Eggsurance? A randomized controlled trial of a decision aid for elective egg freezing.
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ABSTRACT:
SUBMITTER: Sandhu S
PROVIDER: S-EPMC11291942 | biostudies-literature | 2024 Aug
REPOSITORIES: biostudies-literature
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Eggsurance? A randomized controlled trial of a decision aid for elective egg freezing.
Sandhu Sherine S Hickey Martha M Koye Digsu N DN Braat Sabine S Lew Raelia R Hart Roger R Norman Robert J RJ Hammarberg Karin K Anderson Richard A RA Peate Michelle M
Human reproduction (Oxford, England) 20240801 8
<h4>Study question</h4>Does a purpose-designed Decision Aid for women considering elective egg freezing (EEF) impact decisional conflict and other decision-related outcomes?<h4>Summary answer</h4>The Decision Aid reduces decisional conflict, prepares women for decision-making, and does not cause distress.<h4>What is already known</h4>Elective egg-freezing decisions are complex, with 78% of women reporting high decisional conflict. Decision Aids are used to support complex health decisions. We de ...[more]
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Project description:BackgroundUptake of elective egg freezing has increased globally. The decision to freeze eggs is complex, and detailed, unbiased information is needed. To address this, we developed an online Decision Aid for women considering elective egg freezing. Decision Aids are the standard of care to support complex health decisions.ObjectivesThis study will measure the impact of the Decision Aid on decision-making (e.g. decisional conflict, engagement in decision-making, distress, and decision delay) and decision quality (e.g. knowledge, level of informed choice, and regret).Methods and analysisA single-blinded two-arm parallel-group randomized controlled trial. Women considering elective egg freezing will be recruited using social media, newsletters, and fertility clinics. Data will be collected at baseline (recruitment), 6-month, and 12-month post-randomization. The primary hypothesis is that the intervention (Decision Aid plus Victorian Assisted Reproductive Technology Authority website) will reduce decisional conflict (measured using the Decisional Conflict Scale) at 12 months more than control (Victorian Assisted Reproductive Technology Authority website only). Secondary outcomes include engagement in decision-making (Perceived Involvement in Care Scale), distress (Depression, Anxiety, and Stress Scale), decision delay, knowledge, informed choice (Multi-dimensional Measure of Informed Choice), and decisional regret (Decisional Regret Scale).EthicsThe study was approved by the University of Melbourne Human Research Ethics Committee (Ethics ID: 2056457). Informed consent will be obtained from all participants prior to enrolment.DiscussionThis is the first international randomized controlled trial that aims to investigate the effect of an elective egg freezing Decision Aid on decision-related outcomes (e.g. decisional conflict, informed choice, and regret). It is anticipated that participants who receive the Decision Aid will have better decision and health outcomes.Registration detailsACTRN12620001032943: Comparing different information resources on the process and quality of decision-making in women considering elective egg freezing.
| S-EPMC9720825 | biostudies-literature
Project description:BackgroundElective egg freezing decisions are complex. We developed a Decision Aid for elective egg freezing and conducted a phase 1 study to evaluate its acceptability and utility for decision-making.MethodsThe online Decision Aid was developed according to International Patient Decision Aid Standards and evaluated using a pre/post survey design. Twenty-six Australian women aged 18-45 years, interested in receiving elective egg freezing information, proficient in English, and with access to the internet were recruited using social media and university newsletters. Main outcomes were: acceptability of the Decision Aid; feedback on the Decision Aid design and content; concern raised by the Decision Aid, and; utility of the Decision Aid as measured by scores on the Decisional Conflict Scale and on a study-specific scale assessing knowledge about egg freezing and age-related infertility.ResultsMost participants found the Decision Aid acceptable (23/25), balanced (21/26), useful for explaining their options (23/26), and for reaching a decision (18/26). Almost all reported satisfaction with the Decision Aid (25/26) and the level of guidance it provided (25/26). No participant reported serious concerns about the Decision Aid, and most would recommend it to other women considering elective egg freezing (22/26). Median Decisional Conflict Scale score decreased from 65/100 (Interquartile range: 45-80) pre-Decision Aid to 7.5/100 (Interquartile range: 0-37.5) post-Decision Aid review (p < 0.001). Median knowledge score increased from 8.5/14 (Interquartile range: 7-11) pre-Decision Aid to 11/14 (Interquartile range: 10-12) post-Decision Aid review (p = 0.01).ConclusionThis elective egg freezing Decision Aid appears acceptable and useful for decision-making. It improved knowledge, reduced decisional conflict and did not raise serious concerns. The Decision Aid will be further evaluated using a prospective randomised control trial.Study registrationACTRN12618001685202 (retrospectively registered: 12 October 2018).
