Family Planning Ahead

Pregnancy Related Clinical Trial

Official title:

Family Planning Ahead

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03500952
• Other study ID #: 00030871
• Status: Terminated
• Phase: N/A
• Start date: March 22, 2018
• Est. completion date: August 23, 2018

Study information

• Verified date: January 2019
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 41
• Est. completion date: August 23, 2018
• Est. primary completion date: August 23, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Contraception
• Pregnancy Related

Intervention

Other:
• Birth Control After Pregnancy
A 27-page patient decision aid in portable document format (and an accompanying 3-page supporting document in portable document format) hosted online.
• Postpartum Birth Control
A 4-page patient information leaflet in portable document format and text format hosted online.

Locations

Country	Name	City	State
United States	Internet (Dartmouth College)	Lebanon	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. Erratum in: J Med Internet Res. 2015;17(2):e32. J Med Internet Res. 2015;17(2):e32. — View 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. — View 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. — View Citation

Graham, I., & O'Connor, A. (1995). User Manual: Preparation for Decision Making Scale. Retrieved from https://decisionaid.ohri.ca/docs/develop/User_Manuals/UM_PrepDM.pdf

O'Connor, A. (2010). Decisional Conflict Scale: User manual. Retrieved from https://decisionaid.ohri.ca/docs/develop/User_Manuals/UM_Decisional_Conflict.pdf

