Right For Me: Birth Control Decisions Made Easier

• ClinicalTrials.gov Identifier: NCT02759939
• Recruitment Status: Completed
• First Posted: May 3, 2016
• Results First Posted: November 19, 2019
• Last Update Posted: November 19, 2019
• Sponsor: Dartmouth-Hitchcock Medical Center
• Information provided by (Responsible Party): Rachel L. Thompson, Dartmouth-Hitchcock Medical Center

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Factorial Assignment; Masking: None (Open Label); Primary Purpose: Health Services Research
• Condition: Contraception
• Interventions: Other: Video + Prompt Card; Other: Decision Aids + Training
• Enrollment: 5038

Participant Flow

Recruitment Details	The recruitment period was April 1, 2016 to December 30, 2016. Recruitment took place in 16 primary care and/or reproductive health care clinics in the Northeast United States.
Pre-assignment Details	This was a cluster randomized trial. The level of randomization was clinics.

Arm/Group Title	Video + Prompt Card	Decision Aids + Training	Video + Prompt Card and Decision Aids + Training	Usual Care
Arm/Group Description	A brief video intended to be viewed by patients in the clinic immediately before the health care visit that encouraged them to ask their providers three questions, and a small prompt card intended to remind them of the three questions presented in the video.	A set of seven one-page decision aids on contraceptive methods intended to be used by providers with patients during the health care visit, as well as a brief training video and written guidance intended to be viewed by providers before beginning to use the decision aids (and as frequently as desired thereafter).	A brief video intended to be viewed by patients in the clinic immediately before the health care visit that encouraged them to ask their providers three questions, and a small prompt card intended to remind them of the three questions presented in the video. And A set of seven one-page decision aids on contraceptive methods intended to be used by providers with patients during the health care visit, as well as a brief training video and written guidance intended to be viewed by providers before beginning to use the decision aids (and as frequently as desired thereafter).	Care as usual.
Period Title: Overall Study
Started [1]	1256	1143	1393	1246
Analyzed at T1 [2]	1245	1141	1388	1244
Eligible for T2 and T3 [3]	935	962	1022	853
Analyzed at T2 and/or T3 [4]	303	278	373	304
Consented to T2 and T3	579	626	702	564
Completed	200	171	239	203
Not Completed	1056	972	1154	1043
Reason Not Completed
Missing data on first outcome assessed	11	2	5	2
Ineligible for T2 and T3	310	179	366	391
Lost to Follow-up	735	791	783	650
[1] Represents participants who consented to the study and were eligible.; [2] Participants with valid data on the item assessing occurrence of a conversation about contraception.; [3] We imposed additional eligibility criteria for the T2 and T3 surveys to minimize participant burden.; [4] Participants were not required to have completed the T2 survey to be eligible for the T3 survey.

