Pilot Testing a New Pregnancy Decision Making Tool for Women With Physical Disabilities
Phase: NA
Conditions: Disability Physical
Sponsor: University of Michigan

 
 
 
PILOT TESTING A NEW PREGNANCY DECISION MAKING TOOL FOR WOMEN WITH PHYSICAL 
DISABILITIES 
 
NCT04651114 
 
October 28, 2020 
 
 

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INTRODUCTION 
Due to advances in maternal and fetal healthcare and the expansion of civil rights, between 100,000 and 
200,000 American women with physical disabilities (WWPD) are pregnant each year.1 Birth rates among WWPD 
have tripled since 2000,2 with comparable rates of live births as their peers without disability.3  Physical disability 
resulting from injury or illness is characterized by a loss of physical function and mobility. A decision to pursue 
pregnancy should involve well-informed deliberation between a woman and her clinicians given potential risks 
and tradeoffs in health (e.g., pre-term birth, miscarriage, infection) and function (e.g., further loss of mobility 
and independence). Unfortunately, enduring stigma continues to influence the experience of many WWPD 
seeking counsel about pregnancy.4 Receipt of family planning services are highly variable, with WWPD with low 
education, low income and who are unemployed are particularly disadvantaged.5 Clinicians’ limited competence 
in disability6,7 and lack of clinical guidelines8 result in a substandard decision-making process for many. The 
development of a decision-making tool specifically for WWPD considering pregnancy can significantly improve 
the decision-making process by driving high quality decisions – that is, decisions that are informed by the 
evidence and align with the woman’s values and preferences. Ultimately, a better decision-making process can 
improve healthcare quality and outcomes for this population of women. However, many pregnancy-related 
decision-making tools focus on pre-natal testing or delivery options9 and few, if any, focus on the decision to 
become pregnant. None are designed to comprehensively address the complexities, challenges, and biases that 
WWPD often face in the decision to pursue pregnancy.  
Despite a long history of stigma and discrimination, tens of thousands of WWPD in the U.S. are having children 
every year; a substantial number do so despite having a severe disability.1,10 Women with disabilities are no 
different than their non-disabled peers in their desire or intention to have children, but they are almost twice as 
likely to be uncertain whether they will be able to realize their intention.11 For many WWPD, pregnancy is not 
without elevated risk and significant tradeoffs in health, function and independence. The decision to pursue 
pregnancy is too often made in a vacuum of knowledge and guidance by clinicians, and in many cases, in the 
face of bias and discrimination. Clinicians face their own ambivalence and limited knowledge of disability in 
providing necessary care.6 Their ambivalence reflects broader societal expectations that women with disabilities 
are asexual and that pregnancy is highly improbable.12,13 Such longstanding myths and barriers have resulted in 
ill-informed and inadequate healthcare dramatically out of step with the hopes of WWPD.  
METHODS 
Sample Characteristics – In this study, physical disability is defined by loss or impairment of physical function 
limiting one or more important life activities. It can occur as a result of but not limited to: 1) traumatic injury, 
such as spinal cord injury; 2) neuro-developmental conditions, such as cerebral palsy; 3) chronic medical 
conditions, such as multiple sclerosis; or 4) a combination of these. Three items from the Behavioral Risk Factors 
Surveillance System14 will determine disability severity based on the need for assistance with daily life activities 
and/or personal care; women with mild, moderate or severe severity will be eligible. Women who are eligible 
will be actively planning or in the process of making a decision about whether or not to get pregnant in the near 
future. The language is deliberately open based on feedback from women during development. The decision-
making process or many women with physical disabilities can be protracted given many uncertainties and a 
general lack of information and health care provider expertise.  
Description of the Decision Making Tool – The decision making tool is a 23-page tool and set of 9 downloadable 
worksheets (uploaded in Section 12, Exemption 3, #8 of the application). We developed the tool through 
iterative brainstorming sessions with stakeholders and used a survey, focus group, and interview data from 
women with physical disabilities who have been pregnant, decided not to get pregnant, or are considering a 
future pregnancy. The tool covers topics relevant to women with disabilities in considering or planning a 

