Connect To Care (C2C): protocol for two-site randomized controlled pilot trial to improve outcomes for patients with hazardous drinking and PTSD and/or depression symptoms

Michael A Cucciare, Kathy Marchant, Cristy Benton, Deanna Hildebrand, Sharfun Ghaus, Xiaotong Han, Ronald G Thompson, Christine Timko, Michael A Cucciare, Kathy Marchant, Cristy Benton, Deanna Hildebrand, Sharfun Ghaus, Xiaotong Han, Ronald G Thompson, Christine Timko

Abstract

Background: In studies of the general population and of military veterans, many primary care patients with hazardous drinking and PTSD and/or depression (abbreviated here as HD +) do not initiate or engage with alcohol-related care. To address this gap in care, we identified and will pilot test a promising evidence-based intervention, Connect To Care (C2C). C2C is a strengths-based approach, delivered by a Care Coach by telephone and/or video, with four components: (1) identifying and leveraging patient strengths to facilitate care initiation, (2) collaborative decision-making around a menu of care options, (3) identifying and resolving barriers to care, and (4) monitoring and facilitating progress toward care initiation by, for example, checking on barriers, identifying solutions, and revisiting care options.

Methods/design: Aim 1 will involve adapting C2C for use in Veterans Affairs' (VA) primary care. We will use an iterative process that includes focus groups and semi-structured interviews with key stakeholders (patients, primary care providers, and VA national policy leaders). In Aim 2, we will conduct a two-site, pilot randomized controlled trial to determine the feasibility of conducting a larger scale trial to test C2C's effectiveness, ascertain the acceptability of C2C among primary care patients with HD + , and explore the efficacy of C2C to improve veteran patients' initiation of and engagement in alcohol care, and their alcohol and mental health (PTSD, depression) outcomes, at 3-month follow-up. We will explore explanatory mechanisms by which C2C is effective.

Discussion: Study findings are likely to have implications for clinical practice to enhance current approaches to linking patients with HD + to alcohol care by applying a practical intervention such as C2C. The results may improve treatment outcomes for people with HD + by drawing on patients' strengths to problem-solve barriers to care following a process of shared decision-making with a coach. In addition to possibly accelerating the translation of C2C into practice, study findings will also support additional research in terms of a planned effectiveness-implementation hybrid trial, adding to this study's potential for high impact.

Trial registration: ClinicalTrials.gov Identifier: NCT05023317.

Keywords: Alcohol; Care engagement; Care initiation; Depression; PTSD; Primary care; Shared decision-making; Strengths-based case management.

Conflict of interest statement

The authors declare they have no competing interests.

© 2023. Evans Medical Foundation, Inc. and BioMed Central Ltd.

Figures

Fig. 1
Fig. 1
Conceptual model of Connect To Care (C2C) mechanisms
Fig. 2
Fig. 2
Flowchart of participants through the trial

