T1D-CATCH: Type 1 Diabetes- Collaboration Around Technology Using Community Health Workers
Study Details
Study Description
Brief Summary
The objective of this study is to test the early effects and implementation of an enhanced community health worker (CHW) model (T1D-CATCH) that encourages and supports diabetes technology use in young adults from underrepresented minority groups (YA-URMs) with type 1 diabetes (T1D). The investigators will conduct a 6-month randomized controlled trial in which YA-URMs will be randomized toT1D-CATCH or usual care. The investigators will recruit from endocrinology and primary care practices in a large safety-net health system in the Bronx, New York. Our specific aims are to 1) evaluate T1D-CATCH effects on technology initiation and continued use over 6 months and 2) evaluate T1D-CATCH implementation using Proctor's Taxonomy of Implementation Outcomes: feasibility, adoption, fidelity, and cost.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The study will involve a 6-month randomized control trial of usual care versus T1D-CATCH, an intervention that enhances core community health worker (CHW) service roles to support increased use of T1D technology in young adults (underrepresented minorities)(YA_URM's). Participants will be recruited from primary and specialty care practices at Montefiore Medical Center in the Bronx, NY, which is a large safety-net hospital system in one of the poorest counties in the U.S. Two young adult-aged CHWs from the Montefiore CHW program will be trained extensively per our Supporting Emerging Adults with Diabetes (SEAD) program manuals. For YA-URMs, CHWs will conduct hands-on diabetes technology education, goal-setting, peer support, and social service linkage. CHWs will also help shift insurance approval tasks away from busy providers and better align patient-provider priorities through close communication between the YA-URM and provider. Group sessions will be optional and will follow the YA-centric education curriculum developed in Dr. Agarwal's Supporting Emerging Adults with Diabetes (SEAD) program.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: T1D-CATCH The CHW intervention will consist of both individual and optional group sessions with YA-URMs with T1D. In individual sessions, CHWs will provide T1D technology education, goal-setting, peer support, and social needs management. Over the 6-month study period, session frequency will involve weekly individual sessions during Month 1 (4 sessions - month 1), bi-weekly individual sessions during Months 2-3 (4 sessions - months 2-3), monthly individual sessions during Months 4-6 (3 sessions - months 4-6), and an optional monthly CHW-led peer group support session. Total amount of sessions equal 11 individual CHW sessions and 6 potential group sessions over the 6-month study period. CHW individual and group sessions will be held via videoconferencing or in person, per participant preference and institution COVID-19 rules. |
Behavioral: T1D-CATCH
As defined by the CDC, a CHW is "a frontline public health worker who is a trusted member of a community or who has a thorough understanding of the community being served, and leverages this unique position to link health systems, social services, and communities". CHWs engender trust with patients by having direct community and lived experience, offering specific support and empathy that may be difficult for other diabetes care professionals to provide. In addition, CHWs have firsthand understanding of cultural barriers to traditional western healthcare and can promote patient-centered culturally-relevant care. They enhance team-based care by helping providers with extra outreach, social needs management, time-consuming tasks, and aligning patient-provider priorities.
CHWs in this project will provide social needs assessment and management, introduction to diabetes technologies, and support for onboarding to technology.
