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Journal of the American Medical Informatics Association : JAMIA logoLink to Journal of the American Medical Informatics Association : JAMIA
. 2019 Feb 22;26(4):356–363. doi: 10.1093/jamia/ocy176

A systematic review of the effects of implementing clinical pathways supported by health information technologies

Matthew T Neame 1, Jerry Chacko 2, Anna E Surace 2, Ian P Sinha 1,1, Daniel B Hawcutt 2,3,✉,1
PMCID: PMC7647175  PMID: 30794311

Abstract

Objective

Health information technology (HIT) interventions include electronic patient records, prescribing, and ordering systems. Clinical pathways are multidisciplinary plans of care that enable the delivery of evidence-based healthcare. Our objective was to systematically review the effects of implementing HIT-supported clinical pathways.

Materials and Methods

A systematic review protocol was developed including Medline, Embase, and CENTRAL database searches. We recorded data relating to study design, participants, intervention, and outcome characteristics and formally assessed risk of bias.

Results

Forty-four studies involving more than 270 000 patients were included. Investigation methodologies included before-after (n = 16, 36.4%), noncomparative (n = 14, 31.8%), interrupted time series (n = 5, 11.4%), retrospective cohort (n = 4, 9.1%), cluster randomized (n = 2, 4.5%), controlled before-after (n = 1, 2.3%), prospective case-control (n = 1, 2.3%), and prospective cohort (n = 1, 2.3%) study designs. Clinical decision support (n = 25, 56.8%), modified electronic documentation (n = 23, 52.3%), and computerized provider order entry (n = 23, 52.3%) were the most frequently utilized HIT interventions. The majority of studies (n = 38, 86.4%) reported benefits associated with HIT-supported pathways. These included reported improvements in objectively measured patient outcomes (n = 15, 34.1%), quality of care (n = 29, 65.9%), and healthcare resource utilization (n = 10, n = 22.7%).

Discussion

Although most studies reported improvements in outcomes, the strength of evidence was limited by the study designs that were utilized.

Conclusions

Ongoing evaluations of HIT-supported clinical pathways are justified but would benefit from study designs that report key outcomes (including adverse events) and minimize the risk of bias.

Keywords: critical pathways, medical informatics, evidence-based medicine

INTRODUCTION

Over the last decade, healthcare providers in the United States and United Kingdom have been incentivized to implement health information technologies (HITs) through legislative and funding stimulus packages. In 2016, the UK government allocated £4.2 billion ($5.8 billion) to develop the information technology infrastructure in the National Health Service1 and in the United States the government has provided more than $30 billion of investment subsidies since 2009.2 Examples of widely implemented HIT interventions include electronic patient records as well as electronic prescribing and ordering systems.3

There is evidence that HIT interventions (including clinical decision support tools, computerized order entry systems, and electronic prescribing tools) may have a positive effect on health outcomes.4–9 However, these benefits are not identified consistently across studies.3

Like HITs, clinical pathways are a form of complex intervention that have been widely implemented in healthcare settings.10,11 Numerous definitions of clinical pathways have been published (see Figure 1 for an example of a published definition).12,13 However, the most widely cited definitions identify the importance of multidisciplinary team working and the delivery of care in a specific local context as being key to their effective implementation.13–15 These definitions help to discriminate clinical pathways from other, more focused, methods for supporting guideline implementation (eg, clinical decision support systems or order sets). These interventions may be applied more broadly across healthcare systems, but they are less likely to address factors such as the coordination of multidisciplinary teams or the contextual challenges associated with working in a specified healthcare setting.

Figure 1.

Figure 1.

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Definition of a clinical pathway. Adapted text from Rotter et al.13

Although it is clear that there are challenges associated with developing precise definitions of clinical pathways, their use seems to be widespread10 and robust evaluations of their effects have also previously proven to be feasible.13,15 Notably, a Cochrane meta-analysis of the effects of implementing traditional, paper-based clinical pathways was published in 2010 and identified that their use was associated with reductions in the complications of care, length of hospital stay, and the cost of care.13

Given that a number of widely implemented HIT interventions may be well suited to increasing the efficiency or effectiveness of clinical pathways (eg, clinical decision support, electronic communication between health professionals and patients, and the standardization of ordering or prescribing processes) we aimed to evaluate this relationship more closely. We developed a systematic review methodology with the objectives of describing the effects of HIT-supported clinical pathways on health outcomes, and identifying the variables that may affect the effectiveness of these pathways.

MATERIALS AND METHODS

Search strategy

A study protocol was developed in accordance with PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines16 and registered on the PROSPERO database17 before completing the review. The Medline and Embase databases were searched to identify any studies involving the implementation of clinical pathways supported by the application of HITs. This search was supplemented by hand searching reference lists of included studies, a keyword search of the CENTRAL database, and expert recommendation. Abstracts were included and no date or language exclusion criteria were applied (2 Japanese articles were excluded due to resource constraints).

All studies that reported an assessment of a clinical pathway intervention, defined as per the previous example from Rotter et al,13 in which the implementation involved the use of HITs, as defined by the Cochrane Effective Practice and Organisation of Care taxonomy,18 were included.

Titles and abstracts were screened independently by 2 reviewers. Full papers were scrutinized by 2 reviewers and consensus regarding inclusion or exclusion was reached after discussion.

All study types were included, however. a prespecified subgroup analysis was planned for randomized trials, controlled clinical trials, controlled before-and-after studies, and interrupted time series (ITS) studies.

Outcome measures

Primary and secondary outcome measures were predefined and are detailed subsequently. We anticipated that included studies may be heterogenous in terms of included patient groups, settings, and outcomes measured. Therefore, we proposed to categorize outcomes according to prespecified domains, in accordance with recognized guidance for the evaluation of complex interventions.19

Primary outcome

The primary outcome was objectively measured patient outcomes (ie, mortality, patient-reported outcome measures, biochemical markers of disease activity).

Secondary outcomes

Given the breadth of potential settings and participants eligible for inclusion in the analysis, secondary outcomes will be reported and categorized under the following domains:

  1. Other patient outcomes (ie, proxy measures of physical health and treatment outcomes)

  2. Quality (process) outcomes (ie, measures of adherence to guidelines or quality of documentation)

  3. Healthcare resource utilization and access to care (ie, length of stay or waiting times)

  4. Healthcare professional outcomes (ie, staff satisfaction or staff morale)

  5. Adverse events

  6. Patient satisfaction

Data collection and analysis

Relevant data were recorded on predesigned data extraction forms. Reports were interrogated to identify characteristics including type of study, number of participants, population characteristics, and primary and other study outcomes. A quality and risk of bias assessment was completed for randomized trials, controlled clinical trials, controlled before-and-after studies, and ITS analyses using Cochrane Effective Practice and Organisation of Care risk of bias criteria.20 Study interventions were described according to the criteria outlined in the TIDieR (template for intervention description and replication) checklist for reporting interventions21 and these details were completed on a separate data collection form.

Statistical meta-analyses were planned, if studies of adequate quality (assessed by study type [see previous] and formal risk of bias assessment) and homogeneity were identified. For studies not eligible for inclusion in a meta-analysis, a descriptive summary of the types of HIT interventions that were utilized and the outcomes that were reported was undertaken.

RESULTS

The search strategy identified 1377 studies (1158 excluding duplicates). Following title and abstract screening, the full texts of 147 studies were requested and 44 studies met the criteria for inclusion in the review (see Figure 2 for the PRISMA flow chart including the reasons for exclusion). The 44 included studies involved more than 270 000 participants (study characteristics and quality assessments are summarized in the online Supplementary Material). Of the identified studies, 16 (36.4%) were before-and-after studies (uncontrolled), 14 (31.8%) were noncomparative (case studies), 5 (11.4%) were interrupted time series studies, 4 (9.1%) were retrospective cohort studies, 2 (4.5%) were cluster randomized controlled trials, and there were 1 (2.3%) each of controlled before-after, prospective case-control, and prospective cohort studies.

Figure 2.

Figure 2.

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PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) flow diagram indicating results of identification and screening process for included and excluded studies.17 HIT: health information technology; TIDieR: template for intervention description and replication.

Of the included studies, 41 (93.2%) investigated the implementation of HIT-supported clinical pathways in secondary or tertiary care settings and 3 (6.8%) were conducted in primary care settings. Adult participants were involved in 37 (84.1%) studies and 7 (15.9%) studies included children.

Characteristics of HIT utilized in the implementation of clinical pathways

The types of HIT interventions implemented in each study are summarized in the Summary of Intervention Characteristics and Outcomes Table included in the Supplementary Material. This table also includes summary data indicating whether the implementation of the pathway was associated with positive or negative outcomes in each of the reported domains. Descriptions of the most frequently utilized HIT intervention types are provided in Figure 3.22–24

Figure 3.

Figure 3.

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Summarized definitions of health information technology interventions utilized in reported implementations of clinical pathways.