| S-EPMC10161420 | biostudies-literature
Project description:ObjectiveTo estimate the optimal age to pursue elective oocyte cryopreservation.DesignA decision-tree model was constructed to determine the success and cost-effectiveness of oocyte preservation versus no action when considered at ages 25-40 years, assuming an attempt at procreation 3, 5, or 7 years after initial decision.SettingNot applicable.Patient(s)Hypothetical patients 25-40 years old presenting to discuss elective oocyte cryopreservation.Intervention(s)Decision to cryopreserve oocytes from age 25 years to age 40 years versus taking no action.Main outcome and measure(s)Probability of live birth after initial decision whether or not to cryopreserve oocytes.Result(s)Oocyte cryopreservation provided the greatest improvement in probability of live birth compared with no action (51.6% vs. 21.9%) when performed at age 37 years. The highest probability of live birth was seen when oocyte cryopreservation was performed at ages <34 years (>74%), although little benefit over no action was seen at ages 25-30 years (2.6%-7.1% increase). Oocyte cryopreservation was most cost-effective at age 37 years, at $28,759 per each additional live birth in the oocyte cryopreservation group. When the probability of marriage was included, oocyte cryopreservation resulted in little improvement in live birth rates.Conclusion(s)Oocyte cryopreservation can be of great benefit to specific women and has the highest chance of success when performed at an earlier age. At age 37 years, oocyte cryopreservation has the largest benefit over no action and is most cost-effective.
| S-EPMC4457646 | biostudies-literature
Project description:ObjectiveTo evaluate the effectiveness of a contraceptive decision aid in reducing decisional conflict among women seeking reversible contraception.Study designWe conducted a randomized trial of a computer-based decision aid compared to a control group for women presenting for reversible contraception at two clinics affiliated with an academic medical center. The primary outcome was change in decisional conflict, measured before and after the healthcare visit using the validated Decisional Conflict Scale. We hypothesized the decision aid would reduce the decisional conflict score by 10 points on a 100-point scale (0 = no conflict, 100 = high conflict) compared to the control group. Secondary outcomes included contraceptive method chosen and satisfaction with the healthcare visit.ResultsWe enrolled and randomized 253 women, and 241 had complete data for our primary outcome. Overall, pre-visit decisional conflict scores were low, reflecting low levels of decisional conflict in our sample; median score 15 (range 0-80) in the decision aid and 10 (0-85) in the control group (p = 0.45). Both groups had a similar reduction in median decisional conflict after the healthcare visit: -10 (-80 to 25) and -10 (-60 to 5) in the decision aid and control groups respectively (p = 0.99). Choice of contraception (p = 0.23) and satisfaction with healthcare provider (p = 0.79) also did not differ by study group.ConclusionsDecisional conflict around contraception was low in both groups at baseline. Use of a computerized contraceptive decision aid did not reduce decisional conflict, alter method choice, or impact satisfaction compared to the control group among women choosing reversible contraception.ImplicationsUse of a computerized contraceptive decision aid did not reduce decisional conflict or alter method choice compared to the control group among women choosing reversible contraception. Future studies could focus on testing the decision aid in different clinical settings, especially where barriers to providing comprehensive contraceptive counseling exist.
| S-EPMC7821473 | biostudies-literature
Project description:BackgroundShared decision making (SDM) is a widely recommended yet unproven strategy for increasing colorectal cancer (CRC) screening uptake. Previous trials of decision aids to increase SDM and CRC screening uptake have yielded mixed results.PurposeTo assess the impact of decision aid-assisted SDM on CRC screening uptake.DesignRCT.Setting/participantsThe study was conducted at an urban, academic safety-net hospital and community health center between 2005 and 2010. Participants were asymptomatic, average-risk patients aged 50-75 years due for CRC screening.InterventionStudy participants (n=825) were randomized to one of two intervention arms (decision aid plus personalized risk assessment or decision aid alone) or control arm. The interventions took place just prior to a routine office visit with their primary care providers.Main outcome measuresThe primary outcome was completion of a CRC screening test within 12 months of the study visit. Logistic regression was used to identify predictors of test completion and mediators of the intervention effect. Analysis was completed in 2011.ResultsPatients in the decision-aid group were more likely to complete a screening test than control patients (43.1% vs 34.8%, p=0.046) within 12 months of the study visit; conversely, test uptake for the decision aid and decision aid plus personalized risk assessment arms was similar (43.1% vs 37.1%, p=0.15). Assignment to the decision-aid arm (AOR=1.48, 95% CI=1.04, 2.10), black race (AOR=1.52, 95% CI=1.12, 2.06) and a preference for a patient-dominant decision-making approach (AOR=1.55, 95% CI=1.02, 2.35) were independent determinants of test completion. Activation of the screening discussion and enhanced screening intentions mediated the intervention effect.ConclusionsDecision aid-assisted SDM has a modest impact on CRC screening uptake. A decision aid plus personalized risk assessment tool is no more effective than a decision aid alone.Trial registrationThis study is registered at www.clinicaltrials.govNCT00251862.
| S-EPMC3966107 | biostudies-literature
Project description:BackgroundClinicians face challenges in promoting colorectal cancer screening due to multiple competing demands. A decision aid that clarifies patient preferences and improves decision quality can aid shared decision making and be effective at increasing colorectal cancer screening rates. However, exactly how such an intervention improves shared decision making is unclear. This study, funded by the National Cancer Institute, seeks to provide detailed understanding of how an interactive decision aid that elicits patient's risks and preferences impacts patient-clinician communication and shared decision making, and ultimately colorectal cancer screening adherence.Methods/designThis is a two-armed single-blinded randomized controlled trial with the target of 300 patients per arm. The setting is eleven community and three academic primary care practices in Metro Detroit. Patients are men and women aged between 50 and 75 years who are not up to date on colorectal cancer screening. ColoDATES Web (intervention arm), a decision aid that incorporates interactive personal risk assessment and preference clarification tools, is compared to a non-interactive website that matches ColoDATES Web in content but does not contain interactive tools (control arm). Primary outcomes are patient uptake of colorectal cancer screening; patient decision quality (knowledge, preference clarification, intent); clinician's degree of shared decision making; and patient-clinician concordance in the screening test chosen. Secondary outcome incorporates a Structural Equation Modeling approach to understand the mechanism of the causal pathway and test the validity of the proposed conceptual model based on Theory of Planned Behavior. Clinicians and those performing the analysis are blinded to arms.DiscussionThe central hypothesis is that ColoDATES Web will improve colorectal cancer screening adherence through improvement in patient behavioral factors, shared decision making between the patient and the clinician, and concordance between the patient's and clinician's preferred colorectal cancer screening test. The results of this study will be among the first to examine the effect of a real-time preference assessment exercise on colorectal cancer screening and mediators, and, in doing so, will shed light on the patient-clinician communication and shared decision making 'black box' that currently exists between the delivery of decision aids to patients and subsequent patient behavior.Trial registrationClinicalTrials.gov ID NCT01514786.
| S-EPMC3842677 | biostudies-literature
Project description:To determine if implementing attention-deficit/hyperactivity disorder (ADHD) diagnosis and treatment guidelines in a clinical decision support system would result in better care, including higher rates of adherence to clinical care guidelines.We conducted a cluster randomized controlled trial in which we compared diagnosis and management of ADHD in 6- to 12-year-olds after implementation of a computer decision support system in 4 practices.Eighty-four charts were reviewed. In the control group, the use of structured diagnostic assessments dropped from 50% in the baseline period to 38% in the intervention period. In the intervention group, however, it rose from 60% to 81%. This difference was statistically significant, even after controlling for age, gender, and race (odds ratio of structured diagnostic assessment in intervention group versus control group = 8.0, 95% confidence interval 1.6-40.6). Significant differences were also seen in the number of ADHD core symptoms noted at the time of diagnosis. Our study was not powered to detect changes in care and management, but the percent of patients who had documented medication adjustments, mental health referrals, and visits to mental health specialists were higher in the intervention group than the control.The introduction of a clinical decision support module resulted in higher quality of care with respect to ADHD diagnosis including a prospect for higher quality of ADHD management in children. Future work will examine how to further develop the ADHD module and add support for other chronic conditions.
| S-EPMC3876764 | biostudies-literature
Project description:PurposeTo assess whether knowledge following use of a decision aid (DA) for aneuploidy screening and testing is inferior to knowledge in women who saw a genetic counselor (GC) only.MethodsThis is a randomized controlled noninferiority trial of pregnant women at ≤22 weeks. Women who were scheduled for GC were randomly allocated to use a DA before GC or to GC alone. The primary outcome was knowledge score, comparing women who had used the DA only to those who saw GC alone. Analysis was by intent to treat.ResultsBetween January and October 2017, 197 women were randomized, 105 to GC only and 92 to DA use before GC. Demographics and baseline knowledge were similar between groups. Mean knowledge score following DA use was not inferior to mean knowledge score following GC only (10.4 vs. 10.6, p = 0.306). Decisional conflict was similar following completion of the DA to following GC only, but was reduced following completion of both the DA and GC compared with GC only (0.22 vs. 1.74, p = 0.003).ConclusionKnowledge surrounding aneuploidy screening in women who used a DA was not inferior to knowledge in women who underwent GC. Use of the DA in addition to GC reduced decisional conflict.
