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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA201429 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Cancer Institute (NCI) | NIH |
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Using a 2x2 randomized factorial design, we will conduct a statewide field trial in Missouri to compare the relative and combined effects of these two strategies for augmenting an existing, evidence-based tobacco quitline program. Among 2000 low-income smokers, half will receive standard Missouri quitline services and half will receive new Specialized Quitline services targeted to this group. In each of these groups, half also will receive calls from a trained navigator to help them address unmet Basic Needs and the accompanying psychological distress that act as barriers to smoking cessation.
2-1-1 information specialists will deliver standard service, then ask a random number of callers per day if they would be willing to answer a few health questions as part of a new 2-1-1 service. Callers eligible to receive the invitation to screen for study eligibility will be: Missouri residents, calling for themselves, English-speaking, and not in acute crisis. Eligible smokers will then be asked if they are willing to share their contact information with a research team conducting a study to help smokers quit. Smokers who agree to share their contact information will be considered "enrolled". Trained 2-1-1 operators will record all recruitment screening data in a secure electronic database that is shared with research staff. Research staff will attempt to reach enrolled smokers by phone by the next business day.
Alere, through the Missouri Tobacco Quitline, will provide quitline services to smokers in all study conditions. Contact information and study group assignment for smokers will be provided to Alere via secure data transfer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Quitline | No Intervention | Participants will receive standard Missouri quitline services | |
| Specialized Quitline | Experimental | Participants will receive an enhanced version of the standard quitline services |
|
| Standard Quitline with Basic Needs Navigator | Experimental | Participants receive standard quitline services with navigator |
|
| Specialized Quitline with Basic Needs Navigator | Experimental | Participants receive enhanced quitline services with navigator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Specialized Quitline | Behavioral | Very low-income smokers are different from other smokers in important ways not always addressed by standard quitline services. The research team and Alere staff has created custom protocols, scripts, prompts and other content to maximize intervention relevance and acceptability to very low-income smokers. Research Implementation Unit (RIU) coaches who will be delivering the Specialized Quitline services have received training from clinical quitline staff, the research team and 2-1-1 staff who have extensive experience with the target population. Focus areas for training and distinctive content and protocol for the Specialized Quitline include: health literacy, abstract vs. concrete language, lived experience, resource constraints, future orientation, getting cigarettes, living situation, phone/internet access. |
| Measure | Description | Time Frame |
|---|---|---|
| Abstinence 6-months | Report 7-day point prevalence abstinence measured at 6-months post --baseline | 6 months post-baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Abstinence 3-months | Report 7-day point prevalence abstinence measured at 3-months post-baseline | 3 months post-baseline |
| 24hr Quit Attempt | Report quitting smoking for at least 24 hours during intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Kreuter, PhD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University in St. Louis | St Louis | Missouri | 63130 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28260823 | Background | Boyum S, Kreuter MW, McQueen A, Thompson T, Greer R. Getting help from 2-1-1: A statewide study of referral outcomes. J Soc Serv Res. 2016;42(3):402-411. doi: 10.1080/01488376.2015.1109576. Epub 2016 Jan 22. | |
| 26187910 | Background | Cappelletti ER, Kreuter MW, Boyum S, Thompson T. Basic needs, stress and the effects of tailored health communication in vulnerable populations. Health Educ Res. 2015 Aug;30(4):591-8. doi: 10.1093/her/cyv033. |
| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Quitline | Participants will receive standard Missouri quitline services |
| FG001 | Specialized Quitline | Participants will receive an enhanced version of the standard quitline services Specialized Quitline: Very low-income smokers are different from other smokers in important ways not always addressed by standard quitline services. The research team and Alere staff has created custom protocols, scripts, prompts and other content to maximize intervention relevance and acceptability to very low-income smokers. Research Implementation Unit (RIU) coaches who will be delivering the Specialized Quitline services have received training from clinical quitline staff, the research team and 2-1-1 staff who have extensive experience with the target population. Focus areas for training and distinctive content and protocol for the Specialized Quitline include: health literacy, abstract vs. concrete language, lived experience, resource constraints, future orientation, getting cigarettes, living situation, phone/internet access. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 13, 2020 | Jul 25, 2022 |
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| Basic Needs Navigator | Behavioral | Navigators will: (1) identify and assess smokers' needs, including the reasons they called 2-1-1; (2) jointly generate solutions to address the needs; (3) develop plans to carry out the solutions, including; (4) help prioritize among multiple needs; (5) identify community resources that could help solve the problem; (6) determine eligibility for services; (7) help smokers access available resources by scheduling appointments and provide appointment reminders; (8) prepare smokers to interact with service agencies and/or act as an advocate on their behalf; (9) provide instrumental support such as arranging transportation; (10) actively intervene to resolve barriers to basic needs solutions; (11) oversee follow-up of problem solving actions; and (12) review progress made towards resolving unmet basic needs and adapt solutions accordingly. |
|
| 6 months post-baseline |
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| 18358259 | Background | Urbanski P, Wolf A, Herman WH. Cost-effectiveness of diabetes education. J Am Diet Assoc. 2008 Apr;108(4 Suppl 1):S6-11. doi: 10.1016/j.jada.2008.01.019. |
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| 17908315 | Background | Brown HS 3rd, Perez A, Li YP, Hoelscher DM, Kelder SH, Rivera R. The cost-effectiveness of a school-based overweight program. Int J Behav Nutr Phys Act. 2007 Oct 1;4:47. doi: 10.1186/1479-5868-4-47. |
| 23157759 | Background | Kreuter MW. Reach, effectiveness, and connections: the case for partnering with 2-1-1 to eliminate health disparities. Am J Prev Med. 2012 Dec;43(6 Suppl 5):S420-1. doi: 10.1016/j.amepre.2012.09.024. No abstract available. |
| 20850258 | Background | McQueen A, Kreuter MW. Women's cognitive and affective reactions to breast cancer survivor stories: a structural equation analysis. Patient Educ Couns. 2010 Dec;81 Suppl:S15-21. doi: 10.1016/j.pec.2010.08.015. Epub 2010 Sep 17. |
| 21895370 | Background | McQueen A, Kreuter MW, Kalesan B, Alcaraz KI. Understanding narrative effects: the impact of breast cancer survivor stories on message processing, attitudes, and beliefs among African American women. Health Psychol. 2011 Nov;30(6):674-82. doi: 10.1037/a0025395. Epub 2011 Sep 5. |
| 18230016 | Background | McQueen A, Swank PR, Bastian LA, Vernon SW. Predictors of perceived susceptibility of breast cancer and changes over time: a mixed modeling approach. Health Psychol. 2008 Jan;27(1):68-77. doi: 10.1037/0278-6133.27.1.68. |
| 17372245 | Background | McQueen A, Vernon SW, Myers RE, Watts BG, Lee ES, Tilley BC. Correlates and predictors of colorectal cancer screening among male automotive workers. Cancer Epidemiol Biomarkers Prev. 2007 Mar;16(3):500-9. doi: 10.1158/1055-9965.EPI-06-0757. |
| 18768488 | Background | McQueen A, Tiro JA, Vernon SW. Construct validity and invariance of four factors associated with colorectal cancer screening across gender, race, and prior screening. Cancer Epidemiol Biomarkers Prev. 2008 Sep;17(9):2231-7. doi: 10.1158/1055-9965.EPI-08-0176. |
| 20658212 | Background | McQueen A, Vernon SW, Rothman AJ, Norman GJ, Myers RE, Tilley BC. Examining the role of perceived susceptibility on colorectal cancer screening intention and behavior. Ann Behav Med. 2010 Oct;40(2):205-17. doi: 10.1007/s12160-010-9215-3. |
