Clinical trial NCT03500952: Family Planning Ahead
Official title: Family Planning Ahead
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Contraception
Pregnancy Related
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2018-04-18
Enrollment: 41
Sex: FEMALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Family Planning Ahead is a study that aims to improve decision-making about postpartum contraception. Family Planning Ahead will test two different strategies: a patient decision aid and a patient information leaflet.


Eligibility criteria: Inclusion Criteria:

* Currently pregnant
* Between 28 and 38 weeks' gestation at the time of enrollment
* Estimated due date in March, April, May, or June 2018
* 15 years or older
* Can read and write English
* Live in the United States
* Share a valid email address for study purposes

Exclusion Criteria

* Not currently pregnant
* Less than 28 weeks' or more than 38 weeks' gestation at the time of enrollment
* Estimated due date earlier than March 2018 or later than June 2018
* Under 15 years
* Can not read and write English
* Do not live in the United States
* Do not share a valid email address for study purposes

Primary outcomes:
measure: Perceived support in decision-making
timeFrame: T2 (Approximately 7-11 weeks after self-reported estimated due date)
Secondary outcomes:
measure: Perceptions of being informed
timeFrame: T0 (immediately following study enrollment); T1 (one week following study enrollment)
measure: Values clarity
timeFrame: T0 (immediately following study enrollment); T1 (one week following study enrollment)
measure: Decisional uncertainty
timeFrame: T0 (immediately following study enrollment); T1 (one week following study enrollment)
measure: Decision self-efficacy
timeFrame: T0 (immediately following study enrollment); T1 (one week following study enrollment)
measure: Intended contraceptive method(s): LARC vs. other
timeFrame: T0 (immediately following study enrollment); T1 (one week following study enrollment)
measure: Intended contraceptive method(s): Most or moderately effective vs. other
timeFrame: T0 (immediately following study enrollment); T1 (one week following study enrollment)
measure: Intended contraceptive method(s): Method vs. no method or unsure
timeFrame: T0 (immediately following study enrollment); T1 (one week following study enrollment)
measure: Intended timing of contraceptive method(s) initiation: Not unsure vs. unsure
timeFrame: T0 (immediately following study enrollment); T1 (one week following study enrollment)
measure: Values concordance of intended contraceptive method(s)
timeFrame: T0 (immediately following study enrollment); T1 (one week following study enrollment)
measure: Trust in health professional(s)
timeFrame: T2 (Approximately 7-11 weeks after self-reported estimated due date)
measure: Interpersonal quality of family planning care
timeFrame: T2 (Approximately 7-11 weeks after self-reported estimated due date)
measure: Shared decision-making
timeFrame: T2 (Approximately 7-11 weeks after self-reported estimated due date)
measure: Concordance between preferred and actual decision-making involvement (self): Concordant vs. discordant
timeFrame: T2 (Approximately 7-11 weeks after self-reported estimated due date)
measure: Concordance between preferred and actual decision-making involvement (partner): Concordant vs. discordant
timeFrame: T2 (Approximately 7-11 weeks after self-reported estimated due date)
measure: Concordance between preferred and actual decision-making involvement (health professional(s)): Concordant vs. discordant
timeFrame: T2 (Approximately 7-11 weeks after self-reported estimated due date)
measure: Time pressure in decision-making
timeFrame: T2 (Approximately 7-11 weeks after self-reported estimated due date)
measure: Pressure to use a certain contraceptive method
timeFrame: T2 (Approximately 7-11 weeks after self-reported estimated due date)
