ContraceptionNCT03500952
Family Planning Ahead
A study of Contraception and Pregnancy Related, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 15 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception, Pregnancy Related
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2018to 23 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Internet (Dartmouth College)
Lebanon, New Hampshire, 03756
About this study
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
- Being tested
- Birth Control After Pregnancy, Postpartum Birth Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Birth Control After PregnancyOther
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 ControlOther
A 4-page patient information leaflet in portable document format and text format hosted online.
| Study group | Role | What they receive |
|---|---|---|
| Patient Decision Aid | Experimental | Birth Control After Pregnancy patient decision aid and supporting document Receives: Other: Birth Control After Pregnancy |
| Patient Information Leaflet | Active comparator | Postpartum Birth Control patient information leaflet Receives: Other: Postpartum Birth Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: T2 (Approximately 7-11 weeks after self-reported estimated due date)
Secondary outcomes (30)
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).
Measured: T0 (immediately following study enrollment); T1 (one week following study enrollment)
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).
Measured: T0 (immediately following study enrollment); T1 (one week following study enrollment)
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).
Measured: T0 (immediately following study enrollment); T1 (one week following study enrollment)
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).
Measured: T0 (immediately following study enrollment); T1 (one week following study enrollment)
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.
Measured: T0 (immediately following study enrollment); T1 (one week following study enrollment)
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.
Measured: T0 (immediately following study enrollment); T1 (one week following study enrollment)
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.
Measured: T0 (immediately following study enrollment); T1 (one week following study enrollment)
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.
Measured: T0 (immediately following study enrollment); T1 (one week following study enrollment)
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).
Measured: T0 (immediately following study enrollment); T1 (one week following study enrollment)
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).
Measured: T2 (Approximately 7-11 weeks after self-reported estimated due date)
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).
Measured: T2 (Approximately 7-11 weeks after self-reported estimated due date)
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).
Measured: T2 (Approximately 7-11 weeks after self-reported estimated due date)
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.
Measured: T2 (Approximately 7-11 weeks after self-reported estimated due date)
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.
Measured: 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
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.
Measured: T2 (Approximately 7-11 weeks after self-reported estimated due date)
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.
Measured: T2 (Approximately 7-11 weeks after self-reported estimated due date)
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.
Measured: T2 (Approximately 7-11 weeks after self-reported estimated due date)
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).
Measured: T2 (Approximately 7-11 weeks after self-reported estimated due date)
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).
Measured: T2 (Approximately 7-11 weeks after self-reported estimated due date)
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.
Measured: 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
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.
Measured: T2 (Approximately 7-11 weeks after self-reported estimated due date)
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.
Measured: 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
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.
Measured: T2 (Approximately 7-11 weeks after self-reported estimated due date)
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.
Measured: T2 (Approximately 7-11 weeks after self-reported estimated due date)
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.
Measured: T2 (Approximately 7-11 weeks after self-reported estimated due date)
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.
Measured: T2 (Approximately 7-11 weeks after self-reported estimated due date)
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.
Measured: T2 (Approximately 7-11 weeks after self-reported estimated due date)
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.
Measured: T1 (one week following study enrollment)
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.
Measured: T1 (one week following study enrollment)
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).
Measured: T1 (one week following study enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start22 Mar 2018
- Primary completion23 Aug 2018
- Study completion23 Aug 2018
Why it stopped: High incidence of fraudulent enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rachel L. Thompson, Dartmouth-Hitchcock Medical Center
- Investigators
- Rachel Thompson, PhD, Principal investigator, Dartmouth College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03500952
- Sponsor's protocol ID
- 00030871
- Status last verified
- Jan 2019
- First submitted
- 10 Apr 2018
- Last updated
- 9 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 26827879Thompson 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.
PubMed 29061624Dugan 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.
PubMed 16202125Barr 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.
PubMed 24389354Graham, 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. M. (1995). Decision Self Efficacy Scale: User manual. Retrieved from https://decisionaid.ohri.ca/docs/develop/User_Manuals/UM_Decision_SelfEfficacy.pdf
O'Connor, A. (2010). Decisional Conflict Scale: User manual. Retrieved from https://decisionaid.ohri.ca/docs/develop/User_Manuals/UM_Decisional_Conflict.pdf
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Planning Ahead
- ClinicalTrials.gov ID
- NCT03500952
- Acronym / sponsor ID
- 00030871
- Conditions
- Contraception, Pregnancy Related
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: High incidence of fraudulent enrollment.
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- 22 Mar 2018 (actual)
- Primary completion
- 23 Aug 2018 (actual)
- Study completion
- 23 Aug 2018 (actual)
- First posted
- 18 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Decision Aid | Experimental | Other: Birth Control After PregnancyBirth Control After Pregnancy patient decision aid and supporting document |
| Patient Information Leaflet | Active comparator | Other: Postpartum Birth ControlPostpartum Birth Control patient information leaflet |
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Birth Control After PregnancyA 27-page patient decision aid in portable document format (and an accompanying 3-page supporting document in portable document format) hosted online. | Other | Patient Decision Aid |
| Postpartum Birth ControlA 4-page patient information leaflet in portable document format and text format hosted online. | Other | Patient Information Leaflet |
Primary outcome
Perceived support in decision-making
Time frame: 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).
