Frequent Users of Emergency Department (FUEDs) Clinical Trial
— I-CaMOfficial title:
Implementing a Case Management Intervention for Frequent Users of the Emergency Department: An Effectiveness-Implementation Hybrid Trial Study Protocol
Background. Emergency department (ED) overcrowding represents a significant public health problem in developed countries. Frequent users of the emergency departments (FUEDs; reporting 5 or more ED visits in the past year) are often affected by medical, psychological, social, and substance use problems and account for a disproportionately high number of ED visits. Past research indicates that the case management (CM) intervention is a promising way to reduce ED overcrowding and improve FUEDs' quality of life. There is, however, very limited knowledge about how to disseminate and implement this intervention on a large scale to diverse clinical settings, including community hospitals and non-academic centers. This research project aims to implement a CM intervention tailored to FUEDs in the public hospitals with ED in the French-speaking region of Switzerland and to evaluate both the implementation process and effectiveness of the CM intervention. Methods. This research project will examine both implementation and clinical outcomes. The implementation part of the study will describe quantitatively and qualitatively factors that influence the implementation process; the investigators will also examine implementation effectiveness (i.e., whether the implementation of the CM intervention in the ED was successful or not). The clinical part of the study will evaluate participants' trajectories on clinical variables (e.g., quality of life, ED use) after receiving the CM intervention. Discussion. This research project will contribute to implementation science by providing key insights into the processes for implementing CM into broader practice. This research project is also likely to have both clinical and public health implications.
| Status | Recruiting |
| Enrollment | 120 |
| Est. completion date | October 2020 |
| Est. primary completion date | November 20, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Implementation part of the study: Inclusion Criteria: - Being a community or academic public hospital in French-speaking Switzerland - Being interested in implementing the CM intervention No exclusion Criteria: Clinical part of the study: Inclusion Criteria: - Being =18 years - Being able to communicate in a language that is spoken by the local team or a professional interpreter - Reporting =5 visits in the ED in the past 12 months Exclusion Criteria: - Presenting less than two vulnerability dimensions in addition to ED recurrent use [17] - Being unable to provide informed consent - Planning to stay in Switzerland less than 18 months - Being not expected to survive at least 18 months - Awaiting for incarceration or being currently incarcerated - Having a family member already enrolled in the study |
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | Hôpital du Jura | Delémont | Jura |
| Switzerland | Hôpital Fribourgeois | Fribourg | |
| Switzerland | Hôpitaux Universitaires de Genève (HUG) | Genève | |
| Switzerland | Hôpitaux Neuchâtelois (HNE) | Neuchâtel | |
| Switzerland | Hôpital Intercantonal de la Broye (HIB) | Payerne | Vaud |
| Switzerland | Hôpital du Jura Bernois | Saint-Imier | Berne |
| Switzerland | Hôpital du Valais | Sion | Valais |
| Switzerland | Etablissements hospitaliers du Nord Vaudois (eHnv) | Yverdon-les-Bains | Vaud |
| Lead Sponsor | Collaborator |
|---|---|
| University of Lausanne Hospitals |
Switzerland,
10. French adaptation of the general self- efficacy scale - Auto-efficacité généralisée [http://userpage.fu-berlin.de/~health/french.htm]
11. Consortium H-E: Comparative report of health literacy in eight EU member states. The European health literacy survey HLS-EU. 2012.
14. Moullin JC, Erhart MG, Torres EM, Aarons GA: 'Development and testing of a brief EBP implementation intentions scale using Rasch analysis. In Society for Implementation Research Collaboration (SIRC); Seattle, USA. 2017
