Engagement Methods for Community Involvement

(PRECIDENTD-EMS Trial)

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Diabetes, others

Compensation: Varies

Number of Visits: 12

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether different ways of engaging with patients and study staff can improve outcomes in an ongoing diabetes study. It compares a new method called "agile engagement" (an agile methods engagement approach) to a standard approach to determine which better boosts research results, such as patient recruitment and medication adherence in the main diabetes trial. The study also examines whether these engagement methods lead to better cooperation and satisfaction among participants. Potential participants include those already involved as advisors or staff in the main diabetes study. As an unphased trial, this study offers participants the opportunity to contribute to innovative research methods that could enhance diabetes care and patient engagement.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on engagement methods rather than medication changes.

What prior data suggests that these engagement methods are safe for stakeholders?

In a previous study, participants using Agile methods reported feeling safe and supported. This feeling, known as psychological safety, means they were comfortable sharing ideas and concerns without fear of negative consequences. Another study found that Agile methods in healthcare led to positive experiences, with patients feeling more independent and less anxious.

These findings suggest that Agile methods are well-tolerated. The studies reported no specific negative effects, indicating that the approach appears safe. There is no direct evidence of harm from using Agile methods in engagement. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores different methods to boost community involvement through engagement approaches. Unlike standard methods that may use traditional communication and outreach strategies, the experimental "Agile methods engagement approach" aims to be more dynamic and responsive. This approach could lead to higher participation and more effective community involvement by adapting quickly to feedback and changing needs. By testing these methods, researchers hope to discover more efficient ways to engage communities, which could be transformative for future projects and initiatives.

What evidence suggests that this trial's engagement methods could be effective?

This trial will compare the Agile methods engagement approach with the Standard engagement approach. Studies have shown that flexible methods, like those in the Agile approach, can enhance collaboration and goal achievement. Research indicates that involving everyone in planning and working collaboratively leads to better teamwork and communication. A review of studies found that flexible leadership improves efficiency and effectiveness. These methods foster a more engaged and committed team, potentially leading to better study outcomes, such as improved participant recruitment and medication adherence in trials. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for sites involved in the PRECIDENTD study, which focuses on preventing major health events in type 2 diabetes patients. It's not for individual patients but for research sites looking to improve engagement with stakeholders.

Inclusion Criteria

PRECIDENTD patient stakeholder advisory council partners

PRECIDENTD site study staff

PRECIDENTD site investigators

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Engagement Methods Evaluation

Evaluation of agile versus standard engagement methods at study sites

18 months

Baseline and 6, 12, and 18 months post-baseline

Follow-up

Participants are monitored for research outcomes, engagement quality, and partner outcomes

18 months

Baseline and 6, 12, and 18 months post-baseline

What Are the Treatments Tested in This Trial?

Interventions

• Agile methods engagement approach
• Standard engagement approach

Trial Overview PRECIDENTD-EMS compares two stakeholder engagement approaches within a larger diabetes study: one uses standard methods and the other employs agile methods aimed at better collaboration and potentially improved research outcomes.

How Is the Trial Designed?

Group I: Agile methods engagement approach Experimental Treatment 1 Intervention

Group II: Standard engagement approach Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Brigham and Women's Hospital

Collaborator

Trials

1,694

Recruited

14,790,000+

Citations

1. cacm.acm.org cacm.acm.org/blogcacm/developing-effective-stakeholder-engagement-strategies-in-agile-projects/

Developing Effective Stakeholder Engagement Strategies ... This post explores ways to enable effective stakeholder participation in agile environments. It investigates novel strategies such as stakeholder mapping.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1053482224000469

Understanding how agile teams reach effectiveness We systematically reviewed 74 studies on agile teams and identified their key input, mediating, and outcome factors.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10331616/

The Agile Co-production and Evaluation framework for ... The Agile Co-production and Evaluation framework for developing public health interventions, messaging and guidance

4. digitalcommons.harrisburgu.edu digitalcommons.harrisburgu.edu/cgi/viewcontent.cgi?article=1011&context=dandt

Best Practices to Increase Stakeholder Engagement in ... The results indicate a favorable pattern in stakeholders' involvement and the perceived efficiency of agile approaches. Stakeholders view ...

5. jemi.edu.pl jemi.edu.pl/vol-20-issue-2-2024/the-effectiveness-of-agile-leadership-in-practice-a-comprehensive-meta-analysis-of-empirical-studies-on-organizational-outcomes

The effectiveness of agile leadership in practice This study provides a meta-analytic review of the impact of agile leadership on organizational outcomes that cover various common dimensions.

6. medium.com medium.com/the-liberators/psychological-safety-in-the-agile-community-96100e31b6cb

Psychological Safety In The Agile Community This study aims to assess the level of psychological safety in the Agile community, both in online and in-person interactions.

7. socialpinpoint.com socialpinpoint.com/how-agile-methodologies-can-transform-community-engagement/

How Agile Methodologies Can Transform Community ... Agile methodologies can help you to stay in tune with your community while keeping the ball rolling on long-term projects at the same time.

8. aemcorp.com aemcorp.com/educationdata/blog/be-safe-and-realize-the-full-benefits-of-agile-it-practices

Be SAFe and Realize the Full Benefits of Agile IT Practices Decide on what data is the most important to your SAFe implementation, set some initial project tracking data standards, and start to clean up your data.

9. tandfonline.com tandfonline.com/doi/full/10.1080/08956308.2019.1563436

The Role of Psychological Safety in Implementing Agile ... This paper emphasizes the cultural challenges of implementing Agile methods. We applied a psychological safety framework in an empirical case.

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11131107/

Implementation of Agile in healthcare: methodology for a ... Home hospital patients have fewer 30-day readmissions, rate their experience of care more positively, feel more independent and less anxious, are more ...