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(Stroke. 2000;31:1929.)
© 2000 American Heart Association, Inc.

Original Contributions

Randomized Controlled Trial of Integrated (Managed) Care Pathway for Stroke Rehabilitation

David Sulch, MRCP; Inigo Perez, MD; Anne Melbourn, RGN Lalit Kalra, PhD, FRCP

From Guy’s, King’s and St Thomas’ School of Medicine, King’s College, London, UK.

Correspondence to Prof L. Kalra, Department of Medicine, Guy’s, King’s and St Thomas’ School of Medicine, Denmark Hill Campus, Bessemer Rd, London SE5 8PJ, UK. E-mail lalit.kalra{at}kcl.ac.uk

	Abstract

Top Abstract Introduction Subjects and Methods Results Discussion References

 
Background and Purpose—Integrated Care Pathway (ICP) is an organized, goal-defined, and time-managed plan that has the potential of facilitating timely interdisciplinary coordination, improving discharge planning, and reducing length of hospital stay.

Methods—An ICP for stroke rehabilitation based on evidence of best practice, professional standards, and existing infrastructure was developed. Its effectiveness was tested in 152 stroke patients undergoing rehabilitation who were randomized to receive ICP care coordinated by an experienced nurse (n=76) or conventional multidisciplinary care (n=76).

Results—The age, sex, premorbid functional ability, and stroke characteristics of the 2 groups were comparable. There were no differences in mortality rates (10 [13%] versus 6 [8%]), institutionalization (10 [13%] versus 16 [21%]), or length of hospital stay (50±19 versus 45±23 days) between patients receiving ICP or multidisciplinary care. Patients receiving conventional multidisciplinary care improved significantly faster between 4 and 12 weeks (median change in Barthel Activities of Daily Living Index 6 versus 2; P<0.01) and had higher Quality of Life scores at 12 weeks (65 versus 59; P=0.07) and 6 months (72 versus 63; P<0.005). There were no significant differences in the mean duration of physiotherapy (42.8±41.2 versus 39.4±36.4 hours) or occupational therapy (8.5±7.5 versus 8.0±7.5 hours) received between the 2 groups.

Conclusions—ICP management offered no benefit over conventional multidisciplinary care on a stroke rehabilitation unit. Functional recovery was faster and Quality of Life outcomes better in patients receiving conventional multidisciplinary care.

Key Words: effectiveness • hospitalization • integrated care pathways • rehabilitation • stroke

	Introduction

Top Abstract Introduction Subjects and Methods Results Discussion References

 
Current literature consists of several well-designed studies that strongly support the establishment of comprehensive, well-organized, and patient-centered services for stroke patients.^{1 2 3} Much of the proven effectiveness of stroke rehabilitation units has been attributed to interdisciplinary teamwork,⁴ but there may be scope for further gains on these units by adopting strategies that avoid unnecessary delays and reduce the length of inpatient rehabilitation required by stroke patients.^{5 6 7}

The objective of improved effectiveness may be achieved by adoption of the Integrated Care Pathway (ICP) technique, which facilitates the coordination of complex interdisciplinary processes.⁸ The implementation of ICP is often overseen by a healthcare professional designated as the "case manager," who uses the care pathway as the template for provision of appropriate care.⁹ This professional is typically an experienced nurse who is empowered to initiate investigations, request referrals, and prescribe medication within the constraints of the pathway without the need for prior medical consultation.¹⁰ ICPs have been piloted successfully in acute and rehabilitation settings and shown to be particularly effective in reducing hospital length of stay and costs in intensive care, management of chronic disorders, and acute stroke care in several nonrandomized studies of differing designs.^{6 7 11 12 13 14}

Some reports suggest that the complex multidisciplinary nature of stroke rehabilitation may be particularly suitable for ICP management.^{6 7 9} An ICP provides a time-defined template to organize several related therapeutic activities in parallel at each stage of the rehabilitation process, thus reducing the time needed to undertake these activities. Because the length of hospital stay (rather than investigations, medical care, or therapy input) is the major determinant of costs in stroke rehabilitation,^{13 15} a reduction in the duration of inpatient rehabilitation while achieving comparable functional outcome will enhance the efficiency of the rehabilitation process. This hypothesis has not been investigated with use of a randomized controlled design.

