Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Acceptability of Intervention |
Four-item measure with scores ranging from 1 (completely disagree) to 5 (completely agree). Score is determined by calculating the mean, with a higher score indicating higher acceptability. |
Patients- T2 (within 24 hours of intervention) |
|
| Primary |
Intervention Appropriateness Measure |
Four-item measure with scores ranging from 1 (completely disagree) to 5 (completely agree). Score is determined by calculating the mean, with a higher score indicating greater acceptability. |
Patients- T2 (within 24 hours of intervention) |
|
| Primary |
System Usability Scale |
Ten-item measure with scores ranging from 1 (completely disagree) to 5 (completely agree). Score is determined by calculating the mean, with a higher score indicating greater usability. |
Patients- T2 (within 24 hours of intervention) |
|
| Primary |
Perceived Value of Tool to Providers |
Five-item measure with scores ranging from 1 (completely disagree) to 5 (completely agree). Score is determined by calculating the mean, with a higher score indicating higher perceived value. |
Providers- T5 (6 months after recruitment ends) |
|
| Primary |
Acceptability of intervention to providers |
Four-item measure with scores ranging from 1 (completely disagree) to 5 (completely agree). Score is determined by calculating the mean, with a higher score indicating higher acceptability. |
Providers- T5 (6 months after recruitment ends) |
|
| Primary |
Intervention Appropriateness Measure for providers |
Four-item measure with scores ranging from 1 (completely disagree) to 5 (completely agree). Score is determined by calculating the mean, with a higher score indicating greater acceptability. |
Providers- T5 (6 months after recruitment ends) |
|
| Secondary |
ReproKnow (adapted) |
Completion of a 10-item multiple choice instrument adapted from ReproKnow, a validated instrument for assessing knowledge of reproductive health in rheumatic diseases. Answers will be coded as correct or incorrect. The percentage of correct responses across the 10 questions will be calculated for each participant. The score range is 0 to 100%. Participant knowledge will be measured at baseline and following their first clinic visit post-use of the tool to assess the sustained impact of the decision aid on knowledge. |
T3 (up to 12 weeks post-tool use) compared to T0 (baseline) |
|
| Secondary |
Shared Decision-Making (collaboRATE) |
Three-item measure with 5-point Likert scale questions of 0 (no effort was made) to 4 (every effort was made) to assess shared decision-making between patients and providers. The mean of all three items is calculated. Higher scores represent more shared decision-making. |
T3 (up to 12 weeks post-tool use) ; T4 (up to 24 weeks post-tool use) |
|
| Secondary |
Perceived Efficacy in Patient-Physician Interactions |
Five-item measure with 5-point Likert scale questions from 1 (not at all confident) to 5 (very confident). Score is determined by the sum (possible range of 5 to 25) with higher score indicating higher perceived efficacy in communicating with providers |
T3 (up to 12 weeks post-tool use) |
|
| Secondary |
Reproductive Self Efficacy |
Five-item measure with 5-point Likert scale questions from 1 (not at all confident) to 5 (very confident). Score is determined by the sum (possible range of 5 to 25) with higher score indicating higher perceived efficacy in communicating with providers. |
T3 (up to 12 weeks post-tool use) compared to T0 (baseline) |
|
| Secondary |
Change in Pregnancy Intention |
Desire to Avoid Pregnancy scale- 14-item measure with 5-point Likert scale questions from 0 (strongly agree) to 4 (strongly disagree). Score is determined by calculating the mean (range of 0-4) with higher scores reflecting a higher desire to avoid pregnancy |
Change between T3 (up to 12 weeks post-tool use) and T0 (baseline) |
|
| Secondary |
Quantity and quality of reproductive conversations |
Three-item measure. Did you discuss reproductive goals with your CF team- Yes/no/don't know; [if yes] Rate the quality of the discussion from 0 (very poor) to 4 (very good); [if no] why not discussed- Assessed by participant response to a multiple choice item asking why reproductive goals were not discussed (time, patient comfort, provider comfort, unfamiliar provider, other visit priorities, unsure, other) |
T3 (up to 12 weeks post-tool use) ; T4 (up to 24 weeks post-tool use) |
|
| Secondary |
Participant Feedback to Tool |
Informed by in-depth interviews with women about their likes and dislikes of the MyVoice tool, their perceived barriers and facilitators to its use, if/how MyVoice could be used in their own lives. Questions also assess whether the CF team discussed reproductive health and if/how MyVoice influenced those decisions. |
T3 (up to 12 weeks post-tool use) |
|
| Secondary |
Participant Change in Contraceptive Use |
Assessed by participant responses to a multiple choice item asking which methods of contraception they are currently using (in the past 2 weeks). Reasons for non-use assessed by response to a multiple choice item asking why they are not currently using contraception. |
T4 (up to 24 weeks post-tool use) compared to T0 (baseline) |
|
| Secondary |
Participant Confidence in Contraceptive Method Selection |
Assessed by participant responses to a 5-point Likert scale regarding satisfaction with current contraceptive method(s). Response options range from 1 ("Very Unsatisfied") to 5 ("Very Satisfied"). |
T4 (up to 24 weeks post-tool use) compared to T0 (baseline) |
|
| Secondary |
Participant number of pregnancies during study |
Assessed by participant-reported survey responses to a Yes/No item about whether a pregnancy has occurred since enrollment. |
T4 (up to 24 weeks post-tool use) compared to T0 (baseline) |
|
| Secondary |
Participant receipt of infertility care |
Yes/No to question of whether pregnancy occurred with or without medical intervention; multiple choice question assessing what type of medical intervention was used. |
T4 (up to 24 weeks post-tool use) compared to T0 (baseline) |
|
| Secondary |
Participant receipt of preconception counseling |
Y/No to question of whether pregnancy was discussed prior to conception with health care provider; multiple choice question of source of preconception care |
T4 (up to 24 weeks post-tool use)compared to T0 (baseline) |
|
| Secondary |
Participant Desire for future pregnancy |
3-item measure assessing feelings about future pregnancy- question on desire for future child, question on preferred timing, question on emotional response if she became pregnant now. |
T4 (up to 24 weeks post-tool use) compared to T0 (baseline) |
|
| Secondary |
Intent to breastfeed |
1-item measure asking how participant would feed a future baby (breastfeeding, bottle feeding, combination, unknown) |
T4 (up to 24 weeks post-tool use) compared to T0 (baseline) |
|
| Secondary |
Receipt of SRH care |
Asks whether participant has visited a clinic for any of the following over the course of the study: birth control prescription, birth control counselling, pregnancy test, preconception counseling, prenatal care. |
T4 (up to 24 weeks post-tool use) compared to T0 (baseline) |
|
