Speak Up! Video for Diabetes

(ACTIVet-2 Trial)

Recruiting at 10 trial locations

Overseen By Jessica M Gardner

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Dementia, Terminal condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

512 Participants Needed

Trial Summary

What is the purpose of this trial?

Type 2 diabetes is a significant condition in VA affecting 20% of VA patients. Adherence to medication regimens and lifestyle factors is important to achieve care goals for these patients. Patients who use active participatory communication behaviors with their providers have better adherence to treatment and better biomedical outcomes, yet many patients are not prepared to engage in active communication with their providers. Existing coaching interventions have not been adopted in practice because of the cost of trained personnel. The investigators have shown the efficacy of a low-cost video that did not require trained personnel. This proposal proposes to test implementation strategies to deliver that video in VA primary care clinics and to test the effectiveness of the video to improve outcomes in a Hybrid Type 2 effectiveness-implementation trial using a cluster randomized stepped wedge design at eight sites. This proposal will test feasibility of implementing the video and if successful will generate the evidence to justify widespread dissemination of the video.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on testing a video intervention, so it's likely you can continue your current treatment, but please confirm with the trial coordinators.

What data supports the effectiveness of the Speak Up! Video treatment for diabetes?

Research shows that methods like teach-back, which promote active communication and shared decision-making between patients and providers, are linked to better health outcomes in diabetes, such as reduced complications and hospitalizations. ^{1 2 3 4 5}

How is the Speak Up! Video treatment for diabetes different from other treatments?

The Speak Up! Video treatment is unique because it focuses on empowering patients to actively communicate and engage in shared decision-making during medical visits, rather than directly addressing the medical aspects of diabetes management. This approach emphasizes patient involvement and communication, which is different from traditional treatments that primarily focus on medication or lifestyle changes. ^{6 7 8 9 10}

Research Team

Howard S Gordon, MD BS

Principal Investigator

Jesse Brown VA Medical Center, Chicago, IL

Eligibility Criteria

This trial is for adult veterans with Type 2 diabetes who have an A1c level of 7 or higher and are receiving care at a participating site. It's not suitable for those with terminal conditions, severe kidney issues, recent heart problems, dementia, living in nursing facilities, or who are blind/deaf.

Inclusion Criteria

I am 18 years old or older.

Visit at a participating site

Hemoglobin A1c (A1c) 7 or greater

Exclusion Criteria

I am unable to see or hear.

I have diabetes caused by medication.

My kidney function is low, or I've recently had a heart attack or heart failure.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Usual Care

Patients are in a usual care phase until their clinic begins active implementation

Varies

Active Implementation

Patients view the Speak Up! video intervention prior to their visit

1 week

1 visit (in-person)

Follow-up

Participants are monitored for changes in communication self-efficacy, diabetes distress, and HgbA1c levels

3 months

Treatment Details

Interventions

• Speak Up! Video

Trial Overview The trial is testing the 'Speak Up! Video' as a tool to help diabetic patients communicate better with their healthcare providers. The study will evaluate if this video can improve medication adherence and health outcomes without needing trained personnel.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

The study is a type 2 hybrid Effectiveness Implementation trial. The study uses a stepped wedge design. Patients are in a usual care phase until their clinic begins active implementation. Once active implementation begins, patients will view the Speak Up! Video intervention prior to their visit. The 10-minute video program will be provided to patients for viewing on an iPad (or other modality such as a portable DVD player, computer, or TV as appropriate to the site based on PDSA activities during implementation planning). Nurses may also send a video link to the patient via secured messaging as a method of watching the video before the primary care visit.

Speak Up! Video is already approved in United States for the following indications:

Approved in United States as Speak Up Video for:

• Educational tool for improving patient-provider communication in Type 2 diabetes management

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Findings from Research

Shared decision-making in healthcare has numerous benefits, but its implementation is still not widely adopted among healthcare providers.

Utilizing specific tools and frameworks can enhance patient engagement in their own care decisions, potentially improving the overall effectiveness of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How to integrate shared decision-making into your practice. Mackwood, MB., Imset, I., Morrow, C.[2023]

The teach-back method, used with 2901 adults with diabetes, enhances communication between patients and healthcare providers, leading to better shared decision-making and lifestyle advice.

Implementing the teach-back method is linked to a reduction in condition-specific hospitalizations and complications, suggesting it improves health outcomes for patients with diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pathways of Teach-Back Communication to Health Outcomes Among Individuals With Diabetes: A Pathway Modeling. Hong, YR., Jo, A., Huo, J., et al.[2022]

Participatory decision making (PDM) in primary care significantly improved clinical outcomes for diabetic patients, leading to lower hemoglobin A(1c) and LDL cholesterol levels over a 12-month period.

The study found that PDM enhances patient activation, which subsequently improves medication adherence, demonstrating a clear pathway from PDM to better diabetes management outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Participatory decision making, patient activation, medication adherence, and intermediate clinical outcomes in type 2 diabetes: a STARNet study. Parchman, ML., Zeber, JE., Palmer, RF.[2022]

A patient activation tool (PAT) did not significantly improve decision-making outcomes or patient satisfaction for pediatric patients and their caregivers deciding between surgery and nonoperative management for appendicitis, based on a study of 200 participants.

