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BMC Health Services Research

, 17:383

Quality, performance, safety and outcomes


BackgroundWhen tested in a randomized controlled trial RCT of 31,411 patients, the nurse-led 6-PACK falls prevention program did not reduce falls. Poor implementation fidelity i.e., program not implemented as intended may explain this result. Despite repeated calls for the examination of implementation fidelity as an essential component of evaluating interventions designed to improve the delivery of care, it has been neglected in prior falls prevention studies. This study examined implementation fidelity of the 6-PACK program during a large multi-site RCT.

MethodsBased on the 6-PACK implementation framework and intervention description, implementation fidelity was examined by quantifying adherence to program components and organizational support. Adherence indicators were: 1 falls-risk tool completion; and for patients classified as high-risk, provision of 2 a ‘Falls alert’ sign; and 3 at least one additional 6-PACK intervention. Organizational support indicators were: 1 provision of resources executive sponsorship, site clinical leaders and equipment; 2 implementation activities modification of patient care plans; training; implementation tailoring; audits, reminders and feedback; and provision of data; and 3 program acceptability. Data were collected from daily bedside observation, medical records, resource utilization diaries and nurse surveys.

ResultsAll seven intervention components were delivered on the 12 intervention wards. Program adherence data were collected from 103,398 observations and medical record audits. The falls-risk tool was completed each day for 75% of patients. Of the 38% of patients classified as high-risk, 79% had a ‘Falls alert’ sign and 63% were provided with at least one additional 6-PACK intervention, as recommended. All hospitals provided the recommended resources and undertook the nine outlined program implementation activities. Most of the nurses surveyed considered program components important for falls prevention.

ConclusionsWhile implementation fidelity was variable across wards, overall it was found to be acceptable during the RCT. Implementation failure is unlikely to be a key factor for the observed lack of program effectiveness in the 6-PACK trial.

Trial registrationThe 6-PACK cluster RCT is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12611000332921 29 March 2011.

KeywordsFalls prevention Injury prevention Hospitals Program evaluation Implementation fidelity Quality improvement Process evaluation Complex health intervention AbbreviationsFTEFull time equivalent

LOSLength of stay

RCTRandomized controlled trial

Electronic supplementary materialThe online version of this article doi:10.1186-s12913-017-2315-z contains supplementary material, which is available to authorized users.

Autor: Renata T. Morello - Anna L. Barker - Darshini R. Ayton - Fiona Landgren - Jeannette Kamar - Keith D. Hill - Caroline A.


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