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Saudi Journal of Kidney Diseases and Transplantation
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Year : 2017  |  Volume : 28  |  Issue : 6  |  Page : 1282-1292
A pragmatic randomized controlled trial comparing pathway-based versus usual care in community-acquired acute kidney injury

1 Department of Medicine, King Abdulaziz Medical City; Department of Medicine, King Saud Bin Abdulaziz University for Health Sciences, Jeddah, Saudi Arabia
2 College of Nursing, King Saud Bin Abdulaziz University for Health Sciences; Department of Pharmaceutical Care, King Abdulaziz Medical City, Jeddah, Saudi Arabia
3 Department of Medicine, King Abdulaziz Medical City, Jeddah, Saudi Arabia
4 Department of Medicine, King Saud Bin Abdulaziz University for Health Sciences; King Abdullah International Foundation for Dialysis, Jeddah, Saudi Arabia
5 King Abdullah International Medical Research Center, Jeddah, Saudi Arabia
6 Department of Quality Management, King Abdulaziz Medical City, Jeddah, Saudi Arabia
7 Department of Nursing, King Abdulaziz Medical City, Ministry of National Guard Health Affairs, Jeddah, Saudi Arabia
8 Department of Epidemiology and Medical Statistics, University of Ibadan, Nigeria
9 Department of Medicine, National University of Medical Sciences, Rawalpindi, Pakistan

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Date of Web Publication18-Dec-2017


Clinical pathways have shown conflicting evidence in improvement of several patient-centered outcomes across different clinical settings. However, the effectiveness of clinical pathway in management of acute kidney injury (AKI) has not been reported. Therefore, we aimed to assess the length of hospital stay (LOS) and patient-centered outcomes in community acquired AKI and compared pathway care (PC) versus usual care (UC). The CHAMP-Path AKI Trial is a pragmatic, parallel, single-blind randomized controlled trial. Physicians were randomized to provide either UC or PC. Patients were randomized through a computer-generated sequence. Allocation was concealed. Patients presenting to the emergency department with AKI and hemodynamic stability, who were over 14 years with a serum creatinine greater than 1.5 times the baseline were eligible. Patients with chronic kidney disease stages 4 or 5, kidney transplantation recipients, those admitted with obstructive uropathy, suspected glomerular or interstitial disease, and pregnant women were excluded. Thirty-eight patients were enrolled from March 2012 to December 2013. The primary outcome was LOS. Secondary outcomes included: 30-day readmission, in-hospital mortality, determinants of LOS, and patient-centered outcomes. Eighteen patients were randomized to PC, and 20 to UC. Baseline characteristics were comparable in both groups. Using an intention-to-treat analysis, the median LOS was 4.96 [interquartile range (IQR) 6.57] and 4.80 days (IQR 6.84) for PC and UC, respectively (P = 0.770). Of the five readmissions, none were for AKI. No in-hospital mortality was reported. The CHAMP-Path AKI pragmatic trial demonstrated that PC was not different than UC in reducing LOS. There was no difference in 30-day re- admission, in-hospital mortality, and patient-centered outcomes.

How to cite this article:
Almalki AH, Ismail SE, Qureshi MA, Abunijem Z, Balla ME, Karsou S, Qureshi RA, Ahmad A, AlSulami S, Khalil M, Hafez J, Thomson JE, Siddiqui MA, Yusuf OB, Zahrani ZA, Gasim A, Mujtaba Quadri K H. A pragmatic randomized controlled trial comparing pathway-based versus usual care in community-acquired acute kidney injury. Saudi J Kidney Dis Transpl 2017;28:1282-92

How to cite this URL:
Almalki AH, Ismail SE, Qureshi MA, Abunijem Z, Balla ME, Karsou S, Qureshi RA, Ahmad A, AlSulami S, Khalil M, Hafez J, Thomson JE, Siddiqui MA, Yusuf OB, Zahrani ZA, Gasim A, Mujtaba Quadri K H. A pragmatic randomized controlled trial comparing pathway-based versus usual care in community-acquired acute kidney injury. Saudi J Kidney Dis Transpl [serial online] 2017 [cited 2020 Oct 20];28:1282-92. Available from: https://www.sjkdt.org/text.asp?2017/28/6/1282/220872

   Introduction Top

Acute kidney injury (AKI) is a syndrome characterized by rapid loss of kidney function and is associated with significant morbidity, mortality, and resource use.[1],[2],[3],[4] It is a common worldwide medical condition that can complicate the clinical course of hospitalized patients, or develop in the community. It affects 0.2%–2% of all hospitalized patients and 7%–35% of patients admitted to the Intensive Care Unit.[5],[6],[7],[8] Its severity predicts mortality, length of hospital stay (LOS), and hospital costs.[9],[10],[11]

Most of our understanding of the epidemiology and impact of AKI is based on studies of patients who developed AKI while hospitalized, namely, hospital-acquired AKI (HA-AKI). Little is known about the incidence of community-acquired AKI (CA-AKI) and its impact on patient outcomes.[12] However, available data suggest that CA-AKI is a common cause of AKI and is associated with significant impact on LOS, mortality, and development of progressive renal disease.[12],[13],[14] Therefore, attempts are to be made for optimal treatment of AKI to minimize associated clinical outcomes, LOS and health related costs.

Integrated care plans, conventionally known as clinical pathways, have been used in the management of a wide range of conditions in various health-care systems and settings. Studies on integrated care plans in different medical and surgical diagnoses have shown inconsistent results with regard to reducing LOS, in-hospital mortality, patient satisfaction, readmission rate and hospital costs.[15],[16],[17],[18],[19],[20]

Integrated care plans have recently been proposed to improve the quality of care and patient-centered outcomes in nephrology.[21] However, there are no prior studies that have examined their effectiveness in CA-AKI. Therefore, in this trial, we investigated the impact of clinical pathway-based care (PC) vs. usual care (UC) on LOS and patient-centered outcomes in patients admitted with AKI at a tertiary care hospital, the King Abdulaziz Medical City (KAMC) in Jeddah, Saudi Arabia. The AKI Trial is one of five Collaborative Healthcare professional Approach in Monitoring Patient-centered outcomes through Pathways (CHAMP-Path) pragmatic randomized control trials (RCTs) being conducted at the National Guard Health Affairs, KAMC, Jeddah, Saudi Arabia.

   Methods Top

Study design and population

The AKI CHAMP-Path Study is a pragmatic randomized controlled trial. A team of multi-disciplinary health-care professionals consisting of nephrologists, clinical pharmacists, nurses, quality management specialists, nutritionists, health educators, and social workers developed the AKI pathway over 10 meetings in a two-month period. Subsequently, it was integrated into a Computerized Provider Order Entry (CPOE) system as an order set [Figure 1]. Enrollment for the AKI Trial began from March 2012 and ended in December 2013. The study was registered with the ClinicalTrials.gov Identifier: NCT01561885. The study protocol was approved by ethics committees at King Abdullah International Medical Research Center (RC 10/134/J).
Figure 1: A screenshot of order set of computerized acute kidney injury pathway.

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Patients presenting to the Emergency Department (ED) with AKI and hemodynamic stability, aged 14 years or older (patients 14 years and above are considered to be adults in KAMC in Jeddah, Saudi Arabia and are admitted to the adult medical wards) with a serum creatinine greater than 1.5 times the baseline were eligible (AKIN Criteria).[2] Baseline serum creatinine was obtained from the most recent serum creatinine before admission. Patients with chronic kidney disease (CKD) stages 4 or 5, kidney transplantation recipients, those admitted with obstructive uropathy, suspected glomerular or interstitial disease, and pregnant women were excluded from the study.

Intervention and randomization procedures

The AKI clinical pathway was integrated as an order set into a CPOE system. General internal medicine (GIM) physicians and medical residents were randomized by simple randomization to provide either PC or UC, with no crossover permitted. The principal investigators, chief medical resident, and research assistant performed the randomization process for every new medical resident and GIM physician joining the organization during the study period. Electronic access to the AKI-pathway was restricted to the pathway-randomized physicians to avoid possible contamination and awareness bias. Patients were randomized by permuted blocks of unequal sizes through a computer-generated sequence in a 1:1 ratio.

Medical residents screened eligible patients who gave informed consent. To enhance recruitment, the administrative research assistant periodically reminded on-call residents via telephone calls on daily basis. Allocation concealment was done through opaque sealed envelopes provided to the on-call resident by the ED pharmacy.

The PC patients were managed pragmatically according to evidence-based guidelines and institutional policies integrated into the order set. Deviation from the PC was allowed at the discretion of the treating physician to suit the clinical needs of patients.

PC is defined as a multi-disciplinary plan of care within a predefined time frame integrated into a CPOE order set.

The UC is the standard of care which is an evidence-based daily practice of rounding practitioners and as per the standards of JCI accredited organization with no permission to access pathway order set. Patients were blinded to their allocation group and subsequently assessed for successful blinding.

Outcome measures

The primary outcome measure was LOS defined as the interval between the date and time the patient was admitted as inpatient, to discharge, as documented in the electronic patient medical record system. LOS was calculated in days, hours, and minutes using an online date and time calculator.[22]

The secondary outcome measures used to assess the effectiveness of the AKI clinical pathway were in-hospital mortality and 30-day readmission rates. Other AKI pathway-specific targeted outcomes assessed were medication reconciliation performed by the physician and pharmacist within 24-h of ED admission; the patient's oxygen saturation was maintained at greater than 90% on day-1; renal ultrasound was performed within 24-hours of ED admission; and nephrology consultation on day-1. The data were collected by the research assistant from the patient's electronic medical record and chart review.

Sample size determination

A sample size of 30 patients was estimated to detect a difference of two days in LOS based on a mean of 5 ± 1.8 days, to provide an 80% power with an alpha of 5% and, 20% attrition rate.[9] The estimated attrition rate was exceeded in both study-groups, necessitating sample size recalculation to 38 patients to maintain power.

   Statistical Analysis Top

Median LOS with the IQR was reported. Differences in LOS between the PC and UC groups were compared using the Mann–Whitney U-test.

For secondary outcomes, differences in patient outcomes between the two study groups were assessed using the Chi-square test, and the Fisher's exact test for qualitative data.

All outcomes were analyzed on an intention-to-treat (ITT) basis. Statistical Package for the Social Sciences (SPSS) for Windows version 22.0 (SPSS Inc, Chicago, IL, USA) was used for all analyses and all P were two-sided with P <0.05 considered to be statistically significant.

   Results Top

A total of 98 patients were screened for eligibility and 38 participants were enrolled [Figure 2].
Figure 2: Acute kidney injury trial profile in the present study.

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Patients in the PC group were older with a mean age of 69.2 ± 10.9 years compared with those in the UC group (68.6 ± 11.0). More patients with diabetes mellitus, hypertension, CKD and benign prostatic hyperplasia were allocated to the pathway arm. On the contrary, more patients with left ventricular dysfunction (ejection fraction <35%) were allocated to the UC pathway. Baseline characteristics are reported in [Table 1].
Table 1: Baseline characteristics of patients in the clinical pathway and usual care study groups.

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Primary outcome

Based on an ITT analysis, there was no statistically significant difference in the median LOS between the PC [4.96 (IQR: 6.57)] and the UC groups [4.8 (IQR: 6.84)] (P = 0.77) [Figure 3].
Figure 3: Box plot for median hospital length of stay for pathway care vs. usual care.

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A post hoc per-protocol analysis was conducted excluding nine patients due to misclassifications (n = 2), lost to follow-up (n = 5), and discontinued care (n = 2). Based on that, there was no statistically significant difference in the median LOS between the PC [3.12 (IQR: 3.1)] and the UC groups [4.63 (IQR: 5.22)] (P = 0.18).

Secondary outcomes

A total of five participants were readmitted within 30 days of discharge for different primary diagnoses (three in the PC group and two in the UC group). Of these, three patients had AKI as a secondary diagnosis (two in the PC group and one in the UC group). No inhospital mortality was reported for either treatment group. There was no significant difference in social factors (e.g., transportation delays), medical factors (e.g., need for dialysis), and hospital complications (e.g., sentinel events) between patients in the PC group vs. the UC group. Similarly, there were no differences in the pathway-targeted outcomes, such as medication reconciliation and nephrology consultations on day-1. Other secondary outcome measures are shown in [Table 2].
Table 2: Secondary outcomes and pathway-targeted process and outcome indicators.*

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   Discussion Top

Our study investigated the effect of PC on LOS and other clinical outcomes for patients admitted with a diagnosis of community-acquired AKI. Patients in one arm received UC which was at the discretion of the treating team while patients in the other arm were provided with a structured pathway-guided treatment with specific timelines to complete the required plans of care. The results of the primary outcome, hospital LOS, did not show a statistically significant difference between the two arms. Similar findings were observed for the patient-centered secondary outcomes including in-hospital mortality and 30-day readmission rate. Although our study failed to show the efficacy of integrated care pathways in CA-AKI, this has to be approached with caution.

Several considerations were taken into account to improve the quality of our trial. First, the pragmatic design of randomized clinical trials provides the flexibility to determine the clinical effectiveness of pathways in real life settings. Second, it was a randomized clinical trial in which allocation concealment was maintained using permuted blocks of different sizes. Third, AKI pathway was designed after several meetings between content experts in the field of nephrology to incorporate evidence into practice. Fourth, very relevant outcomes were selected for the study. The primary outcome, LOS, was chosen as unnecessary prolonged hospitalization, is common and is associated with increased exposure to risks for developing hospital-related complications and additional costs. In addition to the primary outcome, relevant patient-centered secondary outcomes were studied. Finally, despite the complexity of pathway implementation, the study addressed sources of bias and efforts were made to minimize such bias. Pathway integrated into CPOE access was restricted to the pathway arm to avoid possible contamination and awareness bias.

However, despite its robustness, like for any other RCT this trial has its own limitations. The contamination due to the treating physicians' crossover cannot be ruled out. Despite all efforts made to prevent crossover between teams, during weekends and holidays, some of the PC physicians provided care to UC patients and vice versa. Additionally, over weekends due to limited workforce not all services were provided to the patients, which were all part of the secondary outcomes; in particular, medication reconciliation by pharmacy and rehabilitation services are worth mentioning.

Although the trial was powered for primary outcome, we acknowledge that the effect size of two days difference in LOS may have been overambitious, and hence the sample size was below 100 which led to use of nonparametric testing to account for skewness for non-normality in LOS. There were differences in the baseline characteristics between the two arms. More patients with reduced left ventricular systolic function were allocated to the UC arm. On the other hand, more patients with diabetes mellitus, hypertension, CKD and BPH were assigned to PC which might have diluted the true effect of integrated care pathways. The small trial size precluded conducting regression analysis to adjust for the baseline characteristics.

It is important to mention that the results on efficacy of any intervention including clinical pathways can be affected by the way the pathways are designed and implemented. Incorporating evidence into the pathway is essential to its success. However, this success is never complete unless coupled with proper implementation. In our study, given the pragmatic design, we did not check for the adherence of healthcare professionals to the implementation of integrated care pathways. Despite this, a post hoc per-protocol analysis was performed, which showed a median difference in LOS of 1.5 days (P = 0.18). Although statistically non-significant, a difference of 1.5 days of LOS might be clinically relevant.

Finally, in the absence of an optimal marker for assessing patients with CA-AKI, we used serum creatinine level acknowledging all its shortcomings.[23] Serum creatinine was used for assessment of baseline kidney function and for predicting prognosis or recovery. Three patients were misclassified as stage 3 and included in the trial instead of stage 4 due to improper estimation of glomerular filtration rate based on serum creatinine levels.

With regard to the generalization of our study results, because of the eligibility criteria of the trial excluding several causes of AKI, it is difficult to predict if the same results will be encountered for different spectrum and presentation of AKI. Given the timely nature of tasks conducted using PC provided to patients, it is likely that results might be different for different types of AKI and different underlying diagnoses. More than 60% of the population in both arms was prerenal for which treatment is largely supportive. Our study focused on patients with CA-AKI rather than HA-AKI. The two types have different presentation, etiology, prognosis and treatment. This certainly calls for a need to conduct similar studies on a larger scale for HA-AKI or even for CA-AKI where there are limited resources, to provide the optimum patient-centered care and help in reversing AKI which still carries a very high morbidity and mortality rate.

There are several reasons to believe in the utility of integrated care pathways. They had been introduced in the management of various medical diagnoses to promote efficiency and quality of patient care through the delivery of focused care that streamlines the care processes and addresses specific needs in complex multi-disciplinary approach. Such complex approach has the potential role to help complex medical situations. Furthermore, it provides a mechanism for integration of evidence into patient care in standardized fashion.[24] However, despite all these potential benefits, the results of studies on integrated care pathways across different medical diagnoses have been inconsistent.

In renal patients, the use of integrated care pathways is studied in renal procedures, percutaneous kidney biopsies and vascular access surgeries, and was associated with reduction in the cost per procedure and the LOS.[25] The use of integrated care pathways in the management of patients admitted with community-acquired AKI is scarce and there are no previous studies that had evaluated their effectiveness in patients admitted with community-acquired AKI. This is the main reason why the trial was actually proposed in addition to its part of a broader project which assessed integrated care pathways for the most common admitting diagnoses in our setting.

Integrated care pathways were studied in several other medical diagnoses and procedures. A number of controlled studies have investigated the efficacy of integrated care pathways in the in-hospital management of heart failure and have yielded varying results.[15],[20],[26],[27],[28],[29],[30],[31] Kul et al conducted a meta-analysis of these studies, three RCTs and two controlled clinical studies, and concluded an overall lower mortality [0.45, 95% confidence interval (CI) = 0.21–0.94, P = 0.03] and LOS (weighted mean difference = -1.89, 95% CI = -2.44–1.33 days, P<0.001) with the use of integrated care pathways, but no statistically significant difference in the 30-day readmission rate or cost.[29] When analysis was restricted to the three RCTs with 1099 patients, the difference in mortality was not statistically significant.

Another meta-analysis looked at the impact of integrated care pathways in the management of chronic obstructive pulmonary disease and yielded inconclusive results with clinical outcomes including LOS, in-hospital mortality and, readmission rate.[18] The LOS was significantly reduced in one study,[18] not different from UC in another study,[32] whereas the other two studies had limited statistical analysis where the statistical difference in LOS was not tested.[33],[34]

Similar inconsistent results were observed with the use of integrated care pathways in the management of acute stroke and stroke rehabilitation.[35],[36],[37],[38] Kwan and Sandercock conducted a meta-analysis that included three RCTs with a total of 340 patients,[35],[37],[38] and 12 non-randomized studies, which included 4081 patients. There was significant statistical heterogeneity in the analysis of many of the outcomes. The authors found no significant difference between care pathway and control groups in terms of death or discharge destination. Patients managed with a care pathway were as follows: (a) more dependent at discharge (P = 0.04); (b) less likely to suffer a urinary tract infection [odds ratio (OR) 0.51, 95% CI 0.34 to 0.79]; (c) less likely to be readmitted (OR 0.11, 95% CI 0.03–0.39); and (d) more likely to have neuro-imaging (OR 2.42, 95% CI = 1.12–5.25) .[36] Evidence from randomized trials suggested that patient satisfaction and quality of life were significantly lower in the care pathway group (P = 0.02 and P<0.005, respectively).[36]

Several reasons might explain the inconsistency in findings of studies on clinical pathways including our study. Although RCTs are more likely to give definite answers, their validity can be threatened. Different from trials on medications or surgical procedures, health services like PC is a more complex intervention to evaluate, leading to difficulty in interpreting trial results. The control arm which is the UC may also be complex in nature. This creates difficulties in avoiding protocol violation, ensuring and monitoring protocol adherence and avoiding treatment contamination between the two arms. Positive result on clinical pathway trial is dependent on how well the pathway was designed and how well it was implemented. Like any RCT, clinical trials of care pathways are susceptible to confounding effects. In addition, blinding in trials of clinical pathways can be difficult. While blinding of the health-care professionals is almost impossible, blinding of patients may also be difficult and this can lead to awareness bias. On the other hand, nonrandomized studies are particularly susceptible to biases. One obvious bias is selection bias in which case the clinicians may select the patients with better (or worse) prognosis for PC and hence bias their findings. Assessor blinding was also not reported in most nonrandomized studies on integrated care pathways. Moreover, publication bias may have influenced the results of the nonrandomized studies, such that those showing no benefit or worse outcome with PC may not have been published.[39] Finally, some authors chose to write “no difference” rather than report the actual data, or may have omitted the negative results altogether from their publication, making it more difficult to interpret the results.

In conclusion, management of CA-AKI is mainly supportive, and integrated care pathways provide a structured and timely management plans. To confirm their utility in improving the quality of care provided to patients with CA-AKI, we recommend that future clinical trials should focus on, (a) defining ways to ensure and ascertain pathway adherence; (b) studying and eliminating sources of bias including confounding and contamination and, (c) involving larger sample size to provide higher power while detecting smaller clinically relevant change on LOS and to facilitate multivariable analysis.

   Acknowledgment Top

This trial was supported by the Clinical Research Fund of the King Abdullah International Medical Research Center, Saudi Arabia (RC 10/134/J). The funding sources played no role in the methodology and execution of this manuscript. The authors acknowledge the contribution of all Department of Medicine Residents, General Internal Medicine CTU Consultants, Nursing Managers (ED, Medical, and Surgical wards), Nursing Department, Pharmaceutical Care Department, Quality Management, Health Promotions Department, Clinical Nutrition Department, Clinical Unit Assistants (Emergency Department, Medical, and Surgical wards), Medical Records Department, in facilitating the conduct of this trial.

Trial Registration: ClinicalTrials.gov

Identifier: NCT01561885

Conflict of interest: None declared.

   References Top

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Correspondence Address:
Abdullah H Almalki
Department of Medicine, Nephrology Section, King Abdulaziz Medical City, P. O. Box 9515, Jeddah 21423
Saudi Arabia
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DOI: 10.4103/1319-2442.220872

PMID: 29265039

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  [Table 1], [Table 2]


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