Enhanced recovery pathway for older people with hip fracture and cognitive impairment in acute hospitals: the PERFECTED research programme including an RCT

Background Hip fracture has a substantial impact on the health, well-being and independence of patients and their families. In the 12 months after fracture, patients are at increased risk of cognitive and functional decline, admission to long-term care institutions and higher mortality. People with cognitive impairment are among the most vulnerable in acute hospital settings. They have lower short-term survival, with 24% mortality during admission. They are susceptible to suboptimal and inconsistent care standards that contribute to cognitive deterioration, increase risk of postoperative complications, prolong their length of stay and cause loss of independence. Objectives Establish best-practice from a systematic review of literature, observations of practice, perspectives of service users, carers, healthcare professionals, health service managers and experts in the field. Design the care pathway. Determine cultural/organisational changes necessary to implement and maximise adherence to the enhanced recovery pathway in hospital settings. Develop staff training and a training manual. Undertake a feasibility randomised controlled trial and collect outcomes to identify potential clinical and cost-effectiveness of the enhanced recovery pathway. Disseminate the findings and develop a definitive trial bid. Design A programme to develop an enhanced recovery pathway for people with hip fracture and cognitive impairment, tested for implementation and refined in the clinical environment. This refined enhanced recovery pathway was then tested in a feasibility study in 10 hospitals across the UK. Setting Acute care. Participants Hospital staff, people with cognitive impairment and hip fracture, carers and national and international experts in hip fracture or dementia. Interventions An enhanced recovery care pathway with checklist and an implementation process. Main outcome measures Mortality, patient and carer quality of life, cognition, activities of daily living. Data sources Clinical trial. Results A total of 284 participants were recruited, 132 to the PEFECT-ER intervention arm and 150 to the control arm, had good retention in the study and provided data for analysis. There was no evidence of any systematic between group difference at either the point of discharge from hospital or at 1-month follow-up. However, at 3 months, a relatively small effect of around one quarter of a standard deviation (0.071 units), was evidenced with respect to the health-related quality of life of the patient based on the EuroQol-5 Dimensions, five-level version by proxy in the intervention group (95% confidence interval 0.018 to 0.124; p = 0.009). A difference of 0.099 units in favour of the intervention group was also seen at the 6-month follow-up (95% confidence interval 0.001 to 0.198; p = 0.047). ‘Timed Up and Go’ and the Suitable Informant EuroQol-5 Dimensions, five-level version showed a no statistically significant difference except the model for length of stay. Those individuals in the intervention group had significantly longer lengths of stay, on average 1.22 times longer (95% confidence interval 1.02 to 1.45; p = 0.028). Mortality was similar in both groups, with a 6.1% mortality rate by 30 days post surgery. The process evaluation found that patients and carers were unable to comment on receiving the intervention. Limitations This was a feasibility study and was not designed as a definitive evaluation of the intervention. Lack of direct access to patient notes meant that researchers were unable to verify the Perioperative Enhanced Recovery hip FracturE Care of paTiEnts with Dementia-Enhanced Recovery check listing results. The relationship between changes in documentation of practices and changes in care practices is also unclear. Patient and suitable informants did not assist understandings of implementation, mechanisms of action or experiences of interacting with the intervention. Client Services Receipt Inventory data collection burden was an issue. Conclusions The Perioperative Enhanced Recovery hip FracturE Care of paTiEnts with Dementia-Enhanced Recovery feasibility trial demonstrated mean recruitment of 1.87 participant per centre per month. Retention at 1 month was over 80% and at 6 months approximately 50%. This information is useful for those wishing to design a definitive clinical trial. Although 30-day mortality was the same in both groups, the potential for reduction, by Perioperative Enhanced Recovery hip FracturE Care of paTiEnts with Dementia-Enhanced Recovery being implemented, exists from cumulatively increased good practices across a range of care domains. To compare longer-term survival of patients who received the intervention, we would recommend measuring 3-month (110-day) mortality in addition to 30-day mortality. These data are readily available from National Hip Fracture Database and are thus ideal for efficient trial design. Client Services Receipt Inventory can be reduced for a definitive trial, removing equipment questions and some community health use questions. Qualitative interviews with Perioperative Enhanced Recovery hip FracturE Care of paTiEnts with Dementia-Enhanced Recovery trial patient and carer should not take place. Future work Work to date shows that the intervention pathway for Perioperative Enhanced Recovery hip FracturE Care of paTiEnts with Dementia-Enhanced Recovery required considerable input from champions for delivery. We are exploring further funding options to facilitate work to understand these mechanisms and further test, pilot and produce the Perioperative Enhanced Recovery hip FracturE Care of paTiEnts with Dementia-Enhanced Recovery manual. Trial registration This trial is registered as Current Controlled Trials ISRCTN99336264. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research Programme (NIHR award ref: DTC-RP-PG-0311-12004) and is published in full in Programme Grants for Applied Research ; Vol. 13, No. 1. See the NIHR Funding and Awards website for further award information.