| 22353026 | Background | McQueen A, Vernon SW, Swank PR. Construct definition and scale development for defensive information processing: an application to colorectal cancer screening. Health Psychol. 2013 Feb;32(2):190-202. doi: 10.1037/a0027311. Epub 2012 Feb 20. |
| 21571692 | Background | McQueen A, Tower S, Sumner W. Interviews with "vapers": implications for future research with electronic cigarettes. Nicotine Tob Res. 2011 Sep;13(9):860-7. doi: 10.1093/ntr/ntr088. Epub 2011 May 12. |
| 19763699 | Background | McQueen A, Bartholomew LK, Greisinger AJ, Medina GG, Hawley ST, Haidet P, Bettencourt JL, Shokar NK, Ling BS, Vernon SW. Behind closed doors: physician-patient discussions about colorectal cancer screening. J Gen Intern Med. 2009 Nov;24(11):1228-35. doi: 10.1007/s11606-009-1108-4. Epub 2009 Sep 18. |
| 22272194 | Background | Medina GG, McQueen A, Greisinger AJ, Bartholomew LK, Vernon SW. What would make getting colorectal cancer screening easier? Perspectives from screeners and nonscreeners. Gastroenterol Res Pract. 2012;2012:895807. doi: 10.1155/2012/895807. Epub 2012 Jan 4. |
| 25589676 | Background | McQueen A, Kreuter MW, Boyum S, Thompson VS, Caburnay CA, Waters EA, Kaphingst KA, Rath S, Fu Q. Reactions to FDA-Proposed Graphic Warning Labels Affixed to U.S. Smokers' Cigarette Packs. Nicotine Tob Res. 2015 Jul;17(7):784-95. doi: 10.1093/ntr/ntu339. Epub 2015 Jan 14. |
| 14713709 | Background | Kreuter MW, Caburnay CA, Chen JJ, Donlin MJ. Effectiveness of individually tailored calendars in promoting childhood immunization in urban public health centers. Am J Public Health. 2004 Jan;94(1):122-7. doi: 10.2105/ajph.94.1.122. |
| 19157255 | Background | Caburnay CA, Kreuter MW, Cameron G, Luke DA, Cohen EL, McDaniels L, Wohlberg M, Atkins P. Black newspapers as a tool for cancer education in African American communities. Ethn Dis. 2008 Autumn;18(4):488-95. |
| 22546317 | Background | Caburnay CA, Luke DA, Cameron GT, Cohen EL, Fu Q, Lai CL, Stemmle JT, Paulen M, Jackson L, Kreuter MW. Evaluating the Ozioma cancer news service: a community randomized trial in 24 U.S. cities. Prev Med. 2012 Jun;54(6):425-30. doi: 10.1016/j.ypmed.2012.04.010. Epub 2012 Apr 23. |
| 18048632 | Background | Fellows JL, Bush T, McAfee T, Dickerson J. Cost effectiveness of the Oregon quitline "free patch initiative". Tob Control. 2007 Dec;16 Suppl 1(Suppl 1):i47-52. doi: 10.1136/tc.2007.019943. |
| 23157767 | Background | Alcaraz KI, Arnold LD, Eddens KS, Lai C, Rath S, Greer R, Kreuter MW. Exploring 2-1-1 service requests as potential markers for cancer control needs. Am J Prev Med. 2012 Dec;43(6 Suppl 5):S469-74. doi: 10.1016/j.amepre.2012.08.019. |
| 23157769 | Background | Eddens KS, Alcaraz KI, Kreuter MW, Rath S, Greer R. A 2-1-1 research collaboration: participant accrual and service quality indicators. Am J Prev Med. 2012 Dec;43(6 Suppl 5):S483-9. doi: 10.1016/j.amepre.2012.09.007. |
| 17003247 | Background | Wiehagen T, Caito NM, Thompson VS, Casey CM, Weaver NL, Jupka K, Kreuter MW. Applying projective techniques to formative research in health communication development. Health Promot Pract. 2007 Apr;8(2):164-72. doi: 10.1177/1524839906289818. Epub 2006 Sep 26. |
| 15572439 | Background | Boslaugh SE, Kreuter MW, Nicholson RA, Naleid K. Comparing demographic, health status and psychosocial strategies of audience segmentation to promote physical activity. Health Educ Res. 2005 Aug;20(4):430-8. doi: 10.1093/her/cyg138. Epub 2004 Nov 30. |
| 18990735 | Background | Nicholson RA, Kreuter MW, Lapka C, Wellborn R, Clark EM, Sanders-Thompson V, Jacobsen HM, Casey C. Unintended effects of emphasizing disparities in cancer communication to African-Americans. Cancer Epidemiol Biomarkers Prev. 2008 Nov;17(11):2946-53. doi: 10.1158/1055-9965.EPI-08-0101. |
| 17631608 | Background | Sanders Thompson VL, Cavazos-Rehg PA, Jupka K, Caito N, Gratzke J, Tate KY, Deshpande A, Kreuter MW. Evidential preferences: cultural appropriateness strategies in health communications. Health Educ Res. 2008 Jun;23(3):549-59. doi: 10.1093/her/cym029. Epub 2007 Jul 13. |
| 14672383 | Background | Kreuter MW, Wray RJ. Tailored and targeted health communication: strategies for enhancing information relevance. Am J Health Behav. 2003 Nov-Dec;27 Suppl 3:S227-32. doi: 10.5993/ajhb.27.1.s3.6. |