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pregnancy and reflects core elements of decision making tools based on the Ottawa Framework for Decision 
Support.15 This framework targets determinants of decisions that may be potentially modifiable by a decision-
making tool, but are currently suboptimal for patients and health care providers due to factors such as 
inadequate knowledge, high uncertainty, or biased perceptions of others.  
Section Title 
Content 
Overview of Pregnancy 
Reviews changes in a woman’s body during pregnancy. This is not meant to be 
exhaustive but a general overview. 
Knowing what is important to 
you 
Reflects ODSF’ values component. It has several options to answer questions about 
values to explore what is important to guide decision-making. The associated 
worksheet (#1) focuses on what is important as a foundation for decision-making. 
Partners, family and important 
relationships 
Reflects ODFS’ support component. Guides talking about the decision and engaging 
those most important in discussions. The two associated worksheets support 
conversations about pregnancy and decision making that can be challenging to have 
(#2 and #3).   
Physical function and 
independence 
Reviews major domains of physical function and the possible effects of pregnancy on 
independence. The associated worksheet (#4) highlights topic areas to discuss with 
different health care providers. 
Health and wellbeing 
An overview of the different medical specialties that might be involved in care during 
planning and during a pregnancy and reviews major areas of mental and physical 
health that could be affected during pregnancy. The associated worksheet (#5) 
presents a series of questions to review with family and health care providers. 
Caring for an infant 
Encourages consideration of various aspects of caring for an infant that may be 
relevant. The associated worksheet (#6) provides a list of considerations to support 
further dialog with family and health care providers. 
Financial resources & 
insurance 
Addresses the need for financial planning in anticipation of a pregnancy and childcare. 
The associated worksheet (#7) reviews various aspects of planning to consider as part 
of decision-making. 
How to find reliable 
information and resources 
Provides guidance for how to find information and judge its quality. The associated 
worksheet (#8) provides a step-by-step guide for evaluating online resources. 
Connecting with other women 
with physical disabilities 
General guidance for connecting to peers. 
Dealing with reactions of 
others, stigma and bias, 
pressure 
Addresses the pressures women with disabilities can face during decision-making 
about pregnancy. 
Reaching a decision 
A closing section that highlights acceptance of wherever the user is in the decision-
making process, the different ways they may feel, and encourages taking breaks if 
needed.   
Intervention Delivery, Feasibility and Efficacy Testing – We will provide the tool for a 3-month trial to 40 WWPD, 
allowing each woman to use the tool at her own pace. A pre-post design was selected following the 
recommendations of O’Connor and Jacobsen16 for pilot testing new decision-making tools; this will help us 
prepare the tool for the next phase of testing that will utilize a parallel groups design. Similarly, the sample size 
was based on feasibility at this stage of the tool’s development. We will assess outcomes at baseline, 6 weeks 
and the end of the trial period. For pilot testing at this stage of the tool’s development, we are interested in 
several dimensions of feasibility and preliminary support for its efficacy. Using Bowen et al.’s phases of 

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intervention development,17 we are primarily concerned with assessing “can it work”.  Participants will be 
compensated $40 for their time. 
Outcome Assessment – In pilot testing the new tool, we are interested in feasibility and preliminary 
effectiveness. Specifically, we are interested in the tool’s acceptability, demand for it, and its implementation (or 
use of the tool). For preliminary efficacy, the goal for pilot testing is not for a woman to make a decision about 
pregnancy during the intervention period. Rather, assessment will focus on three domains of interest we expect 
to be influenced positively by the use of the tool.  
We will also ask a sub-set of women if they would be interested in an opened ended interview to learn more 
about their experience using the tool and any other feedback they wish to share. This is not required and is not 
highly structured; it will be an informal conversation for those wishing to share more in depth feedback. 
• 
Decisional conflict is characterized by uncertainty about a decision. The Decisional Conflict Scale (DCS)18 is a 
widely used outcome measure of decision-making with strong support for its validity.18-20 We will use the 
uncertainty sub-scale for decisional conflict, the support subscale for having the support of others, and the 
values subscale for clarity of values.  
• 
Decision or choice predisposition will be assessed using the single-item Stage of Decision-Making Scale.21 
The scale ranges from “haven’t begun to think about choices” to “have already made a decision and unlikely 
to change my mind” but are modified to fit pregnancy and excludes the option of not having begun to think 
about choices since we are only including women actively planning or considering a future pregnancy. 
Outcomes, measures, and time when collected are summarized in the table. All measures will be completed via 
online survey, or by telephone if requested by the participant. 
Dimension of 
feasibility 
Evaluates 
Study-Specific 
Outcomes 
Measures 
When  
Collected (Baseline, 6 
weeks, 12 weeks) 
Acceptability 
How participants 
react to the 
intervention 
Satisfaction with tool; 
usefulness of the tool; 
intent to keep using 
the tool 
Likert scales of overall 
satisfaction, usefulness; 
ratings of the presentation 
and balance of information.  
12 weeks 
Demand 
How much the 
intervention is 
likely to be used 
Frequency of actual 
use of the tool, 
interest in using the 
tool 
Logbook of actual use 
(dates, duration) and 
interest in continuing to use 
the tool 
Demand item: 6 and 
12 weeks. 
Logbook: throughout 
Implementation 
How can the tool 
be delivered 
successfully 
Factors affecting the 
use of the tool, ease or 
difficulty of using the 
tool 
Likert scales of barriers and 
facilitators of tool use 
12 weeks 
Preliminary 
efficacy 
Does the tool 
show promise of 
being successful 
with the intended 
population  
Less decisional conflict; 
support of others; 
more clarity of values; 
greater readiness to 
make a decision (stage 
of decision making) 
Decisional Conflict Scale sub-
scales; Stage of Decision-
Making Scale. 
Baseline, 6 and 12 
weeks 
Analysis – General linear models (GLM) repeated measures will be used to model decisional conflict sub-scales 
and readiness to make a decision as a function of time, with the expectation that scores would increase over the 
course of the pilot testing. Mean imputation will be used for missing data. 

