An interventional study of DA Scaling Strategies in Decision Aid, sponsored by CHU de Quebec-Universite Laval. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-18.
Sponsored by CHU de Quebec-Universite Laval · Not applicable, Interventional, and Health services research
This research project aims at assessing the effectiveness of a decision aid (DA) scaling intervention within the context of prenatal screening for trisomy 21, 18 and 13. The primary outcome is the level of involvement of pregnant women, their partners, and health professionals in shared decision-making (SDM) in the context of prenatal screening for trisomy 21, 18 and 13. The secondary outcome is the rate of use of online and paper versions of the DA by pregnant women, their partners and health professionals. The investigator hypothesize that the DA scaling strategies will increase the level of involvement of pregnant women, their partners (where appropriate), and health professionals in SDM.
Making a decision about prenatal screening for trisomy 21, 18 and 13 can be difficult. This is why it is important for pregnant women and their partners to be informed, accompanied and supported by health care providers. Involving them in shared decision-making (SDM) would allow them to meet their decision-making needs in this context. In addition, the use of a decision aid (DA) would facilitate SDM. To help pregnant women and their partners make informed decisions based on their values, needs and preferences, a DA has been developed. The DA was developed according to recommendations from pregnant women and their partners as well as health professionals who found it relevant. Moreover, the DA scaling up strategies were developed. This research project aim is to assess the effectiveness of the DA scaling strategies on the level of involvement of pregnant women, their partners, and health professionals in SDM on prenatal screening for trisomy 21, 18 and 13. This study, conducted in Quebec, is a randomized cluster stepped wedge trial. The study will be conducted in five periods, each corresponding to a data collection period. During the first period, all groups of clusters will be in control conditions, where health professionals will provide usual prenatal care to pregnant women without DA scaling strategies. Then, following a regular interval of 10 weeks, each group will be exposed to the intervention in 4 stages at the beginning of the periods. Once a group has received the intervention, they will access it until the end of the study. Participants are prenatal services (randomization unit), health professionals (obstetricians-gynecologists, family physicians, midwives, nurses and all other health professionals involved in prenatal care) and pregnant women as well as their partners. The intervention will consist of a DA scaling strategies, including but not limited to an online version of the DA and an online training on SDM incorporating the use of the DA. The investigators will recruit at least 28 prenatal services (study sites) and 35 pregnant women per site. The primary outcome (the level of involvement of study participants in SDM in the context of prenatal screening for trisomy 21, 18 and 13) will be measured with the validated SDM-Q-9 scale, which will be completed by pregnant women and their partners. The primary secondary outcome will be the rate of use of online and paper versions of the DA by pregnant women and their partners.
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confirm that they will follow the research protocol.
To be eligible, health professionals must:
medical residents and interns in midwifery practice, referred by participating prenatal service, are eligible too.
Exclusion Criteria:
The intervention is introduced to the first group (G1) of clusters.
Other: DA Scaling Strategies
The intervention is introduced to the second group (G2) of clusters and G1 remains in intervention conditions.
Other: DA Scaling Strategies
The intervention is introduced to the third group (G3) of clusters and G1 and G2 remains in intervention conditions.
Other: DA Scaling Strategies
The intervention is introduced to the fourth group (G4) of clusters and G1, G2 and G3 remains in intervention conditions.
Other: DA Scaling Strategies
For this study the intervention will consist of different DA scaling strategies : 1) dissemination of an online DA; 2) dissemination of a paper-based DA; 3) online training for healthcare professionals.
Level of SDM adoption
The level of SDM adoption will be measured through the measurement of the level of involvement of health professionals and pregnant women (and their partners) in the decision regarding to have or not a prenatal screening test for trisomy 21, 18 and 13. The SDM adoption will be measured with the SDM-Q-9 scale, which is a validated measurement instrument. The SDM-Q-9 scale is well understood by patients and has the potential to collect valid data on the perceived involvement of patients in SDM. The SDM-Q-9 scale consists of 9 items, each corresponding to the expected behaviour of the health professional in the SDM. Each of the 9 items is rated by a six-point Likert scale (0 = Totally Disagree to 5 = Totally Agree) where higher scores reflect higher level of SDM adoption.