| S-EPMC6417985 | biostudies-literature
Project description:Tamoxifen and raloxifene are chemopreventive drugs that can reduce women’s relative risk of primary breast cancer by 50%; however, most women eligible for these drugs have chosen not to take them. The reasons for low uptake may be related to women’s knowledge or attitudes towards the drugs. We aimed to examine the impact of an online breast cancer chemoprevention decision aid (DA) on informed intentions and decisions of women at high risk of breast cancer.We conducted a randomized clinical trial, assessing the effect of a DA about breast cancer chemoprevention on informed choices about chemoprevention. Women (n = 585), 46- to 74-years old old, completed online baseline, post-test, and three-month follow-up questionnaires. Participants were randomly assigned to either an intervention group, a standard control group that answered questions about chemoprevention at baseline, or a three-month control group that did not answer questions about chemoprevention at baseline. The main outcome measures were whether women’s intentions and decisions regarding chemoprevention drugs were informed, and whether women who viewed the DA were more likely to make informed decisions than women who did not view the DA, using a dichotomous composite variable ‘informed choice’ (yes/no) to classify informed decisions as those reflecting sufficient knowledge and concordance between a woman’s decision and relevant attitudes.Analyses showed that more intervention than standard control participants (52.7% versus 5.9%) made informed decisions at post-test, P <0.001. At the three-month follow-up, differences in rates of informed choice between intervention (16.9%) and both control groups (11.8% and 8.0%) were statistically non-significant, P = 0.067.The DA increased informed decision making about breast cancer chemoprevention, although the impact on knowledge diminished over time. This study was not designed to determine how much knowledge decision makers must retain over time. Examining informed decisions increases understanding of the impact of DAs. A standard for defining and measuring sufficient knowledge for informed decisions is needed.ClinicalTrials.gov: NCT00967824
| S-EPMC3978729 | biostudies-literature
Project description:BackgroundTreatment decision-making regarding immunosuppressive therapy is challenging for individuals with lupus. We assessed the effectiveness of a decision aid for immunosuppressive therapy in lupus nephritis.Methods and findingsIn a United States multicenter, open-label, randomized controlled trial (RCT), adult women with lupus nephritis, mostly from racial/ethnic minority backgrounds with low socioeconomic status (SES), seen in in- or outpatient settings, were randomized to an individualized, culturally tailored, computerized decision aid versus American College of Rheumatology (ACR) lupus pamphlet (1:1 ratio), using computer-generated randomization. We hypothesized that the co-primary outcomes of decisional conflict and informed choice regarding immunosuppressive medications would improve more in the decision aid group. Of 301 randomized women, 298 were analyzed; 47% were African-American, 26% Hispanic, and 15% white. Mean age (standard deviation [SD]) was 37 (12) years, 57% had annual income of <$40,000, and 36% had a high school education or less. Compared with the provision of the ACR lupus pamphlet (n = 147), participants randomized to the decision aid (n = 151) had (1) a clinically meaningful and statistically significant reduction in decisional conflict, 21.8 (standard error [SE], 2.5) versus 12.7 (SE, 2.0; p = 0.005) and (2) no difference in informed choice in the main analysis, 41% versus 31% (p = 0.08), but clinically meaningful and statistically significant difference in sensitivity analysis (net values for immunosuppressives positive [in favor] versus negative [against]), 50% versus 35% (p = 0.006). Unresolved decisional conflict was lower in the decision aid versus pamphlet groups, 22% versus 44% (p < 0.001). Significantly more patients in the decision aid versus pamphlet group rated information to be excellent for understanding lupus nephritis (49% versus 33%), risk factors (43% versus 27%), medication options (50% versus 33%; p ≤ 0.003 for all); and the ease of use of materials was higher in the decision aid versus pamphlet groups (51% versus 38%; p = 0.006). Key study limitations were the exclusion of men, short follow-up, and the lack of clinical outcomes, including medication adherence.ConclusionsAn individualized decision aid was more effective than usual care in reducing decisional conflict for choice of immunosuppressive medications in women with lupus nephritis.Trial registrationClinicaltrials.gov, NCT02319525.
| S-EPMC6505936 | biostudies-literature