Trial Outcomes & Findings for Pilot Testing A Pregnancy Decision Making Tool for Women With Spinal Cord Injury (SCI) (NCT NCT04872569)

Last Updated: 2024-01-16

Results Overview

The Decisional Conflict Scale is a self-report measure. Decisional conflict refers to a state of uncertainty about a course of action. For this study, this refers to uncertainty about pursuing a future pregnancy. The Values Clarity sub-scale refers to how much a respondent is clear about the values that guide their decision-making. Sub-scale items (3) are rated on 5-point Likert scales (ranging from strongly agree \[5\] to strongly disagree \[1\]) and summed for a total score range of 3 to 15. Higher scores represent greater clarity of values.

Recruitment status

COMPLETED

Study phase

Target enrollment

23 participants

Primary outcome timeframe

12 weeks

Results posted on

2024-01-16

Participant Flow

Participant milestones

Participant milestones
Measure	Decision-making Tool Women will receive the decision making tool and use for a 3 month period. Decision-making tool: Participants will be directed to use the decision tool for 3 months using it at their own pace. The tool covers topics relevant to women with SCI considering or planning a pregnancy and reflects core elements of decision making tools based on the Ottawa Framework for Decision Support.
Overall Study STARTED	23
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Decision-making Tool Women will receive the decision making tool and use for a 3 month period. Decision-making tool: Participants will be directed to use the decision tool for 3 months using it at their own pace. The tool covers topics relevant to women with SCI considering or planning a pregnancy and reflects core elements of decision making tools based on the Ottawa Framework for Decision Support.
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Pilot Testing A Pregnancy Decision Making Tool for Women With Spinal Cord Injury (SCI)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Decision-making Tool n=23 Participants Women will receive the decision making tool and use for a 3 month period. Decision-making tool: Participants will be directed to use the decision tool for 3 months using it at their own pace. The tool covers topics relevant to women with SCI in considering or planning a pregnancy and reflects core elements of decision making tools based on the Ottawa Framework for Decision Support.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	32.7 years STANDARD_DEVIATION 6.0 • n=5 Participants
Sex: Female, Male Count by sex · Female	23 Participants n=5 Participants
Sex: Female, Male Count by sex · Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	23 participants n=5 Participants
Decisional Conflict Scale, Values Clarity sub-scale	12.9 units on a scale STANDARD_DEVIATION 1.7 • n=5 Participants
Decisional Conflict Scale, Support for Decision Making sub-scale	12.1 units on a scale STANDARD_DEVIATION 2.3 • n=5 Participants
Decisional Conflict Scale, Uncertainty about the Decision sub-scale	9.9 units on a scale STANDARD_DEVIATION 3.7 • n=5 Participants
Stage of Decision-Making Scale	2.6 units on a scale STANDARD_DEVIATION 1.1 • n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome measures
Measure	Women Using Tool n=21 Participants Women using the tool
Final Decisional Conflict Scale Score - Values Clarity Sub-scale	13.4 units on a scale Standard Deviation 1.6

PRIMARY outcome

Timeframe: 12 weeks

The Decisional Conflict Scale is a self-report measure. Decisional conflict refers to a state of uncertainty about a course of action. For this study, this refers to uncertainty about pursuing a future pregnancy. The Support for Decision Making sub-scale refers to how much support a respondent has from others about their decision-making. Sub-scale items (3) are rated on 5-point Likert scales (ranging from strongly agree \[5\] to strongly disagree \[1\]) and summed for a total score range of 3 to 15. Higher scores represent greater support for decision-making.

Outcome measures

Outcome measures
Measure	Women Using Tool n=21 Participants Women using the tool
Final Decisional Conflict Scale Score - Support Sub-scale	13.1 units on a scale Standard Deviation 2.0

PRIMARY outcome

Timeframe: 12 weeks

The Decisional Conflict Scale is a self-report measure. Decisional conflict refers to a state of uncertainty about a course of action. For this study, this refers to uncertainty about pursuing a future pregnancy. The Uncertainty about the decision sub-scale refers to how much a respondent is uncertain about the decision. Sub-scale items (3) are rated on 5-point Likert scales (ranging from strongly agree \[5\] to strongly disagree \[1\]) and summed for a total score range of 3 to 15. Higher scores represent greater certainty about the decision.

Outcome measures

Outcome measures
Measure	Women Using Tool n=21 Participants Women using the tool
Final Decisional Conflict Scale Score - Uncertainty Sub-scale	11.8 units on a scale Standard Deviation 3.3

PRIMARY outcome

Timeframe: 12 weeks

The Stage of Decision Making is a single item self-report measure. The options range from "haven't begun to think about choices" to "have already made a decision and unlikely to change my mind". The instructions were modified to refer to pregnancy and excluded the first two options of not having begun to think about choices given inclusion criteria. For this study, the scale ranged from 1 (are considering the decision now) to 4 (have already made a decision and am unlikely to change my mind). A higher score reflects greater readiness to make a decision.

Outcome measures

Outcome measures
Measure	Women Using Tool n=21 Participants Women using the tool
Final Readiness to Make a Choice in Stage of Decision-Making Scale	3.19 units on a scale Standard Deviation 1.1

SECONDARY outcome

Timeframe: 12 weeks

Acceptability of decision making tool is refers to whether the intervention is agreeable or satisfactory. In this study we measured this by self-report. We used 13 items that measured the presentation of information of the tool rated on Likert scales ranging from 1 (poor) to 4 (excellent) which are summed across all items. Possible scores can range from 13 to 52, with higher scores reflecting better information presentation.

Outcome measures

Outcome measures
Measure	Women Using Tool n=21 Participants Women using the tool
Feasibility - Acceptability	38.96 units on a scale Standard Deviation 6.5

SECONDARY outcome

Timeframe: 12 weeks

Demand refers to the likelihood of using an intervention after the study is over. For this study, it is a single item rated on Likert scales of 1 (definitely not likely) to 5 (very likely). Higher scores indicate a higher likelihood of using the tool after the study is over.

Outcome measures

Outcome measures
Measure	Women Using Tool n=21 Participants Women using the tool
Feasibility - Demand	3.43 units on a scale Standard Deviation 1.1

SECONDARY outcome

Timeframe: 12 weeks

Ease of use refers to how easy an intervention is to use. In this study, we measures ease of use of the tool with a self-report, single item rated on Likert scales ranging from 1 (very hard) to 5 (very easy). A higher rating means the tool was considered easier to use.

Outcome measures

Outcome measures
Measure	Women Using Tool n=21 Participants Women using the tool
Feasibility - Ease of Use	4.4 units on a scale Standard Deviation 1.0

Adverse Events

Decision Making Tool

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Claire Kalpakjian

University of Michigan

Phone: 734-763-0153

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place