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Right For Me: Birth Control Decisions Made Easier

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
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
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
Hide 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.
Arm/Group Title Video + Prompt Card Decision Aids + Training Video + Prompt Card and Decision Aids + Training Usual Care Total
Hide 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
Hide 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.
1.Primary Outcome
Title Shared Decision-making About Contraceptive Methods
Hide 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]
Hide Outcome Measure Data
Hide 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
Hide 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%
Hide 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]
Hide 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]
Hide 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]
Hide 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
Hide 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
Hide 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)
Hide 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
Hide 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)
Hide 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)
Hide 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
Hide 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
Hide 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)
Hide 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
Hide 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
Hide 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)
Hide 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)
Hide 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
Hide 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
Hide 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
Hide 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
Hide 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)
Hide 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
Hide 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)
Hide 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
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
Hide 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 
Hide 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 
Hide 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 

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.

Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Rachel Thompson
Organization: Dartmouth College
Phone: 6036530860
EMail: rachel.thompson@dartmouth.edu
Publications:
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.
Layout table for additonal information
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