30 secondary outcomes
Perceptions of being informed
Time frame: T0 (immediately following study enrollment); T1 (one week following study enrollment)
Values clarity
Time frame: T0 (immediately following study enrollment); T1 (one week following study enrollment)
Decisional uncertainty
Time frame: T0 (immediately following study enrollment); T1 (one week following study enrollment)
Decision self-efficacy
Time frame: T0 (immediately following study enrollment); T1 (one week following study enrollment)
Intended contraceptive method(s): LARC vs. other
Time frame: T0 (immediately following study enrollment); T1 (one week following study enrollment)
Intended contraceptive method(s): Most or moderately effective vs. other
Time frame: T0 (immediately following study enrollment); T1 (one week following study enrollment)
Intended contraceptive method(s): Method vs. no method or unsure
Time frame: T0 (immediately following study enrollment); T1 (one week following study enrollment)
Intended timing of contraceptive method(s) initiation: Not unsure vs. unsure
Time frame: T0 (immediately following study enrollment); T1 (one week following study enrollment)
Values concordance of intended contraceptive method(s)
Time frame: T0 (immediately following study enrollment); T1 (one week following study enrollment)
Trust in health professional(s)
Time frame: T2 (Approximately 7-11 weeks after self-reported estimated due date)
Interpersonal quality of family planning care
Time frame: T2 (Approximately 7-11 weeks after self-reported estimated due date)
Shared decision-making
Time frame: T2 (Approximately 7-11 weeks after self-reported estimated due date)
Concordance between preferred and actual decision-making involvement (self): Concordant vs. discordant
Time frame: T2 (Approximately 7-11 weeks after self-reported estimated due date)
Concordance between preferred and actual decision-making involvement (partner): Concordant vs. discordant
Time frame: 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
Time frame: T2 (Approximately 7-11 weeks after self-reported estimated due date)
Time pressure in decision-making
Time frame: T2 (Approximately 7-11 weeks after self-reported estimated due date)
Pressure to use a certain contraceptive method
Time frame: T2 (Approximately 7-11 weeks after self-reported estimated due date)
Values concordance of contraceptive method(s) used
Time frame: T2 (Approximately 7-11 weeks after self-reported estimated due date)
Effective decision
Time frame: T2 (Approximately 7-11 weeks after self-reported estimated due date)
Contraceptive method(s) prescribed in first 60 days: LARC vs. other
Time frame: 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
Time frame: T2 (Approximately 7-11 weeks after self-reported estimated due date)
Contraceptive method(s) prescribed in first 3 days: LARC vs. other
Time frame: 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
Time frame: T2 (Approximately 7-11 weeks after self-reported estimated due date)
Contraceptive method(s) used: LARC vs. other
Time frame: T2 (Approximately 7-11 weeks after self-reported estimated due date)
Contraceptive method(s) used: Most or moderately effective vs. other
Time frame: T2 (Approximately 7-11 weeks after self-reported estimated due date)
Contraceptive method(s) used: Method vs. no method
Time frame: T2 (Approximately 7-11 weeks after self-reported estimated due date)
Timing of decision about contraceptive method(s): During pregnancy vs. since giving birth
Time frame: T2 (Approximately 7-11 weeks after self-reported estimated due date)
Likelihood of recommending the intervention to a friend
Time frame: T1 (one week following study enrollment)
Likelihood of reviewing the intervention in the future
Time frame: T1 (one week following study enrollment)
Perceived utility of the intervention
Time frame: T1 (one week following study enrollment)
Results and safety
The study was stopped early (reason given: High incidence of fraudulent enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2019.
- Background: PubMed 26827879Dehlendorf 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.
- Background: PubMed 29061624Thompson 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.
- Background: PubMed 16202125Dugan 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.
- Background: PubMed 24389354Barr 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.
- BackgroundGraham, 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
- BackgroundO'Connor, A. M. (1995). Decision Self Efficacy Scale: User manual. Retrieved from https://decisionaid.ohri.ca/docs/develop/User_Manuals/UM_Decision_SelfEfficacy.pdf
- BackgroundO'Connor, A. (2010). Decisional Conflict Scale: User manual. Retrieved from https://decisionaid.ohri.ca/docs/develop/User_Manuals/UM_Decisional_Conflict.pdf
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel Thompson, PhD principal investigator
Dartmouth College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Contraception and Pregnancy Related, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: High incidence of fraudulent enrollment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived support in decision-making (time frame: T2 (Approximately 7-11 weeks after self-reported estimated due date)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03500952, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2019; AzTrials last refreshed its copy on 29 Oct 2026.