|
| No Intervention: Usual Care Control Condition Control arm participants will receive usual primary or endocrine care at Montefiore. Usual care consists of a physician or nurse practitioner visit with review of blood sugars and treatment decisions based on provider experience. Physicians in endocrinology practices are nested within a diabetes center with access to diabetes nurse practitioners/educators, dieticians, a psychologist, and nurses. In all practices, patients are recommended to see their physician or nurse practitioner every 3 months and attend individual or group sessions. |
Outcome Measures
Primary Outcome Measures
- Technology Use [3 month mark]
Technology use tracked using EMR prescriptions, self-reporting, CHW records, and device platforms and will be measured as a binary variable (yes/no), days of wear (% use)
- Technology Use [6 month mark]
Technology use tracked using EMR prescriptions, self-reporting, CHW records, and device platforms and will be measured as a binary variable (yes/no), days of wear (% use)
Secondary Outcome Measures
- YA-URM Autonomy/ Competence, Social Support [Baseline]
Measured using the Healthcare Self-Determination survey
- YA-URM Autonomy/ Competence, Social Support [3 month mark]
Measured using the Healthcare Self-Determination survey
- YA-URM Autonomy/ Competence, Social Support [6 month mark]
Measured using the Healthcare Self-Determination survey
- Hemoglobin A1c [Baseline]
Obtained by POC (in clinic) or laboratory (DCA Vantage)
- Hemoglobin A1c [3 month mark]
Obtained by POC (in clinic) or laboratory (DCA Vantage)
- Hemoglobin A1c [6 month mark]
Obtained by POC (in clinic) or laboratory (DCA Vantage)
- Quality of Life (Diabetes Distress) [Baseline]
Validated survey: Type 1 Diabetes and Life Scale - Young Adult (T1DAL-YA) Likert Scale: 1-5 (1= no, not at all true, 2=no, not very true, 3=sometimes true, sometimes not true, 4=yes, a little true, 5= yes, very true)
- Quality of Life (Diabetes Distress) [Baseline]
Validated surveys: Problem Areas in Diabetes (PAID) The scores for each item are summed, then multiplied by 1.25 to generate a total score out of 100. Total scores of 40 and above: severe diabetes distress Individual items scored 3 or 4: moderate to severe distress to be discussed during the appointment following completion of the questionnaire.
- Quality of Life (Diabetes Distress) [Baseline]
Validated survey: Diabetes Self-Management Questionnaire (DSMQ)
- Quality of Life (Diabetes Distress) [Baseline]
Validated survey: Healthcare Climate Questionnaire (HCCQ) Likert Scale (1-7) 1= strongly disagree ---- 7= strongly agree Higher average scores represent a higher level of perceived autonomy support.
- Quality of Life (Diabetes Distress) [3 month follow-up]
Validated survey: Type 1 Diabetes and Life Scale - Young Adult (T1DAL-YA) Likert Scale: 1-5 (1= no, not at all true, 2=no, not very true, 3=sometimes true, sometimes not true, 4=yes, a little true, 5= yes, very true)
- Quality of Life (Diabetes Distress) [3 month follow-up]
Validated surveys: Problem Areas in Diabetes (PAID) The scores for each item are summed, then multiplied by 1.25 to generate a total score out of 100. Total scores of 40 and above: severe diabetes distress Individual items scored 3 or 4: moderate to severe distress to be discussed during the appointment following completion of the questionnaire.
- Quality of Life (Diabetes Distress) [3 month follow-up]
Validated survey: Diabetes Self-Management Questionnaire (DSMQ)
- Quality of Life (Diabetes Distress) [3 month follow-up]
Validated survey: Healthcare Climate Questionnaire (HCCQ) Likert Scale (1-7) 1= strongly disagree ---- 7= strongly agree Higher average scores represent a higher level of perceived autonomy support.
- Quality of Life (Diabetes Distress [6 month follow-up]
Validated survey: Type 1 Diabetes and Life Scale - Young Adult (T1DAL-YA) Likert Scale: 1-5 (1= no, not at all true, 2=no, not very true, 3=sometimes true, sometimes not true, 4=yes, a little true, 5= yes, very true)
- Quality of Life (Diabetes Distress) [6 month follow-up]
Validated surveys: Problem Areas in Diabetes (PAID) The scores for each item are summed, then multiplied by 1.25 to generate a total score out of 100. Total scores of 40 and above: severe diabetes distress Individual items scored 3 or 4: moderate to severe distress to be discussed during the appointment following completion of the questionnaire.
- Quality of life (Diabetes Distress) [6 month follow-up]
Validated survey: Diabetes Self-Management Questionnaire (DSMQ)
- Quality of Life (Diabetes Distress) [6 month follow-up]
Validated survey: Healthcare Climate Questionnaire (HCCQ) Likert Scale (1-7) 1= strongly disagree ---- 7= strongly agree Higher average scores represent a higher level of perceived autonomy support.