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

Thompson R, Manski R, Donnelly KZ, Stevens G, Agusti D, Banach M, Boardman MB, Brady P, Colón 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perceived support in decision-making	The extent to which the person feels they received adequate support and advice without pressure to make a decision about postpartum contraceptive methods, measured using adapted versions of the Support subscale of the Decisional Conflict Scale (O'Connor, 1993).	T2 (Approximately 7-11 weeks after self-reported estimated due date)
Secondary	Perceptions of being informed	The extent to which the person feels informed of available postpartum contraceptive methods and the benefits, risks, and side effects of each, measured using an adapted version of the Informed subscale of the Decisional Conflict Scale (O'Connor, 1993).	T0 (immediately following study enrollment); T1 (one week following study enrollment)
Secondary	Values clarity	The extent to which the person feels clear about personal values related to postpartum contraceptive method benefits, risks, and side effects, measured using an adapted version of the Values Clarity subscale of the Decisional Conflict Scale (O'Connor, 1993).	T0 (immediately following study enrollment); T1 (one week following study enrollment)
Secondary	Decisional uncertainty	The extent to which the person feels certain about which postpartum contraceptive method to choose, measured using an adapted version of the Uncertainty subscale of the Decisional Conflict Scale (O'Connor, 1993).	T0 (immediately following study enrollment); T1 (one week following study enrollment)
Secondary	Decision self-efficacy	The extent to which the person has self-confidence or belief in their ability to make decisions about postpartum contraceptive methods, measured using an adapted version of the Decision Self-Efficacy Scale (O'Connor, 1995).	T0 (immediately following study enrollment); T1 (one week following study enrollment)
Secondary	Intended contraceptive method(s): LARC vs. other	The proportion of people who intend to use a long-acting reversible contraceptive (LARC) method (i.e., hormonal intrauterine device, copper intrauterine device, or implant) 'in the first few months after giving birth', measured using a self-developed item.	T0 (immediately following study enrollment); T1 (one week following study enrollment)
Secondary	Intended contraceptive method(s): Most or moderately effective vs. other	The proportion of people who intend to use a most or moderately effective contraceptive method (i.e., female sterilization, hormonal intrauterine device, copper intrauterine device, implant, injection, combined pill, progestin-only pill, patch, ring, diaphragm) 'in the first few months after giving birth', measured using a self-developed item.	T0 (immediately following study enrollment); T1 (one week following study enrollment)
Secondary	Intended contraceptive method(s): Method vs. no method or unsure	The proportion of people who intend to use one or more contraceptive methods (i.e., female sterilization, hormonal intrauterine device, copper intrauterine device, implant, injection, combined pill, progestin-only pill, patch, ring, diaphragm, male condom, internal (female) condom, spermicide, sponge, cervical cap, lactational amenorrhea method, withdrawal, fertility awareness, male sterilization, and/or emergency contraceptive pill) 'in the first few months after giving birth', measured using a self-developed item.	T0 (immediately following study enrollment); T1 (one week following study enrollment)
Secondary	Intended timing of contraceptive method(s) initiation: Not unsure vs. unsure	The proportion of people who are not unsure about how soon after giving birth they will (first) start using a contraceptive method (i.e., intend to start using a contraceptive method 'in the first 10 minutes', 'in the first few days', 'in the first few weeks', 'around 6 weeks', 'in the first few months' or 'other'), measured using a self-developed item.	T0 (immediately following study enrollment); T1 (one week following study enrollment)
Secondary	Values concordance of intended contraceptive method(s)	The proportion of people who perceive optimal values concordance of their intended postpartum contraceptive method(s) (or intention to use no contraceptive methods), measured using the Measure of Alignment of Choices (Thompson et al., 2017).	T0 (immediately following study enrollment); T1 (one week following study enrollment)
Secondary	Trust in health professional(s)	The extent to which the person feels trust in the health professional(s) they talk to about postpartum contraception during and/or after pregnancy, measured using an adapted version of the Patient Trust in a Physician Scale (Dugan et al., 2005).	T2 (Approximately 7-11 weeks after self-reported estimated due date)
Secondary	Interpersonal quality of family planning care	The proportion of people who report high interpersonal quality of family planning care during and/or after pregnancy, measured using an adapted version of the four-item Interpersonal Quality of Family Planning Care (IQFP-R) scale (Dehlendorf et al. 2016).	T2 (Approximately 7-11 weeks after self-reported estimated due date)
Secondary	Shared decision-making	The extent to which which the person feels they experienced shared decision-making about postpartum contraceptive methods during and/or after pregnancy, measured using the CollaboRATE measure (Barr et al., 2014).	T2 (Approximately 7-11 weeks after self-reported estimated due date)
Secondary	Concordance between preferred and actual decision-making involvement (self): Concordant vs. discordant	The proportion of people who report concordance between their actual and preferred involvement in the decision to use their postpartum contraceptive method(s), measured using two self-developed items.	T2 (Approximately 7-11 weeks after self-reported estimated due date)
Secondary	Concordance between preferred and actual decision-making involvement (partner): Concordant vs. discordant	The proportion of people who report concordance between the actual involvement of their partner and their preferences pertaining to partner involvement in the decision to use their postpartum contraceptive method(s), measured using two self-developed items.	T2 (Approximately 7-11 weeks after self-reported estimated due date)
