Trial Outcomes & Findings for Pilot Testing a New Pregnancy Decision Making Tool for Women With Physical Disabilities (NCT NCT04651114)

Last Updated: 2022-07-14

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

38 participants

Primary outcome timeframe

12 weeks

Results posted on

2022-07-14

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: Women will be directed to a secure website to download a copy of the decision making tool and worksheets (they can download as many copies as they wish to). The women will use the tool and worksheets at their own pace for the pilot study period. The decision making tool is a 23-page tool and set of 9 downloadable worksheets. The tool covers topics relevant to women with disabilities in considering or planning a pregnancy: 1) Overview of Pregnancy: 2) Knowing what is important; 3) Partners, family and important relationships; 4) Physical function and independence; 5) Health and wellbeing; 6) Caring for an infant; 7) Financial resources \& insurance; 8) How to find reliable information and resources; 9) Connecting with other women with physical disabilities; 10) Dealing with reactions of others, stigma and bias, pressure; and 11) Reaching a decision.
Overall Study STARTED	38
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	8

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: Women will be directed to a secure website to download a copy of the decision making tool and worksheets (they can download as many copies as they wish to). The women will use the tool and worksheets at their own pace for the pilot study period. The decision making tool is a 23-page tool and set of 9 downloadable worksheets. The tool covers topics relevant to women with disabilities in considering or planning a pregnancy: 1) Overview of Pregnancy: 2) Knowing what is important; 3) Partners, family and important relationships; 4) Physical function and independence; 5) Health and wellbeing; 6) Caring for an infant; 7) Financial resources \& insurance; 8) How to find reliable information and resources; 9) Connecting with other women with physical disabilities; 10) Dealing with reactions of others, stigma and bias, pressure; and 11) Reaching a decision.
Overall Study Withdrawal by Subject	8

Baseline Characteristics

Pilot Testing a New Pregnancy Decision Making Tool for Women With Physical Disabilities

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Decision-making Tool n=38 Participants Women will receive the decision making tool and use for a 3 month period. Decision-making tool: Women will be directed to a secure website to download a copy of the decision making tool and worksheets (they can download as many copies as they wish to). The women will use the tool and worksheets at their own pace for the pilot study period. The decision making tool is a 23-page tool and set of 9 downloadable worksheets. The tool covers topics relevant to women with disabilities in considering or planning a pregnancy: 1) Overview of Pregnancy: 2) Knowing what is important; 3) Partners, family and important relationships; 4) Physical function and independence; 5) Health and wellbeing; 6) Caring for an infant; 7) Financial resources \& insurance; 8) How to find reliable information and resources; 9) Connecting with other women with physical disabilities; 10) Dealing with reactions of others, stigma and bias, pressure; and 11) Reaching a decision.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	38 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	33.1 years STANDARD_DEVIATION 5.1 • n=5 Participants
Sex: Female, Male Female	38 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 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	3 Participants n=5 Participants
Race (NIH/OMB) White	33 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	38 Participants n=5 Participants
Decisional Conflict Scale, Values Clarity sub-scale	12.59 units on a scale STANDARD_DEVIATION 2.3 • n=5 Participants
Decisional Conflict Scale, Support for Decision Making sub-scale	11.03 units on a scale STANDARD_DEVIATION 3.0 • n=5 Participants
Decisional Conflict Scale, Uncertainty about the Decision sub-scale	9.37 units on a scale STANDARD_DEVIATION 3.6 • n=5 Participants
Stage of Decision-Making Scale	2.17 units on a scale STANDARD_DEVIATION 1.2 • n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome measures
Measure	Decision-making Tool n=30 Participants Women will receive the decision making tool and use for a 3 month period. Decision-making tool: Women will be directed to a secure website to download a copy of the decision making tool and worksheets (they can download as many copies as they wish to). The women will use the tool and worksheets at their own pace for the pilot study period. The decision making tool is a 23-page tool and set of 9 downloadable worksheets. The tool covers topics relevant to women with disabilities in considering or planning a pregnancy: 1) Overview of Pregnancy: 2) Knowing what is important; 3) Partners, family and important relationships; 4) Physical function and independence; 5) Health and wellbeing; 6) Caring for an infant; 7) Financial resources \& insurance; 8) How to find reliable information and resources; 9) Connecting with other women with physical disabilities; 10) Dealing with reactions of others, stigma and bias, pressure; and 11) Reaching a decision.
Final Decisional Conflict Scale Score - Values Clarity Sub-scale	13.1 units on a scale Standard Deviation 2.3

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	Decision-making Tool n=30 Participants Women will receive the decision making tool and use for a 3 month period. Decision-making tool: Women will be directed to a secure website to download a copy of the decision making tool and worksheets (they can download as many copies as they wish to). The women will use the tool and worksheets at their own pace for the pilot study period. The decision making tool is a 23-page tool and set of 9 downloadable worksheets. The tool covers topics relevant to women with disabilities in considering or planning a pregnancy: 1) Overview of Pregnancy: 2) Knowing what is important; 3) Partners, family and important relationships; 4) Physical function and independence; 5) Health and wellbeing; 6) Caring for an infant; 7) Financial resources \& insurance; 8) How to find reliable information and resources; 9) Connecting with other women with physical disabilities; 10) Dealing with reactions of others, stigma and bias, pressure; and 11) Reaching a decision.
Final Decisional Conflict Scale Score - Support Sub-scale	12.6 units on a scale Standard Deviation 2.1