The objective of this prospective, randomized, controlled trial was to evaluate the effectiveness of ICP-based management in reducing the length of hospital stay without affecting functional outcome in stroke patients undergoing specialist rehabilitation.

	Subjects and Methods

Top Abstract Introduction Subjects and Methods Results Discussion References

 
The study was undertaken in acute stroke patients within 2 weeks of ictus. Patients were eligible for inclusion if they had persistent motor, sensory, vision, speech, perceptual, or cognitive impairment resulting in limitation of personal activities for daily living and required inpatient rehabilitation. Patients with mild deficits who did not require inpatient rehabilitation were excluded from the study. Patients were also excluded if they had severe premorbid physical or cognitive disability. Informed consent was obtained from patients; assent was obtained from the next of kin in patients unable to give consent.

Design, Sample Size, and Randomization
A prospective, open, randomized design was used with 2 parallel groups followed for 6 months. The primary outcome measure was the hospital length of stay, because this has been the main objective of implementing ICP management in service settings.^{6 13 14} The estimated mean length of stay on the unit was 53 (SD 17) days⁷ ; ICP methodology was expected to reduce this by 7 days (15%) to be clinically relevant. A sample size of 136 (68 in each group) was required for the study to have 80% power to detect this difference at the 5% significance level. This sample size also had 80% power to detect a 3-point difference in the Barthel Index, 20% relative difference in Quality of Life scores, and 20% relative difference in the combined end point of death and institutionalization at the 5% significance level.

Patients were randomized before transfer to the stroke rehabilitation unit when they were medically and neurologically stable. The responsible physician called the randomization office, which confirmed eligibility and allocated consecutive patients to intervention or control group on the basis of a computer-generated list of random numbers. Block randomization was used in groups of 10 because of practical reasons of bed availability and to guard against imbalance caused by time trends over the duration of the study.¹⁶

Interventions
The study was carried out on a stroke rehabilitation unit, which consisted of 2 separate bed areas managed by separate teams of nurses. Although both areas had a well-developed multidisciplinary approach to patient care, the 2 teams worked independent of each other, with separate team meetings. The ICP was introduced in one area where all patients using this methodology were treated and the other was used as the control setting with conventional multidisciplinary care.

Integrated Care Pathway
The ICP (Appendix) was developed by the stroke multidisciplinary team consisting of a physician, nurses, physiotherapists, occupational therapists, speech therapists, and a social worker, all with expertise in stroke management. An extensive review of available literature was undertaken with the MEDLINE, CINAHL, Nursing, and Health Services databases. Information was also collected on ICP projects that were not published but were known to members of the multidisciplinary team. This information was collated with local data and experience to be relevant to local service requirements.

Each professional group listed therapeutic activities necessary for ensuring best practice in rehabilitation and discharge planning. Specific activities were grouped according to stage and predicted patient needs at a given time. The overall goals of the rehabilitation program were determined by stroke severity, number and degree of impairments, expected outcome, premorbid functional status, and patient/caregiver attributes or needs. Key short-term goals for each therapeutic intervention and the time estimated to achieve these were defined in advance. A senior nurse with experience in acute care, rehabilitation, and management was appointed to implement ICP management. This was necessary to prevent existing staff seeing ICP implementation as an "add-on" work commitment, which could compromise its effectiveness.

The study was preceded by multidisciplinary training sessions on the philosophy, operational aspects, and expected gains of the integrated pathway. The ICP was piloted for a 3-month period in the study area to achieve staff competence with the new methodology, resolve operational problems, and reduce practice bias in the study.

Conventional Care
Conventional care was provided by means of the multidisciplinary model of care. Patients were assessed comprehensively, and an individualized rehabilitation program was designed by members of the multidisciplinary team. In contrast to the ICP method, in which therapeutic activities, short-term goals, and the time taken to achieve these goals were defined in advance, these aspects were discussed in weekly multidisciplinary meetings and determined on the basis of patients’ progress. The multidisciplinary process of care and documentation was reviewed, and a 3-month period of strict implementation of all aspects of multidisciplinary care was undertaken to exclude bias caused by the placebo effect of undertaking the trial.