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REFERENCES 
 
1. 
Iezzoni LI, Yu J, Wint AJ, Smeltzer SC, Ecker JL. Prevalence of current pregnancy among US women with 
and without chronic physical disabilities. Med Care. 2013;51(6):555-562. 
2. 
Horner-Johnson W, Biel FM, Darney BG, Caughey AB. Time trends in births and cesarean deliveries 
among women with disabilities. Disabil Health J. 2017;10(3):376-381. 
3. 
Horner-Johnson W, Kulkarni-Rajasekhara S, Darney BG, Dissanayake M, Caughey AB. Live birth, 
miscarriage, and abortion among U.S. women with and without disabilities. Disabil Health J. 
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4. 
Mitra M, Clements KM, Zhang J, Iezzoni LI, Smeltzer SC, Long-Bellil LM. Maternal Characteristics, 
Pregnancy Complications, and Adverse Birth Outcomes Among Women With Disabilities. Medical care. 
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5. 
Mosher W, Bloom T, Hughes R, Horton L, Mojtabai R, Alhusen JL. Disparities in receipt of family planning 
services by disability status: New estimates from the National Survey of Family Growth. Disabil Health J. 
2017;10(3):394-399. 
6. 
Walsh-Gallagher D, Mc Conkey R, Sinclair M, Clarke R. Normalising birth for women with a disability: The 
challenges facing practitioners. Midwifery. 2013;29(4):294-299. 
7. 
Long-Bellil L, Mitra M, Iezzoni LI, Smeltzer SC, Smith LD. Experiences and unmet needs of women with 
physical disabilities for pain relief during labor and delivery. Disabil Health J. 2017;10(3):440-444. 
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Mitra M, Smith LD, Smeltzer SC, Long-Bellil LM, Sammet Moring N, Iezzoni LI. Barriers to providing 
maternity care to women with physical disabilities: Perspectives from health care practitioners. Disabil 
Health J. 2017. 
9. 
Dugas M, Shorten A, Dube E, Wassef M, Bujold E, Chaillet N. Decision aid tools to support women's 
decision making in pregnancy and birth: a systematic review and meta-analysis. Social science & 
medicine (1982). 2012;74(12):1968-1978. 
10. 
Horner-Johnson W, Darney BG, Kulkarni-Rajasekhara S, Quigley B, Caughey AB. Pregnancy among US 
women: differences by presence, type, and complexity of disability. Am J Obstet Gynecol. 
2016;214(4):e1-9. 
11. 
Shandra CL, Hogan DP, Short SE. Planning for motherhood: fertility attitudes, desires and intentions 
among women with disabilities. Perspect Sex Reprod Health. 2014;46(4):203-210. 
12. 
Iezzoni LI, Wint AJ, Smeltzer SC, Ecker JL. "How did that happen?" Public responses to women with 
mobility disability during pregnancy. Disabil Health J. 2015;8(3):380-387. 
13. 
Iezzoni LI, Mitra M. Transcending the counter-normative: Sexual and reproductive health and persons 
with disability. Disabil Health J. 2017;10(3):369-370. 
14. 
Diab ME, Johnston MV. Relationships between level of disability and receipt of preventive health 
services. Arch Phys Med Rehabil. 2004;85(5):749-757. 
15. 
O'Connor AM, Tugwell P, Wells GA, et al. A decision aid for women considering hormone therapy after 
menopause: decision support framework and evaluation. Patient Educ Couns. 1998;33:267-279. 
16. 
O'Connor A, Jacobsen MJ. Workbook on Developing and Evaluating Patient Decision Aids. The Ottawa 
Hospital Research Institute; 2003. 
17. 
Bowen DJ, Kreuter M, Spring B, et al. How we design feasibility studies. American journal of preventive 
medicine. 2009;36(5):452-457. 
18. 
O'Connor AM. Validation of a decisional conflict scale. Med Decis Making. 1995;15(1):25-30. 
19. 
Katapodi MC, Munro ML, Pierce PF, Williams RA. Psychometric testing of the decisional conflict scale: 
genetic testing hereditary breast and ovarian cancer. Nursing research. 2011;60(6):368-377. 
20. 
Song MK, Sereika SM. An evaluation of the Decisional Conflict Scale for measuring the quality of end-of-
life decision making. Patient Educ Couns. 2006;61(3):397-404. 
21. 
O'Connor A. User Manual - Stage of Decision Making. Ottawa Research Institute;2000. 
 