2. Allison PD: Missing data. Thousand Oaks, CA: Sage; 2001.
3. Tabachnick BG, Fidell LS: Using Multivariate Statistics. 5th edn. Boston: Allyn and Bacon; 2007.
5. Normalization Process Theory On-line Users' Manual, Toolkt and NoMad instrument [http://www.normalizationprocess.org]
Althaus F, Paroz S, Hugli O, Ghali WA, Daeppen JB, Peytremann-Bridevaux I, Bodenmann P. Effectiveness of interventions targeting frequent users of emergency departments: a systematic review. Ann Emerg Med. 2011 Jul;58(1):41-52.e42. doi: 10.1016/j.annemergmed.2011.03.007. Review. — View Citation
Bergeron P, Courteau J, Vanasse A. Proximity and emergency department use: Multilevel analysis using administrative data from patients with cardiovascular risk factors. Can Fam Physician. 2015 Aug;61(8):e391-7. — View Citation
Bieler G, Paroz S, Faouzi M, Trueb L, Vaucher P, Althaus F, Daeppen JB, Bodenmann P. Social and medical vulnerability factors of emergency department frequent users in a universal health insurance system. Acad Emerg Med. 2012 Jan;19(1):63-8. doi: 10.1111/j.1553-2712.2011.01246.x. Epub 2012 Jan 5. — View Citation
Bodenmann P, Baggio S, Iglesias K, Althaus F, Velonaki VS, Stucki S, Ansermet C, Paroz S, Trueb L, Hugli O, Griffin JL, Daeppen JB. Characterizing the vulnerability of frequent emergency department users by applying a conceptual framework: a controlled, cross-sectional study. Int J Equity Health. 2015 Dec 9;14:146. doi: 10.1186/s12939-015-0277-5. — View Citation
Bodenmann P, Velonaki VS, Griffin JL, Baggio S, Iglesias K, Moschetti K, Ruggeri O, Burnand B, Wasserfallen JB, Vu F, Schupbach J, Hugli O, Daeppen JB. Case Management may Reduce Emergency Department Frequent use in a Universal Health Coverage System: a Randomized Controlled Trial. J Gen Intern Med. 2017 May;32(5):508-515. doi: 10.1007/s11606-016-3789-9. Epub 2016 Jul 11. — View Citation
Byrne M, Murphy AW, Plunkett PK, McGee HM, Murray A, Bury G. Frequent attenders to an emergency department: a study of primary health care use, medical profile, and psychosocial characteristics. Ann Emerg Med. 2003 Mar;41(3):309-18. — View Citation
Chamberlain P, Brown CH, Saldana L. Observational measure of implementation progress in community based settings: the Stages of Implementation Completion (SIC). Implement Sci. 2011 Oct 6;6:116. doi: 10.1186/1748-5908-6-116. — View Citation
Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005 Nov;15(9):1277-88. — View Citation
Huang JA, Tsai WC, Chen YC, Hu WH, Yang DY. Factors associated with frequent use of emergency services in a medical center. J Formos Med Assoc. 2003 Apr;102(4):222-8. — View Citation
Jacobs SR, Weiner BJ, Bunger AC. Context matters: measuring implementation climate among individuals and groups. Implement Sci. 2014 Apr 17;9:46. doi: 10.1186/1748-5908-9-46. — View Citation
Johnson MO, Rose CD, Dilworth SE, Neilands TB. Advances in the conceptualization and measurement of Health Care Empowerment: development and validation of the Health Care Empowerment inventory. PLoS One. 2012;7(9):e45692. doi: 10.1371/journal.pone.0045692. Epub 2012 Sep 19. — View Citation
Kwok OM, Underhill AT, Berry JW, Luo W, Elliott TR, Yoon M. Analyzing Longitudinal Data with Multilevel Models: An Example with Individuals Living with Lower Extremity Intra-articular Fractures. Rehabil Psychol. 2008 Aug;53(3):370-386. — View Citation
LaCalle E, Rabin E. Frequent users of emergency departments: the myths, the data, and the policy implications. Ann Emerg Med. 2010 Jul;56(1):42-8. doi: 10.1016/j.annemergmed.2010.01.032. Epub 2010 Mar 26. Review. — View Citation
Locker TE, Baston S, Mason SM, Nicholl J. Defining frequent use of an urban emergency department. Emerg Med J. 2007 Jun;24(6):398-401. — View Citation
Saldana L, Chamberlain P, Bradford WD, Campbell M, Landsverk J. The Cost of Implementing New Strategies (COINS): A Method for Mapping Implementation Resources Using the Stages of Implementation Completion. Child Youth Serv Rev. 2014 Apr 1;39:177-182. — View Citation
Shea CM, Jacobs SR, Esserman DA, Bruce K, Weiner BJ. Organizational readiness for implementing change: a psychometric assessment of a new measure. Implement Sci. 2014 Jan 10;9:7. doi: 10.1186/1748-5908-9-7. — View Citation
Skevington SM, Lotfy M, O'Connell KA; WHOQOL Group. The World Health Organization's WHOQOL-BREF quality of life assessment: psychometric properties and results of the international field trial. A report from the WHOQOL group. Qual Life Res. 2004 Mar;13(2):299-310. — View Citation
van Tiel S, Rood PP, Bertoli-Avella AM, Erasmus V, Haagsma J, van Beeck E, Patka P, Polinder S. Systematic review of frequent users of emergency departments in non-US hospitals: state of the art. Eur J Emerg Med. 2015 Oct;22(5):306-15. doi: 10.1097/MEJ.0000000000000242. Review. — View Citation
Vu F, Daeppen JB, Hugli O, Iglesias K, Stucki S, Paroz S, Canepa Allen M, Bodenmann P. Screening of mental health and substance users in frequent users of a general Swiss emergency department. BMC Emerg Med. 2015 Oct 9;15:27. doi: 10.1186/s12873-015-0053-2. — View Citation
Walton MA, Ngo QM, Chermack ST, Blow FC, Ehrlich PF, Bonar EE, Cunningham RM. Understanding Mechanisms of Change for Brief Alcohol Interventions Among Youth: Examination of Within-Session Interactions. J Stud Alcohol Drugs. 2017 Sep;78(5):725-734. — View Citation
Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3. — View Citation
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Change in levels of acceptability of the CM intervention in staff involved with the implementation between the preparation and the operation phase as assessed with the Acceptability Intervention Measure (AIM) [13] | The four-item AIM will assess the extent to which staff evaluate the intervention as acceptable using a 5-point Likert scale, where 1 = strongly disagree and 5 = strongly agree. Mean scores will be computed and higher scores will indicate higher levels of acceptability of the intervention. | An average of 12 and 18 months | |
| Other | Change in levels of the CM intervention appropriateness perception in staff involved with the implementation between the preparation and the operation phase as assessed with the Appropriateness Measure (IAM) [13]. | The four-item IAM will assess the extent to which staff evaluate the intervention as appropriate using a 5-point Likert scale, where 1 = strongly disagree and 5 = strongly agree. Mean scores will be computed and higher scores will indicate higher levels of appropriateness perception of the intervention. | An average of 12 and 18 months | |
| Other | Change in levels of the CM intervention feasibility perception in staff involved with the implementation between the preparation and the operation phase as assessed with the Feasibility of the Intervention Measure (FIM) [13] | The four-item FIM will assess the extent to which staff evaluate the intervention as feasible using a 5-point Likert scale, where 1 = strongly disagree and 5 = strongly agree. Mean scores will be computed and higher scores will indicate higher levels of feasibility perception of the intervention. | An average of 12 and 18 months | |
| Other | Change in intentions to use the CM intervention in staff involved with the implementation between the preparation and the operation phase as assessed with the Measure of Innovation Specific Implementation Intentions (MISII) [14] | The three-item MISII will assess intentions to use the CM intervention. Participants are asked to indicate to which intent they intent to use the CM intervention with a 5-point Likert scale, where 1 = not at all and 5 = to a very great extent. Higher scores will indicate higher intentions to use the CM intervention. | An average of 12 and 18 months | |
| Other | Change in implementation climate in hospitals implementing the CM intervention between the preparation and operation phase as assessed with the implementation climate scale [15] | The implementation climate scale includes 6 items assessing to which intent staff perceive that CM intervention use is expected, supported and rewarded by the institution. Participants answered to each item with a 5-point Likert scale, where 0 = disagree and 4 = agree. Higher scores indicate more supportive implementation climates. | An average of 12 and 18 months | |
| Other | Change in organizational readiness for change assessed in staff involved with the implementation between the preparation and operation phase as assessed with the Organizational Readiness for Implementation Change (ORIC) [16] | The ORIC includes 12 items assessing organizational readiness to change using a 5-point Likert scale where 1 = strongly disagree and 5 = strongly agree. Mean scores will be computed and higher scores will indicate higher perceived organizational readiness to change. | An average of 12 and 18 months | |
| Primary | Adoption rate as assessed by the number of hospitals included in the research project divided by the number of hospitals invited to participate | In total, 22 hospitals will be invited to participate therefore the number of hospitals included will be divided by 22 | An average of 6 months | |
| Primary | Reach as assessed by the number of patients receiving the CM intervention divided by the total number of eligible patients at the operation phase | An average of 18 months | ||
| Primary | Reach as assessed by the number of patients receiving the CM intervention divided by the total number of eligible patients at the sustainability phase | An average of 36 months | ||
| Primary | Level of the CM intervention integration as assessed with the Normalization MeAsure Development survey (NoMad) at the operation phase [5] | The NoMad survey includes 20 items organized around four subscales (coherence, cognitive participation, collective action and reflexive monitoring). Participants (i.e., staff involved in the CM intervention implementation) are asked to indicate the degree to which they agree or disagree with 20 statements related to the CM intervention integration, using a 5-point Likert-scale, where 1 = strongly disagree and 5 = strongly agree. Descriptive statistics (means and percentages) will be computed for each item. Higher scores will indicate higher agreement from the sample. | An average of 18 months | |
| Primary | Level of the CM intervention integration as assessed with the Normalization MeAsure Development survey (NoMad) at the sustainability phase [5] | The NoMad survey includes 20 items organized in four subscales (coherence, cognitive participation, collective action and reflexive monitoring). Participants (i.e., staff involved in the CM intervention implementation) are asked to indicate the degree to which they agree or disagree with 20 statements related to the CM intervention integration, using a 5-point Likert-scale, where 1 = strongly disagree and 5 = strongly agree. Descriptive statistics (means and percentages) will be computed for each item. Higher scores will indicate higher agreement from the sample. | An average of 36 months | |
| Primary | Level of normalization of the CM intervention as assessed with the Measure of Inner Context Sustainment (MICS; in development and testing) at the operation phase | Participants (i.e., staff involved in the CM intervention implementation) are asked to indicate to which extent they agree with 22 statements related to the CM intervention normalization using a 5-point Likert scale, where 0 = not at all and 4 = to a very great extent. Descriptive statistics (means, percentages) will be computed for each item. Higher scores will indicate higher levels of agreement from the sample. | An average of 18 months | |
| Primary | Level of normalization of the CM intervention as assessed with the Measure of Inner Context Sustainment (MICS; in development and testing) at the sustainability phase | Participants (i.e., staff involved in the CM intervention implementation) are asked to indicate to which extent they agree with 22 statements related to the CM intervention normalization using a 5-point Likert scale, where 0 = not at all and 4 = to a very great extent. Descriptive statistics (means, percentages) will be computed for each item. Higher scores will indicate higher levels of agreement from the sample. | An average of 36 months | |
| Primary | Change in the number of emergency department visits between baseline and 12 months follow-up assessments over the 12 months study period among FUEDs receiving the CM intervention | Number of ED visits over the past 12 months will be extracted from medical records. | Baseline and 12-month follow-up assessments | |
| Primary | Trajectories in quality of life over the 12 months study period among FUEDs receiving the CM intervention as assessed with the World Health Organization Quality of Life - Bref scale (WHOQOL-BREF) [6] (among FUEDs receiving the CM intervention). | The WHOQOL-BREF includes 22 items assessing four domains of quality of life (4 subscales): physical health, psychological health, social relationships and environment. Each question refers to the last past two week and uses a 5-point Likert scale (where 1 = very unsatisfied and 5 = very satisfied, 1= never and 5 = always or 1 = strongly disagree and 5 = strongly agree depending on item content. Following the instrument guideline, percentage ratings within each domain will be computed ranging from 0 to 100, where 0 = lowest quality of life and 100 = highest quality of life | Baseline, 3-, 6- and 12-month follow-up assessments | |
| Secondary | Number of implementation stages completed as assessed with an adapted version of the Stages of Implementation Completion tool [7] (in hospitals included in the study) | The SIC is a quasi-quantitative questionnaire measuring progression of implementation activities organized in eight stages by recording the dates implementation activities were completed. | An average of 36 months | |
| Secondary | Time spent in each implementation stage as assessed with an adapted version of the Stages of Implementation Completion Tool (SIC) | The SIC is a quasi-quantitative questionnaire measuring progression of implementation activities organized in eight stages by recording the dates implementation activities were completed. | An average of 36 months | |
| Secondary | Proportion of activities completed on each stage as assessed with an adapted version of the Stages of Implementation Completion Tool (SIC) | The SIC is a quasi-quantitative questionnaire measuring progression of implementation activities organized in eight stages by recording the dates implementation activities were completed. | An average of 36 months | |
| Secondary | Costs salary required for staff implementing the CM intervention as assessed with an adapted version of the Stages of Implementation Completion Tool (SIC) [8] | The SIC will be used to track hours put forth among staff involved with the CM intervention implementation on sites. Full time equivalent and averaged salary costs scores will be computed based on these data. | An average of 36 months | |
| Secondary | Costs salary required for the research team to assist the CM intervention implementation as assessed with an adapted version of the Stages of Implementation Completion Tool (SIC) [8] | The SIC will be used to track hours put forth among research staff involved with the CM intervention implementation. Full time equivalent and averaged salary costs scores will be computed based on these data. | An average of 36 months | |
| Secondary | Trajectories in health-care reorientations over the 12 months study period among FUEDs receiving the CM intervention | Health-care reorientations will be extracted from medical records. | Baseline, 3, 6 and 12-months follow-up assessments | |
| Secondary | Trajectories in empowerment over the 12 months study period among FUEDs receiving the CM intervention as assessed with the Health Care Empowerment Informed, Committed, Collaborative and Engaged subscales of the Health Care Empowerment Inventory [9]. | The Health Care Empowerment Informed, Committed, Collaborative and Engaged subscales of the Health Care Empowerment Inventory includes 4 items assessing empowerment. Participants are asked to indicate to what extent they agree with 4 statements using a 5-point Likert scale where 1=strongly disagree and 5 strongly agree. Means scores will be computed. Higher scores indicate higher levels of empowerment. | Baseline, 3, 6 and 12-months follow-up assessments | |
| Secondary | Trajectories in self-efficacy over the 12 months study period among FUEDs receiving the CM intervention as assessed with the General Self-Efficacy scale [10]. | The General Self-Efficacy scale includes 10 items assessing self-efficacy. Participants are asked to indicate to what extent they agree with 10 statements, using a 4-point Likert scale where 1=not at all true and 4=completely true. Means scores will be computed. Higher scores indicate higher levels of general self-efficacy. | Baseline, 3, 6 and 12-months follow-up assessments | |
| Secondary | Trajectories in health literacy over the 12 months study period among FUEDs receiving the CM intervention using the European Health Literacy Project Questionnaire [11] | The European Health Literacy Project Questionnaire is a 16-item questionnaire assessing health-literacy. Participants are asked to indicate to what extent they find easy or difficult to access, understand and appraise health-related information using a 4-point Likert scale where 1 = very difficult and 4 = very easy. Mean scores will be computed. Higher scores indicate higher health literacy. | Baseline, 3, 6 and 12-months follow-up assessments | |
| Secondary | Trajectories in precursors of alcohol use changes over the 12-months study period among FUEDs receiving the CM intervention as assessed with four single-item visual analog rulers [12]. | The four single-item visual analog rulers will assess importance, intentions, readiness and confidence regarding alcohol use changes. Participants are asked to indicate how important it is to change their alcohol use, to what extend the intend to change their alcohol use, to what extent they are ready and self-confident to do so, using a visual analog rulers ranging from 1 to 10, where 1= not at all and 10 = completely. Each item will provide a score, and higher scores will indicate higher levels of readiness to change alcohol use. | Baseline, 3, 6 and 12-months follow-up assessments |