Targeted versus tailored multimedia patient engagement to enhance depression recognition and treatment in primary care: randomized controlled trial protocol for the AMEP2 study

Daniel J Tancredi, Christina K Slee, Anthony Jerant, Peter Franks, Jasmine Nettiksimmons, Camille Cipri, Dustin Gottfeld, Julia Huerta, Mitchell D Feldman, Maja Jackson-Triche, Steven Kelly-Reif, Andrew Hudnut, Sarah Olson, Janie Shelton, Richard L Kravitz, Daniel J Tancredi, Christina K Slee, Anthony Jerant, Peter Franks, Jasmine Nettiksimmons, Camille Cipri, Dustin Gottfeld, Julia Huerta, Mitchell D Feldman, Maja Jackson-Triche, Steven Kelly-Reif, Andrew Hudnut, Sarah Olson, Janie Shelton, Richard L Kravitz

Abstract

Background: Depression in primary care is common, yet this costly and disabling condition remains underdiagnosed and undertreated. Persisting gaps in the primary care of depression are due in part to patients' reluctance to bring depressive symptoms to the attention of their primary care clinician and, when depression is diagnosed, to accept initial treatment for the condition. Both targeted and tailored communication strategies offer promise for fomenting discussion and reducing barriers to appropriate initial treatment of depression.

Methods/design: The Activating Messages to Enhance Primary Care Practice (AMEP2) Study is a stratified randomized controlled trial comparing two computerized multimedia patient interventions -- one targeted (to patient gender and income level) and one tailored (to level of depressive symptoms, visit agenda, treatment preferences, depression causal attributions, communication self-efficacy and stigma)-- and an attention control. AMEP2 consists of two linked sub-studies, one focusing on patients with significant depressive symptoms (Patient Health Questionnaire-9 [PHQ-9] scores ≥ 5), the other on patients with few or no depressive symptoms (PHQ-9 < 5). The first sub-study examined effectiveness of the interventions; key outcomes included delivery of components of initial depression care (antidepressant prescription or mental health referral). The second sub-study tracked potential hazards (clinical distraction and overtreatment). A telephone interview screening procedure assessed patients for eligibility and oversampled patients with significant depressive symptoms. Sampled, consenting patients used computers to answer survey questions, be randomized, and view assigned interventions just before scheduled primary care office visits. Patient surveys were also collected immediately post-visit and 12 weeks later. Physicians completed brief reporting forms after each patient's index visit. Additional data were obtained from medical record abstraction and visit audio recordings. Of 6,191 patients assessed, 867 were randomized and included in analysis, with 559 in the first sub-study and 308 in the second.

Discussion: Based on formative research, we developed two novel multimedia programs for encouraging patients to discuss depressive symptoms with their primary care clinicians. Our computer-based enrollment and randomization procedures ensured that randomization was fully concealed and data missingness minimized. Analyses will focus on the interventions' potential benefits among depressed persons, and the potential hazards among the non-depressed.

Trial registration: ClinicialTrials.gov Identifier: NCT01144104.

Figures

Figure 1
Figure 1
Study design.
Figure 2
Figure 2
CONSORT diagram.