Clinical decision support

Clinical decision support (CDS) tools were the most frequently utilized HIT intervention and 25 (56.8%) studies reported their use. Eighteen (n = 18 of 25, 72.0%) of these studies reported the development of CDS interventions that were fully integrated within the electronic health record (EHR). The remaining studies described CDS that were accessed via web-based portals or computerized order entry systems.

The majority of interventions (7 of 8, 87.5%) included in the subgroup effects analysis included CDS tools.25–31 Interventions involved both web-based and EHR-embedded tools. Examples included modules for admission assessments, risk assessment, therapy and discharge planning,25 computerized order entry modules with CDS that utilized rules based on a patient’s clinical parameters to support the evidence-based investigation of pediatric appendicitis,26 and sepsis alerts designed to trigger earlier assessment and treatment for acutely unwell patients.30

Electronic documentation

Twenty-three (52.3%) studies included a description of the use of electronic documentation designed specifically for use as part of the pathway implementation process. Examples of the types of pathway-specific documentation utilized in interventions included electronic checklists31,32 and the use of structured data formats to allow automation of audit and variance analysis processes.33,34

Computerized provider order entry

Twenty-three (52.3%) studies included in the review also reported the use of modified computerized provider order entry systems. Computerized order sets (in which a bundle of investigations, referrals, or treatment orders are combined to ensure that patients with specific conditions receive standardized management) were used in the majority of studies that included computerized provider order entry interventions.

Automated performance feedback to providers

Nine (20.5%) studies reported the use of interventions that enabled peer-review or feedback processes designed to promote the adoption of recommended care processes. Examples included the development of live “dashboards” indicating unit level compliance with ventilator care protocols,35 automated requests for peer review when providers administered radiotherapy treatment courses outside the recommended ranges,36,37 and the development of a pathway tool that provided automated interrogation of the EHR to detect episodes in which emergency department clinicians may have missed diagnoses of acute coronary syndrome.38

Other

A number of other HIT interventions were also utilized to support the implementation of clinical pathways. In 6 (13.6%) studies, investigators reported the implementation of clinical pathways supported by clinical guidelines accessible directly via the EHR (eg, info buttons or context-sensitive decision support). Examples included the provision of access to locally developed39 and national guidelines.40

Other interventions included clinical pathways supported by web-based portals designed to increase standardization of care across 2 regions in the United Kingdom,41,42 the development of an electronic tool to enable the capture of patient reported outcomes,33 and a mobile application designed to support pathway implementation by allowing patients to view their EHR (patient portal).43

Effects of HIT-supported clinical pathways on health outcomes

Objectively measured patient outcomes

Twenty-two (50.0%) studies included in the review described some association between the implementation of HIT-supported clinical pathways and objectively measured patient outcomes. Fifteen (34.1%) studies reported improvements in objectively measured patient outcomes, 5 (11.4%) studies described equivocal effects and in 1 (2.3%) study the intervention was associated with complications associated with the use of therapeutic hypothermia.44 Reported benefits included reductions in thromboembolic complications,39 mortality,33,45 myocardial infarction, stroke, and retinopathy,27 and improvements in biochemical markers of glycemic control (hemoglobin A1c [HbA1c]).40

Secondary outcomes

Assessments of quality (or process) outcomes were reported in 30 (68.2%) studies and improvements in quality were reported in 29 (65.9%) of the included investigations. Examples included reports of increased or favorable rates of compliance with recommended practice such as the appropriate utilization of investigations or therapeutic interventions.36,37,39,40,44,46–50

Improvements in healthcare resource utilization, including reductions in hospital length of stay, were reported in 10 (22.7%) studies (a total of 15 [34.1%] studies reported some healthcare resource utilization outcomes). Reductions in length of stay were not reported universally.25,26 In 1 study, the proportion of patients receiving their operation in a day case or outpatient setting increased after the introduction of a HIT-supported clinical pathway41 and in 1 study this was associated with a reduction in the length of waiting times for treatments and consultations.51 Reductions in healthcare costs associated with the implementations of HIT-supported clinical pathways were also described in 1 investigation.52 A number of investigators also reported subjective descriptions detailing increased satisfaction or approval from staff or patients following the implementation of HIT-supported clinical pathways.41,43,53

Only 3 (6.8%) investigators reported adverse events associated with the implementation of HIT-supported clinical pathways. In 1 study that included patients following cardiopulmonary arrest, treated using a HIT-supported therapeutic hypothermia clinical pathway, a higher proportion of patients developed refractory shock following pathway implementation.44 In another study investigating the implementation of a computerized clinical pathway designed to standardize preoperative assessments, some nursing staff reported a perception that they engaged in less eye contact with patients and that completion of documentation may have taken longer than when using paper records.41 In another study involving standardized sedation weaning protocols for ventilated patients, the introduction of the pathway was initially associated with an increase in mortality among older patients.54 However, following modifications to the protocol, this increase resolved.

