Specialty Medical Homes for IBD and Behavioral Health Conditions

Overseen By Jessica Meyers, MS Ed

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: No smartphone, English proficiency, others

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

Compensation: Varies

Number of Visits: 1

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two different ways to care for people with Inflammatory Bowel Disease (IBD), such as Crohn's or Ulcerative Colitis, who also face mental health challenges. One approach, called TEAM, involves in-person visits with healthcare providers. The other, known as TECH, primarily uses technology, like video calls. The trial aims to determine which method more effectively helps patients manage their conditions. Individuals with IBD who experience mild to severe mental health symptoms might be suitable candidates for this trial. As an unphased study, this trial offers a unique opportunity to explore innovative care methods that could enhance quality of life.

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's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both the TEAM and TECH methods for managing inflammatory bowel disease (IBD) and mental health conditions are generally safe for patients. The TEAM care model, involving face-to-face visits, reduces hospital stays and decreases the need for steroids and painkillers, indicating it is well-received by patients with IBD.

The TECH model, which uses telehealth through digital tools, also shows promise. Studies on telemedicine for IBD have demonstrated its effectiveness in managing symptoms and improving patients' quality of life, suggesting the TECH approach is safe and beneficial.

In summary, both TEAM and TECH methods have been researched and found to be safe options for people with IBD and mental health needs. Each method offers unique benefits depending on the preference for in-person or remote care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to manage inflammatory bowel disease (IBD) and behavioral health conditions through specialized medical homes. The TEAM-care approach is unique because it tailors the frequency and focus of in-person visits based on the complexity of a patient's physical and behavioral health needs, offering a more personalized care experience. On the other hand, the TECH-telehealth approach leverages technology to maintain continuous care with minimal in-person visits, which can be especially convenient and efficient for patients. Both methods aim to enhance overall patient care by integrating physical and behavioral health management in a cohesive and adaptable way, something current standard treatments often lack.

What evidence suggests that this trial's treatments could be effective for IBD and behavioral health conditions?

This trial will compare two approaches: the TEAM-care as usual approach and the TECH-telehealth approach. Research has shown that TEAM-care, which involves a team of different healthcare professionals, improves outcomes for people with inflammatory bowel disease (IBD). Studies have found that this approach increases patients' confidence in managing their condition and helps them handle life challenges, especially when a nurse is actively involved. Another study found that including mental health support in IBD treatment helps patients feel more in control and engaged, with 66% reporting better disease management.

For the TECH-telehealth approach, research supports its cost-effectiveness compared to regular care for IBD patients. Telemedicine has improved quality of life and reduced the need for clinic visits. Online monitoring may also lead to better management of medications, making it a promising option for ongoing care. ^{2 3 6 7 8}

Who Is on the Research Team?

Eva Szigethy, MD, PhD

Principal Investigator

University of Pittsburgh Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals with Inflammatory Bowel Disease (IBD), such as Crohn's or Ulcerative Colitis, who also have mild to severe behavioral health symptoms. Participants must score at least a 6 on the PHQ4 questionnaire. People without a smartphone or those unable to speak, read, or understand English well enough are not eligible.

Inclusion Criteria

I have mild to severe behavioral health symptoms.

I have been diagnosed with Crohn's disease or Ulcerative Colitis.

Exclusion Criteria

Unable to speak, read or understand English at the minimum-required level.

Lack of smart phone

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either TEAM-care or TECH-telehealth approach for managing IBD and BH conditions

12 months

1 visit (in-person) per year, additional visits as needed, technology-supported interactions

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• TEAM
• TECH

Trial Overview The study compares two strategies for managing IBD and behavioral health: in-person supported care versus technology-supported care. It uses a randomized design and collects both quantitative data (like self-reports) and qualitative data (such as interviews).

How Is the Trial Designed?

Group I: TEAM-care as usual approach Active Control 1 Intervention

Patients will be triaged based on their physical health (PH) and behavioral health (BH) complexity to determine the frequency of in-person visits and how much of these visits will be devoted to medical versus BH issues. Minor modifications were made to the TEAM approach during the COVID-19 public health emergency to account for reduced face-to-face time without changing the underlying differentiation between the two models of delivering SMH care.

Group II: TECH-telehealth approach Active Control 1 Intervention

Each patient will have an initial face-to-face visit with the core treatment team described above and undergo the same triage process to determine their PH/BH care needs. Each TECH patient will participate in one face-to-face treatment team visit per year unless more frequent visits are deemed to be medically necessary; however, all other interactions will be conducted via technology-supported modalities

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

Mount Sinai Hospital, New York

Collaborator

Trials

37

Recruited

892,000+

The Cleveland Clinic

Collaborator

Trials

1,072

Recruited

1,377,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Citations

1. pcori.org pcori.org/research-results/2018/comparing-effectiveness-two-programs-treat-people-inflammatory-bowel-disease-and-behavioral-health-conditions

Comparing the Effectiveness of Two Programs To Treat ... This study compares the clinical effectiveness of two specialty medical home-based programs for treating individuals living with ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11151502/

Influence of multidisciplinary team care with abundant ... Multidisciplinary team care with abundant nurse staffing may improve self-efficacy and ease difficulties of life among patients with IBD in clinical remission.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9294946/

Implementing Collaborative Care Management of ... The collaborative care management (CoCM) model may be a more effective approach for integrating behavioral health into IBD care. CoCM is a patient-centered, ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2514664524012591

Process and Systems: A population-based model of care ... There is a demonstrable improvement in perception of IBD control and in the patient activation measure, with 66% of those who have used the open access service ...

5. journals.lww.com journals.lww.com/ajg/fulltext/2024/10001/s1366_effectiveness_of_a_community_based.1367.aspx

S1366 Effectiveness of A Community-Based Inflammatory ... A multi-disciplinary patient-centered medical home for IBD patients is feasible in the community and resulted in improved outcomes including higher steroid ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9802273/

Models of Care for Inflammatory Bowel Disease Studies of dedicated IBD services show reduced hospital admissions, wait times for surgical procedures, and patient steroid and opioid use. According to ...

7. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/00/NCT03985800/Prot_SAP_000.pdf

Specialty Medical Homes to Improve Outcomes for Patients with ... delivering care within a specialty medical home (SMH) clinical model for patients with inflammatory bowel disease (IBD) and behavioral health (BH) conditions.

8. academic.oup.com academic.oup.com/ecco-jcc/article/18/Supplement_2/ii55/7848701

Framework of IBD Care Delivery Across Ages - Oxford Academic This framework should focus on several key parameters: [1] better long-term outcomes; [2] optimal use of health care resources; [3] patient ...