References

    1. Hays RD, Wells KB, Sherbourne CD, Rogers W, Spritzer K. Functioning and Well-Being Outcomes of Patients with Depression Compared with Chronic General Medical Illnesses. Arch Gen Psychiatry. 1995;52(1):11–19. doi: 10.1001/archpsyc.1995.03950130011002.
    1. Wells KB, Stewart A, Hays RD, Burnam MA, Rogers W, Daniels M, Berry S, Greenfield S, Ware J. The Functioning and Well-Being of Depressed-Patients - Results from the Medical Outcomes Study. JAMA. 1989;262(7):914–919. doi: 10.1001/jama.1989.03430070062031.
    1. Broadhead WE, Blazer DG, George LK, Tse CK. Depression, disability days, and days lost from work in a prospective epidemiologic survey. JAMA. 1990;264(19):2524–2528. doi: 10.1001/jama.1990.03450190056028.
    1. Mintz J, Mintz LI, Arruda MJ, Hwang SS. Treatments of depression and the functional capacity to work. Arch Gen Psychiatry. 1992;49(10):761–768. doi: 10.1001/archpsyc.1992.01820100005001.
    1. Zhang M, Rost KM, Fortney JC, Smith GR. A community study of depression treatment and employment earnings. Psychiatry Serv. 1999;50(9):1209–1213.
    1. Klerman GL, Weissman MM. The course, morbidity, and costs of depression. Arch Gen Psychiatry. 1992;49(10):831–834. doi: 10.1001/archpsyc.1992.01820100075013.
    1. Kessler RC, Berglund P, Demler O, Jin R, Koretz D, Merikangas KR, Rush AJ, Walters EE, Wang PS. The epidemiology of major depressive disorder: results from the National Comorbidity Survey Replication (NCS-R) JAMA. 2003;289(23):3095–3105. doi: 10.1001/jama.289.23.3095.
    1. Frasure-Smith N, Lesperance F, Talajic M. Depression following myocardial infarction. Impact on 6-month survival. JAMA. 1993;270(15):1819–1825. doi: 10.1001/jama.1993.03510150053029.
    1. Stein MB, Cox BJ, Afifi TO, Belik SL, Sareen J. Does co-morbid depressive illness magnify the impact of chronic physical illness? A population-based perspective. Psychol Med. 2006;36(5):587–596. doi: 10.1017/S0033291706007239.
    1. Simon GE, VonKorff M. Recognition, management, and outcomes of depression in primary care. Arch Fam Med. 1995;4(2):99–105. doi: 10.1001/archfami.4.2.99.
    1. Unutzer J, Patrick DL, Simon G, Grembowski D, Walker E, Rutter C, Katon W. Depressive symptoms and the cost of health services in HMO patients aged 65 years and older. A 4-year prospective study. JAMA. 1997;277(20):1618–1623. doi: 10.1001/jama.1997.03540440052032.
    1. Arnow BA, Blasey CM, Lee J, Fireman B, Hunkeler EM, Dea R, Robinson R, Hayward C. Relationships among depression, chronic pain, chronic disabling pain, and medical costs. Psychiatry Serv. 2009;60(3):344–350. doi: 10.1176/appi.ps.60.3.344.
    1. Goldman LS, Nielsen NH, Champion HC. Awareness, diagnosis, and treatment of depression. J Gen Intern Med. 1999;14(9):569–580. doi: 10.1046/j.1525-1497.1999.03478.x.
    1. Sheehan DV. Depression: underdiagnosed, undertreated, underappreciated. Manag Care. 2004;13:6–8. 6 Suppl Depression.
    1. Cepoiu M, McCusker J, Cole MG, Sewitch M, Belzile E, Ciampi A. Recognition of depression by non-psychiatric physicians–a systematic literature review and meta-analysis. J Gen Intern Med. 2008;23(1):25–36. doi: 10.1007/s11606-007-0428-5.
    1. Mitchell AJ, Vaze A, Rao S. Clinical diagnosis of depression in primary care: a meta-analysis. Lancet. 2009;374(9690):609–619. doi: 10.1016/S0140-6736(09)60879-5.
    1. Regier DA, Goldberg ID, Taube CA. The de facto US mental health services system: a public health perspective. Arch Gen Psychiatry. 1978;35(6):685–693. doi: 10.1001/archpsyc.1978.01770300027002.
    1. Gray GV, Brody DS, Hart MT. Primary care and the de facto mental health care system: improving care where it counts. Manag Care Interface. 2000;13(3):62–65.
    1. Kessler RC, Demler O, Frank RG, Olfson M, Pincus HA, Walters EE, Wang P, Wells KB, Zaslavsky AM. Prevalence and treatment of mental disorders, 1990 to 2003. N Engl J Med. 2005;352(24):2515–2523. doi: 10.1056/NEJMsa043266.
