- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT02355262
CATCH-UP Intervention in Increasing Cancer Screening and Prevention Care in Uninsured Patients at Community Health Centers
Community-Based HIT Tools for Cancer Screening and Health Insurance Promotion (CATCH-UP)
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Részletes leírás
PRIMARY OBJECTIVES:
I. Evaluate the effect of the CATCH-UP intervention on up-to-date status of cancer screening and preventive care received by patients.
II. Evaluate the effect of the CATCH-UP intervention on patients? insurance coverage rates.
III. Evaluate the intervention implementation process, patient and community health center (CHC) staff acceptance and use of the CATCH-UP tools, and the patient-, provider-, and system-level factors associated with successful implementation and sustainability of the tools, using mixed methods.
OUTLINE: CHC clinics are randomized to 1 of 2 groups. We compare between groups and with a matched-comparison group.
GROUP I (INTERVENTION ARM 1): Participants receive CATCH-UP tools which include a panel management/data aggregator system that identifies patients who may be eligible for public coverage but are not yet insured, or who are nearing coverage expiration, coupled with automated patient outreach and communication at baseline.
GROUP II (INTERVENTION ARM 2): Participants receive CATCH-UP tools which include a panel management/data aggregator system that identifies patients who may be eligible for public coverage but are not yet insured, or who are nearing coverage expiration, coupled with automated patient outreach and communication. Participants also receive additional implementation support such as trainings, assistance with workflows, and practice facilitation.
Matched-comparison group: A clinic-level matched comparison group will be derived from the OCHIN membership by using propensity score matching techniques. Comparison group clinics will not participate actively in any study activities but, as part of their member business associate agreement with OCHIN, have already agreed to provide data through OCHIN for pre- and post-implementation analysis in the study.
Tanulmány típusa
Beiratkozás (Tényleges)
Kapcsolatok és helyek
Tanulmányi helyek
-
-
Oregon
-
Portland, Oregon, Egyesült Államok, 97239
- OHSU Knight Cancer Institute
-
-
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Mintavételi módszer
Tanulmányi populáció
Leírás
Inclusion Criteria:
- Established patients at CHC sites
- Low-income
- Ethnically diverse populations with lower rates of cancer screening compared to national rates
- Uninsured patients
- Patients 18 to 64 years of age
- Clinics must be primary care sites, with greater than 1,000 adult patients in the past year, be located in a state that expanded Medicaid, and have implemented the OCHIN EHR prior to January 1, 2012
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
Kohorszok és beavatkozások
Csoport / Kohorsz |
Beavatkozás / kezelés |
---|---|
Arm I (Independent Tool Implementation)
Participants receive CATCH-UP tools which include a panel management/data aggregator system that identifies patients who may be eligible for public coverage but are not yet insured, or who are nearing coverage expiration, coupled with automated patient outreach and communication at baseline.
|
Receive CATCH-UP intervention
|
Arm II (Tool Implementation with Interactive Facilitation)
Participants receive CATCH-UP tools which include a panel management/data aggregator system that identifies patients who may be eligible for public coverage but are not yet insured, or who are nearing coverage expiration, coupled with automated patient outreach and communication.
Participants also receive additional implementation support such as trainings, assistance with workflows, and practice facilitation.
|
Receive CATCH-UP intervention
|
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Changes in the proportion of clinic patients who receive age- and gender-appropriate recommended cancer screening and preventive care (clinic-level)
Időkeret: Baseline to up to 6 years
|
Pre- and post-implementation differences in proportion of patients with insurance continuity will be calculated between implementation and control community health centers (?difference-in-differences? analysis).
Generalized linear/non-linear mixed models will be used, which offer flexible regression modeling to accommodate different sources of correlations (serial and intra-clinic), categorical and continuous covariates, and fixed and time-dependent covariates.
|
Baseline to up to 6 years
|
Changes in the proportion of clinic patients with insurance continuity
Időkeret: Baseline to up to 6 years
|
Pre- and post-implementation differences in proportion of patients with insurance continuity will be calculated between implementation and control community health centers (?difference-in-differences? analysis).
Generalized linear/non-linear mixed models will be used, which offer flexible regression modeling to accommodate different sources of correlations (serial and intra-clinic), categorical and continuous covariates, and fixed and time-dependent covariates.
Serial and intra-clinic correlations will be modeled as random effects.
|
Baseline to up to 6 years
|
Total number of months uninsured (total gap months)
Időkeret: Up to 6 years
|
The Community-based Health Information Technology (HIT) Tools for Cancer Screening and Health Insurance Promotion tool?s impact on total number of months uninsured (total gap months) will be evaluated.
The distribution of total gap months will be examined before selecting a specific model to use for the analysis.
Analytic models will be refined through an iterative process, guided by the hypotheses and preliminary analyses.
|
Up to 6 years
|
Együttműködők és nyomozók
Szponzor
Együttműködők
Nyomozók
- Kutatásvezető: Jennifer DeVoe, OHSU Knight Cancer Institute
Publikációk és hasznos linkek
Általános kiadványok
- Hoopes MJ, Angier H, Gold R, Bailey SR, Huguet N, Marino M, DeVoe JE. Utilization of Community Health Centers in Medicaid Expansion and Nonexpansion States, 2013-2014. J Ambul Care Manage. 2016 Oct-Dec;39(4):290-8. doi: 10.1097/JAC.0000000000000123.