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	Decision-making Tool n=30 Participants Women will receive the decision making tool and use for a 3 month period. Decision-making tool: Women will be directed to a secure website to download a copy of the decision making tool and worksheets (they can download as many copies as they wish to). The women will use the tool and worksheets at their own pace for the pilot study period. The decision making tool is a 23-page tool and set of 9 downloadable worksheets. The tool covers topics relevant to women with disabilities in considering or planning a pregnancy: 1) Overview of Pregnancy: 2) Knowing what is important; 3) Partners, family and important relationships; 4) Physical function and independence; 5) Health and wellbeing; 6) Caring for an infant; 7) Financial resources \& insurance; 8) How to find reliable information and resources; 9) Connecting with other women with physical disabilities; 10) Dealing with reactions of others, stigma and bias, pressure; and 11) Reaching a decision.
Final Decisional Conflict Scale Score - Uncertainty Sub-scale	11.3 units on a scale Standard Deviation 2.9

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	Decision-making Tool n=30 Participants Women will receive the decision making tool and use for a 3 month period. Decision-making tool: Women will be directed to a secure website to download a copy of the decision making tool and worksheets (they can download as many copies as they wish to). The women will use the tool and worksheets at their own pace for the pilot study period. The decision making tool is a 23-page tool and set of 9 downloadable worksheets. The tool covers topics relevant to women with disabilities in considering or planning a pregnancy: 1) Overview of Pregnancy: 2) Knowing what is important; 3) Partners, family and important relationships; 4) Physical function and independence; 5) Health and wellbeing; 6) Caring for an infant; 7) Financial resources \& insurance; 8) How to find reliable information and resources; 9) Connecting with other women with physical disabilities; 10) Dealing with reactions of others, stigma and bias, pressure; and 11) Reaching a decision.
Final Readiness to Make a Choice in Stage of Decision-Making Scale	3.1 units on a scale Standard Deviation 1.0

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 11 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 11 to 44, with higher scores reflecting better information presentation.

Outcome measures

Outcome measures
Measure	Decision-making Tool n=30 Participants Women will receive the decision making tool and use for a 3 month period. Decision-making tool: Women will be directed to a secure website to download a copy of the decision making tool and worksheets (they can download as many copies as they wish to). The women will use the tool and worksheets at their own pace for the pilot study period. The decision making tool is a 23-page tool and set of 9 downloadable worksheets. The tool covers topics relevant to women with disabilities in considering or planning a pregnancy: 1) Overview of Pregnancy: 2) Knowing what is important; 3) Partners, family and important relationships; 4) Physical function and independence; 5) Health and wellbeing; 6) Caring for an infant; 7) Financial resources \& insurance; 8) How to find reliable information and resources; 9) Connecting with other women with physical disabilities; 10) Dealing with reactions of others, stigma and bias, pressure; and 11) Reaching a decision.
Feasibility - Acceptability	35.7 units on a scale Standard Deviation 6.4

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	Decision-making Tool n=30 Participants Women will receive the decision making tool and use for a 3 month period. Decision-making tool: Women will be directed to a secure website to download a copy of the decision making tool and worksheets (they can download as many copies as they wish to). The women will use the tool and worksheets at their own pace for the pilot study period. The decision making tool is a 23-page tool and set of 9 downloadable worksheets. The tool covers topics relevant to women with disabilities in considering or planning a pregnancy: 1) Overview of Pregnancy: 2) Knowing what is important; 3) Partners, family and important relationships; 4) Physical function and independence; 5) Health and wellbeing; 6) Caring for an infant; 7) Financial resources \& insurance; 8) How to find reliable information and resources; 9) Connecting with other women with physical disabilities; 10) Dealing with reactions of others, stigma and bias, pressure; and 11) Reaching a decision.
Feasibility - Demand	4 units on a scale Standard Deviation 1.3

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	Decision-making Tool n=30 Participants Women will receive the decision making tool and use for a 3 month period. Decision-making tool: Women will be directed to a secure website to download a copy of the decision making tool and worksheets (they can download as many copies as they wish to). The women will use the tool and worksheets at their own pace for the pilot study period. The decision making tool is a 23-page tool and set of 9 downloadable worksheets. The tool covers topics relevant to women with disabilities in considering or planning a pregnancy: 1) Overview of Pregnancy: 2) Knowing what is important; 3) Partners, family and important relationships; 4) Physical function and independence; 5) Health and wellbeing; 6) Caring for an infant; 7) Financial resources \& insurance; 8) How to find reliable information and resources; 9) Connecting with other women with physical disabilities; 10) Dealing with reactions of others, stigma and bias, pressure; and 11) Reaching a decision.
Feasibility - Ease of Use	4.5 units on a scale Standard Deviation 1.2

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