Virtual vs Telephonic Outreach for Multiple Chronic Conditions

Overseen By Karen R Estacio, MHA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kaiser Permanente

Disqualifiers: Dementia, Psychosis, Extremely high utilizers

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

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which method better supports individuals with multiple chronic conditions. It compares "telephonic navigation," where a health navigator calls and checks in for up to three months, with "virtual outreach," which uses texts, emails, or letters to share information about available services. Suitable participants include those with at least two chronic conditions, some missed medical care, and at least one social issue, such as transportation difficulties or financial insecurity. As an unphased trial, this study provides a unique opportunity to explore innovative support methods that could enhance the healthcare experience.

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 seems to focus on outreach methods rather than medication changes.

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

Research shows that both phone calls and online methods are commonly used to manage long-term health issues. However, some safety concerns should be considered.

One study found that 86% of patients receiving phone support reported at least one problem or issue. While phone support can be useful, it may also present challenges or side effects for some individuals.

In contrast, online support has shown positive results. Telemedicine, which includes online support, has improved patient health and satisfaction, particularly in managing long-term conditions like diabetes. Although specific problems with online support are not detailed in the sources provided, the focus on better outcomes suggests general patient approval.

Overall, while both phone and online methods aim to assist with long-term health issues, phone support might present more potential problems. Online support appears safer based on patient satisfaction and health improvements. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to support people with multiple chronic conditions. Unlike traditional methods that rely heavily on in-person visits and consultations, this trial compares two modern approaches: virtual outreach and telephonic navigation. Virtual outreach employs a lower-intensity approach using text, email, or letters to provide important information about benefits and services, making it highly accessible and convenient. On the other hand, telephonic navigation involves more personalized, high-intensity support through direct calls from health navigators, offering a proactive follow-up over several months. This trial aims to determine which method is more effective in providing continuous care and support, potentially leading to better health outcomes for patients managing multiple chronic conditions.

What evidence suggests that this trial's treatments could be effective for patients with multiple chronic conditions?

This trial will compare two outreach methods for individuals with multiple chronic conditions: Telephonic Navigation and Virtual Outreach. Research has shown that phone calls, similar to the Telephonic Navigation arm in this trial, can enhance the physical, mental, and social well-being of patients with several long-term health issues. Studies have found that patients receiving phone support often experience reduced anxiety and depression. Similarly, virtual support, as provided in the Virtual Outreach arm, has proven effective in managing long-term conditions. It can improve quality of life and mental health, particularly for individuals with illnesses like asthma and diabetes. Both phone and virtual support offer valuable assistance, making them promising methods to help people with multiple chronic health problems. ^{6 7 8 9 10}

Who Is on the Research Team?

Richard W Grant, MD MPH

Principal Investigator

Kaiser Permanente

Are You a Good Fit for This Trial?

This trial is for adults with multiple chronic conditions, including Chorda Tympani Disorder. It's designed to see if addressing social needs can improve health outcomes. Participants must be able to engage in virtual or telephonic communication.

Inclusion Criteria

I face challenges like transportation, food, or housing that affect my healthcare.

Two or more chronic medical conditions from a defined list of 24 chronic conditions

I have missed some treatments or check-ups for my condition.

Exclusion Criteria

Major cognitive barriers (dementia, psychosis)

Multiple prior year hospitalizations ('extremely high utilizers')

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either higher intensity telephonic navigation or lower intensity virtual outreach to address social needs

3 months

Multiple contacts via phone, text, email, or letter

Follow-up

Participants are monitored for receipt of social services, closure of clinical care gaps, and reduction in social needs

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Telephonic Outreach
• Virtual Outreach

Trial Overview The study compares two strategies: higher intensity 'telephonic navigation' and lower intensity 'virtual outreach'. Both are usual care methods for helping patients manage social aspects related to their chronic conditions.

How Is the Trial Designed?