Both groups showed high levels of decisional self-efficacy and healthcare satisfaction, indicating that caregivers and children can effectively engage in shared decision-making even without the use of the PAT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Patient Activation Tool on Decision Making Between Surgery and Nonoperative Management for Pediatric Appendicitis: A Randomized Clinical Trial. Minneci, PC., Cooper, JN., Leonhart, K., et al.[2020]

The study involving 684 participants (324 patients and 360 disease-naïve individuals) found that communicating choice awareness positively influenced patients' perceived involvement in treatment decisions, while physician preference communication did not significantly affect this perception.

However, when physicians expressed a preference for a treatment option, it led patients to favor that option, indicating that how physicians communicate their preferences can influence patient choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fostering Patient Choice Awareness and Presenting Treatment Options Neutrally: A Randomized Trial to Assess the Effect on Perceived Room for Involvement in Decision Making. Pieterse, AH., Brandes, K., de Graaf, J., et al.[2022]

The Diabetes Conversation Map™ program, which engages diabetes patients in group discussions, shows potential for improving patient behaviors and outcomes, but current evidence is limited and mostly indicates non-significant differences in objective health measures like HbA1c levels.

Out of 24 studies reviewed, most reported no significant changes in health indicators such as blood pressure, suggesting that while the program may be beneficial, more rigorous and larger studies are needed to confirm its effectiveness on long-term health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes Conversation Map™ and health outcomes: A systematic literature review. Srulovici, E., Key, C., Rotem, M., et al.[2019]

In the PRIDE trial involving 24 participants with prediabetes, Hispanic and non-Hispanic Black individuals reported more barriers to weight loss compared to non-Hispanic White participants, particularly due to time constraints and limited financial resources.

To improve weight loss outcomes and ensure equitable access to diabetes prevention programs, there is a need for increased support for lifestyle changes and more flexible program delivery options tailored to the needs of underresourced populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differences in Weight Loss by Race and Ethnicity in the PRIDE Trial: a Qualitative Analysis of Participant Perspectives. Saju, R., Castellon-Lopez, Y., Turk, N., et al.[2022]

The current instability in the healthcare system highlights the need for patient and physician involvement in policy decisions, especially regarding chronic conditions like diabetes.

A collaborative effort among stakeholders in the diabetes community is essential to advocate for patient-centered care and to ensure that access to treatment and patient-reported outcomes are prioritized in healthcare value assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Achieving a Patient-Centered, Value-Based System of Diabetes Care in the United States: Report on a National Stakeholder Summit. Nash, DB., Skoufalos, A., Harris, D.[2018]

The Diabetes Conversation Map™ Program significantly improved clinical outcomes in participants with type 2 diabetes, showing lower HbA1c, glucose, and LDL levels, as well as increased frequency of glucose testing over a 36-month period compared to matched controls.

Participants also experienced better health behaviors, such as higher HDL and lower triglyceride levels at 6- and 12-month follow-ups, along with improved medication adherence and lower diastolic blood pressure at 6 months, indicating sustained benefits from the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term effectiveness of the Diabetes Conversation Map™ Program on health outcomes: A case-control retrospective cohort study. Srulovici, E., Leventer-Roberts, M., Curtis, B., et al.[2021]

Adolescents often face challenges in communicating with healthcare providers, including negative experiences, lack of education, and low self-confidence, which can hinder their participation in diabetes care.

The development of a Question Prompt List (QPL) through an adolescent-led co-design approach can empower young patients to ask important questions and engage more actively during clinic visits, addressing the gap in perceived knowledge between adolescents and adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Encouraging adolescents' participation during paediatric diabetes clinic visits: Design and development of a question prompt list intervention. Pembroke, S., Cody, D., Roche, EF., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

How to integrate shared decision-making into your practice. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Pathways of Teach-Back Communication to Health Outcomes Among Individuals With Diabetes: A Pathway Modeling. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Participatory decision making, patient activation, medication adherence, and intermediate clinical outcomes in type 2 diabetes: a STARNet study. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Effects of a Patient Activation Tool on Decision Making Between Surgery and Nonoperative Management for Pediatric Appendicitis: A Randomized Clinical Trial. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Fostering Patient Choice Awareness and Presenting Treatment Options Neutrally: A Randomized Trial to Assess the Effect on Perceived Room for Involvement in Decision Making. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Diabetes Conversation Map™ and health outcomes: A systematic literature review. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Differences in Weight Loss by Race and Ethnicity in the PRIDE Trial: a Qualitative Analysis of Participant Perspectives. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Achieving a Patient-Centered, Value-Based System of Diabetes Care in the United States: Report on a National Stakeholder Summit. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Long-term effectiveness of the Diabetes Conversation Map™ Program on health outcomes: A case-control retrospective cohort study. [2021]

10. Ireland pubmed.ncbi.nlm.nih.gov

Encouraging adolescents' participation during paediatric diabetes clinic visits: Design and development of a question prompt list intervention. [2022]