Family Planning Ahead

NCT03500952 | Terminated

• 1 other identifier: 00030871
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Contraception; Pregnancy Related

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (30)

• Perceptions of being informed

  T0 (immediately following study enrollment); T1 (one week following study enrollment)

• Values clarity

  T0 (immediately following study enrollment); T1 (one week following study enrollment)

• Decisional uncertainty

  T0 (immediately following study enrollment); T1 (one week following study enrollment)

• Decision self-efficacy

  T0 (immediately following study enrollment); T1 (one week following study enrollment)

• Intended contraceptive method(s): LARC vs. other

  T0 (immediately following study enrollment); T1 (one week following study enrollment)

Study Arms (2)

Patient Decision Aid

EXPERIMENTAL

Birth Control After Pregnancy patient decision aid and supporting document

Other: Birth Control After Pregnancy

Patient Information Leaflet

ACTIVE COMPARATOR

Postpartum Birth Control patient information leaflet

Other: Postpartum Birth Control

Interventions

Birth Control After Pregnancy OTHER

A 27-page patient decision aid in portable document format (and an accompanying 3-page supporting document in portable document format) hosted online.

Patient Decision Aid

Postpartum Birth Control OTHER

A 4-page patient information leaflet in portable document format and text format hosted online.

Patient Information Leaflet

Eligibility Criteria

• Age: 15 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Internet (Dartmouth College)

Lebanon, New Hampshire, 03756, United States

Location

Related Publications (7)

• 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.

  PMID: 26827879 BACKGROUND

• 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.

  PMID: 29061624 BACKGROUND

• 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.

  PMID: 16202125 BACKGROUND

• 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.

  PMID: 24389354 BACKGROUND

• 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.

  PMID: 19560303 BACKGROUND

• 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

  BACKGROUND

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

  BACKGROUND

Study Officials

• Rachel Thompson, PhD

  Dartmouth College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, The Dartmouth Institute

Study Record Dates

• First Submitted: April 10, 2018
• First Posted: April 18, 2018
• Study Start: March 22, 2018
• Primary Completion: August 23, 2018
• Study Completion: August 23, 2018
• Last Updated: January 9, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)