Abstract
Objectives: Assess feasibility of a cluster randomised controlled trial (RCT) to measure clinical and cost-effectiveness of an enhanced recovery pathway for people with hip fracture and cognitive impairment (CI).
Design: Feasibility trial undertaken between 2016 and 2018.
Setting: Eleven acute hospitals from three UK regions.
Participants: 284 participants (208 female:69 male). Inclusion criteria: aged >60 years, confirmed proximal hip fracture requiring surgical fixation and CI; preoperative AMTS ≤8 in England or a 4AT score ≥1 in Scotland; minimum of 5 days on study ward; a ‘suitable informant’ able to provide proxy measures, recruited within 7 days of hip fracture surgery. Exclusion criteria: no hip surgery; not expected to survive beyond 4 weeks; already enrolled in a clinical trial.
Intervention: PERFECT-ER, an enhanced recovery pathway with 15 quality targets supported by a checklist and manual, a service improvement lead a process lead and implemented using a plan–do–study–act model.
Primary and secondary outcome measures: Feasibility outcomes: recruitment and attrition, intervention acceptability, completion of participant reported outcome measures, preliminary estimates of potential effectiveness using mortality, EQ-5D-5L, economic and clinical outcome scores.
Results: 282 participants were consented and recruited (132, intervention) from a target of 400. Mean recruitment rates were the same in intervention and control sites, (range: 1.2 and 2.7 participants/month). Retention was 230 (86%) at 1 month and 54%(144) at 6 months. At 3 months a relatively small effect (one quarter of an SD) was observed on health-related quality of life of the patient measured with EQ-5D-5L proxy in the intervention group.
Conclusion: This trial design was feasible with modifications to recruitment. Mechanisms for delivering consistency in the PERFECT-ER intervention and participant retention need to be addressed. However, an RCT may be a suboptimal research design to evaluate this intervention due to the complexity of caring for people with CI after hip fracture.
Design: Feasibility trial undertaken between 2016 and 2018.
Setting: Eleven acute hospitals from three UK regions.
Participants: 284 participants (208 female:69 male). Inclusion criteria: aged >60 years, confirmed proximal hip fracture requiring surgical fixation and CI; preoperative AMTS ≤8 in England or a 4AT score ≥1 in Scotland; minimum of 5 days on study ward; a ‘suitable informant’ able to provide proxy measures, recruited within 7 days of hip fracture surgery. Exclusion criteria: no hip surgery; not expected to survive beyond 4 weeks; already enrolled in a clinical trial.
Intervention: PERFECT-ER, an enhanced recovery pathway with 15 quality targets supported by a checklist and manual, a service improvement lead a process lead and implemented using a plan–do–study–act model.
Primary and secondary outcome measures: Feasibility outcomes: recruitment and attrition, intervention acceptability, completion of participant reported outcome measures, preliminary estimates of potential effectiveness using mortality, EQ-5D-5L, economic and clinical outcome scores.
Results: 282 participants were consented and recruited (132, intervention) from a target of 400. Mean recruitment rates were the same in intervention and control sites, (range: 1.2 and 2.7 participants/month). Retention was 230 (86%) at 1 month and 54%(144) at 6 months. At 3 months a relatively small effect (one quarter of an SD) was observed on health-related quality of life of the patient measured with EQ-5D-5L proxy in the intervention group.
Conclusion: This trial design was feasible with modifications to recruitment. Mechanisms for delivering consistency in the PERFECT-ER intervention and participant retention need to be addressed. However, an RCT may be a suboptimal research design to evaluate this intervention due to the complexity of caring for people with CI after hip fracture.
| Original language | English |
|---|---|
| Article number | e055267 |
| Journal | BMJ Open |
| Volume | 12 |
| Issue number | 2 |
| DOIs | |
| Publication status | Published - 28 Feb 2022 |
Keywords
- Hip
- delirium & cognitive disorders
- geriatric medicine
- rehabilitation medicine