Other Outcome Measures
- Feasibility Check [6 months (post-intervention)]
Post-intervention interviews examining intervention content, complexity, comfort, delivery, and credibility
- Adoption [6 months (post-intervention)]
Measured by recruitment logs
- Adoption [6 months (post-intervention)]
Measured by electronic medical records (EMR)
- Adoption [6 months (post-intervention)]
Measured by young adult participant consent rates
- Adoption [6 months (post-intervention)]
Measured by percentage of provider opt-in
- Adoption [6 months (post-intervention)]
Measured by CHW communications
- Fidelity [Baseline]
Measured by the community health worker (CHW) dashboard
- Fidelity [Baseline]
Measured by session recordings
- Fidelity [Baseline]
Measured by electronic medical records (EMR) to analyze session attendance
- Fidelity [Baseline]
Measured by content delivery
- Fidelity [Baseline]
Measured by insurance tasks
- Fidelity [3 month mark]
Measured by community health workers (CHW) dashboard
- Fidelity [3 month mark]
Measured by CHW session recordings
- Fidelity [3 month mark]
Measured by EMR to analyze session attendance
- Fidelity [3 month mark]
Measured by content delivery
- Fidelity [3 month mark]
Measured by insurance tasks
- Fidelity [6 month mark]
Measured by CHW dashboard
- Fidelity [6 month mark]
Measured by CHW session recordings
- Fidelity [6 month mark]
Measured by EMR to analyze session attendance
- Fidelity [6 month mark]
Measured by content delivery
- Fidelity [6 month mark]
Measured by insurance tasks
- Cost [6 months (post-intervention)]
Measured by time sheets, receipts, and budget to analyze CHW salary/benefits
- Cost [6 months (post-intervention)]
Measured by time sheets, receipts, and budget to analyze CHW equipment
- Cost [6 months (post-intervention)]
Measured by time sheets, receipts, and budget to analyze CHW consumables
Eligibility Criteria
Criteria
Inclusion Criteria:
-
T1D duration ≥6 months
-
18-30 years old
-
Self-identified URM status: non-Hispanic Black or Hispanic
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English- or Spanish-speaking
-
Not currently on diabetes technology (includes never offered, discontinued, or previously refused technology)
Exclusion Criteria:
-
Developmental or sensory disability interfering with study participation
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Current pregnancy
-
Participation in another behavioral or technology intervention study in the past 6 months.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Albert Einstein College of Medicine | Bronx | New York | United States | 10461 |
Sponsors and Collaborators
- Albert Einstein College of Medicine
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
- Principal Investigator: Shivani Agarwal, MD, MPH, Albert Einstein College of Medicine
Study Documents (Full-Text)
More Information
Publications
- Addala A, Auzanneau M, Miller K, Maier W, Foster N, Kapellen T, Walker A, Rosenbauer J, Maahs DM, Holl RW. A Decade of Disparities in Diabetes Technology Use and HbA(1c) in Pediatric Type 1 Diabetes: A Transatlantic Comparison. Diabetes Care. 2021 Jan;44(1):133-140. doi: 10.2337/dc20-0257. Epub 2020 Sep 16.
- Addala A, Hanes S, Naranjo D, Maahs DM, Hood KK. Provider Implicit Bias Impacts Pediatric Type 1 Diabetes Technology Recommendations in the United States: Findings from The Gatekeeper Study. J Diabetes Sci Technol. 2021 Sep;15(5):1027-1033. doi: 10.1177/19322968211006476. Epub 2021 Apr 15.
- Agarwal S, Crespo-Ramos G, Long JA, Miller VA. "I Didn't Really Have a Choice": Qualitative Analysis of Racial-Ethnic Disparities in Diabetes Technology Use Among Young Adults with Type 1 Diabetes. Diabetes Technol Ther. 2021 Sep;23(9):616-622. doi: 10.1089/dia.2021.0075.
- Agarwal S, Schechter C, Gonzalez J, Long JA. Racial-Ethnic Disparities in Diabetes Technology use Among Young Adults with Type 1 Diabetes. Diabetes Technol Ther. 2021 Apr;23(4):306-313. doi: 10.1089/dia.2020.0338. Epub 2020 Dec 1.
- Ballard M, Westgate C, Alban R, Choudhury N, Adamjee R, Schwarz R, Bishop J, McLaughlin M, Flood D, Finnegan K, Rogers A, Olsen H, Johnson A, Palazuelos D, Schechter J. Compensation models for community health workers: Comparison of legal frameworks across five countries. J Glob Health. 2021 Feb 15;11:04010. doi: 10.7189/jogh.11.04010. Review.
- Berkowitz SA, Kalkhoran S, Edwards ST, Essien UR, Baggett TP. Unstable Housing and Diabetes-Related Emergency Department Visits and Hospitalization: A Nationally Representative Study of Safety-Net Clinic Patients. Diabetes Care. 2018 May;41(5):933-939. doi: 10.2337/dc17-1812. Epub 2018 Jan 4.
- Berkowitz SA, Meigs JB, DeWalt D, Seligman HK, Barnard LS, Bright OJ, Schow M, Atlas SJ, Wexler DJ. Material need insecurities, control of diabetes mellitus, and use of health care resources: results of the Measuring Economic Insecurity in Diabetes study. JAMA Intern Med. 2015 Feb;175(2):257-65. doi: 10.1001/jamainternmed.2014.6888.
- C3 Project. The Community Health Worker Core Consensus Project (C3): Roles and Competencies. C3 Project Findings. Published 2018. Accessed April 29, 2021. https://www.c3project.org/roles-competencies
- Findley SE, Matos S, Hicks AL, Campbell A, Moore A, Diaz D. Building a consensus on community health workers' scope of practice: lessons from New York. Am J Public Health. 2012 Oct;102(10):1981-7. doi: 10.2105/AJPH.2011.300566. Epub 2012 Aug 16.
- Foster NC, Beck RW, Miller KM, Clements MA, Rickels MR, DiMeglio LA, Maahs DM, Tamborlane WV, Bergenstal R, Smith E, Olson BA, Garg SK. State of Type 1 Diabetes Management and Outcomes from the T1D Exchange in 2016-2018. Diabetes Technol Ther. 2019 Feb;21(2):66-72. doi: 10.1089/dia.2018.0384. Epub 2019 Jan 18. Erratum in: Diabetes Technol Ther. 2019 Apr;21(4):230.
- Franklin CM, Bernhardt JM, Lopez RP, Long-Middleton ER, Davis S. Interprofessional Teamwork and Collaboration Between Community Health Workers and Healthcare Teams: An Integrative Review. Health Serv Res Manag Epidemiol. 2015 Mar 16;2:2333392815573312. doi: 10.1177/2333392815573312. eCollection 2015 Jan-Dec.
- Hagiwara N, Elston Lafata J, Mezuk B, Vrana SR, Fetters MD. Detecting implicit racial bias in provider communication behaviors to reduce disparities in healthcare: Challenges, solutions, and future directions for provider communication training. Patient Educ Couns. 2019 Sep;102(9):1738-1743. doi: 10.1016/j.pec.2019.04.023. Epub 2019 Apr 19.
- Hall WJ, Chapman MV, Lee KM, Merino YM, Thomas TW, Payne BK, Eng E, Day SH, Coyne-Beasley T. Implicit Racial/Ethnic Bias Among Health Care Professionals and Its Influence on Health Care Outcomes: A Systematic Review. Am J Public Health. 2015 Dec;105(12):e60-76. doi: 10.2105/AJPH.2015.302903. Epub 2015 Oct 15. Review.