Time frame: At the 23rd week of pregnancy
The rate of the DA utilization by pregnant women, their partners and health professionals
At the 23rd week of pregnancy, pregnant women and their partners will answer questions about whether they used the DA to help them make their decision. For each intervention period of the study, the research team will compile the number of utilization of the online DA as well as the city of the users. The research team will also track the number of hard copies of the DA used by each prenatal service recruited.
Time frame: At the 23rd week of pregnancy (for pregnant women and their partners), and the research team will compile the information on the online and hard copies of DA utilization during weeks 10 to 50 of the study (Intervention phases)
Perceived role in decision-making
Pregnant women and their partners will be be asked to assess their perceived role in deciding whether or not to have prenatal screening for trisomies 21, 18 and 13. The investigators will use a validated 1-question scale with five options of responses (A, B, C, D and E). The investigators will combine choices A and B to identify the proportion of pregnant women (and their partners) who will have made the decision alone, choice C to identify the frequency of SDM, and thte investigators will combine D and E choices to identify the proportion of pregnant women (and their partners) who have had a passive role.
Time frame: At the 23rd week of pregnancy
DA appreciation
This study will assess the participants' general appreciation of the DA. Once pregnant women and their partners have used the online or paper DA, they will respond to a questionnaire (questions with different options of responses) assessing their appreciation on the DA (on its presentation, acceptability, usefulness, neutrality, quantity and quality of information, etc.). Questions to be responded to will be adapted according to the version used (online or paper based DA).
Time frame: At the 23rd week of pregnancy
Appreciation of the online SDM training
Once health care professionals have completed the online SDM training, they will respond to questions aiming at assessing their overall appreciation (on its presentation, acceptability, usefulness, quantity and quality of information, etc.). Open-ended questions will allow them to say what they liked or did not like, to offer suggestions for improvement or to add any other comments.
Time frame: Immediately after the online training
Decisional conflict
To measure the level of decisional conflict among pregnant women and their partners, the investigators will use the validated scale that assess the decisional conflict. The scale has 16 items evaluated with a 5-point Likert scale (1 = Strongly agree, 5 = Strongly disagree).
Time frame: At the 23rd week of pregnancy
Decisions made and chosen tests
Pregnant women and their partners will answer questions about what was their decision as to whether or not to do a screening test. If they chose to do a screening test, what was the test(s) and whether the test(s) was done in the public or private network. In addition, they will be asked if they went further for a diagnostic test.
Time frame: At the 23rd week of pregnancy
Facilitators and barriers to the use of the DA
Pregnant women and their partners will be asked open-ended questions to find out what helped, or allowed, and what limited, or prevented them from using our DA in the format used (paper based or online DA).
Time frame: At the 23rd week of pregnancy
Duration of the prenatal consultation
The investigators will ask pregnant women and their partners how long the targeted prenatal consultation (with the discussion on prenatal testing ) lasted.
Time frame: At the 23rd week of pregnancy
Efforts and costs related to the use of the DA
Pregnant women and their partners will answer questions about whether they used our DA, and if so, will follow questions aiming at assessing the energy or effort invested in using it and the possibility that the use of the DA was associated with financial expenses or losses.
Time frame: At the 23rd week of pregnancy
Efforts and costs related to the use and the distribution of the DA
The investigators will ask prenatal service leaders or champions what level of effort and energy they had to invest to use and/or distribute the DA to pregnant women and their partners. In addition, the investigators will ask them if the use and/or distribution of the DA caused them financial expenses or losses, or if this required more human resources.
Time frame: Immediately after the intervention
DA use fidelity for pregnant women and their partners
After deciding whether to do or not the prenatal screening test, pregnant women and their partners will answer questions to assess the extent to which they have used the tool (e.g. number of sections read and/or completed) and when they used it. These questions are used to assess whether pregnant women (and their partners) used the tool as intended.
Time frame: At the 23rd week of pregnancy
DA use fidelity for healthcare providers
A set of questions will be asked to pregnant women and their partners to assess whether a person has given them the DA (in hard copy or the internet link), and if so, by whom and when. The investigators also want to know if the healthcare providers used the DA during the prenatal consultation and how.
Time frame: At the 23rd week of pregnancy
Long-term use of DA and proposed adaptations for the DA
Pregnant women and their partners will answer questions to assess whether they intend to reuse the DA for a future pregnancy or if they would like to use another DA for another medical decision.
Time frame: At the 23rd week of pregnancy
Ran from Feb 2023 to primary completion in Jul 2024, 17 months.
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