Baseline Characteristics

Arm/Group Title		Video + Prompt Card	Decision Aids + Training	Video + Prompt Card and Decision Aids + Training	Usual Care	Total
Arm/Group Description		A brief video intended to be viewed by patients in the clinic immediately before the health care visit that encouraged them to ask their providers three questions, and a small prompt card intended to remind them of the three questions presented in the video.	A set of seven one-page decision aids on contraceptive methods intended to be used by providers with patients during the health care visit, as well as a brief training video and written guidance intended to be viewed by providers before beginning to use the decision aids (and as frequently as desired thereafter).	A brief video intended to be viewed by patients in the clinic immediately before the health care visit that encouraged them to ask their providers three questions, and a small prompt card intended to remind them of the three questions presented in the video. And A set of seven one-page decision aids on contraceptive methods intended to be used by providers with patients during the health care visit, as well as a brief training video and written guidance intended to be viewed by providers before beginning to use the decision aids (and as frequently as desired thereafter).	Care as usual.	Total of all reporting groups
Overall Number of Baseline Participants		1245	1141	1388	1244	5018
Baseline Analysis Population Description		[Not Specified]
Age, Customized [1]; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	1245 participants	1141 participants	1388 participants	1244 participants	5018 participants
15 to 19 years		224 18.0%	172 15.1%	181 13.0%	180 14.5%	757 15.1%
20 to 24 years		427 34.3%	336 29.4%	369 26.6%	359 28.9%	1491 29.7%
25 to 29 years		341 27.4%	299 26.2%	336 24.2%	290 23.3%	1266 25.2%
30 to 34 years		137 11.0%	173 15.2%	234 16.9%	165 13.3%	709 14.1%
35 to 39 years		60 4.8%	93 8.2%	127 9.1%	109 8.8%	389 7.8%
40 to 44 years		39 3.1%	41 3.6%	77 5.5%	79 6.4%	236 4.7%
45 to 49 years		17 1.4%	27 2.4%	64 4.6%	62 5.0%	170 3.4%
		[1] Measure Description: Source: Self-developed. Precise wording of item and response options is available on request.
Sex: Female, Male [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	1245 participants	1141 participants	1388 participants	1244 participants	5018 participants
	Female	1245 100.0%	1141 100.0%	1388 100.0%	1244 100.0%	5018 100.0%
	Male	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
		[1] Measure Description: Source: Self-developed. Precise wording of item and response options is available on request.
Current Gender Identity [1]; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	1245 participants	1141 participants	1388 participants	1244 participants	5018 participants
Female		1224 98.3%	1120 98.2%	1370 98.7%	1233 99.1%	4947 98.6%
Male		0 0.0%	1 0.1%	0 0.0%	1 0.1%	2 0.0%
Trans Woman		0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Trans Man		4 0.3%	2 0.2%	4 0.3%	1 0.1%	11 0.2%
Genderqueer		13 1.0%	13 1.1%	10 0.7%	6 0.5%	42 0.8%
Other		2 0.2%	0 0.0%	1 0.1%	2 0.2%	5 0.1%
Two or more		2 0.2%	5 0.4%	3 0.2%	1 0.1%	11 0.2%
		[1] Measure Description: Source: Cahill et al., 2014. Precise wording of item and response options is available on request.