- Lai CW, Lipman TH, Willi SM, Hawkes CP. Racial and Ethnic Disparities in Rates of Continuous IRB NUMBER: 2021-13714 IRB APPROVAL DATE: 03/23/2022 Glucose Monitor Initiation and Continued Use in Children With Type 1 Diabetes. 2020;(Online ahead of print). doi:10.2337/dc20-1663
- Livingstone SJ, Levin D, Looker HC, Lindsay RS, Wild SH, Joss N, Leese G, Leslie P, McCrimmon RJ, Metcalfe W, McKnight JA, Morris AD, Pearson DW, Petrie JR, Philip S, Sattar NA, Traynor JP, Colhoun HM; Scottish Diabetes Research Network epidemiology group; Scottish Renal Registry. Estimated life expectancy in a Scottish cohort with type 1 diabetes, 2008-2010. JAMA. 2015 Jan 6;313(1):37-44. doi: 10.1001/jama.2014.16425.
- McKergow E, Parkin L, Barson DJ, Sharples KJ, Wheeler BJ. Demographic and regional disparities in insulin pump utilization in a setting of universal funding: a New Zealand nationwide study. Acta Diabetol. 2017 Jan;54(1):63-71. doi: 10.1007/s00592-016-0912-7. Epub 2016 Sep 20.
- Palmas W, March D, Darakjy S, Findley SE, Teresi J, Carrasquillo O, Luchsinger JA. Community Health Worker Interventions to Improve Glycemic Control in People with Diabetes: A Systematic Review and Meta-Analysis. J Gen Intern Med. 2015 Jul;30(7):1004-12. doi: 10.1007/s11606-015-3247-0. Epub 2015 Mar 4. Review.
- Saydah S, Imperatore G, Cheng Y, Geiss LS, Albright A. Disparities in Diabetes Deaths Among Children and Adolescents - United States, 2000-2014. MMWR Morb Mortal Wkly Rep. 2017 May 19;66(19):502-505. doi: 10.15585/mmwr.mm6619a4.
- Schaaf M, Warthin C, Freedman L, Topp SM. The community health worker as service extender, cultural broker and social change agent: a critical interpretive synthesis of roles, intent and accountability. BMJ Glob Health. 2020 Jun;5(6). pii: e002296. doi: 10.1136/bmjgh-2020-002296.
- Spencer MS, Kieffer EC, Sinco B, Piatt G, Palmisano G, Hawkins J, Lebron A, Espitia N, Tang T, Funnell M, Heisler M. Outcomes at 18 Months From a Community Health Worker and Peer Leader Diabetes Self-Management Program for Latino Adults. Diabetes Care. 2018 Jul;41(7):1414-1422. doi: 10.2337/dc17-0978. Epub 2018 Apr 27.
- Walker AF, Hood KK, Gurka MJ, Filipp SL, Anez-Zabala C, Cuttriss N, Haller MJ, Roque X, Naranjo D, Aulisio G, Addala A, Konopack J, Westen S, Yabut K, Mercado E, Look S, Fitzgerald B, Maizel J, Maahs DM. Barriers to Technology Use and Endocrinology Care for Underserved Communities With Type 1 Diabetes. Diabetes Care. 2021 Jul;44(7):1480-1490. doi: 10.2337/dc20-2753. Epub 2021 May 17.
- Walker RJ, Gebregziabher M, Martin-Harris B, Egede LE. Independent effects of socioeconomic and psychological social determinants of health on self-care and outcomes in Type 2 diabetes. Gen Hosp Psychiatry. 2014 Nov-Dec;36(6):662-8. doi: 10.1016/j.genhosppsych.2014.06.011. Epub 2014 Jul 9.
- Walker RJ, Gebregziabher M, Martin-Harris B, Egede LE. Quantifying direct effects of social determinants of health on glycemic control in adults with type 2 diabetes. Diabetes Technol Ther. 2015 Feb;17(2):80-7. doi: 10.1089/dia.2014.0166. Epub 2014 Oct 31.
- Willi SM, Miller KM, DiMeglio LA, Klingensmith GJ, Simmons JH, Tamborlane WV, Nadeau KJ, Kittelsrud JM, Huckfeldt P, Beck RW, Lipman TH; T1D Exchange Clinic Network. Racial-ethnic disparities in management and outcomes among children with type 1 diabetes. Pediatrics. 2015 Mar;135(3):424-34. doi: 10.1542/peds.2014-1774.
- 2021-13714
- R01DK132302