Pregnancy Related, Spinal Cord Injuries
Conditions
Keywords
Decision tool
Brief summary
The purpose of this project is to pilot test a decision-making tool that is tailored for women with SCI to support them in the decision-making process. Pilot testing focuses on feasibility and preliminary efficacy.
Detailed description
The purpose of this project is to pilot test a decision-making tool that is tailored for women with SCI to support them in the decision-making process. Pilot testing focuses on feasibility and preliminary efficacy.
Interventions
BEHAVIORALDecision-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 disabilities in considering or planning a pregnancy and reflects core elements of decision making tools based on the Ottawa Framework for Decision Support.
Sponsors
The Craig H. Neilsen Foundation
University of Michigan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Spinal cord injury (traumatic or non-traumatic) * Need for assistance with daily life activities and/or personal care; women with mild, moderate or severe severity will be eligible * actively planning or in the process of making a decision about whether or not to get pregnant in the near future
Exclusion criteria
\- No plans for getting pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Final Decisional Conflict Scale Score - Values Clarity Sub-scale | 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 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. |
| Final Decisional Conflict Scale Score - Support Sub-scale | 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. |
| Final Decisional Conflict Scale Score - Uncertainty Sub-scale | 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. |
| Final Readiness to Make a Choice in Stage of Decision-Making Scale | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility - Demand | 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. |
| Feasibility - Ease of Use | 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. |
| Feasibility - Acceptability | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 in considering or planning a pregnancy and reflects core elements of decision making tools based on the Ottawa Framework for Decision Support. | 23 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Decision-making Tool |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants |
| Age, Continuous | 32.7 years STANDARD_DEVIATION 6 |
| Decisional Conflict Scale, Support for Decision Making sub-scale | 12.1 units on a scale STANDARD_DEVIATION 2.3 |
| Decisional Conflict Scale, Uncertainty about the Decision sub-scale | 9.9 units on a scale STANDARD_DEVIATION 3.7 |
| Decisional Conflict Scale, Values Clarity sub-scale | 12.9 units on a scale STANDARD_DEVIATION 1.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 19 Participants |
| Region of Enrollment United States | 23 participants |
| Sex: Female, Male Count by sex Female | 23 Participants |
| Sex: Female, Male Count by sex Male | 0 Participants |
| Stage of Decision-Making Scale | 2.6 units on a scale STANDARD_DEVIATION 1.1 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 23 |
| other Total, other adverse events | 0 / 23 |
| serious Total, serious adverse events | 0 / 23 |
Outcome results
Primary
Final Decisional Conflict Scale Score - Support Sub-scale
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.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Women Using Tool | Final Decisional Conflict Scale Score - Support Sub-scale | 13.1 units on a scale | Standard Deviation 2 |
Primary
Final Decisional Conflict Scale Score - Uncertainty Sub-scale
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.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Women Using Tool | Final Decisional Conflict Scale Score - Uncertainty Sub-scale | 11.8 units on a scale | Standard Deviation 3.3 |
Primary
Final Decisional Conflict Scale Score - Values Clarity Sub-scale
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.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Women Using Tool | Final Decisional Conflict Scale Score - Values Clarity Sub-scale | 13.4 units on a scale | Standard Deviation 1.6 |
Primary
Final Readiness to Make a Choice in Stage of Decision-Making Scale
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.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Women Using Tool | Final Readiness to Make a Choice in Stage of Decision-Making Scale | 3.19 units on a scale | Standard Deviation 1.1 |
Secondary
Feasibility - Acceptability
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.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Women Using Tool | Feasibility - Acceptability | 38.96 units on a scale | Standard Deviation 6.5 |
Secondary
Feasibility - Demand
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.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Women Using Tool | Feasibility - Demand | 3.43 units on a scale | Standard Deviation 1.1 |
Secondary
Feasibility - Ease of Use
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.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Women Using Tool | Feasibility - Ease of Use | 4.4 units on a scale | Standard Deviation 1 |