Secondary	Concordance between preferred and actual decision-making involvement (health professional(s)): Concordant vs. discordant	The proportion of people who report concordance between the actual involvement of their health professional(s) and their preferences pertaining to health professional involvement in the decision to use their postpartum contraceptive method(s), measured using two self-developed items.	T2 (Approximately 7-11 weeks after self-reported estimated due date)
Secondary	Time pressure in decision-making	The extent to which the person feels they had (or have) enough time to make a decision about postpartum contraceptive methods, measured using a self-developed item.	T2 (Approximately 7-11 weeks after self-reported estimated due date)
Secondary	Pressure to use a certain contraceptive method	The extent to which the person felt (or feels) pushed to use a certain postpartum contraceptive method, measured using a self-developed item.	T2 (Approximately 7-11 weeks after self-reported estimated due date)
Secondary	Values concordance of contraceptive method(s) used	The proportion of people who perceive optimal values concordance of the postpartum contraceptive method(s) they have used, measured using the Measure of Alignment of Choices (Thompson et al., 2017).	T2 (Approximately 7-11 weeks after self-reported estimated due date)
Secondary	Effective decision	The extent to which the person feels they made an effective decision about postpartum contraceptive methods, measured using an adapted version of the Effective Decision subscale of the Decisional Conflict Scale (O'Connor, 1993).	T2 (Approximately 7-11 weeks after self-reported estimated due date)
Secondary	Contraceptive method(s) prescribed in first 60 days: LARC vs. other	The proportion of people who report being given or prescribed a long-acting reversible contraceptive (LARC) method (i.e., hormonal intrauterine device, copper intrauterine device, or implant) in the first 60 days after giving birth, measured using a self-developed item.	T2 (Approximately 7-11 weeks after self-reported estimated due date)
Secondary	Contraceptive method(s) prescribed in first 60 days: Most or moderately effective vs. other	The proportion of people who report being given or prescribed a most or moderately effective contraceptive method (i.e., female sterilization, hormonal intrauterine device, copper intrauterine device, implant, injection, combined pill, progestin-only pill, patch, ring, diaphragm) in the first 60 days after giving birth, measured using a self-developed item.	T2 (Approximately 7-11 weeks after self-reported estimated due date)
Secondary	Contraceptive method(s) prescribed in first 3 days: LARC vs. other	The proportion of people who report being given or prescribed a long-acting reversible contraceptive (LARC) method (i.e., hormonal intrauterine device, copper intrauterine device, or implant) in the first 3 days after giving birth, measured using a self-developed item.	T2 (Approximately 7-11 weeks after self-reported estimated due date)
Secondary	Contraceptive method(s) prescribed in first 3 days: Most or moderately effective vs. other	The proportion of people who report being given or prescribed a most or moderately effective contraceptive method (i.e., female sterilization, hormonal intrauterine device, copper intrauterine device, implant, injection, combined pill, progestin-only pill, patch, ring, diaphragm) in the first 3 days after giving birth, measured using a self-developed item.	T2 (Approximately 7-11 weeks after self-reported estimated due date)
Secondary	Contraceptive method(s) used: LARC vs. other	The proportion of people who, at the time of survey completion, report having used a long-acting reversible contraceptive (LARC) method (i.e., hormonal intrauterine device, copper intrauterine device, or implant) since giving birth, measured using a self-developed item.	T2 (Approximately 7-11 weeks after self-reported estimated due date)
Secondary	Contraceptive method(s) used: Most or moderately effective vs. other	The proportion of people who, at the time of survey completion, report having used a most or moderately effective contraceptive method (i.e., female sterilization, hormonal intrauterine device, copper intrauterine device, implant, injection, combined pill, progestin-only pill, patch, ring, diaphragm) since giving birth, measured using a self-developed item.	T2 (Approximately 7-11 weeks after self-reported estimated due date)
Secondary	Contraceptive method(s) used: Method vs. no method	The proportion of people who, at the time of survey completion, report having used one or more contraceptive methods (i.e., female sterilization, hormonal intrauterine device, copper intrauterine device, implant, injection, combined pill, progestin-only pill, patch, ring, diaphragm, male condom, internal (female) condom, spermicide, sponge, cervical cap, lactational amenorrhea method, withdrawal, fertility awareness, male sterilization, and/or emergency contraceptive pill) since giving birth, measured using a self-developed item.	T2 (Approximately 7-11 weeks after self-reported estimated due date)
Secondary	Timing of decision about contraceptive method(s): During pregnancy vs. since giving birth	The proportion of people who report deciding to use their postpartum contraceptive method(s) during pregnancy, measured using a self-developed item.	T2 (Approximately 7-11 weeks after self-reported estimated due date)
Secondary	Likelihood of recommending the intervention to a friend	The proportion of people who report that they are extremely likely to recommend the intervention to a friend, measured using a self-developed item.	T1 (one week following study enrollment)
Secondary	Likelihood of reviewing the intervention in the future	The proportion of people who report that they are extremely likely to review the intervention in the future, measured using a self-developed item.	T1 (one week following study enrollment)
Secondary	Perceived utility of the intervention	The extent to which the person perceives that the intervention was useful in preparing them to communicate with their health professional and make a decision, measured using an adapted version of the Preparation for Decision Making Scale (Graham & O'Connor, 2010).	T1 (one week following study enrollment)

External Links

•   Study Website