- Hatch B, Tillotson C, Angier H, Marino M, Hoopes M, Huguet N, DeVoe J. Using the electronic health record for assessment of health insurance in community health centers. J Am Med Inform Assoc. 2016 Sep;23(5):984-90. doi: 10.1093/jamia/ocv179. Epub 2016 Jan 23.
- DeVoe JE, Tillotson CJ, Marino M, O'Malley J, Angier H, Wallace LS, Gold R. Trends in Type of Health Insurance Coverage for US Children and Their Parents, 1998-2011. Acad Pediatr. 2016 Mar;16(2):192-9. doi: 10.1016/j.acap.2015.06.009. Epub 2015 Aug 18.
- DeVoe JE, Huguet N, Likumahuwa-Ackman S, Angier H, Nelson C, Marino M, Cohen D, Sumic A, Hoopes M, Harding RL, Dearing M, Gold R. Testing health information technology tools to facilitate health insurance support: a protocol for an effectiveness-implementation hybrid randomized trial. Implement Sci. 2015 Aug 25;10:123. doi: 10.1186/s13012-015-0311-4.
- Angier H, Hoopes M, Gold R, Bailey SR, Cottrell EK, Heintzman J, Marino M, DeVoe JE. An early look at rates of uninsured safety net clinic visits after the Affordable Care Act. Ann Fam Med. 2015 Jan-Feb;13(1):10-6. doi: 10.1370/afm.1741.
- Heintzman J, Marino M, Hoopes M, Bailey SR, Gold R, O'Malley J, Angier H, Nelson C, Cottrell E, Devoe J. Supporting health insurance expansion: do electronic health records have valid insurance verification and enrollment data? J Am Med Inform Assoc. 2015 Jul;22(4):909-13. doi: 10.1093/jamia/ocv033. Epub 2015 Apr 17.
- DeVoe JE, Angier H, Burdick T, Gold R. Health information technology: an untapped resource to help keep patients insured. Ann Fam Med. 2014 Nov-Dec;12(6):568-72. doi: 10.1370/afm.1721.
- Gold R, Burdick T, Angier H, Wallace L, Nelson C, Likumahuwa-Ackman S, Sumic A, DeVoe JE. Improve Synergy Between Health Information Exchange and Electronic Health Records to Increase Rates of Continuously Insured Patients. EGEMS (Wash DC). 2015 Aug 6;3(1):1158. doi: 10.13063/2327-9214.1158. eCollection 2015.
- Huguet N, Hoopes MJ, Angier H, Marino M, Holderness H, DeVoe JE. Medicaid Expansion Produces Long-Term Impact on Insurance Coverage Rates in Community Health Centers. J Prim Care Community Health. 2017 Oct;8(4):206-212. doi: 10.1177/2150131917709403. Epub 2017 May 17.
- Huguet N, Valenzuela S, Marino M, Moreno L, Hatch B, Baron A, Cohen DJ, DeVoe JE. Effectiveness of an insurance enrollment support tool on insurance rates and cancer prevention in community health centers: a quasi-experimental study. BMC Health Serv Res. 2021 Oct 30;21(1):1186. doi: 10.1186/s12913-021-07195-5. Erratum In: BMC Health Serv Res. 2022 May 2;22(1):587.
- Hatch B, Tillotson C, Huguet N, Marino M, Baron A, Nelson J, Sumic A, Cohen D, E DeVoe J. Implementation and adoption of a health insurance support tool in the electronic health record: a mixed methods analysis within a randomized trial. BMC Health Serv Res. 2020 May 15;20(1):428. doi: 10.1186/s12913-020-05317-z.
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Tényleges)
A tanulmány befejezése (Tényleges)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Becslés)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
- Emésztőrendszeri betegségek
- Bőrbetegségek
- Vírusos betegségek
- Fertőzések
- Neoplazmák szövettani típus szerint
- Neoplazmák webhelyenként
- Neoplazmák, mirigyes és epiteliális
- Gasztrointesztinális neoplazmák
- Emésztőrendszeri neoplazmák
- Emésztőrendszeri betegségek
- Mellbetegségek
- Vastagbélbetegségek
- Bélbetegségek
- DNS vírusfertőzések
- Bél neoplazmák
- Rektális betegségek
- Tumor vírusfertőzések
- Neoplazmák
- Mellrák neoplazmák
- Karcinóma
- Kolorektális neoplazmák
- Papillomavírus fertőzések
Egyéb vizsgálati azonosító számok
- IRB00009862 (Egyéb azonosító: OHSU Knight Cancer Institute)
- NCI-2014-02326 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- CR00024554
- 5219
- MR00042926
- MR00044877
- R01CA181452 (Az Egyesült Államok NIH támogatása/szerződése)
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .