Process Evaluation of an Implementation Trial: Design, Rationale, and Early Lessons Learnt From an International Cluster Clinical Trial in Intracerebral Hemorrhage

Menglu Ouyang, Craig S Anderson, Lili Song, Alejandra Malavera, Stephen Jan, Guojuan Cheng, Honglin Chu, Xin Hu, Lu Ma, Xiaoying Chen, Chao You, Hueiming Liu, Menglu Ouyang, Craig S Anderson, Lili Song, Alejandra Malavera, Stephen Jan, Guojuan Cheng, Honglin Chu, Xin Hu, Lu Ma, Xiaoying Chen, Chao You, Hueiming Liu

Abstract

Background: The third INTEnsive care bundle with blood pressure Reduction in Acute Cerebral Hemorrhage Trial (INTERACT3) is an ongoing, international, multicenter, stepped-wedge cluster, prospective, randomized, open, blinded endpoint assessed trial evaluating the effectiveness of a quality improvement "care bundle" for the management of patients with acute spontaneous intracerebral hemorrhage (ICH) in low- and middle-income countries (LMICs). An embedded process evaluation aims to explore the uptake and implementation of the intervention, and understand the context and stakeholder perspectives, for interpreting the trial outcomes.

Methodology: The design was informed by Normalization Process Theory and the UK Medical Research Council process evaluation guidance. Mixed methods are used to evaluate the implementation outcomes of fidelity, reach, dose, acceptability, appropriateness, adoption, sustainability, and relevant contextual factors and mechanisms affecting delivery of the care bundle. Semi-structured interviews and non-participant observations are conducted with the primary implementers (physicians and nurses) and patients/carers to explore how the care bundle was integrated into routine care. Focus group discussions are conducted with investigators and project operational staff to understand challenges and possible solutions in the organization of the trial. Data from observational records, surveys, routine monitoring data, field notes and case report forms, inform contextual factors, and adoption of the intervention. Purposive sampling of sites according to pre-specified criteria is used to achieve sample representativeness.

Discussion: Implementation outcomes, and relevant barriers and facilitators to integrating the care bundle into routine practice, will be reported after completion of the process evaluation. The embedded process evaluation will aid understanding of the causal mechanisms between care bundle elements and clinical outcomes within complex health systems across diverse LMIC settings.

Trial registration: The INTERACT3 study is registered at ClinicalTrials.gov (NCT03209258).

Keywords: clinical trial; implementation science; intracerebral hemorrhage; process evaluation; stroke.

Conflict of interest statement

CA and LS declare that they received speaker fees and travel reimbursement from Takeda. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Copyright © 2022 Ouyang, Anderson, Song, Malavera, Jan, Cheng, Chu, Hu, Ma, Chen, You and Liu.

Figures

Figure 1
Figure 1
Stepped-wedge design of INTERACT3.
Figure 2
Figure 2
Implementation research logic model of INTERACT3 process evaluation.

References

    1. van Asch C, Luitse M, Rinkel G, van Der Tweel I, Algra A, Klijn C. Incidence, case fatality, and functional outcome of intracerebral haemorrhage over time, according to age, sex, and ethnic origin: a systematic review and meta-analysis. Lancet Neurol. (2010) 9:167–76. 10.1016/S1474-4422(09)70340-0
    1. Feigin V, Lawes C, Bennett D, Barker-Collo S, Parag V. Worldwide stroke incidence and early case fatality reported in 56 population-based studies: a systematic review. Lancet Neurol. (2009) 8:355–69. 10.1016/S1474-4422(09)70025-0
    1. Krishnamurthi RV, Ikeda T, Feigin VL. Global, regional and country-specific burden of ischaemic stroke, intracerebral haemorrhage and subarachnoid haemorrhage: a systematic analysis of the global burden of disease study 2017. Neuroepidemiology. (2020) 54:171–9. 10.1159/000506396
    1. Parry-Jones AR, Sammut-Powell C, Paroutoglou K, Birleson E, Rowland J, Lee S, et al. . An intracerebral hemorrhage care bundle is associated with lower case fatality. Ann Neurol. (2019) 86:495–503. 10.1002/ana.25546
    1. Dreischulte T, Grant A, Donnan P, Guthrie B. Pro's and con's of the stepped wedge design in cluster randomised trials of quality improvement interventions: two current examples. Trials. (2013) 14: O87. 10.1186/1745-6215-14-S1-O87
    1. Campbell M, Katikireddi SV, Hoffmann T, Armstrong R, Waters E, Craig P. Tidier-php: a reporting guideline for population health and policy interventions. BMJ. (2018) 361:k1079. 10.1136/bmj.k1079
    1. Hoffmann TC, Walker MF. ‘Tidier-ing up' the reporting of interventions in stroke research: the importance of knowing what is in the ‘black box'. Int J Stroke. (2015) 10:657–8. 10.1111/ijs.12524
    1. Scott SD, Rotter T, Hartling L, Chambers T, Bannar-Martin KH. A protocol for a systematic review of the use of process evaluations in knowledge translation research. Syst Rev. (2014) 3:149. 10.1186/2046-4053-3-149
    1. Wallin L. Knowledge translation and implementation research in nursing. Int J Nurs Stud. (2009) 46:576–87. 10.1016/j.ijnurstu.2008.05.006
    1. Peters DH, Adam T, Alonge O, Agyepong IA, Tran N. Implementation research: what it is and how to do it. BMJ. (2013) 347:f6753. 10.1136/bmj.f6753
    1. Moore GF, Audrey S, Barker M, Bond L, Bonell C, Hardeman W, et al. . Process evaluation of complex interventions: medical research council guidance. BMJ. (2015) 350:h1258. 10.1136/bmj.h1258
    1. Grant A, Treweek S, Dreischulte T, Foy R, Guthrie B. Process evaluations for cluster-randomised trials of complex interventions: a proposed framework for design and reporting. Trials. (2013) 14:15. 10.1186/1745-6215-14-15
    1. Limbani F, Goudge J, Joshi R, Maar MA, Miranda JJ, Oldenburg B, et al. . Process evaluation in the field: global learnings from seven implementation research hypertension projects in low-and middle-income countries. BMC Public Health. (2019) 19:953. 10.1186/s12889-019-7261-8
    1. Fayers PM, Jordhoy MS, Kaasa S. Cluster-randomized trials. Palliat Med. (2002) 16:69–70. 10.1191/0269216302pm503xx
    1. Song L, Hu X, Ma L, Chen X, Ouyang M, Billot L, et al. . Intensive care bundle with blood pressure reduction in acute cerebral hemorrhage trial (interact3): study protocol for a pragmatic stepped-wedge cluster-randomized controlled trial. Trials. (2021) 22:943. 10.1186/s13063-021-05881-7
    1. May C, Finch T. Implementing, embedding, and integrating practices: an outline of normalization process theory. Sociology. (2009) 43:535–54. 10.1177/0038038509103208
    1. May C, Cummings A, Girling M, Bracher M, Mair F, May C, et al. . Using normalization process theory in feasibility studies and process evaluations of complex healthcare interventions: a systematic review. Implement Sci. (2018) 13:80. 10.1186/s13012-018-0758-1
    1. Murray E, Treweek S, Pope C, Macfarlane A, Ballini L, Dowrick C, et al. . Normalisation process theory: a framework for developing, evaluating and implementing complex interventions. BMC Med. (2010) 8:63. 10.1186/1741-7015-8-63
    1. Smith JD, Li DH, Rafferty MR. The implementation research logic model: a method for planning, executing, reporting, and synthesizing implementation projects. Implement Sci. (2020) 15:84. 10.1186/s13012-020-1041-8
    1. Suri H. Purposeful sampling in qualitative research synthesis. Qual Res J. (2011) 11:63–75. 10.3316/QRJ1102063
    1. Shorten A, Smith J. Mixed methods research: expanding the evidence base. Evid Based Nurs. (2017) 20:74–5. 10.1136/eb-2017-102699
    1. Liu H, Lindley R, Alim M, Felix C, Gandhi DBC, Verma SJ, et al. . Protocol for process evaluation of a randomised controlled trial of family-led rehabilitation post stroke (ATTEND) in india. BMJ Open. (2016) 6:e012027. 10.1136/bmjopen-20166-012027
    1. Nowell LS, Norris JM, White DE, Moules NJ. Thematic analysis: striving to meet the trustworthiness criteria. Int J Qual Methods. (2017) 16:1–13. 10.1177/1609406917733847
    1. Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol. (2006) 3:77–101. 10.1191/1478088706q66qp0p63o33oa
    1. Fetters MD, Curry LA, Creswell JW. Achieving integration in mixed methods designs-principles and practices. Health Serv Res. (2013) 48:2134–56. 10.1111/1475-6773.12117
    1. Johnson RE, Grove AL, Clarke A. Pillar integration process: a joint display technique to integrate data in mixed methods research. J Mix Methods Res. (2019) 13:301–20. 10.1177/1558689817743108
    1. Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (coreq): a 32-item checklist for interviews and focus groups. Int J Qual Health Care. (2007) 19:349–57. 10.1093/intqhc/mzm042
    1. Lazo-Porras M, Liu H, Miranda JJ, Moore G, Burri M, Chappuis F, et al. . Process evaluation of complex interventions in chronic and neglected tropical diseases in low- and middle-income countries—a scoping review protocol. Syst Rev. (2021) 10:244. 10.1186/s13643-021-01801-7
    1. Thrift AG, Pandian J, Abd-Allah F, Yaria J, Phan HT, Roth G, et al. . The state of stroke services across the globe: report of world stroke organization–world health organization surveys. Int J Stroke. (2021) 16:889–901. 10.1177/17474930211019568
    1. Baatiema L, Aikins A, Sav A, Mnatzaganian G, Chan CK, Somerset S. Barriers to evidence-based acute stroke care in Ghana: a qualitative study on the perspectives of stroke care professionals. BMJ Open. (2017) 7:e015385. 10.1136/bmjopen-2016-015385
    1. Scott SD, Rotter T, Flynn R, Brooks HM, Plesuk T, Bannar-Martin KH, et al. . Systematic review of the use of process evaluations in knowledge translation research. Syst Rev. (2019) 8:266. 10.1186/s13643-019-1161-y

Source: PubMed

Szponzorok és közreműködők

Egészségi állapot

Kábítószer-beavatkozások

3
Iratkozz fel