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 HUM00189778 Protocol v2, 10.28.2020                                                                                                                                   Page 7 of 9 
 
OUTCOME MEASURES 
Acceptability – How participants react to the intervention 
Items drawn from O'Connor and Cranney, User Manual - Acceptability, 1996, 2002. www.ohri.ca/decisionaid.) 
• 
Collected at the end of the trial. 
Items 
Response set 
Please rate each section about how the information 
was presented in section X. (Each section header 
given.) 
poor, fair, good, excellent 
The length of the tool was … 
too long, too short, just right 
The amount of information in the tool was … 
too much information, too little information, just 
right  
The way information was presented in the tool was 
… 
slanted toward getting pregnant, slanted towards not 
getting pregnant, balanced 
How was this tool useful or not in supporting your 
decision making about pregnancy?  
 Open ended comments 
How useful was the worksheet for X (each one in 
separate item)? 
Very useful, somewhat useful, uncertain, not very 
useful, not at all useful 
Do you think the tool will help women with a 
disability make a decision about whether or not to 
get pregnant?   
Yes, No, Uncertain; Comments  
What did you like or not like about the tool and 
worksheets? 
Open ended comments 
What suggestions do you have to improve the tool 
and worksheets? 
Open ended comments 
Demand – How much the intervention is likely to be used  
• 
Collected during trial (log book) and 6 weeks and end of trial (likelihood of using) 
Item 
Response set 
Log book of use 
Simple paper or digital log of dates and duration the woman used the 
tool during the pilot testing period. 
How likely are you to keep using 
the tool after the study is over?  
Very likely, somewhat likely, not sure, not likely, definitely not likely 
 
 

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Implementation – How can the tool be delivered successfully  
• 
Collected at the end of the trial. 
Item 
Response set 
In general, how easy was it to use the tool? This would 
be things like going through the chapters, using the 
worksheets. 
Very easy, somewhat easy, neither easy nor hard, 
somewhat hard, very hard 
What made the tool easy or hard to use? 
Open comments 
Were there things that made the tool hard to use, if 
any?  
Open comments 
Were there things that made the tool easy to use? 
Open comments 
Preliminary Efficacy 
Decisional Conflict Scale: Values clarity, Support, and Uncertainty subscales (O'Connor AM. Validation of a 
decisional conflict scale. Med Decis Making. 1995;15(1):25-30.) 
• 
Response scale: strongly agree, agree, neither agree nor disagree, disagree, strongly disagree 
• 
Collected at baseline, 6 weeks and end of pilot testing 
Sub-scale 
Items 
Values Clarity 
I am clear about which values matter most to me.  
  
I am clear about which risks matter most. 
  
I am clear about what is important to me. 
Support 
I have enough support from others to make a choice. 
  
I am choosing without pressure from others. 
  
I have enough advice to make a choice. 
Uncertainty 
I am clear about the best choice for me. 
  
I feel sure about what to choose. 
  
This decision is easy for me to make.  
Stage of Decision-Making Scale (O'Connor A. User Manual - Stage of Decision Making. Ottawa Research 
Institute;2000). 
• 
Collected at baseline, 6 weeks and end of pilot testing 
Item 
Response set 
Making a decision about whether 
or not to get pregnant can be 
complicated. At this time, would 
you say you: 
haven't begun to think about it (1)* 
haven't begun to think about it, but am interested in doing so (2)* 
are considering the decision now (3) 
are close to making a decision (4) 

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have already made a decision, but am willing to reconsider (5) 
have already made a decision and am unlikely to change my mind (6) 
* These options are not relevant given our inclusion criteria