Engaging Long-Term Care Workers in Research: Recruitment Approaches and Participant Characteristics From a Randomized Controlled Trial to Improve COVID-19 Vaccine Confidence.

OBJECTIVE: To describe and compare the recruitment methods employed in a randomized controlled trial targeting long-term care workers, and resulting participant baseline characteristics. DESIGN: We used a multifaceted recruitment process to enroll long-term care workers in our 3-arm randomized controlled trial comparing 2 interventions to enhanced usual practice, for improving COVID-19 vaccine confidence and other outcomes. SETTING AND PARTICIPANTS: Adult long-term care workers living in the United States employed within the last 2 years were invited to join the study. Participants also had to meet specific screening criteria related to their degree of worry about the vaccine and/or their vaccination status. METHODS: We used a participatory approach to engage our long-term care stakeholders in codesigning and executing a combination of recruitment methods, including targeted e-recruitment, paid e-recruitment, and in-person recruitment. Participants were screened, consented, and enrolled online. We implemented a participant verification process to ensure the integrity of our study data, and used a tailored participant management platform to manage enrollment. RESULTS: We enrolled 1930 long-term care workers between May 2022 and January 2023. We met our enrollment target, despite each recruitment method having limitations. Total variable costs of approximately $102,700 were incurred and differed on a per-enrolled participant basis across methods: $25.73 for targeted e-recruitment, $57.12 for paid e-recruitment, and $64.92 for in-person methods. Our sample differed from the national population in age, gender, race/ethnicity, education, and role in long-term care. Differences were also observed between online and in-person recruitment methods. CONCLUSIONS AND IMPLICATIONS: Our results support the feasibility of enrolling a large number of long-term care workers in a randomized controlled trial to increase COVID-19 vaccine confidence. Findings build upon the evidence base for engaging this important population in research, a critical step to improving long-term care resident health and well-being. Results from our trial are anticipated in 2024.

The CONFIDENT study protocol: a randomized controlled trial comparing two methods to increase long-term care worker confidence in the COVID-19 vaccines.

BACKGROUND: Clinical and real-world effectiveness data for the COVID-19 vaccines have shown that they are the best defense in preventing severe illness and death throughout the pandemic. However, in the US, some groups remain more hesitant than others about receiving COVID-19 vaccines. One important group is long-term care workers (LTCWs), especially because they risk infecting the vulnerable and clinically complex populations they serve. There is a lack of research about how best to increase vaccine confidence, especially in frontline LTCWs and healthcare staff. Our aims are to: (1) compare the impact of two interventions delivered online to enhanced usual practice on LTCW COVID-19 vaccine confidence and other pre-specified secondary outcomes, (2) determine if LTCWs' characteristics and other factors mediate and moderate the interventions' effect on study outcomes, and (3) explore the implementation characteristics, contexts, and processes needed to sustain a wider use of the interventions. METHODS: We will conduct a three-arm randomized controlled effectiveness-implementation hybrid (type 2) trial, with randomization at the participant level. Arm 1 is a dialogue-based webinar intervention facilitated by a LTCW and a medical expert and guided by an evidence-based COVID-19 vaccine decision tool. Arm 2 is a curated social media web application intervention featuring interactive, dynamic content about COVID-19 and relevant vaccines. Arm 3 is enhanced usual practice, which directs participants to online public health information about COVID-19 vaccines. Participants will be recruited via online posts and advertisements, email invitations, and in-person visits to care settings. Trial data will be collected at four time points using online surveys. The primary outcome is COVID-19 vaccine confidence. Secondary outcomes include vaccine uptake, vaccine and booster intent for those unvaccinated, likelihood of recommending vaccination (both initial series and booster), feeling informed about the vaccines, identification of vaccine information and misinformation, and trust in COVID-19 vaccine information provided by different people and organizations. Exploration of intervention implementation will involve interviews with study participants and other stakeholders, an in-depth process evaluation, and testing during a subsequent sustainability phase. DISCUSSION: Study findings will contribute new knowledge about how to increase COVID-19 vaccine confidence and effective informational modalities for LTCWs. TRIAL REGISTRATION: NCT05168800 at ClinicalTrials.gov, registered December 23, 2021.

Using incorpoRATE to examine clinician willingness to engage in shared decision making: A study of Family Medicine residents.