References

    1. MacKillop J, Agabio R, Feldstein Ewing SW, Heilig M, Kelly JF, Leggio L, et al. Hazardous drinking and alcohol use disorders. Nat Rev Dis Primers. 2022;8:80. doi: 10.1038/s41572-022-00406-1.
    1. Sterling SA, Palzes VA, Lu Y, Kline-Simon AH, Parthasarathy S, Ross T, et al. Associations between medical conditions and alcohol consumption levels in an adult primary care population. JAMA Netw Open. 2020;3(5):e204687. doi: 10.1001/jamanetworkopen.2020.4687.
    1. Bachrach RL, Blosnich JR, Williams EC. Alcohol screening and brief intervention in a representative sample of veterans receiving primary care services. J Subst Abuse Treat. 2018;95:18–25. doi: 10.1016/j.jsat.2018.09.003.
    1. Burnett-Zeigler I, Ilgen M, Valenstein M, Zivin K, Gorman L, Blow A, et al. Prevalence and correlates of alcohol misuse among returning Afghanistan and Iraq veterans. Addict Behav. 2011;36(8):801–806. doi: 10.1016/j.addbeh.2010.12.032.
    1. Hawkins EJ, Lapham GT, Kivlahan DR, Bradley KA. Recognition and management of alcohol misuse in OEF/OIF and other veterans in the VA: a cross-sectional study. Drug Alcohol Depend. 2010;109(1–3):147–153. doi: 10.1016/j.drugalcdep.2009.12.025.
    1. Lai HM, Cleary M, Sitharthan T, Hunt GE. Prevalence of comorbid substance use, anxiety and mood disorders in epidemiological surveys, 1990–2014: a systematic review and meta-analysis. Drug Alcohol Depend. 2015;154:1–13. doi: 10.1016/j.drugalcdep.2015.05.031.
    1. Seal KH, Cohen G, Waldrop A, Cohen BE, Maguen S, Ren L. Substance use disorders in Iraq and Afghanistan veterans in VA healthcare, 2001–2010: implications for screening, diagnosis and treatment. Drug Alcohol Depend. 2011;116(1–3):93–101. doi: 10.1016/j.drugalcdep.2010.11.027.
    1. Debell F, Fear NT, Head M, Batt-Rawden S, Greenberg N, Wessely S, et al. A systematic review of the comorbidity between PTSD and alcohol misuse. Soc Psychiatry Psychiatr Epidemiol. 2014;49(9):1401–1425. doi: 10.1007/s00127-014-0855-7.
    1. Trivedi RB, Post EP, Sun H, Pomerantz A, Saxon AJ, Piette JD, et al. Prevalence, comorbidity, and prognosis of mental health among US Veterans. Am J Public Health. 2015;105(12):2564–2569. doi: 10.2105/AJPH.2015.302836.
    1. Campbell DG, Lombardero A, English I, Waltz TJ, Hoggatt KJ, Simon BF, et al. Depression complexity prevalence and outcomes among veterans affairs patients in integrated primary care. Fam Syst Health. 2022;40(1):35–45. doi: 10.1037/fsh0000637.
    1. Chen JA, Owens MD, Browne KC, Williams EC. Alcohol-related and mental health care for patients with unhealthy alcohol use and posttraumatic stress disorder in a National Veterans Affairs cohort. J Subst Abuse Treat. 2018;85:1–9. doi: 10.1016/j.jsat.2017.11.007.
    1. Lee DJ, Kearns JC, Wisco BE, Green JD, Gradus JL, Sloan DM, et al. A longitudinal study of risk factors for suicide attempts among operation enduring freedom and operation Iraqi freedom veterans. Depress Anxiety. 2018;35(7):609–618. doi: 10.1002/da.22736.
    1. Norman SB, Haller M, Hamblen JL, Southwick SM, Pietrzak RH. The burden of co-occurring alcohol use disorder and PTSD in US Military veterans: comorbidities, functioning, and suicidality. Psychol Addict Behav. 2018;32(2):224–229. doi: 10.1037/adb0000348.
    1. Boden JM, Fergusson DM. Alcohol and depression. Addiction. 2011;106(5):906–914. doi: 10.1111/j.1360-0443.2010.03351.x.
    1. U.S. Department of Veterans Affairs. PTSD and problems with alcohol use. Accessed 14 May 2018.
    1. Bahorik AL, Leibowitz A, Sterling SA, Travis A, Wiesner C, Satre DD. The role of hazardous drinking reductions in predicting depression and anxiety symptom improvement among psychiatry patients: a longitudinal study. J Affect Disord. 2016;206:169–173. doi: 10.1016/j.jad.2016.07.039.
    1. Foa EB, Yusko DA, McLean CP, Suvak MK, Bux DA, Jr, Oslin D, et al. Concurrent naltrexone and prolonged exposure therapy for patients with comorbid alcohol dependence and PTSD: a randomized clinical trial. JAMA. 2013;310(5):488–495. doi: 10.1001/jama.2013.8268.
    1. Frost MC, Glass JE, Bradley KA, Williams EC. Documented brief intervention associated with reduced linkage to specialty addictions treatment in a national sample of VA patients with unhealthy alcohol use with and without alcohol use disorders. Addiction. 2020;115(4):668–678. doi: 10.1111/add.14836.