| 16923835 | Background | Kreuter MW, Black WJ, Friend L, Booker AC, Klump P, Bobra S, Holt CL. Use of computer kiosks for breast cancer education in five community settings. Health Educ Behav. 2006 Oct;33(5):625-42. doi: 10.1177/1090198106290795. Epub 2006 Aug 21. |
| 15916993 | Background | Kreuter MW, Sugg-Skinner C, Holt CL, Clark EM, Haire-Joshu D, Fu Q, Booker AC, Steger-May K, Bucholtz D. Cultural tailoring for mammography and fruit and vegetable intake among low-income African-American women in urban public health centers. Prev Med. 2005 Jul;41(1):53-62. doi: 10.1016/j.ypmed.2004.10.013. Epub 2004 Nov 26. |
| 15152880 | Background | Kreuter MW, Skinner CS, Steger-May K, Holt CL, Bucholtz DC, Clark EM, Haire-Joshu D. Responses to behaviorally vs culturally tailored cancer communication among African American women. Am J Health Behav. 2004 May-Jun;28(3):195-207. doi: 10.5993/ajhb.28.3.1. |
| 14581907 | Background | Kreuter MW, Steger-May K, Bobra S, Booker A, Holt CL, Lukwago SN, Skinner CS. Sociocultural characteristics and responses to cancer education materials among African American women. Cancer Control. 2003 Sep-Oct;10(5 Suppl):69-80. doi: 10.1177/107327480301005s10. |
| 21566702 | Background | Eddens KS, Kreuter MW. Proactive screening for health needs in United Way's 2-1-1 information and referral service. J Soc Serv Res. 2011;37(2):113-123. doi: 10.1080/01488376.2011.547445. |
| 18287923 | Background | Kreuter MW, Alcaraz KI, Pfeiffer D, Christopher K. Using dissemination research to identify optimal community settings for tailored breast cancer information kiosks. J Public Health Manag Pract. 2008 Mar-Apr;14(2):160-9. doi: 10.1097/01.PHH.0000311895.57831.02. |
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| 19556966 | Background | Deshpande AD, Sanders Thompson VL, Vaughn KP, Kreuter MW. The use of sociocultural constructs in cancer screening research among African Americans. Cancer Control. 2009 Jul;16(3):256-65. doi: 10.1177/107327480901600308. |
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| 24629557 | Background | McQueen A, Shacham E, Sumner W, Overton ET. Beliefs, experience, and interest in pharmacotherapy among smokers with HIV. Am J Health Behav. 2014 Mar;38(2):284-96. doi: 10.5993/AJHB.38.2.14. |
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| 25602863 | Background | Kegler MC, Bundy L, Haardorfer R, Escoffery C, Berg C, Yembra D, Kreuter M, Hovell M, Williams R, Mullen PD, Ribisl K, Burnham D. A minimal intervention to promote smoke-free homes among 2-1-1 callers: a randomized controlled trial. Am J Public Health. 2015 Mar;105(3):530-7. doi: 10.2105/AJPH.2014.302260. Epub 2015 Jan 20. |
| 22643622 | Background | Purnell JQ, Kreuter MW, Eddens KS, Ribisl KM, Hannon P, Williams RS, Fernandez ME, Jobe D, Gemmel S, Morris M, Fagin D. Cancer control needs of 2-1-1 callers in Missouri, North Carolina, Texas, and Washington. J Health Care Poor Underserved. 2012 May;23(2):752-67. doi: 10.1353/hpu.2012.0061. |
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| 37408953 | Derived | Kreuter MW, Garg R, Fu Q, Caburnay C, Thompson T, Roberts C, Sandheinrich D, Javed I, Wolff JM, Butler T, Grimes LM, Carpenter KM, Pokojski R, Engelbrecht K, Howard V, McQueen A. Helping low-income smokers quit: findings from a randomized controlled trial comparing specialized quitline services with and without social needs navigation. Lancet Reg Health Am. 2023 Jun 24;23:100529. doi: 10.1016/j.lana.2023.100529. eCollection 2023 Jul. |
| 36335079 | Derived | McQueen A, Wartts JG, Garg R, Carpenter KM, Kreuter MW. Leveling the Playing Field: Mailing Pharmacotherapy to Medicaid Members Who Smoke. Am J Prev Med. 2023 Feb;64(2):227-234. doi: 10.1016/j.amepre.2022.09.008. Epub 2022 Nov 3. |
| 34849423 | Derived | Garg R, McQueen A, Roberts C, Butler T, Grimes LM, Thompson T, Caburnay C, Wolff J, Javed I, Carpenter KM, Wartts JG, Charles C, Howard V, Kreuter MW. Stress, depression, sleep problems and unmet social needs: Baseline characteristics of low-income smokers in a randomized cessation trial. Contemp Clin Trials Commun. 2021 Nov 11;24:100857. doi: 10.1016/j.conctc.2021.100857. eCollection 2021 Dec. |
| FG002 | Standard Quitline With Basic Needs Navigator | Participants receive standard quitline services with navigator Basic Needs Navigator: Navigators will: (1) identify and assess smokers' needs, including the reasons they called 2-1-1; (2) jointly generate solutions to address the needs; (3) develop plans to carry out the solutions, including; (4) help prioritize among multiple needs; (5) identify community resources that could help solve the problem; (6) determine eligibility for services; (7) help smokers access available resources by scheduling appointments and provide appointment reminders; (8) prepare smokers to interact with service agencies and/or act as an advocate on their behalf; (9) provide instrumental support such as arranging transportation; (10) actively intervene to resolve barriers to basic needs solutions; (11) oversee follow-up of problem solving actions; and (12) review progress made towards resolving unmet basic needs and adapt solutions accordingly. |
| FG003 | Specialized Quitline With Basic Needs Navigator | Participants receive Specialized quitline services (see previous description) with navigator. Basic Needs Navigator: Navigators will: (1) identify and assess smokers' needs, including the reasons they called 2-1-1; (2) jointly generate solutions to address the needs; (3) develop plans to carry out the solutions, including; (4) help prioritize among multiple needs; (5) identify community resources that could help solve the problem; (6) determine eligibility for services; (7) help smokers access available resources by scheduling appointments and provide appointment reminders; (8) prepare smokers to interact with service agencies and/or act as an advocate on their behalf; (9) provide instrumental support such as arranging transportation; (10) actively intervene to resolve barriers to basic needs solutions; (11) oversee follow-up of problem solving actions; and (12) review progress made towards resolving unmet basic needs and adapt solutions accordingly. |
| COMPLETED |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Standard Quitline | Participants will receive standard Missouri quitline services |
| BG001 | Specialized Quitline | Participants will receive an enhanced version of the standard quitline services Specialized Quitline: Very low-income smokers are different from other smokers in important ways not always addressed by standard quitline services. The research team and Alere staff has created custom protocols, scripts, prompts and other content to maximize intervention relevance and acceptability to very low-income smokers. Research Implementation Unit (RIU) coaches who will be delivering the Specialized Quitline services have received training from clinical quitline staff, the research team and 2-1-1 staff who have extensive experience with the target population. Focus areas for training and distinctive content and protocol for the Specialized Quitline include: health literacy, abstract vs. concrete language, lived experience, resource constraints, future orientation, getting cigarettes, living situation, phone/internet access. |
| BG002 | Standard Quitline With Basic Needs Navigator | Participants receive standard quitline services with navigator Basic Needs Navigator: Navigators will: (1) identify and assess smokers' needs, including the reasons they called 2-1-1; (2) jointly generate solutions to address the needs; (3) develop plans to carry out the solutions, including; (4) help prioritize among multiple needs; (5) identify community resources that could help solve the problem; (6) determine eligibility for services; (7) help smokers access available resources by scheduling appointments and provide appointment reminders; (8) prepare smokers to interact with service agencies and/or act as an advocate on their behalf; (9) provide instrumental support such as arranging transportation; (10) actively intervene to resolve barriers to basic needs solutions; (11) oversee follow-up of problem solving actions; and (12) review progress made towards resolving unmet basic needs and adapt solutions accordingly. |
| BG003 | Specialized Quitline With Basic Needs Navigator | Participants receive Specialized quitline services (see previous description) with navigator. Basic Needs Navigator: Navigators will: (1) identify and assess smokers' needs, including the reasons they called 2-1-1; (2) jointly generate solutions to address the needs; (3) develop plans to carry out the solutions, including; (4) help prioritize among multiple needs; (5) identify community resources that could help solve the problem; (6) determine eligibility for services; (7) help smokers access available resources by scheduling appointments and provide appointment reminders; (8) prepare smokers to interact with service agencies and/or act as an advocate on their behalf; (9) provide instrumental support such as arranging transportation; (10) actively intervene to resolve barriers to basic needs solutions; (11) oversee follow-up of problem solving actions; and (12) review progress made towards resolving unmet basic needs and adapt solutions accordingly. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Abstinence 6-months | Report 7-day point prevalence abstinence measured at 6-months post --baseline | Intention-to-treat sample | Posted | Count of Participants | Participants | 6 months post-baseline |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Abstinence 3-months | Report 7-day point prevalence abstinence measured at 3-months post-baseline | Intention-to-treat sample | Posted | Count of Participants | Participants | 3 months post-baseline |
| |||||||||||||||||||||||||||||||||||||
| Secondary | 24hr Quit Attempt | Report quitting smoking for at least 24 hours during intervention | Intention-to-treat sample | Posted | Count of Participants | Participants | 6 months post-baseline |
|
6 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Quitline | Participants will receive standard Missouri quitline services | 0 | 485 | 0 | 485 | 0 | 485 |
| EG001 | Specialized Quitline | Participants will receive an enhanced version of the standard quitline services Specialized Quitline: Very low-income smokers are different from other smokers in important ways not always addressed by standard quitline services. The research team and Alere staff has created custom protocols, scripts, prompts and other content to maximize intervention relevance and acceptability to very low-income smokers. Research Implementation Unit (RIU) coaches who will be delivering the Specialized Quitline services have received training from clinical quitline staff, the research team and 2-1-1 staff who have extensive experience with the target population. Focus areas for training and distinctive content and protocol for the Specialized Quitline include: health literacy, abstract vs. concrete language, lived experience, resource constraints, future orientation, getting cigarettes, living situation, phone/internet access. | 1 | 485 | 0 | 485 | 0 | 485 |
| EG002 | Standard Quitline With Basic Needs Navigator | Participants receive standard quitline services with navigator Basic Needs Navigator: Navigators will: (1) identify and assess smokers' needs, including the reasons they called 2-1-1; (2) jointly generate solutions to address the needs; (3) develop plans to carry out the solutions, including; (4) help prioritize among multiple needs; (5) identify community resources that could help solve the problem; (6) determine eligibility for services; (7) help smokers access available resources by scheduling appointments and provide appointment reminders; (8) prepare smokers to interact with service agencies and/or act as an advocate on their behalf; (9) provide instrumental support such as arranging transportation; (10) actively intervene to resolve barriers to basic needs solutions; (11) oversee follow-up of problem solving actions; and (12) review progress made towards resolving unmet basic needs and adapt solutions accordingly. | 1 | 484 | 0 | 484 | 0 | 484 |
| EG003 | Specialized Quitline With Basic Needs Navigator | Participants receive Specialized quitline services (see previous description) with navigator. Basic Needs Navigator: Navigators will: (1) identify and assess smokers' needs, including the reasons they called 2-1-1; (2) jointly generate solutions to address the needs; (3) develop plans to carry out the solutions, including; (4) help prioritize among multiple needs; (5) identify community resources that could help solve the problem; (6) determine eligibility for services; (7) help smokers access available resources by scheduling appointments and provide appointment reminders; (8) prepare smokers to interact with service agencies and/or act as an advocate on their behalf; (9) provide instrumental support such as arranging transportation; (10) actively intervene to resolve barriers to basic needs solutions; (11) oversee follow-up of problem solving actions; and (12) review progress made towards resolving unmet basic needs and adapt solutions accordingly. | 1 | 490 | 0 | 490 | 0 | 490 |
Not provided
Not provided
The final 9 months of the trial took place during the COVID-19 pandemic, which slowed recruitment.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matthew Kreuter | Washington University in St. Louis | 314-935-3701 | mkreuter@wustl.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 8, 2017 | Jul 25, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D000073869 | Tobacco Smoking |