Ethnicity [1]; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	1245 participants	1141 participants	1388 participants	1244 participants	5018 participants
Not of Hispanic, Latino, or Spanish origin		1153 92.6%	1085 95.1%	1294 93.2%	1080 86.8%	4612 91.9%
Of Hispanic, Latino, or Spanish origin(s)		71 5.7%	44 3.9%	63 4.5%	145 11.7%	323 6.4%
Missing		21 1.7%	12 1.1%	31 2.2%	19 1.5%	83 1.7%
		[1] Measure Description: Source: US Census Bureau, 2015. Precise wording of item and response options is available on request.
Race [1]; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	1245 participants	1141 participants	1388 participants	1244 participants	5018 participants
White		991 79.6%	1036 90.8%	1238 89.2%	1018 81.8%	4283 85.4%
Black or African American		49 3.9%	12 1.1%	27 1.9%	70 5.6%	158 3.1%
American Indian or Alaska Native		11 0.9%	9 0.8%	10 0.7%	12 1.0%	42 0.8%
Asian		93 7.5%	15 1.3%	15 1.1%	16 1.3%	139 2.8%
Native Hawaiian or Some other race(s)		16 1.3%	15 1.3%	18 1.3%	52 4.2%	101 2.0%
Two or more		62 5.0%	43 3.8%	53 3.8%	54 4.3%	212 4.2%
Missing		23 1.8%	11 1.0%	27 1.9%	22 1.8%	83 1.7%
		[1] Measure Description: Source: US Census Bureau, 2015. Precise wording of item and response options is available on request.
Health literacy [1]; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	1245 participants	1141 participants	1388 participants	1244 participants	5018 participants
Limited		264 21.2%	221 19.4%	296 21.3%	280 22.5%	1061 21.1%
Adequate		964 77.4%	912 79.9%	1069 77.0%	949 76.3%	3894 77.6%
Missing		17 1.4%	8 0.7%	23 1.7%	15 1.2%	63 1.3%
		[1] Measure Description: Source: Chew et al., 2008; Chew et al., 2004; Wallace et al., 2006; Dageforde et al., 2015; Sarkar et al., 2011. Precise wording of item and response options is available on request.
Educational attainment [1]; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	1245 participants	1141 participants	1388 participants	1244 participants	5018 participants
12th grade or less		64 5.1%	118 10.3%	148 10.7%	151 12.1%	481 9.6%
High school graduate		289 23.2%	304 26.6%	367 26.4%	293 23.6%	1253 25.0%
College or some college		705 56.6%	623 54.6%	705 50.8%	652 52.4%	2685 53.5%
After Bachelor's degree		169 13.6%	88 7.7%	145 10.4%	130 10.5%	532 10.6%
Missing		18 1.4%	8 0.7%	23 1.7%	18 1.4%	67 1.3%
		[1] Measure Description: Source: US Census Bureau, 2015. Precise wording of item and response options is available on request.
Health insurance coverage [1]; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	1245 participants	1141 participants	1388 participants	1244 participants	5018 participants
None		212 17.0%	206 18.1%	231 16.6%	98 7.9%	747 14.9%
Temporary Medicaid		21 1.7%	33 2.9%	24 1.7%	22 1.8%	100 2.0%
Medicaid		186 14.9%	296 25.9%	465 33.5%	526 42.3%	1473 29.4%
Private		650 52.2%	491 43.0%	526 37.9%	481 38.7%	2148 42.8%
Other		136 10.9%	84 7.4%	105 7.6%	88 7.1%	413 8.2%
Two or more		19 1.5%	22 1.9%	16 1.2%	14 1.1%	71 1.4%
Missing		21 1.7%	9 0.8%	21 1.5%	15 1.2%	66 1.3%
		[1] Measure Description: Source: Jones et al., 2008. Precise wording of item and response options is available on request.
Survey language [1]; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	1245 participants	1141 participants	1388 participants	1244 participants	5018 participants
English		1244 99.9%	1140 99.9%	1386 99.9%	1219 98.0%	4989 99.4%
Spanish		1 0.1%	1 0.1%	2 0.1%	25 2.0%	29 0.6%
		[1] Measure Description: Source: Administrative data.
Number of pregnancies [1]; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	1245 participants	1141 participants	1388 participants	1244 participants	5018 participants
None		800 64.3%	496 43.5%	715 51.5%	663 53.3%	2674 53.3%
One		180 14.5%	250 21.9%	226 16.3%	195 15.7%	851 17.0%
Two		99 8.0%	175 15.3%	180 13.0%	150 12.1%	604 12.0%
Three or more		137 11.0%	208 18.2%	236 17.0%	214 17.2%	795 15.8%
Missing		29 2.3%	12 1.1%	31 2.2%	22 1.8%	94 1.9%
		[1] Measure Description: Source: Self-developed. Precise wording of item and response options is available on request.
Number of births [1]; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	1245 participants	1141 participants	1388 participants	1244 participants	5018 participants
None		1008 81.0%	732 64.2%	875 63.0%	804 64.6%	3419 68.1%
One		117 9.4%	197 17.3%	198 14.3%	152 12.2%	664 13.2%
Two		63 5.1%	128 11.2%	185 13.3%	154 12.4%	530 10.6%
Three or more		22 1.8%	65 5.7%	91 6.6%	107 8.6%	285 5.7%
Missing		35 2.8%	19 1.7%	39 2.8%	27 2.2%	120 2.4%
		[1] Measure Description: Source: Self-developed. Precise wording of item and response options is available on request.
Number of abortions [1]; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	1245 participants	1141 participants	1388 participants	1244 participants	5018 participants
None		899 72.2%	742 65.0%	1086 78.2%	981 78.9%	3708 73.9%
One		203 16.3%	258 22.6%	193 13.9%	168 13.5%	822 16.4%
Two		82 6.6%	89 7.8%	59 4.3%	47 3.8%	277 5.5%
Three or more		33 2.7%	31 2.7%	13 0.9%	16 1.3%	93 1.9%
Missing		28 2.2%	21 1.8%	37 2.7%	32 2.6%	118 2.4%
		[1] Measure Description: Source: Self-developed. Precise wording of item and response options is available on request.
Number of miscarriages [1]; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	1245 participants	1141 participants	1388 participants	1244 participants	5018 participants
None		1124 90.3%	943 82.6%	1166 84.0%	1029 82.7%	4262 84.9%
One		66 5.3%	142 12.4%	132 9.5%	128 10.3%	468 9.3%
Two		10 0.8%	27 2.4%	30 2.2%	43 3.5%	110 2.2%
Three or more		10 0.8%	8 0.7%	21 1.5%	16 1.3%	55 1.1%
Missing		35 2.8%	21 1.8%	39 2.8%	28 2.3%	123 2.5%
		[1] Measure Description: Source: Self-developed. Precise wording of item and response options is available on request.
Previous contraceptive method(s) [1]; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	1245 participants	1141 participants	1388 participants	1244 participants	5018 participants
Highly effective method(s)		244 19.6%	255 22.3%	334 24.1%	327 26.3%	1160 23.1%
Less effective method(s)		624 50.1%	609 53.4%	660 47.6%	474 38.1%	2367 47.2%
No methods		162 13.0%	187 16.4%	154 11.1%	164 13.2%	667 13.3%
Missing		4 0.3%	1 0.1%	6 0.4%	4 0.3%	15 0.3%
Not asked		211 16.9%	89 7.8%	234 16.9%	275 22.1%	809 16.1%
		[1] Measure Description: Operationalized as what, if any, contraceptive method(s) participants used in the 4 weeks before the health care visit. Source: Self-developed. Precise wording of item and response options is available on request.