measure: Values concordance of contraceptive method(s) used
timeFrame: T2 (Approximately 7-11 weeks after self-reported estimated due date)
measure: Effective decision
timeFrame: T2 (Approximately 7-11 weeks after self-reported estimated due date)
measure: Contraceptive method(s) prescribed in first 60 days: LARC vs. other
timeFrame: T2 (Approximately 7-11 weeks after self-reported estimated due date)
measure: Contraceptive method(s) prescribed in first 60 days: Most or moderately effective vs. other
timeFrame: T2 (Approximately 7-11 weeks after self-reported estimated due date)
measure: Contraceptive method(s) prescribed in first 3 days: LARC vs. other
timeFrame: T2 (Approximately 7-11 weeks after self-reported estimated due date)
measure: Contraceptive method(s) prescribed in first 3 days: Most or moderately effective vs. other
timeFrame: T2 (Approximately 7-11 weeks after self-reported estimated due date)
measure: Contraceptive method(s) used: LARC vs. other
timeFrame: T2 (Approximately 7-11 weeks after self-reported estimated due date)
measure: Contraceptive method(s) used: Most or moderately effective vs. other
timeFrame: T2 (Approximately 7-11 weeks after self-reported estimated due date)
measure: Contraceptive method(s) used: Method vs. no method
timeFrame: T2 (Approximately 7-11 weeks after self-reported estimated due date)
measure: Timing of decision about contraceptive method(s): During pregnancy vs. since giving birth
timeFrame: T2 (Approximately 7-11 weeks after self-reported estimated due date)
measure: Likelihood of recommending the intervention to a friend
timeFrame: T1 (one week following study enrollment)
measure: Likelihood of reviewing the intervention in the future
timeFrame: T1 (one week following study enrollment)
measure: Perceived utility of the intervention
timeFrame: T1 (one week following study enrollment)
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Internet (Dartmouth College)
state: New Hampshire
Study officials:
affiliation: Dartmouth College
name: Rachel Thompson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dehlendorf C, Henderson JT, Vittinghoff E, Grumbach K, Levy K, Schmittdiel J, Lee J, Schillinger D, Steinauer J. Association of the quality of interpersonal care during family planning counseling with contraceptive use. Am J Obstet Gynecol. 2016 Jul;215(1):78.e1-9. doi: 10.1016/j.ajog.2016.01.173. Epub 2016 Jan 28.
citation: Thompson R, Manski R, Donnelly KZ, Stevens G, Agusti D, Banach M, Boardman MB, Brady P, Colon Bradt C, Foster T, Johnson DJ, Li Z, Norsigian J, Nothnagle M, Olson AL, Shepherd HL, Stern LF, Tosteson TD, Trevena L, Upadhya KK, Elwyn G. Right For Me: protocol for a cluster randomised trial of two interventions for facilitating shared decision-making about contraceptive methods. BMJ Open. 2017 Oct 22;7(10):e017830. doi: 10.1136/bmjopen-2017-017830.
citation: Dugan E, Trachtenberg F, Hall MA. Development of abbreviated measures to assess patient trust in a physician, a health insurer, and the medical profession. BMC Health Serv Res. 2005 Oct 3;5:64. doi: 10.1186/1472-6963-5-64.
citation: Barr PJ, Thompson R, Walsh T, Grande SW, Ozanne EM, Elwyn G. The psychometric properties of CollaboRATE: a fast and frugal patient-reported measure of the shared decision-making process. J Med Internet Res. 2014 Jan 3;16(1):e2. doi: 10.2196/jmir.3085.
citation: Bennett C, Graham ID, Kristjansson E, Kearing SA, Clay KF, O'Connor AM. Validation of a preparation for decision making scale. Patient Educ Couns. 2010 Jan;78(1):130-3. doi: 10.1016/j.pec.2009.05.012. Epub 2009 Jun 26.
citation: O'Connor, A. M. (1995). Decision Self Efficacy Scale: User manual. Retrieved from https://decisionaid.ohri.ca/docs/develop/User_Manuals/UM_Decision_SelfEfficacy.pdf
citation: O'Connor, A. (2010). Decisional Conflict Scale: User manual. Retrieved from https://decisionaid.ohri.ca/docs/develop/User_Manuals/UM_Decisional_Conflict.pdf