim 1
Convenient access to care
Aim 1a.
Ease of access
New users of HC Clinical cohort
APAC cohort
Initiation of HC will be measured as a prescription for HC with no history of prior HC utilization in the preceding 30 days.
Aim 1a.
Ease of access
Number of months of contraceptive dispensed Clinical cohort
APAC cohort
Number of months and type of contraceptive coverage a woman receives per health system interaction.
Aim 1b.
Out of pocket payments
Amount a woman needs to pay per month of coverage Clinical cohort Amount a woman reports paying for care.
Aim 2
Safety
Aim 2a. Appropriate and safe prescription of HC for all women Women with common contraindications to estrogen who are using a progestin only method Clinical cohort
APAC cohort
Contraindications will be identified as having received an ICD-9 or ICD-10 diagnosis code for hypertension, diabetes, migraines with aura, epilepsy, or blood clots in the last year on a claim in the last year. Pharmacy claims for these conditions will be identified with NDC codes.
Aim 2b.
Access to follow-up
Ability to access follow-up care Clinical cohort Utilization and location of follow-up after HC initiation.
Aim 3
Comparative Effectiveness
Aim 3a. Contraceptive continuation Ongoing use of a contraceptive method Clinical cohort
APAC cohort
Ongoing use of contraceptive method (self-reported).
No breaks in contraceptive claims of greater than 30 days.
Missed days of contraception (self-reported).
Gap of 3–29 days between the conclusion of one HC prescription and the fill of the next.
Aim 3b.
Pregnancy incidence
Pregnancies experienced by contracepting women Clinical cohort
APAC cohort
Self-reported pregnancy.
Medical claims for any episode of pregnancy related care in study cohort using ICD9 &10 codes.