| D000073865 | Cigarette Smoking |
| D000073868 | Pipe Smoking |
| D012907 | Smoking |
| D016739 | Behavior, Addictive |
| D064424 | Tobacco Use |
| D014029 | Tobacco Use Disorder |
| D020340 | Tobacco Use Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D003192 | Compulsive Behavior |
| D007175 | Impulsive Behavior |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Participants receive standard quitline services with navigator Basic Needs Navigator: Navigators will: (1) identify and assess smokers' needs, including the reasons they called 2-1-1; (2) jointly generate solutions to address the needs; (3) develop plans to carry out the solutions, including; (4) help prioritize among multiple needs; (5) identify community resources that could help solve the problem; (6) determine eligibility for services; (7) help smokers access available resources by scheduling appointments and provide appointment reminders; (8) prepare smokers to interact with service agencies and/or act as an advocate on their behalf; (9) provide instrumental support such as arranging transportation; (10) actively intervene to resolve barriers to basic needs solutions; (11) oversee follow-up of problem solving actions; and (12) review progress made towards resolving unmet basic needs and adapt solutions accordingly. |
| OG003 | Specialized Quitline With Basic Needs Navigator | Participants receive Specialized quitline services (see previous description) with navigator. Basic Needs Navigator: Navigators will: (1) identify and assess smokers' needs, including the reasons they called 2-1-1; (2) jointly generate solutions to address the needs; (3) develop plans to carry out the solutions, including; (4) help prioritize among multiple needs; (5) identify community resources that could help solve the problem; (6) determine eligibility for services; (7) help smokers access available resources by scheduling appointments and provide appointment reminders; (8) prepare smokers to interact with service agencies and/or act as an advocate on their behalf; (9) provide instrumental support such as arranging transportation; (10) actively intervene to resolve barriers to basic needs solutions; (11) oversee follow-up of problem solving actions; and (12) review progress made towards resolving unmet basic needs and adapt solutions accordingly. |
|
|
Participants receive standard quitline services with navigator Basic Needs Navigator: Navigators will: (1) identify and assess smokers' needs, including the reasons they called 2-1-1; (2) jointly generate solutions to address the needs; (3) develop plans to carry out the solutions, including; (4) help prioritize among multiple needs; (5) identify community resources that could help solve the problem; (6) determine eligibility for services; (7) help smokers access available resources by scheduling appointments and provide appointment reminders; (8) prepare smokers to interact with service agencies and/or act as an advocate on their behalf; (9) provide instrumental support such as arranging transportation; (10) actively intervene to resolve barriers to basic needs solutions; (11) oversee follow-up of problem solving actions; and (12) review progress made towards resolving unmet basic needs and adapt solutions accordingly. |
| OG003 | Specialized Quitline With Basic Needs Navigator | Participants receive Specialized quitline services (see previous description) with navigator. Basic Needs Navigator: Navigators will: (1) identify and assess smokers' needs, including the reasons they called 2-1-1; (2) jointly generate solutions to address the needs; (3) develop plans to carry out the solutions, including; (4) help prioritize among multiple needs; (5) identify community resources that could help solve the problem; (6) determine eligibility for services; (7) help smokers access available resources by scheduling appointments and provide appointment reminders; (8) prepare smokers to interact with service agencies and/or act as an advocate on their behalf; (9) provide instrumental support such as arranging transportation; (10) actively intervene to resolve barriers to basic needs solutions; (11) oversee follow-up of problem solving actions; and (12) review progress made towards resolving unmet basic needs and adapt solutions accordingly. |
|
|