OBJECTIVES: We evaluated the willingness of Family Medicine residents to engage in SDM, before and after an educational intervention. METHODS: We delivered a lecture and a workshop for residents on implementing SDM in preventive health care. Before the lecture (T1), participants completed a measure of their willingness to engage in SDM. Six months later, participants completed the measure a second time (T2). RESULTS: At T1, 64 of 73 residents who attended the educational session completed incorpoRATE. Six months later, 44 of 64 participants completed the measure a second time (T2). The range of incorpoRATE sum scores at T1 was from 4.9 to 9.1 out of 10. Among the 44 participants who completed incorpoRATE at both time points, the mean scores were 7.0 ± 1.0 at T1 and 7.4 ± 1.0 at T2 (t = -2.833, p = 0.007, Cohen's D = 0.43). CONCLUSION: Among Family Medicine residents, the willingness to engage in SDM is highly variable. This suggests a lack of consensus in the mind of these residents about SDM. Although mean scores at T2 were significantly higher, we question the educational importance of this change. PRACTICE IMPLICATIONS: incorpoRATE is a promising measure for educators. Understanding how willing a particular physician audience is to undertake SDM, and which elements require attention, could be helpful in designing more targeted curricula. Further research is needed to understand how the perceived stakes of a clinical situation influence physician willingness to engage in SDM.

Co-Development of a Web Application (COVID-19 Social Site) for Long-Term Care Workers ("Something for Us"): User-Centered Design and Participatory Research Study.

BACKGROUND: Improving confidence in and uptake of COVID-19 vaccines and boosters among long-term care workers (LTCWs) is a crucial public health goal, given their role in the care of elderly people and people at risk. While difficult to reach with workplace communication interventions, most LTCWs regularly use social media and smartphones. Various social media interventions have improved attitudes and uptake for other vaccines and hold promise for the LTCW population. OBJECTIVE: We aimed to develop a curated social web application (interactive website) to increase COVID-19 vaccine confidence (a 3-arm randomized trial is underway). METHODS: Following user-centric design and participatory research approaches, we undertook the following 3 steps: (1) content identification, (2) platform development, and (3) community building. A LTCW and stakeholder advisory group provided iterative input. For content identification (step 1), we identified topics of concern about COVID-19 vaccines via desktop research (published literature, public opinion polls, and social media monitoring), refined by interviewing and polling LTCWs. We also conducted a national online panel survey. We curated and fact-checked posts from popular social media platforms that addressed the identified concerns. During platform development (step 2), we solicited preferences for design and functionality via interviews and user experience testing with LTCWs. We also identified best practices for online community building (step 3). RESULTS: In the interviews (n=9), we identified 3 themes: (1) LTCWs are proud of their work but feel undervalued; (2) LTCWs have varying levels of trust in COVID-19-related information; and (3) LTCWs would welcome a curated COVID-19 resource that is easy to understand and use-"something for us". Through desktop research, LTCW interviews, and our national online panel survey (n=592) we found that participants are interested in information about COVID-19 in general, vaccine benefits, vaccine risks, and vaccine development. Content identification resulted in 434 posts addressing these topic areas, with 209 uploaded to the final web application. Our LTCW poll (n=8) revealed preferences for personal stories and video content. The platform we developed is an accessible WordPress-based social media web application, refined through formal (n=3) and informal user experience testing. Users can sort posts by topic or subtopic and react to or comment on posts. To build an online community, we recruited 3 LTCW "community ambassadors" and instructed them to encourage discussion, acknowledge concerns, and offer factual information on COVID-19 vaccines. We also set "community standards" for the web application. CONCLUSIONS: An iterative, user-centric, participatory approach led to the launch of an accessible social media web application with curated content for COVID-19 vaccines targeting LTCWs in the United States. Through our trial, we will determine if this approach successfully improves vaccine confidence. If so, a similar social media resource could be used to develop curated social media interventions in other populations and with other public health goals.

Eliciting patients' healthcare goals and concerns: Do questions influence responses?