    1. Olfson M, Marcus SC, Druss B, Elinson L, Tanielian T, Pincus HA. National trends in the outpatient treatment of depression. JAMA. 2002;287(2):203–209. doi: 10.1001/jama.287.2.203.
    1. Rost K, Zhang M, Fortney J, Smith J, Coyne J, Smith GR Jr. Persistently poor outcomes of undetected major depression in primary care. Gen Hosp Psychiatry. 1998;20(1):12–20. doi: 10.1016/S0163-8343(97)00095-9.
    1. Hirschfeld RM, Keller MB, Panico S, Arons BS, Barlow D, Davidoff F, Endicott J, Froom J, Goldstein M, Gorman JM. The National Depressive and Manic-Depressive Association consensus statement on the undertreatment of depression. JAMA. 1997;277(4):333–340. doi: 10.1001/jama.1997.03540280071036.
    1. Unutzer J, Simon G, Belin TR, Datt M, Katon W, Patrick D. Care for depression in HMO patients aged 65 and older. J Am Geriatr Soc. 2000;48(8):871–878.
    1. Trivedi MH, Lin EH, Katon WJ. Consensus recommendations for improving adherence, self-management, and outcomes in patients with depression. CNS Spectr. 2007;12(8 Suppl 13):1–27.
    1. Gonzalez HM, Vega WA, Williams DR, Tarraf W, West BT, Neighbors HW. Depression care in the United States: too little for too few. Arch Gen Psychiatry. 2010;67(1):37–46. doi: 10.1001/archgenpsychiatry.2009.168.
    1. Corrigan PW, Bodenhausen G, Markowitz F, Newman L, Rasinski K, Watson A. Demonstrating translational research for mental health services: an example from stigma research. Ment Health Serv Res. 2003;5(2):79–88. doi: 10.1023/A:1023277327044.
    1. Glozier N. Workplace effects of the stigmatization of depression. J Occup Environ Med/Am College Occup Environ Med. 1998;40(9):793–800. doi: 10.1097/00043764-199809000-00008.
    1. Graf J, Lauber C, Nordt C, Ruesch P, Meyer PC, Rossler W. Perceived stigmatization of mentally ill people and its consequences for the quality of life in a Swiss population. J Nerv Ment Dis. 2004;192(8):542–547. doi: 10.1097/01.nmd.0000135493.71192.3a.
    1. Kaufman JM, Johnson C. Stigmatized individuals and the process of identity. Sociol Q. 2004;45(4):807–833. doi: 10.1111/j.1533-8525.2004.tb02315.x.
    1. Bazargan M, Bazargan-Hejazi S, Baker RS. Treatment of self-reported depression among Hispanics and African Americans. J Health Care Poor Underserved. 2005;16(2):328–344. doi: 10.1353/hpu.2005.0025.
    1. Garland AF, Lau AS, Yeh M, McCabe KM, Hough RL, Landsverk JA. Racial and ethnic differences in utilization of mental health services among high-risk youths. Am J Psychiatry. 2005;162(7):1336–1343. doi: 10.1176/appi.ajp.162.7.1336.
    1. Lewis-Fernandez R, Das AK, Alfonso C, Weissman MM, Olfson M. Depression in US Hispanics: diagnostic and management considerations in family practice. J Am Board Fam Pract. 2005;18(4):282–296. doi: 10.3122/jabfm.18.4.282.
    1. Melfi CA, Croghan TW, Hanna MP, Robinson RL. Racial variation in antidepressant treatment in a Medicaid population. J Clin Psychiatry. 2000;61(1):16–21. doi: 10.4088/JCP.v61n0105.
    1. Pingitore D, Snowden L, Sansone RA, Klinkman M. Persons with depressive symptoms and the treatments they receive: A comparison of primary care physicians and psychiatrists. Int J Psychiatry Med. 2001;31(1):41–60. doi: 10.2190/6BUL-MWTQ-0M18-30GL.
    1. Strothers HS, Rust G, Minor P, Fresh E, Druss B, Satcher D. Disparities in antidepressant treatment in Medicaid elderly diagnosed with depression. J Am Geriatr Soc. 2005;53(3):456–461. doi: 10.1111/j.1532-5415.2005.53164.x.
    1. U.S. Department of Health and Human Services. Mental Health: Culture, Race, and Ethnicity: A Supplement to Mental Health: A Report of the Surgeon General. Rockville, MD: U.S. Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, Center for Mental Health Services; 2001.
    1. Unutzer J, Katon W, Callahan CM, Williams JW, Hunkeler E, Harpole L, Hoffing M, Della Penna RD, Noel PH, Lin EHB. Collaborative care management of late-life depression in the primary care setting: a randomized controlled trial. JAMA. 2002;288(22):2836–2845. doi: 10.1001/jama.288.22.2836.
    1. Vega WA, Rodriguez MA, Ang A. Addressing stigma of depression in Latino primary care patients. Gen Hosp Psychiatry. 2010;32(2):182–191. doi: 10.1016/j.genhosppsych.2009.10.008.
    1. Balsa AI, McGuire TG, Meredith LS. Testing for statistical discrimination in health care. Health Serv Res. 2005;40(1):227–252. doi: 10.1111/j.1475-6773.2005.00351.x.
    1. Steele L, Dewa C, Lee K. Socioeconomic status and self-reported barriers to mental health service use. Can J Psychiatry. 2007;52(3):201–206.
    1. Epstein RM, Duberstein PR, Feldman MD, Rochlen AB, Bell RA, Kravitz RL, Cipri C, Becker JD, Bamonti PM, Paterniti DA. "I Didn't Know What Was Wrong:" How People With Undiagnosed Depression Recognize, Name and Explain Their Distress. J Gen Intern Med. 2010;25(9):954–961. doi: 10.1007/s11606-010-1367-0.
    1. Kravitz RL, Paterniti DA, Epstein RM, Rochlen AB, Bell RA, Cipri C, Garcia EFY, Feldman MD, Duberstein P. Relational barriers to depression help-seeking in primary care. Patient Educ Couns. 2011;82(2):207–213. doi: 10.1016/j.pec.2010.05.007.
    1. Bell RA, Paterniti DA, Azari R, Duberstein PR, Epstein RM, Rochlen AB, Johnson MD, Orrange SE, Slee C, Kravitz RL. Encouraging patients with depressive symptoms to seek care: A mixed methods approach to message development. Patient Educ Couns. 2010;78(2):198–205. doi: 10.1016/j.pec.2009.07.007.
    1. Bell RA, Franks P, Duberstein PR, Epstein RM, Feldman MD, Garcia EFY, Kravitz RL. Suffering in Silence: Reasons for Not Disclosing Depression in Primary Care. Ann Fam Med. 2011;9(5):439–446. doi: 10.1370/afm.1277.
    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. Kreuter MW, Skinner CS. Tailoring: what's in a name? Health Educ Res. 2000;15(1):1–4. doi: 10.1093/her/15.1.1.
    1. Backer TE, Rogers EM, Sopory P. Designing health communication campaigns : what works? Newbury Park, Calif: Sage; 1992.
    1. Kravitz RL, Epstein RM, Bell RA, Rochlen AB, Duberstein P, Riby CH, Caccamo AF, Slee CK, Cipri CS, Paterniti DA. An academic-marketing collaborative to promote depression care: A tale of two cultures. Patient Educ Couns. 2011;90(3):411–419.
    1. Jerant A, Sohler N, Fiscella K, Franks B, Franks P. Tailored interactive multimedia computer programs to reduce health disparities: opportunities and challenges. Patient Educ Couns. 2011;85(2):323–330. doi: 10.1016/j.pec.2010.11.012.
    1. Campbell MK, DeVellis BM, Strecher VJ, Ammerman AS, DeVellis RF, Sandler RS. Improving dietary behavior: the effectiveness of tailored messages in primary care settings. Am J Publ Health. 1994;84(5):783–787. doi: 10.2105/AJPH.84.5.783.
    1. Etter JF, Perneger TV. Effectiveness of a computer-tailored smoking cessation program: a randomized trial. Arch Intern Med. 2001;161(21):2596–2601. doi: 10.1001/archinte.161.21.2596.
    1. Irvine AB, Ary DV, Grove DA, Gilfillan-Morton L. The effectiveness of an interactive multimedia program to influence eating habits. Health Educ Res. 2004;19(3):290–305. doi: 10.1093/her/cyg027.
    1. 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;94(1):122–127. doi: 10.2105/AJPH.94.1.122.
    1. Kreuter MW, Farrell DW, Olevitch LR, Brennan LK. Tailoring health messages : customizing communication with computer technology. Mahwah, N.J.: L. Erlbaum; 2000.
    1. Kreuter MW, Strecher VJ. Do tailored behavior change messages enhance the effectiveness of health risk appraisal? Results from a randomized trial. Health Educ Res. 1996;11(1):97–9105. doi: 10.1093/her/11.1.97.
    1. Duffy SA, Ronis DL, Valenstein M, Lambert MT, Fowler KE, Gregory L, Bishop C, Myers LL, Blow FC, Terrell JE. A tailored smoking, alcohol, and depression intervention for head and neck cancer patients. Canc Epidemiol Biomarkers Prev. 2006;15(11):2203–2208. doi: 10.1158/1055-9965.EPI-05-0880.
    1. Ryan GL, Skinner CS, Farrell D, Champion VL. Examining the boundaries of tailoring: the utility of tailoring versus targeting mammography interventions for two distinct populations. Health Educ Res. 2001;16(5):555–566. doi: 10.1093/her/16.5.555.
    1. Fournier JC, DeRubeis RJ, Hollon SD, Dimidjian S, Amsterdam JD, Shelton RC, Fawcett J. Antidepressant Drug Effects and Depression Severity A Patient-Level Meta-analysis. Jama-J Am Med Assoc. 2010;303(1):47–53. doi: 10.1001/jama.2009.1943.
    1. Thase ME, Greenhouse JB, Frank E, Reynolds CF, Pilkonis PA, Hurley K, Grochocinski V, Kupfer DJ. Treatment of major depression with psychotherapy or psychotherapy-pharmacotherapy combinations. Arch Gen Psychiatry. 1997;54(11):1009–1015. doi: 10.1001/archpsyc.1997.01830230043006.
    1. Fancher TL, Kravitz RL. In the clinic. Depression. Ann Intern Med. 2010;152(9) ITC51-15; quiz ITC55-16.
    1. Manea L, Gilbody S, McMillan D. Optimal cut-off score for diagnosing depression with the Patient Health Questionnaire (PHQ-9): a meta-analysis. CMAJ: Can Med Assoc J J Assoc Med Can. 2012;184(3):E191–196. doi: 10.1503/cmaj.110829.
    1. Kroenke K, Strine TW, Spitzer RL, Williams JBW, Berry JT, Mokdad AH. The PHQ-8 as a measure of current depression in the general population. J Affect Disord. 2009;114(1–3):163–173.
    1. Jenkinson C, Layte R, Jenkinson D, Lawrence K, Petersen S, Paice C, Stradling J. A shorter form health survey: can the SF-12 replicate results from the SF-36 in longitudinal studies? J Public Health Med. 1997;19(2):179–186. doi: 10.1093/oxfordjournals.pubmed.a024606.
    1. Maly RC, Frank JC, Marshall GN, DiMatteo MR, Reuben DB. Perceived efficacy in patient-physician interactions (PEPPI): validation of an instrument in older persons. J Am Geriatr Soc. 1998;46(7):889–894.
    1. Kanter JW, Rusch LC, Brondino MJ. Depression self-stigma: a new measure and preliminary findings. J Nerv Ment Dis. 2008;196(9):663–670. doi: 10.1097/NMD.0b013e318183f8af.
    1. Feldman MD, Franks P, Duberstein PR, Vannoy S, Epstein R, Kravitz RL. Let's not talk about it: suicide inquiry in primary care. Ann Fam Med. 2007;5(5):412–418. doi: 10.1370/afm.719.
    1. Kaboli PJ, Glasgow JM, Jaipaul CK, Barry WA, Strayer JR, Mutnick B, Rosenthal GE. Identifying Medication Misadventures: Poor Agreement Among Medical Record, Physician, Nurse, and Patient Reports. Pharmacotherapy. 2010;30(5):529–538. doi: 10.1592/phco.30.5.529.
    1. Krebs EE, Bair MJ, Carey TS, Weinberger M. Documentation of pain care processes does not accurately reflect pain management delivered in primary care. J Gen Intern Med. 2010;25(3):194–199. doi: 10.1007/s11606-009-1194-3.
    1. Pakhomov SV, Jacobsen SJ, Chute CG, Roger VL. Agreement between patient-reported symptoms and their documentation in the medical record. Am J Manag Care. 2008;14(8):530–539.
    1. Nicholson JM, Hennrikus DJ, Lando HA, McCarty MC, Vessey J. Patient recall versus physician documentation in report of smoking cessation counselling performed in the inpatient setting. Tob Contr. 2000;9(4):382–388. doi: 10.1136/tc.9.4.382.
    1. Julious SA. Sample sizes for clinical trials. Boca Raton: CRC Press/Taylor & Francis; 2010.
    1. Farrington CP, Manning G. Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non-zero risk difference or non-unity relative risk. Stat Med. 1990;9(12):1447–1454. doi: 10.1002/sim.4780091208.
    1. McCulloch CE, Searle SR, Neuhaus JM. Generalized, Linear, and Mixed Models. Hoboken, NJ: Wiley; 2008.
    1. Diggle PJ, Liang K-Y, Zeger SL. Analysis of Longitudinal Data. Oxford: Oxford University Press; 1994.
    1. Kravitz RL, Epstein RM, Feldman MD, Franz CE, Azari R, Wilkes MS, Hinton L, Franks P. Influence of patients' requests for direct-to-consumer advertised antidepressants: a randomized controlled trial. JAMA. 2005;293(16):1995–2002. doi: 10.1001/jama.293.16.1995.
    1. Donohue JM, Cevasco M, Rosenthal MB. A decade of direct-to-consumer advertising of prescription drugs. N Eng J Med. 2007;357(7):673–681. doi: 10.1056/NEJMsa070502.

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