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Treatment protocol effectiveness

Hip and knee replacement [1]
Results
Comment
Fractured neck of femur [2]
Results
Comment
Inpatient asthma management [3]
Results
Comment
Community-acquired pneumonia [4]
Results
Comment
Stroke rehabilitation [5]
Results
Comment
Use of laboratory tests [6]
Results
Comment
Heart failure [7]
Results
Comment
Overall comment

The unique biology of the patient, with their special circumstances, drives diagnosis and treatment. Yet individuals are often sufficiently similar one to another to make a treatment protocol, based on evidence, seem worthwhile. Even if it ensures that nothing important is missed, it should reduce error and might improve results. To that end treatment protocols, or clinical pathways, critical pathways or care paths have been developed and are used.

Do they deliver? This is not just being precious about evidence, but has real importance. Treatment protocols often require more front-end resources. Where the biggest constraint is one of capacity, as in the NHS right now, we need to know that professionals' time is likely to be used to the best advantage.

Treatment protocols are often used in hospital, where the advantage might be reduced length of stay. Where beds are restricted or waiting times long, more throughput could be a major benefit.

So Bandolier has been looking for evidence from randomised trials that treatment protocols deliver the goods. What follows is not an exhaustive systematic review, but a taster of papers we found. There are seven examples, in different situations with different goals and outcomes, all in secondary care. For each we give a brief outline of the method and results. The main outcome in most is length of hospital stay.

Hip and knee replacement [1]


This study in Australia randomised patients admitted for standard hip or knee replacement to:


The main outcome was length of stay, but others collected included complications (wound infection, chest infection, deep vein thrombosis, for instance) and readmission rates.

Results


The 92 patients randomised to the pathway and 71 to control were similar in age, weight and co-morbid conditions. Those treated in the pathway sat out of bed and were ambulant earlier, and were discharged after 7.1 rather than 8.6 days (Figure 1). There were fewer complications, and the proportion readmitted within three months was 4% for the pathway, against 13% for controls.

Figure 1: Outcomes in knee and hip replacement



Comment


Reduced length of stay did not increase the complication rate. This might have been a concern, perhaps, about whether the patients were having too little time in hospital with more complications and higher readmissions later on. Readmissions did not increase, but fell. No costs or resource allocation are given in the paper, but there is no indication that this care pathway should cost more to provide better quality of care.

Fractured neck of femur [2]


Another Australian study randomised (but by date of birth) uncomplicated patients with fractured neck of femur to usual care or to a clinical pathway. The main components of this pathway included an admission information checklist, specific pathway documentation specifying responsibilities and time, with a discharge package, and with discharge planning begun on admission.

Results


The 55 patients randomised to the pathway and 56 to control were similar in age and weight. Those treated in the pathway had earlier mobilisation, and were discharged after 6.6 rather than 8.0 days. There were fewer in-hospital complications (24% versus 26%), and the proportion readmitted within one month was 4% for the pathway, against 11% for controls, though these last two were not statistically different.

Comment


This was a small study in a unit already operating with an on-site rehabilitation unit and quite short background length of stay. Patients included those who, on admission, were confused (40%), had a co-morbid condition (33%) or who did not speak English (26%), so that the population studied was not over-selected. Their mean age was 83 years.

Inpatient asthma management [3]


In this study from Johns Hopkins a paediatric multidisciplinary team combined to create the care pathway, plus a weaning protocol designed for asthma patients between two and 18 years of age. Patients being admitted with a primary diagnosis of asthma exacerbation were randomised to a bed on the intervention unit (in which staff had been trained in the pathway) or a control unit in which they received standard care.

Results


There were 55 patients treated using the clinical pathway, and 55 usual care controls. They were similar apart from clinical path children being slightly older. The duration of hospital stay was significantly shorter using the clinical pathway (40 versus 54 hours, Figure 2) with a larger percentage discharged in the first day (38% versus 15%). The pathway also resulted in less use of β-agonists. The average cost was almost US$1,000 per patient lower for patients in the clinical pathway.

Figure 2: Outcomes in asthma management in children



Comment


A particularly detailed and interesting paper, this. It shows shorter stay, better outcomes, and lower cost. One problem was that only a quarter of eligible patients could be enrolled in the study because of bed shortages.

Community-acquired pneumonia [4]


A critical pathway for treating patients had three main components: use of a clinical prediction rule to assist admission decisions, treatment with levofloxacin (a fluoroquinolone antibiotic with good oral bioavailability and broad antimicrobial activity), and practice guidelines for care of inpatients. Nineteen hospitals were randomised to continue conventional management or implement the critical pathway.

Results


Over six months 1,743 patients were evaluated. Hospitals using the critical pathway had an 18% reduction in the admission of low-risk patients (31% versus 49% of admissions were low risk). Those treated in hospitals using the pathway spent 1.7 fewer days in hospital (5.0 versus 6.7 days), despite having more severe disease. Patients at hospitals implementing the pathway were also much more likely to be treated with a single antibiotic (64% versus 27%). There was no difference in the rate of adverse clinical outcomes (intensive care admission, mortality, readmission, complication), or quality of life indicators.

Comment


Combining the lower admission rate and reduced hospital stay, this care pathway, the authors computed a reduced cost of treating each case of US$1,700. This was at no reduction in quality of care or clinical outcomes.

Stroke rehabilitation [5]


An integrated care pathway based on evidence of best practice and professional standards was developed and coordinated by an experienced nurse in London. Eligible patients were those with persistent impairment within two weeks of the event. Exclusions were those with severe premorbid conditions or cognitive disability, or who had only mild deficits not needing rehabilitation. The stroke rehabilitation unit had two independent teams of carers, and the care pathway was introduced in one of them.

Results


There were 76 patients in each group, with a mean age of 75 years and no difference at baseline. There was no difference between the groups in outcomes or length of stay, institutional admission, or mortality.

Comment


This negative result could, of course, be due to the fact that care was already so good that it could not be bettered. The average length of stay was about 50 days, but the standard deviation was a huge 20 days, indicating the large variations between patients. This may have been influenced by issues other than those in the study. And there could have been cross-over between the two teams. Whatever, the additional cost of a coordinating nurse made the pathway more expensive at no benefit.

Use of laboratory tests [6]


Prospective randomised studies of patients undergoing elective surgery or acute medical admissions using clinical pathways were examined for use of laboratory tests in this Australian study.

Results


In the elective surgery study of 224 patients, use of laboratory tests was reduced by about 70% using the care pathway (1 versus 3 tests per patient for hernias, 3 versus 7 tests per patient for cholecystectomy). For acute medical admissions, there were 12 versus 16 tests per patient using the care pathway. These were mainly haematology and clinical chemistry tests. Estimated cost reductions were of the order of A$68 (£26) per patient.

Comment


There was no suggestion that patient care was in any way impaired by this reduction in laboratory testing. As laboratory tests have often been shown to be over-used, this outcome is a beneficial effect from using a care pathway.

Heart failure [7]


This randomised study from Johns Hopkins concerned patients at high risk of coronary heart failure readmission. This was defined by the presence of one or more of a rather long list that included age over 70 years, low left ventricular ejection fraction, at least one admission for heart failure in the previous year. An intervention team involved a telephone nurse coordinator, a heart failure nurse, heart failure cardiologist and the patient's primary physician. The cardiologist designed and documented a treatment plan for all study patients before randomisation and saw patients at baseline and after six months. The primary care physician delivered the interventions and looked after all non heart failure problems. The heart failure nurse visited patients on a monthly basis, and the telephone coordinator also kept in contact. In the usual care control group the cardiologist's plan was documented without further intervention.

Results


Two hundred patients were enrolled, and the two groups were similar at baseline. There were fewer heart failure hospital admissions or death over six months using the care pathway (49% versus 73%; Figure 3). Patients in the care pathway group were more likely to hit targets of treatment (weight, diet, vasodilators), and have stable or improved symptoms. Inpatient and outpatient resource use had similar costs, though the care pathway group tended to have lower costs and shorter lengths of stay.

Figure 3: Outcomes in heart failure management in the community



Comment


For every 10 patients treated in the care pathway, one fewer would have died or had a hospital admission for heart failure compared with usual care. Better quality was delivered at the same cost.

Overall comment


Some of the seven studies were of extremely high quality, particularly those from Johns Hopkins. The studies probably do not constitute the world literature on randomised studies of care pathways or use of treatment protocols. For instance, Bandolier's Internet migraine site describes a trial of treatment strategies for migraine. But these studies of care pathways do demonstrate a general consistency in delivering better care, or lower costs, or both.

When the system in which we work is constrained by lack of capacity, beds, or professionals, or both, then interventions that reduce bed stay are especially valued. When they also deliver better standards of care, and at lower costs, then they become imperative.

Nor did the design of these pathways require rocket science. They usually involved several disciplines working together to design written protocols based on evidence, experience, and guidelines. What is missing so far is similar evidence on the use of treatment protocols wholly in primary care. The evidence in heart failure management of complicated patients in primary care [7] is that care pathways are effective here too, but we failed to find other evidence. Perhaps we looked in the wrong place.

References:

  1. MM Dowsey et al. Clinical pathways in hip and knee arthroplasty: a prospective randomised controlled study. Medical Journal of Australia 1999 170: Kr-62.
  2. PF Choong et al. Clinical pathway for fractured neck of femur: a prospective, controlled study. Medical Journal of Australia 2000 172: 423-427.
  3. KB Johnson et al. Effectiveness of a clinical pathway for inpatient asthma management. Pediatrics 2000 106: 1006-1012.
  4. TJ Marrie et al. A controlled trial of a critical pathway for treatment of community-acquired pneumonia. JAMA 2000 283: 749-755.
  5. D Sulch et al. Randomized controlled trial of integrated (managed) care pathway for stroke rehabilitation. Stroke 2000 31: 1929-1934.
  6. N Board et al. Use of pathology services in re-engineered clinical pathways. Journal of Quality in Clinical Practice 2000 20: 24-29.
  7. EK Kasper. A randomized trial of the efficacy of multidisciplinary care in heart failure outpatients at high risk of hospital readmission. Journal of the American College of Cardiology 2002 39: 471-480.
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