    1. Papini S, Chi FW, Schuler A, Satre DD, Liu VX, Sterling SA. Comparing the effectiveness of a brief intervention to reduce unhealthy alcohol use among adult primary care patients with and without depression: a machine learning approach with augmented inverse probability weighting. Drug Alcohol Depend. 2022;239:109607. doi: 10.1016/j.drugalcdep.2022.109607.
    1. Mintz CM, Hartz SM, Fisher SL, Ramsey AT, Geng EH, Grucza RA, et al. A cascade of care for alcohol use disorder: using 2015–2019 National Survey on Drug Use and Health data to identify gaps in past 12-month care. Alcohol Clin Exp Res. 2021;45(6):1276–1286. doi: 10.1111/acer.14609.
    1. Rapp RC, Otto AL, Lane DT, Redko C, McGatha S, Carlson RG. Improving linkage with substance abuse treatment using brief case management and motivational interviewing. Drug Alcohol Depend. 2008;94(1–3):172–182. doi: 10.1016/j.drugalcdep.2007.11.012.
    1. Strathdee SA, Ricketts EP, Huettner S, Cornelius L, Bishai D, Havens JR, et al. Facilitating entry into drug treatment among injection drug users referred from a needle exchange program: results from a community-based behavioral intervention trial. Drug Alcohol Depend. 2006;83(3):225–232. doi: 10.1016/j.drugalcdep.2005.11.015.
    1. Rapp RC, Van Den Noortgate W, Broekaert E, Vanderplasschen W. The efficacy of case management with persons who have substance abuse problems: a three-level meta-analysis of outcomes. J Consult Clin Psychol. 2014;82(4):605–618. doi: 10.1037/a0036750.
    1. Vanderplasschen W, Wolf J, Rapp RC, Broekaert E. Effectiveness of different models of case management for substance-abusing populations. J Psychoactive Drugs. 2007;39(1):81–95. doi: 10.1080/02791072.2007.10399867.
    1. Center for Substance Abuse Treatment. Comprehensive case management for substance abuse treatment. Treatment Improvement Protocol (TIP) Series, No. 27. HHS Publication No. (SMA) 15–4215. Rockville, MD: Center for Substance Abuse Treatment, 2015.
    1. Center for Disease Control. ARTAS Linkage to Care. Antiretroviral Treatment and Access to Services (ARTAS). Implementation Manual. . Accessed from 21 Nov 2022.
    1. Cucciare MA, Coleman EA, Timko C. A conceptual model to facilitate transitions from primary care to specialty substance use disorder care: a review of the literature. Prim Health Care Res Dev. 2015;16(5):492–505. doi: 10.1017/S1463423614000164.
    1. Miller WR, Rollnick S. Motivational interviewing: Helping people change. 3. New York: Guilford Press; 2013.
    1. Bradley KA, Bobb JF, Ludman EJ, Chavez LJ, Saxon AJ, Merrill JO, et al. Alcohol-related nurse care management in primary care: a randomized clinical trial. JAMA Intern Med. 2018;178(5):613–621. doi: 10.1001/jamainternmed.2018.0388.
    1. Watkins KE, Ober AJ, Lamp K, Lind M, Setodji C, Osilla KC, et al. Collaborative care for opioid and alcohol use disorders in primary care: the SUMMIT randomized clinical trial. JAMA Intern Med. 2017;177(10):1480–1488. doi: 10.1001/jamainternmed.2017.3947.
    1. Hagedorn HJ, Wisdom JP, Gerould H, Pinsker E, Brown R, Dawes M, et al. Implementing alcohol use disorder pharmacotherapy in primary care settings: a qualitative analysis of provider-identified barriers and impact on implementation outcomes. Addict Sci Clin Pract. 2019;14(1):24. doi: 10.1186/s13722-019-0151-7.
    1. Landes SJ, McBain SA, Curran GM. An introduction to effectiveness-implementation hybrid designs. Psychiatry Res. 2019;280:112513. doi: 10.1016/j.psychres.2019.112513.
    1. Kemp JE, Morrison GR, Ross SM. Designing Effective Instruction. 2. Upper Saddle River, NJ: Prentice-Hall, Inc; 1998.
    1. Guest G, Bunce A, Johnson L. How many interviews are enough? An experiment with data saturation and variability. Field Meth. 2006;18(1):59–82. doi: 10.1177/1525822X05279903.
    1. Hennink MM, Kaiser BN, Marconi VC. Code saturation versus meaning saturation: How many interviews are enough? Qual Health Res. 2017;27(4):591–608. doi: 10.1177/1049732316665344.
    1. Prins A, Bovin MJ, Smolenski DJ, Marx BP, Kimerling R, Jenkins-Guarnieri MA, et al. The Primary Care PTSD screen for DSM-5 (PC-PTSD-5): development and evaluation within a veteran primary care sample. J Gen Intern Med. 2016;31(10):1206–1211. doi: 10.1007/s11606-016-3703-5.