Effects of HIT-supported clinical pathways on health outcomes: Subgroup analysis

We identified 8 (18.2%) studies that were eligible for inclusion in the subgroup, effectiveness analysis. We identified 5 interrupted time series studies,26,28,30,31,55 2 cluster randomized trials,25,56 and 1 controlled before-after study (see Supplementary Material for Study Characteristics and Results and Quality tables).27

Objectively measured patient outcomes

Five studies reported the effects of HIT-supported pathway interventions on objectively measured patient outcomes.27,28,31,55,56 Reported effects included reductions in the rate of central line–associated bloodstream infections31,55; reduced hazard ratios for myocardial infarction, stroke, and retinopathy27; and improvements in a schizophrenia symptom scale.25 These results were not eligible for meta-analysis due to significant heterogeneity in terms of the outcome measurements reported and the populations that were investigated. A GRADE analysis of these results57 identified that there is very low-quality evidence that HIT-supported clinical pathways improve objectively measured patient outcomes. The quality rating was downgraded due to the unrandomized nature of the majority of included studies, concerns about risk of bias in the included studies (see Results and Quality table in Supplementary Material), evidence of inconsistency of effect, and concerns regarding indirectness (due to the heterogeneous nature of the described interventions and outcome measures used).

Quality outcomes

Three studies reported the effects of HIT-supported pathway interventions on quality outcomes.25,26,29 Reported effects included a reduction in the time taken to initiate sepsis therapies30 and a reduction in the rate of falls among inpatients.56 A GRADE analysis of these results57 identified that there is very low-quality evidence that HIT-supported clinical pathways improve quality outcomes. The quality rating was downgraded due to the unrandomized nature of the majority of included studies, concerns about risk of bias in the included studies (see Results and Quality table in Supplementary Material), evidence of inconsistency of effect (1 study reported no improvement in quality outcomes),26 and concerns regarding indirectness (owing to the heterogeneous nature of the described interventions and outcome measures used).

Healthcare resource utilization

Two studies reported a reduction in inpatient length of stay in association with the implementation of a HIT-supported clinical pathway.25,28 A GRADE analysis determined that there was very low-quality evidence to support these findings. The quality rating was downgraded due to the unrandomized nature of 1 of the studies, o to concerns about risk of bias in the included studies (see Results and Quality table in Supplementary Material) and due to concerns about the degree of imprecision of the results (due to limited reporting of the study data25 and the use of statistical process control charts rather than a regression analysis with estimation of confidence intervals).28

DISCUSSION

To our knowledge, this is the first systematic evaluation of the effects of implementing HIT-supported clinical pathways. As with previous systematic reviews of clinical pathway interventions, we identified challenges associated with defining and identifying the most appropriate studies for inclusion in the review.13,15 To mitigate against these challenges, we used a previously validated definition of clinical pathways and included interventions that were described using alternative terminology when they met our preagreed definition of a pathway intervention. We also sought to improve the internal validity of our study by using 2 reviewers who worked independently to screen the results of our database searches. With these pragmatic mitigations, we hope that this review will provide a useful resource for healthcare commissioners and providers tasked with evaluating the use of HIT-supported clinical pathways as an approach to quality improvement.

Although most of the studies that we identified reported improved outcomes following the implementation of HIT-supported clinical pathways, our assessments were limited by a number of factors. These included the study designs that were utilized, the risk of bias noted in included studies and the proportion of studies that reported measures of our primary outcome of interest. Due to the heterogenous nature of the studies that were eligible for inclusion in the effects analysis, we were unable to conduct a meta-analysis of the effects of HIT-supported clinical pathways.

Only a minority of included studies (n = 21, 47.7%) reported the effects of implementing pathways on objectively measured patient outcomes (the prespecified primary outcome for this systematic review). Previous systematic evaluations of HIT interventions have identified similarly heterogeneous and process focused outcome reporting58,59 and studies of HIT interventions have also been recognized to be vulnerable to outcome reporting and publication bias.60,61 Therefore, although we anticipated that the studies included in this review may describe a heterogenous range of outcome domains, we had anticipated that more studies would report on the health outcomes directly experienced by patients. We would suggest that this represents a limitation in relation to the meaningful evaluation of the effects of HIT-supported clinical pathways, and that future studies of HIT interventions could be enhanced by the inclusion of objectively measured patient outcomes.