Group I: Telephonic Navigation Experimental Treatment 1 Intervention

Higher Intensity (active telephonic outreach from a health navigator with follow-up contacts for up to 3 months)

Group II: Virtual Outreach Active Control 1 Intervention

Lower Intensity (outreach via text, email, and/or letter with materials that contain information about available local, state, and federal governmental benefits and services)

Who Is Running the Clinical Trial?

Kaiser Permanente

Lead Sponsor

Trials

563

Recruited

27,400,000+

Published Research Related to This Trial

A significant 86% of the 111 diabetes patients experienced at least one adverse event (AE) or potential adverse event (PotAE) over a 9-month period, highlighting the prevalence of safety issues in chronic disease management.

The majority of AEs (63%) were related to medication management, and 77% of events involved patient actions, indicating that enhancing patient self-management and communication with healthcare providers is crucial for preventing these events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What happens between visits? Adverse and potential adverse events among a low-income, urban, ambulatory population with diabetes. Sarkar, U., Handley, MA., Gupta, R., et al.[2021]

A systematic review of 200 articles identified that videoconferencing for therapeutic interventions in chronic conditions yields clinical outcomes comparable to in-person treatments, supported by evidence from four high-quality randomized controlled trials.

Patient satisfaction with telerehabilitation is generally high, indicating that a strong therapeutic alliance can be formed, although clinical staff reported lower satisfaction levels compared to patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic videoconferencing interventions for the treatment of long-term conditions. Steel, K., Cox, D., Garry, H.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10176143/

Evaluation of the Effectiveness of Telehealth Chronic ... TCDMS positively affected patients' physical, mental, and social quality of life across multiple chronic diseases.

2. pcori.org pcori.org/research-results/2020/evaluating-effect-telehealth-use-patients-chronic-disease-during-covid-19-pandemic

Evaluating the Effect of Telehealth Use for Patients with ... Researchers reviewed claims and health record data for 33,100 patients with one or more chronic conditions who were receiving primary care ...

3. aging.jmir.org aging.jmir.org/2024/1/e59588/

An eHealth Intervention to Improve Quality of Life ... - JMIR Aging The results suggested that (1) ET may be more effective for patients who are dealing with multiple chronic conditions (MCCs), given that primary ...

4. urban.org urban.org/sites/default/files/2023-03/How%20Adults%20with%20Chronic%20Health%20Conditions%20Experience%20Telehealth.pdf

How Adults with Chronic Health Conditions Experience ... However, nonelderly adults with chronic conditions who had both phone and video visits were much more likely to have anxiety or depression and ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT00608530

NCT00608530 | Telehealth Outreach for Chronic Back Pain In both studies patients were randomized to one of two conditions, either a Cognitive Behavioral-based Therapy or a control condition, a supportive (Rogerian) ...

6. withpower.com withpower.com/trial/phase-disease-8-2025-7aa7a

Virtual vs Telephonic Outreach for Multiple Chronic Conditions A significant 86% of the 111 diabetes patients experienced at least one adverse event (AE) or potential adverse event (PotAE) over a 9-month period, ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10100602/

Telehealth for Chronic Disease Management Among ... The study examined telehealth chronic disease management among low-income minority groups. We used Florida Medicaid claims data from March to December 2020.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S221307641400013X

A mobile health infrastructure to support underserved ... Outreach messages were sent to patients overdue for laboratory tests and medications. Manual review of pharmacy and laboratory outreach data was conducted for ...

9. cdc.gov cdc.gov/cardiovascular-resources/php/data-research/telehealth.html

Telehealth Interventions to Improve Chronic Disease The Community Preventive Services Task Force (CPSTF) recommends several telehealth interventions for reducing chronic disease risk factors in patients.

10. ahrq.gov ahrq.gov/ncepcr/about/impact-stories/predictive-model.html

An EHR-based Predictive Model to Identify Higher ... Patients with MCC have two or more chronic conditions at the same time, such as diabetes, hypertension, and asthma. Individuals with MCC account for a ...