Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Family Planning Ahead

7 janvier 2019 mis à jour par: Rachel L. Thompson, Dartmouth-Hitchcock Medical Center
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.

Aperçu de l'étude

Statut

Résilié

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

41

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • New Hampshire
      • Lebanon, New Hampshire, États-Unis, 03756
        • Internet (Dartmouth College)

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

15 ans et plus (Enfant, Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Femelle

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Autre
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Patient Decision Aid
Birth Control After Pregnancy patient decision aid and supporting document
Autre: 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.
Comparateur actif: Patient Information Leaflet
Postpartum Birth Control patient information leaflet
Autre: Postpartum Birth Control
A 4-page patient information leaflet in portable document format and text format hosted online.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Perceived support in decision-making
Délai: T2 (Approximately 7-11 weeks after self-reported estimated due date)
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)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Perceptions of being informed
Délai: T0 (immediately following study enrollment); T1 (one week following study enrollment)
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)
Values clarity
Délai: T0 (immediately following study enrollment); T1 (one week following study enrollment)
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)
Decisional uncertainty
Délai: T0 (immediately following study enrollment); T1 (one week following study enrollment)
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)
Decision self-efficacy
Délai: T0 (immediately following study enrollment); T1 (one week following study enrollment)
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)
Intended contraceptive method(s): LARC vs. other
Délai: T0 (immediately following study enrollment); T1 (one week following study enrollment)
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)
Intended contraceptive method(s): Most or moderately effective vs. other
Délai: T0 (immediately following study enrollment); T1 (one week following study enrollment)
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)
Intended contraceptive method(s): Method vs. no method or unsure
Délai: T0 (immediately following study enrollment); T1 (one week following study enrollment)
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)
Intended timing of contraceptive method(s) initiation: Not unsure vs. unsure
Délai: T0 (immediately following study enrollment); T1 (one week following study enrollment)
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)
Values concordance of intended contraceptive method(s)
Délai: T0 (immediately following study enrollment); T1 (one week following study enrollment)
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)
Trust in health professional(s)
Délai: T2 (Approximately 7-11 weeks after self-reported estimated due date)
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)
Interpersonal quality of family planning care
Délai: T2 (Approximately 7-11 weeks after self-reported estimated due date)
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)
Shared decision-making
Délai: T2 (Approximately 7-11 weeks after self-reported estimated due date)
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)
Concordance between preferred and actual decision-making involvement (self): Concordant vs. discordant
Délai: T2 (Approximately 7-11 weeks after self-reported estimated due date)
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)
Concordance between preferred and actual decision-making involvement (partner): Concordant vs. discordant
Délai: T2 (Approximately 7-11 weeks after self-reported estimated due date)
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)
Concordance between preferred and actual decision-making involvement (health professional(s)): Concordant vs. discordant
Délai: T2 (Approximately 7-11 weeks after self-reported estimated due date)
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)
Time pressure in decision-making
Délai: T2 (Approximately 7-11 weeks after self-reported estimated due date)
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)
Pressure to use a certain contraceptive method
Délai: T2 (Approximately 7-11 weeks after self-reported estimated due date)
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)
Values concordance of contraceptive method(s) used
Délai: T2 (Approximately 7-11 weeks after self-reported estimated due date)
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)
Effective decision
Délai: T2 (Approximately 7-11 weeks after self-reported estimated due date)
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)
Contraceptive method(s) prescribed in first 60 days: LARC vs. other
Délai: T2 (Approximately 7-11 weeks after self-reported estimated due date)
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)
Contraceptive method(s) prescribed in first 60 days: Most or moderately effective vs. other
Délai: T2 (Approximately 7-11 weeks after self-reported estimated due date)
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)
Contraceptive method(s) prescribed in first 3 days: LARC vs. other
Délai: T2 (Approximately 7-11 weeks after self-reported estimated due date)
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)
Contraceptive method(s) prescribed in first 3 days: Most or moderately effective vs. other
Délai: T2 (Approximately 7-11 weeks after self-reported estimated due date)
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)
Contraceptive method(s) used: LARC vs. other
Délai: T2 (Approximately 7-11 weeks after self-reported estimated due date)
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)
Contraceptive method(s) used: Most or moderately effective vs. other
Délai: T2 (Approximately 7-11 weeks after self-reported estimated due date)
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)
Contraceptive method(s) used: Method vs. no method
Délai: T2 (Approximately 7-11 weeks after self-reported estimated due date)
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)
Timing of decision about contraceptive method(s): During pregnancy vs. since giving birth
Délai: T2 (Approximately 7-11 weeks after self-reported estimated due date)
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)
Likelihood of recommending the intervention to a friend
Délai: T1 (one week following study enrollment)
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)
Likelihood of reviewing the intervention in the future
Délai: T1 (one week following study enrollment)
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)
Perceived utility of the intervention
Délai: T1 (one week following study enrollment)
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)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Dartmouth-Hitchcock Medical Center

Les enquêteurs

  • Chercheur principal: Rachel Thompson, PhD, Dartmouth College

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

22 mars 2018

Achèvement primaire (Réel)

23 août 2018

Achèvement de l'étude (Réel)

23 août 2018

Dates d'inscription aux études

Première soumission

10 avril 2018

Première soumission répondant aux critères de contrôle qualité

10 avril 2018

Première publication (Réel)

18 avril 2018

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

9 janvier 2019

Dernière mise à jour soumise répondant aux critères de contrôle qualité

7 janvier 2019

Dernière vérification

1 janvier 2019

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • 00030871

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

Oui

Description du régime IPD

The investigators will make an anonymized copy of the final participant-level data set available to others for research purposes, either via data sharing on request or digital repository deposit.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner