Effect of enhanced feedback to hospitals that are part of an emerging clinical information network on uptake of revised childhood pneumonia treatment policy: study protocol for a cluster randomized trial

Philip Ayieko, Grace Irimu, Mike English, Philip Ayieko, Grace Irimu, Mike English

Abstract

Background: The national pneumonia treatment guidelines in Kenya changed in February 2016 but such guideline changes are often characterized by prolonged delays in affecting practice. We designed an enhanced feedback intervention, delivered within an ongoing clinical network that provides a general form of feedback, aimed at improving and sustaining uptake of the revised pneumonia treatment policy. The objective was to determine whether an enhanced feedback intervention will improve correctness of classification and treatment of childhood pneumonia, compared to an existing approach to feedback, after nationwide treatment policy change and within an existing hospital network.

Methods/design: A pragmatic, cluster randomized trial conducted within a clinical network of 12 Kenyan county referral hospitals providing inpatient pediatric care to children (aged 2-59 months) with acute medical conditions between March and November 2016. The intervention comprised enhanced feedback (monthly written feedback incorporating goal setting, and action planning delivered by a senior clinical coordinator for selected pneumonia indicators) and this was compared to standard feedback (2-monthly written feedback on multiple quality of pediatric care indicators) both delivered within a clinical network promoting clinical leadership linked to mentorship and peer-to-peer support, and improved use of health information on service delivery. The 12 hospitals were randomized to receive either enhanced feedback (n = 6) or standard feedback (n = 6) delivered over a 9-month period following nationwide pneumonia treatment policy change. The primary outcome is the proportion of all admitted patients with pneumonia (fulfilling criteria for treatment with orally administered amoxicillin) who are correctly classified and treated in the first 24 h. The secondary outcome will be measured over the course of the admission as any change in treatment for pneumonia after the first 24 h.

Discussion: This trial protocol employs a pragmatic trial design during a period of nationwide change in treatment guidelines to address two high-priority areas within implementation research: promoting adoption of health policies and optimizing effectiveness of feedback.

Trial registration: ClinicalTrials.gov, ID: NCT02817971 . Registered retrospectively on 27 June 2016.

Keywords: Audit; Cluster trial; Feedback; Guidelines; Pneumonia; Pragmatic trial; Quality of care.

Conflict of interest statement

Ethics approval and consent to participate

The study was approved by the Kenya Medical Research Institute Scientific and Ethical Review Committee (KEMRI SERC – SSC protocol no. 2465). KEMRI SERC is a National Review Board mandated by the Kenyan Ministry of Health to provide ethical clearance to conduct studies within Kenyan health facilities. This National Committee approved the use of hospital assent to participate in the trial rather than written consent of the hospital administration and all hospitals retained their right to withdraw from the study at any point. The Ethics Committee also confirmed that informed consent was not needed from individual patients (or their carers) whose data were obtained retrospectively from medical records for the purposes of service evaluation and implementation research.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Clinical information network (CIN)-enhanced feedback intervention schedule of enrollment, interventions, and assessments
Fig. 2
Fig. 2
Graphical depiction of interventions in clinical information network (CIN)-enhanced feedback trial (adapted from Perera et al. [25])

References

    1. Amin AA, Zurovac D, Kangwana BB, et al. The challenges of changing national malaria drug policy to artemisinin-based combinations in Kenya. Malar J. 2007;6:72. doi: 10.1186/1475-2875-6-72.
    1. English M, Gathara D, Mwinga S, et al. Adoption of recommended practices and basic technologies in a low-income setting. Arch Dis Child. 2014;99:452–6. doi: 10.1136/archdischild-2013-305561.
    1. Wasunna B, Zurovac D, Goodman CA, Snow RW. Why don’t health workers prescribe ACT? A qualitative study of factors affecting the prescription of artemether-lumefantrine. Malar J. 2008;7:29. doi: 10.1186/1475-2875-7-29.
    1. Ivers N, Jamtvedt G, Flottorp S, et al. Audit and feedback: effects on professional practice and healthcare outcomes. Cochrane database Syst Rev. 2012;(6):CD000259. doi:10.1002/14651858.CD000259.pub3.
    1. Hysong SJ. Meta-analysis: audit and feedback features impact effectiveness on care quality. Med Care. 2009;47:356–63. doi: 10.1097/MLR.0b013e3181893f6b.
    1. Ivers NM, Sales A, Colquhoun H, et al. No more “business as usual” with audit and feedback interventions: towards an agenda for a reinvigorated intervention. Implement Sci. 2014;9:14. doi: 10.1186/1748-5908-9-14.
    1. Tuti T, Bitok M, Paton C, et al. Innovating to enhance clinical data management using non-commercial and open source solutions across a multi-center network supporting inpatient pediatric care and research in Kenya. J Am Med Inform Assoc. 2016;23:184–92. doi: 10.1093/jamia/ocv028.
    1. Tuti T, Bitok M, Malla L, et al. Improving documentation of clinical care within a clinical information network: an essential initial step in efforts to understand and improve care in Kenyan hospitals. BMJ Glob Heal. 2016;1:e000028. doi: 10.1136/bmjgh-2016-000028.
    1. English M. Designing a theory-informed, contextually appropriate intervention strategy to improve delivery of paediatric services in Kenyan hospitals. Implement Sci. 2013;8:39. doi: 10.1186/1748-5908-8-39.
    1. Forrest CB, Margolis PA, Bailey LC, et al. PEDSnet: a national pediatric learning health system. J Am Med Inform Assoc. 2014;21:602–6. doi: 10.1136/amiajnl-2014-002743.
    1. Agweyu A, Gathara D, Oliwa J, et al. Oral amoxicillin versus benzyl penicillin for severe pneumonia among Kenyan children: a pragmatic randomized controlled noninferiority trial. Clin Infect Dis. 2015;60:1216–24. doi: 10.1093/cid/ciu1166.
    1. Ministry of Health. Republic of Kenya. 4th ed. Nairobi: Basic paediatric protocols; 2016.
    1. WHO. Pocket book of hospital care for children. 2nd ed. Geneva: WHO; 2015.
    1. Chan A-W, Tetzlaff JM, Gøtzsche PC, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586. doi: 10.1136/bmj.e7586.
    1. Hayes RJ, Moulton LH. Cluster randomised trials. New York: CRC Press; 2009.
    1. Ayieko P, Ogero M, Makone B, et al. Characteristics of admissions and variations in the use of basic investigations, treatments and outcomes in Kenyan hospitals within a new Clinical Information Network. Arch Dis Child. 2016;101:223–9. doi: 10.1136/archdischild-2015-309269.
    1. Hattie J, Timperley H. The power of feedback. Rev Educ Res. 2007;77:81–112. doi: 10.3102/003465430298487.
    1. Mwakyusa S, Wamae A, Wasunna A, et al. Implementation of a structured paediatric admission record for district hospitals in Kenya—results of a pilot study. BMC Int Health Hum Rights. 2006;6:9. doi: 10.1186/1472-698X-6-9.
    1. Ayieko P, Ntoburi S, Wagai J, et al. A multifaceted intervention to implement guidelines and improve admission paediatric care in Kenyan district hospitals: a cluster randomised trial. PLoS Med. 2011;8:e1001018. doi: 10.1371/journal.pmed.1001018.
    1. Scales DC, Dainty K, Hales B, et al. An innovative telemedicine knowledge translation program to improve quality of care in intensive care units: protocol for a cluster randomized pragmatic trial. Implement Sci. 2009;4:5. doi: 10.1186/1748-5908-4-5.
    1. Dainty KN, Scales DC, Brooks SC, et al. A knowledge translation collaborative to improve the use of therapeutic hypothermia in post-cardiac arrest patients: protocol for a stepped wedge randomized trial. Implement Sci. 2011;6:4. doi: 10.1186/1748-5908-6-4.
    1. Tunis SR, Stryer DB, Clancy CM. Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policy. JAMA. 2003;290:1624–32. doi: 10.1001/jama.290.12.1624.
    1. Habicht JP, Victora CG, Vaughan JP. Evaluation designs for adequacy, plausibility and probability of public health programme performance and impact. Int J Epidemiol. 1999;28:10–8. doi: 10.1093/ije/28.1.10.
    1. Victora CG, Schellenberg JA, Huicho L, et al. Context matters: interpreting impact findings in child survival evaluations. Health Policy Plan. 2005;20(Suppl 1):i18–31. doi: 10.1093/heapol/czi050.
    1. Perera R, Heneghan C, Yudkin P. Graphical method for depicting randomised trials of complex interventions. BMJ. 2007;334:127–9. doi: 10.1136/bmj.39045.396817.68.

Source: PubMed

3
Tilaa