Implementation fidelity of a nurse-led falls prevention program in acute hospitals during the 6-PACK trial

This study concerns the implementation fidelity of the 6-PACK program, a targeted nurse-led multi-component falls prevention program designed specifically for acute hospital wards [29]. It incorporates a nine-item falls-risk tool (the TNH-STRATIFY) [28] and delivery of up to six interventions to patients classified as high-risk based on the tool. However, when tested in a multi-center cluster randomized controlled trial (RCT) (n = 31,411 patients), the 6-PACK program did not reduce falls (IRR = 1 · 04, 95% CI, 0 · 78–1 · 37; P = 0 · 796) or fall injuries (IRR, 0 · 96; 95% CI, 0 · 72–1 · 27; P = 0 · 766) [31]. The primary trial explored reasons for no effect and provided evidence that contamination and confounding were highly unlikely [31]. Given the complexity of falls prevention in the acute ward setting, trial results may have been influenced by the degree to which the program was implemented into practice. The aim of this study was to examine the implementation fidelity— program adherence and organizational support—of the 6-PACK falls prevention program during a cluster RCT [31] to assist with the interpretation of trial results.

The methodology and findings of the RCT, conducted between January 2012 and April 2013, are described elsewhere [29, 31]. Intervention wards that participated in the RCT were included in this study—12 acute wards (medical or surgical) from six public hospitals (both metropolitan and regional teaching hospitals) in two states in Australia (Victoria and New South Wales). Participating wards comprised of general medical (n = 3), general surgical (n = 3), general medical short stay (n = 1), specialist medical (n = 4) and specialist surgical (n = 1). All patients admitted to participating wards were included in this study.

The RCT was a pragmatic trial with the 6-PACK program implemented by ward nursing staff as part of usual care practice. Data from a sample of intervention ward nurses and senior managers from each hospital were used in this evaluation. Sampling procedures are described in the data collection section below.

The 6-PACK program (Fig. 1) was implemented onto the 12 participating intervention wards during the cluster RCT. Nurses were required to complete the falls-risk tool for each patient on their daily care plan. For patients classified as high falls risk, nurses were to select, document and apply a ‘Falls alert’ sign above the patient’s bed and one or more of the remaining 6-PACK interventions (supervision while in the bathroom; use of a low-low bed, lowered as close as possible to the floor; ensuring their walking aid is within reach; establishment of a toileting regime; and use of a bed/chair alarm when they are in the bed/chair). The selection of 6-PACK interventions were based on the nurse’s clinical judgement of the patient’s needs.

The implementation of the 6-PACK program was managed at a central level (by the research team) and tailored locally by participating hospitals. It was informed by two mixed-methods studies: 1) perceived acceptability of the 6-PACK program (suitability, practicality and benefits) [32] and 2) perceived barriers to, and enablers of, implementation of the 6-PACK program [33]. It incorporated a number of implementation strategies (Table 1), that focused on the training and support of a hospital appointed part-time site clinical leader to facilitate program implementation on intervention wards.

Site clinical leaders were provided with a comprehensive 6-PACK implementation, training and monitoring guide. Throughout the trial, support was also provided by the research team (program designer [JK], change management facilitator [FL], project manager [RM] and chief investigator [AB]) on a needs basis via telephone, email and site visits. Need was determined by the site clinical leader or the research team and based primarily on ward program adherence. This included review of complex fall cases, additional training of site clinical leaders on the program and implementation strategies such as audit and feedback and trouble-shooting problems arising with equipment use. Further detail on the 6-PACK program and its implementation can be found elsewhere [29, 31].

An adapted version of the framework developed by Carroll and colleagues was used to assess implementation fidelity. Outcome indicators and data collection sources are summarized in Table 2.

Nursing practice adherence indicators (program dose) were: 1) falls-risk tool completion each day of admission; and for patients classified as high-risk provision of 2) a ‘Falls alert’ sign; and 3) a sign and at least one additional 6-PACK intervention. As this was a ward-based intervention and all patients admitted to participating wards were recruited as part of this study, program coverage was not specifically examined. Organizational support indicators were: 1) provision of hospital and ward 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 among nursing staff.

Data were prospectively collected. Data on program adherence were collected through daily audit of patient care plans and structured bedside observation. Data collection was undertaken by members of the research team (site data collectors) using a standardized tool. Budget constraints meant these data were only able to be collected from the commencement of the cluster RCT until December 2013. Weekly site clinical leader resource utilization diaries detailed time spent on program implementation activities. A member of the research team recorded attendance to site clinical leader training sessions and meetings and kept a log on the compliance of hospitals and wards to resource commitment, care-plan integration and data provision. Nurse perceptions were explored as part of a staff knowledge, attitudes and practices survey, developed by the research team. Nineteen items in the staff survey related to program acceptability scored on a 5-point Likert scale (1 = strongly disagree; 5 = strongly agree). The survey was administered prior to program implementation. The researcher attended handover sessions or designated ward meetings to distribute the survey. Nurses that had worked on an intervention ward for at least 7.5 h per week in the 2 months prior were invited to complete the survey. Completed surveys were placed in sealed boxes collected by the researcher at the end of the 2-week dissemination period. To avoid hierarchical coercion, Nurse Unit Managers were not involved in the distribution of the surveys. The number of surveys distributed to, and returned from, each ward was recorded.

Descriptive statistics were used to profile the study sample, program adherence and staff perceptions. Adherence to program content was categorized into three levels: adherent, partially adherent and non-adherent. Program dose was defined as a proportion. Data on hospital and ward resources and implementation activities were measured against expectations and/or recommendations and categorized into three level of adherence: adherent, partially adherent and non-adherent. Items were only coded as adherent if the recommendation was completely met. Analyses were undertaken using Stata MP v13 statistical software. Data visualizations of staff survey item responses were created using Tableau Desktop v9.0.

Data on program use were collected from 103,398 daily observations and medical record audits (Table 3). All participating wards were adherent to program content. Overall, 75% of patients had their falls-risk tool completed each day of their admission (range: 52–90%). Of patients classified as high-risk, 79% had a ‘Falls alert’ sign placed above the bed (range: 61–90%) and 63% were provided with a sign and at least one additional 6-PACK intervention (range: 48–74%). Use of 6-PACK program components increased during the RCT period. By the 10th month of data collection 79% of high-risk patients had a ‘Falls alert’ sign plus at least one other intervention (range: 61–95%). Substantial fluctuations in program adherence over the study period and between hospitals were noted (Additional file 1).

Table 4 summarizes data on the organizational support provided by hospitals during the trial period.

When interpreting these results, the following methodological limitations should be considered. The provision of 6-PACK interventions was reliant on the daily completion of the falls-risk tool and accurate classification of patients at high-risk. In addition, it does not necessarily reflect optimum practice (the provision of a ‘Falls alert’ sign and all relevant 6-PACK strategies for those identified as high-risk) or allow for the examination of the appropriate use of strategies. The authors acknowledge that qualitative data would provide additional insights into the factors influencing implementation fidelity, yet it was beyond the scope of this study. Considerable but different barriers to implementation appeared to be present in some hospitals/wards during the 6-PACK trial. Further exploration of organizational characteristics, existing infrastructure and surrounding social structures, ward location, the availability, skills and leadership qualities of the local implementation team and other competing priorities experienced by staff should be considered.