There is increasing interest in asking patients questions before their visits to elicit goals and concerns, which is part of the move to support the concept of coproducing care. The phrasing and delivery of such questions differs across settings and is likely to influence responses. This report describes a study that (i) used a three-level model to categorize the goals and concerns elicited by two different pre-visit questions, and (ii) describes associations between responses elicited and the phrasing and delivery of the two questions. The questions were administered to patients with rheumatic disease, and patients with inflammatory bowel disease (IBD). Paper-based responses from 150 patients with rheumatic disease and 338 patients with IBD were analyzed (163 paper, 175 electronic). The goals and concerns elicited were primarily disease or symptom-specific. The specific goal and concern examples featured in one pre-visit question were more commonly reported in responses to that question, compared to the question without examples. Questions completed electronically before the visit were associated with longer responses than those completed on paper in the waiting room. In conclusion, how and when patients' goals and concerns are elicited appears to have an impact on responses and warrants further investigation.

Assessing Shared Decision-Making in Cystic Fibrosis Care Using collaboRATE: A Cross-Sectional Study of 159 Programs.

There are numerous opportunities for shared decision-making (SDM) in cystic fibrosis (CF) care, yet little is known about patients' SDM experiences. This study evaluated SDM across 159 CF care programs (4024 participants) in the United States. Shared decision-making was assessed using the patient-reported collaboRATE measure, which was included in the CF Foundation's Patient and Family Experience of Care Survey over 18 months. Overall, 69% of respondents reported experiencing SDM. Respondents at pediatric programs were more likely to experience SDM than those at adult programs (72% vs 67%, P < .001). Multivariable logistic regression analyses showed a relationship between SDM and patient age, whereby SDM was less likely to occur with patients aged 18 to 24 years, compared to some younger and older age groups (P = .02-<.001). Shared decision-making was more likely to occur at pediatric programs when patients had better general health (P = .02-<.01), and at pediatric and adult programs when patients had better mental health (P = .02-<.001). Disparities in SDM experiences highlight a need to improve decision-making processes in CF care. Interventions tailored for improving SDM among specific patient populations may be particularly advantageous.

Measuring Patient Experiences of Integration in Health Care Delivery: Psychometric Validation of IntegRATE Under Controlled Conditions.

The objective of this study was to assess the psychometric properties of IntegRATE-a 4-item patient-reported measure of integration in health care delivery-under controlled conditions. Adults who reported having received health care in the previous year were exposed to a fictional health care scenario featuring good, mixed, or poor integration on 1 or 2 occasions. They were then asked to imagine themselves as a patient in the scenario and complete IntegRATE and other measures. The data collected were analyzed to assess the discriminative, concurrent, and divergent validity of IntegRATE and its test-retest reliability and responsiveness using both "sum score" and "top score" scoring approaches. Six-hundred people participated in the study with 190 taking part on 2 occasions. The IntegRATE sum score demonstrated discriminative validity, concurrent validity, divergent validity, and responsiveness and partially demonstrated test-retest reliability. The IntegRATE top score demonstrated concurrent validity, divergent validity, and responsiveness and partially demonstrated discriminative validity and test-retest reliability. We conclude that the IntegRATE sum score exhibits encouraging psychometric properties and performs more optimally than the IntegRATE top score.

The development of incorpoRATE: A measure of physicians' willingness to incorporate shared decision making into practice.

OBJECTIVES: To develop 'incorpoRATE', a brief and broadly applicable measure of physicians' willingness to incorporate shared decision making (SDM) into practice. METHODS: incorpoRATE was developed across three phases: 1) A review of relevant literature to inform candidate domain and item development, 2) Cognitive interviews with US physicians to iteratively refine the measure, and 3) Pilot testing of the measure across a larger sample of US physicians to explore item and measure performance. RESULTS: The final measure consists of seven items that assess physician perspectives on various components of SDM use that may present as barriers in practice. During pilot testing, the majority of physicians expressed positive opinions about the overall concept of SDM, yet were less comfortable acting on informed patient choices when there was known incongruence with their own recommendations. CONCLUSIONS: incorpoRATE is a novel physician-reported measure that assesses physicians' willingness to incorporate SDM in practice. PRACTICE IMPLICATIONS: incorpoRATE has the potential to help us further understand the limited adoption of SDM and areas of focus for improving the use of SDM in the future. We recommend that incorpoRATE be subject to further psychometric, real-world testing, in order to explore its performance across different samples of physicians and organizations.

Investigation of factors influencing the implementation of two shared decision-making interventions in contraceptive care: a qualitative interview study among clinical and administrative staff.