Outcome Measures

1. Primary Outcome

Title	Shared Decision-making About Contraceptive Methods
Description	Shared decision-making about contraceptive methods in the health care visit, measured using the three-item CollaboRATE measure (Barr et al., 2014; Elwyn et al., 2013). We used the version of CollaboRATE with a five-point response scale and adopted the binary scoring approach, which yields a score of 0 (no shared decision-making) and 1 (shared decision-making) for each participant. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).
Time Frame	Immediately after the index health care visit (Time 1 (T1)) [for both pre-implementation and post-implementation participants]

Outcome Measure Data

Analysis Population Description

Participants with valid data on the primary outcome of shared decision-making about contraceptive methods and all covariates included in the adjusted analytic model. Data were collected at three time points from samples receiving care before (pre-implementation) and after (post-implementation) introduction of any intervention(s).

Arm/Group Title		Video + Prompt Card	Decision Aids + Training	Video + Prompt Card and Decision Aids + Training	Usual Care
Arm/Group Description:		A brief video intended to be viewed by patients in the clinic immediately before the health care visit that encouraged them to ask their providers three questions, and a small prompt card intended to remind them of the three questions presented in the video.	A set of seven one-page decision aids on contraceptive methods intended to be used by providers with patients during the health care visit, as well as a brief training video and written guidance intended to be viewed by providers before beginning to use the decision aids (and as frequently as desired thereafter).	A brief video intended to be viewed by patients in the clinic immediately before the health care visit that encouraged them to ask their providers three questions, and a small prompt card intended to remind them of the three questions presented in the video. And A set of seven one-page decision aids on contraceptive methods intended to be used by providers with patients during the health care visit, as well as a brief training video and written guidance intended to be viewed by providers before beginning to use the decision aids (and as frequently as desired thereafter).	Care as usual.
Overall Number of Participants Analyzed		995	1031	1117	937
Measure Type: Count of Participants; Unit of Measure: Participants
Pre-implementation	Number Analyzed	296 participants	414 participants	345 participants	299 participants
	Shared decision-making	165 55.7%	272 65.7%	222 64.3%	190 63.5%
	No shared decision-making	131 44.3%	142 34.3%	123 35.7%	109 36.5%
Post-implementation	Number Analyzed	699 participants	617 participants	772 participants	638 participants
	Shared decision-making	392 56.1%	427 69.2%	459 59.5%	360 56.4%
	No shared decision-making	307 43.9%	190 30.8%	313 40.5%	278 43.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Video + Prompt Card, Usual Care
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.80
	Comments	Adjusted for multiple comparisons using the Scheffe method
	Method	See below
	Comments	Random effects logistic regression with a random intercept for clinic and adjustment for participant characteristics that differed across trial arms
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.23
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Decision Aids + Training, Usual Care
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.32
	Comments	Adjusted for multiple comparisons using the Scheffe method
	Method	See below
	Comments	Random effects logistic regression with a random intercept for clinic and adjustment for participant characteristics that differed across trial arms
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.47
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Video + Prompt Card, Video + Prompt Card and Decision Aids + Training
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.99
	Comments	Adjusted for multiple comparisons using the Scheffe method
	Method	See below
	Comments	Random effects logistic regression with a random intercept for clinic and adjustment for participant characteristics that differed across trial arms
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.95
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Decision Aids + Training, Video + Prompt Card and Decision Aids + Training
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.72
	Comments	Adjusted for multiple comparisons using the Scheffe method
	Method	See below
	Comments	Random effects logistic regression with a random intercept for clinic and adjustment for participant characteristics that differed across trial arms
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.80
	Estimation Comments	[Not Specified]

2. Secondary Outcome

Title	Conversation About Contraception
Description	Whether participants experienced a conversation about contraception in the health care visit, measured using a self-developed item. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).
Time Frame	Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]

Outcome Measure Data Not Reported

3. Secondary Outcome

Title	Satisfaction With Conversation About Contraception
Description	Participants' satisfaction with the conversation about contraception in the health care visit, measured using an adapted item (Weisman et al., 2002). Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).
Time Frame	Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]

Outcome Measure Data Not Reported

4. Secondary Outcome

Title	Intended Contraceptive Method(s)
Description	What, if any, contraceptive method(s) participants intend to use in the next four weeks, measured using a self-developed checklist. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).
Time Frame	Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]

Outcome Measure Data Not Reported

5. Secondary Outcome

Title	Intention to Use a Highly Effective Contraceptive Method
Description	Whether participants intend to use at least one highly effective contraceptive method in the next four weeks, derived from data on intended contraceptive method(s). Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).
Time Frame	Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]

Outcome Measure Data Not Reported

6. Secondary Outcome

Title	Values Concordance of Intended Contraceptive Method(s)
Description	Participants' perceptions of the degree of concordance between the contraceptive method(s) they intend(ed) to use and their individual values, needs, and preferences, measured using a self-developed item. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).
Time Frame	Immediately after the index health care visit (T1); 4 weeks after the index health care visit (Time 2 (T2)); 6 months after the index health care visit (Time 3 (T3)) [for both pre-implementation and post-implementation participants]

Outcome Measure Data Not Reported

7. Secondary Outcome

Title	Decision Regret About Intended Contraceptive Method(s)
Description	Participants' feelings of decision regret about the contraceptive method(s) they intended to use, measured using an adaptation of the five-item Decision Regret Scale (Brehaut et al., 2003; O'Connor, 1996). Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).
Time Frame	4 weeks after the index health care visit (T2); 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants]

Outcome Measure Data Not Reported

8. Secondary Outcome

Title	Contraceptive Method(s) Used
Description	What, if any, contraceptive method(s) participants used in the last four weeks, measured using a self-developed checklist. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).
Time Frame	4 weeks after the index health care visit (T2); 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants]