We also note that reports of adverse events associated with the implementation of HIT-supported clinical pathways were only described in 3 cases.41,44,54 A balanced appraisal of any healthcare intervention requires a consideration of both the benefits and disadvantages or risks62–64; however, the majority of studies included in this review did not describe methodologies for actively identifying or reporting adverse findings. Based on the results of this review, it is therefore difficult to assess with certainty, whether adverse events were under-reported or not. We would suggest that future investigations of the effects HIT-supported clinical pathways would benefit from the use of study protocols that allow investigators to actively identify and report adverse events.

Although a significant majority of the studies we identified reported an association between the implementation of HIT-supported clinical pathways and improvements in outcomes, the interpretation of these results was limited by the methodological quality of the included studies. Only 8 of the identified reports were eligible for inclusion in a subgroup analysis of studies that employed methodologies designed to minimize the risk of bias (ITS studies, cluster randomized controlled trial, and a controlled before-after study). The remaining studies (n = 36) employed study designs such as noncomparative reporting (ie, case studies [n = 14]) or uncontrolled before-and-after designs (n = 16). It therefore remains difficult to draw firm conclusions regarding the effects of implementing HIT-supported clinical pathways, as the results of these studies are likely to be significantly affected by biases introduced during the implementation and assessment phases of the evaluations.

We also note that the relative heterogeneity of the small number of studies eligible for inclusion in the subgroup effects analysis impacted upon the results of the GRADE quality analysis of the effects. For all of the outcomes that were assessed using the GRADE analysis, the quality score was downgraded, in part, due to concerns regarding the directness (generalizability) of the reported effects. One reason for this is that the included studies utilized a relatively heterogeneous range of interventions and outcome measures. We also note that of the 8 studies included in the subgroup effects analysis, 1 identified no benefits associated with implementation of the HIT-supported clinical pathway26 and the authors of the other study provided no statistical analysis of the benefits that they did report.25

Noting the limitations described previously, our assessment of the narrative review of the included studies suggests that HIT-supported clinical pathway interventions with “active ingredients” (eg, clinical decision support and automated feedback, audit or reporting processes) may represent the most promising area for future research. These interventions tended to be utilized to try and ensure that clinical teams managed patients according to recommended practice and would therefore seem well suited to supporting the objectives associated with the implementation of clinical pathways.

Given the ongoing investment in HITs there is a need for investigation of the implementation of these technologies using robust study designs that minimize the risk of bias. It would also be helpful for future evaluations to carefully consider the outcome measures that they report, to ensure that these are likely to be of relevance to key stakeholders. Ideally these outcome sets should include objectively measured patient outcomes and adverse events to allow a full appraisal of the effects of the intervention being investigated.

Owing to a lack of high-quality studies there is only limited evidence to support the hypothesis that HIT-supported clinical pathways improve objectively measured patient outcomes or other healthcare outcomes. However, the majority of identified reports do suggest that the implementation of these pathways may be associated with benefits and they do not seem to be associated with a high rate of adverse events.

CONCLUSION

Ongoing evaluations of HIT-supported clinical pathways are justified but would benefit from study designs that report key outcomes (including adverse events) and minimize the risk of bias.

Supplementary Material

Supplementary Data
Click here for additional data file. (156KB, docx)

ACKNOWLEDGMENTS

This is a summary of independent research funded by the National Health Service Global Digital Exemplar scheme and carried out at the National Institute for Health Research, Alder Hey Clinical Research Facility. The views expressed are those of the author(s) and not necessarily those of the Global Digital Exemplar scheme, National Health Service, the National Institute for Health Research, or the Department of Health.

Conflict of interest statement. None declared.

FUNDING

This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors. DH is part funded by the National Institute for Health Research Alder Hey Clinical Research Facility.

AUTHOR CONTRIBUTORS

Dr Neame designed the search strategy and data collection instruments, reviewed the identified titles, abstracts and articles for inclusion in the review, completed the data collection process, carried out the initial analyses and produced the initial manuscript.

Mr Chacko and Ms Surace contributed to the development of the study protocol, reviewed the titles, abstracts and selected articles identified during the database searches to identify relevant studies for inclusion in the review and contributed significantly to the drafting of the initial manuscript.

Dr Sinha helped to prepare the review protocol and data collection instruments, coordinated and supervised data collection and critically reviewed and revised the manuscript for important intellectual content.

Dr Hawcutt coordinated and supervised data collection and critically reviewed and revised the manuscript for important intellectual content.

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