BACKGROUND: There is limited evidence on how to implement shared decision-making (SDM) interventions in routine practice. We conducted a qualitative study, embedded within a 2 × 2 factorial cluster randomized controlled trial, to assess the acceptability and feasibility of two interventions for facilitating SDM about contraceptive methods in primary care and family planning clinics. The two SDM interventions comprised a patient-targeted intervention (video and prompt card) and a provider-targeted intervention (encounter decision aids and training). METHODS: Participants were clinical and administrative staff aged 18 years or older who worked in one of the 12 clinics in the intervention arm, had email access, and consented to being audio-recorded. Semi-structured telephone interviews were conducted upon completion of the trial. Audio recordings were transcribed verbatim. Data collection and thematic analysis were informed by the 14 domains of the Theoretical Domains Framework, which are relevant to the successful implementation of provider behaviour change interventions. RESULTS: Interviews (n = 29) indicated that the interventions were not systematically implemented in the majority of clinics. Participants felt the interventions were aligned with their role and they had confidence in their skills to use the decision aids. However, the novelty of the interventions, especially a need to modify workflows and change behavior to use them with patients, were implementation challenges. The interventions were not deeply embedded in clinic routines and their use was threatened by lack of understanding of their purpose and effect, and staff absence or turnover. Participants from clinics that had an enthusiastic study champion or team-based organizational culture found these social supports had a positive role in implementing the interventions. CONCLUSIONS: Variation in capabilities and motivation among clinical and administrative staff, coupled with inconsistent use of the interventions in routine workflow contributed to suboptimal implementation of the interventions. Future trials may benefit by using implementation strategies that embed SDM in the organizational culture of clinical settings.

Right For Me: protocol for a cluster randomised trial of two interventions for facilitating shared decision-making about contraceptive methods.

INTRODUCTION: Despite the observed and theoretical advantages of shared decision-making in a range of clinical contexts, including contraceptive care, there remains a paucity of evidence on how to facilitate its adoption. This paper describes the protocol for a study to assess the comparative effectiveness of patient-targeted and provider-targeted interventions for facilitating shared decision-making about contraceptive methods. METHODS AND ANALYSIS: We will conduct a 2×2 factorial cluster randomised controlled trial with four arms: (1) video+prompt card, (2) decision aids+training, (3) video+prompt card and decision aids+training and (4) usual care. The clusters will be clinics in USA that deliver contraceptive care. The participants will be people who have completed a healthcare visit at a participating clinic, were assigned female sex at birth, are aged 15-49 years, are able to read and write English or Spanish and have not previously participated in the study. The primary outcome will be shared decision-making about contraceptive methods. Secondary outcomes will be the occurrence of a conversation about contraception in the healthcare visit, satisfaction with the conversation about contraception, intended contraceptive method(s), intention to use a highly effective method, values concordance of the intended method(s), decision regret, contraceptive method(s) used, use of a highly effective method, use of the intended method(s), adherence, satisfaction with the method(s) used, unintended pregnancy and unwelcome pregnancy. We will collect study data via longitudinal patient surveys administered immediately after the healthcare visit, four weeks later and six months later. ETHICS AND DISSEMINATION: We will disseminate results via presentations at scientific and professional conferences, papers published in peer-reviewed, open-access journals and scientific and lay reports. We will also make an anonymised copy of the final participant-level dataset available to others for research purposes. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Identifier: NCT02759939.

Choosing a Model of Maternity Care: Decision Support Needs of Australian Women.

BACKGROUND: Access to information on the features and outcomes associated with the various models of maternity care available in Australia is vital for women's informed decision-making. This study sought to identify women's preferences for information access and decision-making involvement, as well as their priority information needs, for model of care decision-making. METHODS: A convenience sample of adult women of childbearing age in Queensland, Australia were recruited to complete an online survey assessing their model of care decision support needs. Knowledge on models of care and socio-demographic characteristics were also assessed. RESULTS: Altogether, 641 women provided usable survey data. Of these women, 26.7 percent had heard of all available models of care before starting the survey. Most women wanted access to information on models of care (90.4%) and an active role in decision-making (99.0%). Nine priority information needs were identified: cost, access to choice of mode of birth and care provider, after hours provider contact, continuity of carer in labor/birth, mobility during labor, discussion of the pros/cons of medical procedures, rates of skin-to-skin contact after birth, and availability at a preferred birth location. This information encompassed the priority needs of women across age, birth history, and insurance status subgroups. CONCLUSIONS: This study demonstrates Australian women's unmet needs for information that supports them to effectively compare available options for model of maternity care. Findings provide clear direction on what information should be prioritized and ideal channels for information access to support quality decision-making in practice.