Outcome Measure Data Not Reported

9. Secondary Outcome

Title	Use of a Highly Effective Contraceptive Method
Description	Whether participants used at least one highly effective contraceptive method in the last four weeks, derived from data on contraceptive method(s) used. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).
Time Frame	4 weeks after the index health care visit (T2); 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants]

Outcome Measure Data Not Reported

10. Secondary Outcome

Title	Use of Intended Contraceptive Method(s)
Description	Whether participants used their intended contraceptive method(s) in the last four weeks, derived from data on intended contraceptive method(s) and contraceptive method(s) used. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).
Time Frame	4 weeks after the index health care visit (T2); 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants]

Outcome Measure Data Not Reported

11. Secondary Outcome

Title	Adherence to Contraceptive Method(s) Used
Description	Participants' adherence to the contraceptive method(s) they used in the last four weeks, measured using a self-developed, 21-item measure. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).
Time Frame	4 weeks after the index health care visit (T2); 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants]

Outcome Measure Data Not Reported

12. Secondary Outcome

Title	Satisfaction With Contraceptive Method(s) Used
Description	Participants' satisfaction with the contraceptive method(s) they used in the last four weeks, measured using a self-developed item. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).
Time Frame	4 weeks after the index health care visit (T2); 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants]

Outcome Measure Data Not Reported

13. Secondary Outcome

Title	Unintended Pregnancy (Pregnancy Timing Preferences)
Description	Participants' experience of one or more unintended pregnancies since the health care visit (as defined by their pregnancy timing preferences), measured using an adapted item (Centers for Disease Control and Prevention, 2012). Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).
Time Frame	6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants]

Outcome Measure Data Not Reported

14. Secondary Outcome

Title	Unintended Pregnancy (Pregnancy Seeking)
Description	Participants' experience of one or more unintended pregnancies since the health care visit (as defined by their pregnancy seeking), measured using an adapted item (Kavanaugh & Schwarz, 2009). Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).
Time Frame	6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants]

Outcome Measure Data Not Reported

15. Secondary Outcome

Title	Unwelcome Pregnancy
Description	Participants' experience of one or more unwelcome pregnancies since the health care visit, measured using an adapted item (Centers for Disease Control and Prevention, 2012). Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).
Time Frame	6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants]

Outcome Measure Data Not Reported

16. Other Pre-specified Outcome

Title	Exposure to Video
Description	Participants' exposure to the video and timing of exposure, measured using an adapted item (Shepherd et al., 2015). Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).
Time Frame	Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]

Outcome Measure Data Not Reported

17. Other Pre-specified Outcome

Title	Exposure to Prompt Card
Description	Participants' exposure to the prompt card and timing of exposure, measured using a self-developed item. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).
Time Frame	Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]

Outcome Measure Data Not Reported

18. Other Pre-specified Outcome

Title	Use of Three Questions
Description	Participants' use of each of the three patient questions in the health care visit, measured using three adapted items (Shepherd et al., 2015). Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).
Time Frame	Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]

Outcome Measure Data Not Reported

19. Other Pre-specified Outcome

Title	Exposure to Decision Aid(s)
Description	Participants' exposure to one or more of the decision aids and timing of exposure, measured using a self-developed item. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).
Time Frame	Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]

Outcome Measure Data Not Reported

20. Other Pre-specified Outcome

Title	Acceptability of Video
Description	The acceptability of the video to participants, measured using a self-developed item. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).
Time Frame	Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]

Outcome Measure Data Not Reported

21. Other Pre-specified Outcome

Title	Acceptability of Decision Aid(s)
Description	The acceptability of the decision aid(s) to participants, measured using a self-developed item. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).
Time Frame	Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]

