The value of nonoperative versus operative treatment of frail institutionalized elderly patient with a hip fracture in the shade of life (FRAIL-HIP); a multicenter observational study

BACKGROUND

A proximal femoral fracture is strongly associated with mortality. Mortality is highest among elderly with both physical and cognitive comorbidities. There are no strict guidelines on whether or not to operate these patients. NICE advises to discuss if patients are open to hospital admission and possible surgery, and Dutch guidelines advocate operative treatment in patients with a life expectancy beyond six weeks. Common practice is to decide on treatment based on shared decision, yet nonoperative management is not commonly used. Practice variation occurs, and it remains unknown if nonoperative treatment would result in at least the same quality of life of femoral fracture patients who are institutionalized and have a limited life expectancy. Treatment decision will be reached following a structured shared decision process, in which pros and cons of both operative and nonoperative management are discussed with patients, their relatives, and all relevant care providers involved.

AIM

The primary aim is to determine the effect of nonoperative management versus operative management on the quality of life (EQ-5D) until six months in frail institutionalized elderly with a limited life expectancy who fracture their proximal femur. Secondary aims are to determine the effect of nonoperative management versus operative management on the quality of life (QUALIDEM), level of pain (PACSLAC-D) and use of analgesic medication, rate of complications, time to death, the satisfaction of the patient’s relatives and caregiver with the management strategy and health care consumption (with associated costs) in these patients. The ultimate aim is to determine the cost-efficacy of nonoperative management versus operative management in these patients.



STUDY DESIGN

Multicenter, observational cohort study.

POPULATION

Frail institutionalized elderly (70 years or older who have a body mass index <18.5, a Functional Ambulation Category of 2 or lower pre-trauma, or an ASA 4-5), who sustained a proximal femoral fracture.

INTERVENTION

Following a structured shared decision process, patients and treating physicians will decide on the best treatment for each individual patient. This will be:

1) Nonoperative management

2) Operative management

ENDPOINTS

Primary outcome measure: quality of life (EQ-5D).

Secondary outcome measures: quality of life (QUALIDEM); pain and pain medication; satisfaction of patient (or proxy) and caregivers with the management approach; time to death; and direct medical costs.

Data will be collected at 7, 14, and 30 days, and 3 and 6 months after trauma.

RECRUITING COUNTRIES

The Netherlands

We expect that quality of life after nonoperative treatment is at least as good as after operative treatment.

Seven, 14, and 30 days, and 3 and 6 months after trauma.

Patients in the intervention group will be treated nonoperatively. The control group will receive operative management.