Patient decision aids in routine maternity care: Benefits, barriers, and new opportunities.

BACKGROUND AND AIM: Participation in decision-making, supported by comprehensive and quality information provision, is increasingly emphasised as a priority for women in maternity care. Patient decision aids are tools that can offer women greater access to information and guidance to participate in maternity care decision-making. Relative to their evaluation in controlled settings, the implementation of patient decision aids in routine maternity care has received little attention and our understanding of which approaches may be effective is limited. This paper critically discusses the application of patient decision aids in routine maternity care and explores viable solutions for promoting their successful uptake. DISCUSSION: A range of patient decision aids have been developed for use within maternity care, and controlled trials have highlighted their positive impact on the decision-making process for women. Nevertheless, evidence of successful patient decision aid implementation in real world health care settings is lacking due to practical and ideological barriers that exist. Patient-directed social marketing campaigns are a relatively novel approach to patient decision aid delivery that may facilitate their adoption in maternity care, at least in the short-term, by overcoming common implementation barriers. Social marketing may also be particularly well suited to maternity care, given the unique characteristics of this health context. CONCLUSIONS: The potential of social marketing campaigns to facilitate patient decision aid adoption in maternity care highlights the need for pragmatic trials to evaluate their effectiveness. Identifying which sub-groups of women are more or less likely to respond to these strategies will further direct implementation.

What are pregnant women told about models of maternity care in Australia? A retrospective study of women's reports.

OBJECTIVE: To describe women's reports of the model of care options General Practitioners (GPs) discussed with them at the first pregnancy consultation and women's self-reported role in decision-making about model of care. METHODS: Women who had recently given birth responded to survey items about the models of care GPs discussed, their role in final decision-making, and socio-demographic, obstetric history, and early pregnancy characteristics. RESULTS: The proportion of women with whom each model of care was discussed varied between 8.2% (for private midwifery care with home birth) and 64.4% (GP shared care). Only 7.7% of women reported that all seven models were discussed. Exclusive discussion about private obstetric care and about all public models was common, and women's health insurance status was the strongest predictor of the presence of discussions about each model. Most women (82.6%) reported active involvement in final decision-making about model of care. CONCLUSION: Although most women report involvement in maternity model of care decisions, they remain largely uninformed about the breadth of available model of care options. PRACTICAL IMPLICATIONS: Strategies that facilitate women's access to information on the differentiating features and outcomes for all models of care should be prioritized to better ensure equitable and quality decisions.

Overdue choices: how information and role in decision-making influence women's preferences for induction for prolonged pregnancy.

BACKGROUND: Enabling women to make informed decisions is a crucial component of consumer-focused maternity care. Current evidence suggests that health care practitioners' communication of care options may not facilitate patient involvement in decision-making. The aim of this study was to investigate the effect of specific variations in health caregiver communication on women's preferences for induction of labor for prolonged pregnancy. METHODS: A convenience sample of 595 female participants read a hypothetical scenario in which an obstetrician discusses induction of labor with a pregnant woman. Information provided on induction and the degree of encouragement for the woman's involvement in decision-making was manipulated to create four experimental conditions. Participants indicated preference with respect to induction, their perceptions of the quality of information received, and other potential moderating factors. RESULTS: Participants who received information that was directive in favor of medical intervention were significantly more likely to prefer induction than those given nondirective information. No effect of level of involvement in decision-making was found. Participants' general trust in doctors moderated the relationship between health caregiver communication and preferences for induction, such that the influence of information provided on preferences for induction differed across levels of involvement in decision-making for women with a low trust in doctors, but not for those with high trust. Many women were not aware of the level of information required to make an informed decision. CONCLUSIONS: Our findings highlight the potential value of strategies such as patient decision aids and health care professional education to improve the quality of information available to women and their capacity for informed decision-making during pregnancy and birth.