Outcome Measure Data Not Reported

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	No adverse event data were collected.
Arm/Group Title	Video + Prompt Card	Decision Aids + Training	Video + Prompt Card and Decision Aids + Training	Usual Care
Arm/Group Description	A brief video intended to be viewed by patients in the clinic immediately before the health care visit that encouraged them to ask their providers three questions, and a small prompt card intended to remind them of the three questions presented in the video.	A set of seven one-page decision aids on contraceptive methods intended to be used by providers with patients during the health care visit, as well as a brief training video and written guidance intended to be viewed by providers before beginning to use the decision aids (and as frequently as desired thereafter).	A brief video intended to be viewed by patients in the clinic immediately before the health care visit that encouraged them to ask their providers three questions, and a small prompt card intended to remind them of the three questions presented in the video. And A set of seven one-page decision aids on contraceptive methods intended to be used by providers with patients during the health care visit, as well as a brief training video and written guidance intended to be viewed by providers before beginning to use the decision aids (and as frequently as desired thereafter).	Care as usual.
All-Cause Mortality
	Video + Prompt Card	Decision Aids + Training	Video + Prompt Card and Decision Aids + Training	Usual Care
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/0	0/0	0/0	0/0
Serious Adverse Events
	Video + Prompt Card	Decision Aids + Training	Video + Prompt Card and Decision Aids + Training	Usual Care
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/0	0/0	0/0	0/0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Video + Prompt Card	Decision Aids + Training	Video + Prompt Card and Decision Aids + Training	Usual Care
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/0	0/0	0/0	0/0

Limitations and Caveats

Suboptimal retention at follow-up undermined our power to detect intervention effects on most secondary outcomes.

Modest rates of intervention implementation, according to patient-reported data, should be considered when results are interpreted.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Rachel Thompson
• Organization: Dartmouth College
• Phone: 6036530860
• EMail: rachel.thompson@dartmouth.edu

Publications:

Shepherd HL, Barratt A, Jones A, Bateson D, Carey K, Trevena LJ, McGeechan K, Del Mar CB, Butow PN, Epstein RM, Entwistle V, Weisberg E. Can consumers learn to ask three questions to improve shared decision making? A feasibility study of the ASK (AskShareKnow) Patient-Clinician Communication Model((R)) intervention in a primary health-care setting. Health Expect. 2016 Oct;19(5):1160-8. doi: 10.1111/hex.12409. Epub 2015 Sep 14.

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.

Elwyn G, Barr PJ, Grande SW, Thompson R, Walsh T, Ozanne EM. Developing CollaboRATE: a fast and frugal patient-reported measure of shared decision making in clinical encounters. Patient Educ Couns. 2013 Oct;93(1):102-7. doi: 10.1016/j.pec.2013.05.009. Epub 2013 Jun 12.

Weisman CS, Maccannon DS, Henderson JT, Shortridge E, Orso CL. Contraceptive counseling in managed care: preventing unintended pregnancy in adults. Womens Health Issues. 2002 Mar-Apr;12(2):79-95. doi: 10.1016/s1049-3867(01)00147-5.

Brehaut JC, O'Connor AM, Wood TJ, Hack TF, Siminoff L, Gordon E, Feldman-Stewart D. Validation of a decision regret scale. Med Decis Making. 2003 Jul-Aug;23(4):281-92. doi: 10.1177/0272989X03256005.

O'Connor, A. 1996. User Manual - Decision Regret Scale. Ottawa. Retrieved from http://decisionaid.ohri.ca/docs/develop/User_Manuals/UM_Regret_Scale.pdf

Centers for Disease Control and Prevention. 2012. Pregnancy Risk Assessment Monitoring System (PRAMS) Phase 7 Questionnaire: Topic Reference. Atlanta, GA.

Kavanaugh ML, Schwarz EB. Prospective assessment of pregnancy intentions using a single- versus a multi-item measure. Perspect Sex Reprod Health. 2009 Dec;41(4):238-43. doi: 10.1363/4123809.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Rachel L. Thompson, Dartmouth-Hitchcock Medical Center
• ClinicalTrials.gov Identifier: NCT02759939
• Other Study ID Numbers: 00028721
• First Submitted: February 3, 2016
• First Posted: May 3, 2016
• Results First Submitted: July 24, 2018
• Results First Posted: November 19, 2019
• Last Update Posted: November 19, 2019