    1. Kroenke K, Spitzer RL, Williams JB. The Patient Health Questionnaire-2: validity of a two-item depression screener. Med Care. 2003;41(11):1284–1292. doi: 10.1097/01.MLR.0000093487.78664.3C.
    1. Nasreddine ZS, Phillips NA, Bédirian V, Charbonneau S, Whitehead V, Collin I, et al. The montreal cognitive assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005;53(4):695–699. doi: 10.1111/j.1532-5415.2005.53221.x.
    1. DeMarce JM, Gnys M, Raffa SD, Kumpula M, Karlin BE. Dissemination of cognitive behavioral therapy for substance use disorders in the department of veterans affairs health care system: description and evaluation of veteran outcomes. Subst Abus. 2021;42(2):168–174. doi: 10.1080/08897077.2019.1674238.
    1. Nevedal AL, Reardon CM, Opra Widerquist MA, Jackson GL, Cutrona SL, White BS, et al. Rapid versus traditional qualitative analysis using the Consolidated Framework for Implementation Research (CFIR) Implement Sci. 2021;16(1):67. doi: 10.1186/s13012-021-01111-5.
    1. Taylor B, Henshall C, Kenyon S, Litchfield I, Greenfield S. Can rapid approaches to qualitative analysis deliver timely, valid findings to clinical leaders? A mixed methods study comparing rapid and thematic analysis. BMJ Open. 2018;8(10):e019993. doi: 10.1136/bmjopen-2017-019993.
    1. Borrelli B, Sepinwall D, Ernst D, Bellg AJ, Czajkowski S, Breger R, et al. A new tool to assess treatment fidelity and evaluation of treatment fidelity across 10 years of health behavior research. J Consult Clin Psychol. 2005;73(5):852–860. doi: 10.1037/0022-006X.73.5.852.
    1. Kendra MS, Weingardt KR, Cucciare MA, Timko C. Satisfaction with substance use treatment and 12-step groups predicts outcomes. Addict Behav. 2015;40:27–32. doi: 10.1016/j.addbeh.2014.08.003.
    1. Sobell LC, Brown J, Leo GI, Sobell MB. The reliability of the alcohol timeline followback when administered by telephone and by computer. Drug Alcohol Depend. 1996;42(1):49–54. doi: 10.1016/0376-8716(96)01263-x.
    1. American Psychiatric Association . Diagnostic and Statistical Manual of Mental Disorders. 5. Arlington, VA: American Psychiatric Publishing; 2013.
    1. Fazzino TL, Rose GL, Burt KB, Helzer JE. A test of the DSM-5 severity scale for alcohol use disorder. Drug Alcohol Depend. 2014;141:39–43. doi: 10.1016/j.drugalcdep.2014.05.004.
    1. Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001;16(9):606–613. doi: 10.1046/j.1525-1497.2001.016009606.x.
    1. Bovin MJ, Marx BP, Weathers FW, Gallaher MW, Rodriguez P, Schnurr PP, et al. Psychometric properties of the PTSD checklist for diagnostic and statistical manual of mental disorders-fifth edition (PCL-5) in veterans. Psychol Assess. 2016;28(11):1379–1391. doi: 10.1037/pas0000254.
    1. Humeniuk R, Ali R, Babor TF, Farrell M, Formigoni ML, Jittiwutikarn J, et al. Validation of the alcohol, smoking and substance involvement screening test (ASSIST) Addiction. 2008;103(6):1039–1047. doi: 10.1111/j.1360-0443.2007.02114.x.
    1. McLellan AT, Kushner H, Metzger D, Peters R, Smith I, Grissom G. et al. 1992. The Fifth Edition of the Addiction Severity Index. J Subst Abuse Treat. 9(3); 199–213. 10.1016/0740-5472(92)90062-s.
    1. Lau YK, Caverly TJ, Cao P, Cherng ST, West M, Gaber C, et al. Evaluation of a personalized, web-based decision aid for lung cancer screening. Am J Prev Med. 2015;49(6):e125–e129. doi: 10.1016/j.amepre.2015.07.027.
    1. Shirk JD, Crespi CM, Saucedo JD, Lambrechts S, Dahan E, Kaplan R, et al. Does patient preference measurement in decision aids improve decisional conflict? A randomized trial in men with prostate cancer. Patient. 2017;10(6):785–798. doi: 10.1007/s40271-017-0255-7.
    1. Harris TR, Walters ST, Leahy MM. Readiness to change among a group of heavy-drinking college students: correlates of readiness and a comparison of measures. J Am Coll Health. 2008;57(3):325–330. doi: 10.3200/JACH.57.3.325-330.
    1. Anhang Price R, Sloss EM, Cefalu M, Farmer CM, Hussey PS. Comparing quality of care in Veterans Affairs and non-Veterans Affairs settings. J Gen Intern Med. 2018;33(10):1631–1638. doi: 10.1007/s11606-018-4433-7.
    1. Stacey D, Légaré F, Lewis K, Barry MJ, Bennett CL, Eden KB, et al. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2017;4(4):1431. doi: 10.1002/14651858.CD001431.pub5.

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