Inpatient vs Outpatient Total Hip Replacement
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      This study is a pragmatic randomized clinical trial comparing standard inpatient total hip
      arthroplasty with same day discharge. Patients who are medically well and have a good support
      structure at home will be randomized to inpatient or same day discharge. The investigators
      will compare patient costs from the perspective of the Ministry of Health, the institution,
      society and the patient. The investigators will also record complications, patient
      satisfaction, functional ability and quality of life.
    

Detailed description: 
      Total Hip Arthroplasty (THA) is currently one of the most successful procedures in
      orthopaedics. Over the last 40 years, postoperative care has significantly evolved.
      Initially, the standard procedure following THA was that patients were required to stay in
      the hospital to recover for 2.5 to 3 weeks. However, with the implementation of less invasive
      techniques, coupled with early weight bearing and more comprehensive postoperative
      rehabilitation protocols, inpatient stays have drastically decreased on average to 2 to 3
      days. A new, minimally invasive surgical (MIS) technique has led to an even larger decrease
      in hospital stays, culminating in a same day discharge. The possibility of early
      mobilization, combined with an increasing push from patients to accelerate recovery and
      return to activities, have led to the implementation of outpatient THA in select patients.
      For same day discharge to succeed, extensive preoperative and perioperative care must
      accompany the procedure. Furthermore, more aggressive rehabilitation and improved pain
      control is crucial for successful outpatient THA. For younger patients that need to return to
      work as early as possible, a quicker recovery time is essential. Perfecting outpatient THA is
      a crucial step towards achieving these requirements.

      There are 4 major components to a successful THA: pain relief, functional recovery, patient
      satisfaction and durable reconstruction. Outpatient THA is a fairly new concept in
      arthroplasty, and patient satisfaction has not been properly assessed following this new THA
      protocol. Satisfaction in accordance with THA refers to a patient achieving their functional
      and pain expectations. A similar study evaluating patient satisfaction of a randomized
      control trial (RCT) of inpatient versus outpatient anterior cruciate ligament (ACL)
      reconstructions reported that outpatient satisfaction following surgery is higher than
      inpatient satisfaction. Although this is a different procedure, it would seem outpatient ACL
      reconstruction and outpatient THA has similar pain levels, safety and patient satisfaction.
      The goal with outpatient surgery with regards to satisfaction is providing patients with
      relief of their anxiety, while allowing them earlier control of their independence. Potential
      advantages of outpatient surgery include that patients are permitted to recover in a secure,
      private and comfortable home environment, while surgeons will improve efficiency and time
      management with the decreased responsibilities of having to visit their inpatients.

      In addition to the potential satisfaction benefit, outpatient THA is a potential source of
      cost savings for both the patient and the hospital. Numerous efforts by hospitals have been
      made to decrease costs and increase available beds for additional patients. A previous study
      investigating the financial effects of outpatient THA found that the average hospital bill
      for outpatients was $4000 less than for the inpatients. Including preoperative physical
      therapy and home healthcare, the total charges for outpatients was $2500 less than
      inpatients. A similar study demonstrated that select individuals can successfully undergo THA
      in an outpatient setting with no increase in complications, while also receiving a
      substantial savings to the patient and the healthcare system. By reducing costs and
      increasing healthcare staff availability, hospitals can allocate more money to areas in need
      of funding, while wait times can drastically reduce for future patients.

      The most important part of preoperative care for a successful outpatient THA is giving the
      patient appropriate goals and expectations. Patients should be educated by the
      anaesthesiology team, the physical and occupational therapist, the surgeon, the nurses, and
      anyone else involved in the surgery. Patients are required to attend classes explaining the
      various aspects of the operative experience, as well as discharge goals and techniques for
      postoperative home rehabilitation. Furthermore, functional and symptomatic goals need to be
      clearly defined. In these educational sessions, pain management strategies are one of the
      main focuses. To have a successful same day discharge, patients must be well versed in pain
      management and proper rehabilitation strategies. Before the preoperative class, all patients
      are instructed to practice certain skills, such as bed transfer, cane/crutches use and gait
      training. Potential complications are discussed so that the patient is reassured with what is
      normally supposed to happen following surgery. The goal of preoperative care is that the
      patient has a defined set of goals and expectations for their surgery, medications, and
      rehabilitation.

      For outpatient THA surgery, it is preferred to perform the surgery in the morning to
      facilitate same day discharge. Immediately following surgery, the primary goals are to treat
      pain, nausea and hypovolemia. Prior to symptoms arriving, these issues have to be dealt with
      using the proper fluids and medications. Physical therapy is usually initiated 3 to 4 hours
      following surgery. The combination of this early rehabilitation program, combined with the
      minimally invasive surgical technique is vital to the rapid recovery process. Home physical
      therapy should begin immediately, with a focus on ambulation. The patient is then asked for a
      follow-up visit within 1 week of the surgery to make sure all of the patient's goals have
      been met.

      The primary concern with outpatient THA is safety of the patient. There are also concerns
      including emergency room readmissions in patients who have difficulty once home in the
      immediate postoperative period. Furthermore, some patients will require transfer to an
      inpatient facility when they are experiencing a delayed recovery after surgery.

      Anecdotal data was collected prior to the start of this research project. Since there was a
      clinical practice change, informal conversations with outpatient THA demonstrated that 10/11
      patients would have outpatient surgery again, and 9/11 would recommend outpatient THA surgery
      to others. These encouraging findings are an important justification for performing the
      present study.

      Although previous THA outpatient studies have demonstrated successful results, it is
      imperative to complete a RCT to diminish any bias associated with these findings. In the
      absence of high quality comparative evidence, the success in same day discharge THA may be a
      result of selection bias, since previous research is largely driven by observational studies
      of highly selected populations. This would severely decrease the generalizability of previous
      studies. To our knowledge, this will be the first level one study that will investigate the
      cost, early complications and patient satisfaction associated with outpatient THA in a
      pragmatic selection of patients. This study will answer important questions on how to best
      treat patients undergoing THA, and whether an earlier discharge following surgery affects
      patient outcomes.

      A retrospective analysis of over 50,000 THA and TKA procedures found no differences in 30-day
      major complications or readmissions among patients with a zero to two-day hospital stay
      compared to those discharged on day three or four postoperative. The rate of serious adverse
      events in the inpatient group is expected to be greater than five percent. To define a
      non-inferiority margin we agreed that no more than a five percent increase in the risk of
      serious adverse event (RD ≥ 6% favoring inpatient care) was acceptable. If the risk in the
      inpatient group ranges between five to eight percent and there is truly no difference in risk
      of serious adverse event between the groups, then a maximum of 506 patients are required to
      be 80% certain that the upper limit of a one-sided 95% confidence interval will exclude a
      difference in favour of the inpatient group of more than six percent. Given that the primary
      outcome is being measured at 3-months postoperative, we anticipate a low lost-to-follow-up
      rate. Previous studies conducted at the study site in similar patients demonstrate loss to
      follow up rates less than one percent for the first 3 months. Therefore, to account for a
      potential one percent dropout rate we inflated our sample size to 511.
    

Intervention name(s): Outpatient; Inpatient
Intervention type(s): Procedure; Procedure
Intervention description(s): Patients in the outpatient group will be discharged from the hospital the same day of surgery following a total hip arthroplasty; Patients in the inpatient group will be discharged from the hospital the following day after a total hip arthroplasty
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Health Services Research
Keywords: cost; total hip replacement; outpatient Surgery; satisfaction; arthroplasty