Assessments and Data Analysis
Data on age, sex, stroke side, stroke subtype,¹⁷ neurological deficit,¹⁸ and premorbid abilities were collected as baseline. Patients were assessed for incontinence, dysphasia, dysphagia, and visual/sensory inattention on entry to the study. The Barthel Activities of Daily Living Index¹⁹ was assessed at 1, 4, 12, and 26 weeks. Anxiety and depression scores were assessed with the Hospital Anxiety and Depression Scale²⁰ at 4, 12, and 26 weeks. Rankin Score²¹ and Euroqol Quality of Life Score²² were assessed at 12 and 26 weeks. The total therapy time for physiotherapy and occupational therapy was logged on a daily basis. Data on mortality, cause of death, and discharge destination were collected up to 26 weeks. Research assessments were undertaken by 2 observers who were not directly involved in patient care. Both observers undertook independent assessments on each patient, and scores on which there was agreement were used. The value for interobserver agreement was 0.78 for Barthel and 0.86 for Rankin scores. In instances in which the assessments differed, the observers reviewed the patient together to arrive at a consensus.

Data were analyzed on an intention-to-treat basis. Continuous variables such as age, length of stay, and duration of therapy were compared with a t test. Comparison of qualitative variables such as sex, stroke subtype, stroke side, premorbid function, mortality, and institutionalization were assessed by ² tests. Nonparametric variables such as Barthel Index and Quality of Life were compared by means of the Mann-Whitney test.

	Results

Top Abstract Introduction Subjects and Methods Results Discussion References

 
The sample was drawn from 335 consecutive, acute-stroke patients. Of these, 69 (21%) patients died in the acute phase (0 to 14 days) and 63 (19%) patients with mild deficits did not require inpatient rehabilitation. Twenty-one (6%) patients were excluded because of severe cognitive or physical disability before stroke. A further 30 (9%) patients with severe strokes were excluded because they could not comply with specialist rehabilitation procedures when assessed within the first 2 weeks. One hundred fifty-two (45%) eligible patients were randomized (median 6 days; range 2 to 10 days), and 76 patients were allocated to each group.

Review of the ICP records in 76 patients managed by this methodology showed good compliance with the care pathway in all domains assessed (Table 1). The vast majority of interventions and events were recorded appropriately; only 14 (18%) sets of records showed incomplete documentation in 1 or more domains assessed. At least 80% of the specified interventions had been undertaken in >80% of the patients who had complete records.

View this table: [in this window] [in a new window]   Table 1. Compliance With and Variance From the ICP Algorithm in 76 Patients Managed Using ICP Methodology in the RCT

There were no significant differences in age and stroke characteristics between the 2 groups (Table 2). Although there were more men in the ICP-managed group, this difference was not statistically significant. The 2 groups were also comparable for premorbid function, neurological impairment, and level of disability at randomization (Table 2).

View this table: [in this window] [in a new window]   Table 2. Patient Characteristics of 152 Subjects on Entry to the Randomized Study

There were no significant differences in the length of hospital stay (the primary outcome measure) between patients assigned to ICP management and those assigned to conventional multidisciplinary care (Table 3). Patients receiving ICP care stayed in the hospital for 5 more days on average (95% CI -14 to 24 days) compared with those receiving conventional multidisciplinary care. Although more patients died in the ICP group, most of these deaths were after discharge from the hospital, and the difference did not achieve statistical significance. Causes of death were recurrent stroke (n=4), bronchopneumonia (n=4), myocardial infarction (n=2), and pulmonary embolism (n=3). A higher institutionalization rate was seen in patients receiving conventional multidisciplinary care (21% versus 13%). The trend toward shorter length of stay for multidisciplinary care was not at the cost of increased institutionalization in patients treated with this strategy (Table 3). Odds ratios for death [0.6 (95% CI 0.3 to 2.3)], institutionalization [1.5 (95% CI 0.5 to 2.8)], and the combined end points of death or institutionalization [1.1 (95% CI 0.5 to 2.1)] did not show significant difference between the 2 groups.

View this table: [in this window] [in a new window]   Table 3. Length of Hospital Stay, Mortality, and Institutionalization

The median Barthel Index and Rankin scores were comparable between the 2 groups at all assessment points (Table 4). Patients receiving conventional multidisciplinary care improved significantly faster between 4 and 12 weeks (median change in Barthel Index 6 versus 2; P<0.01). There were no significant differences in the proportion of patients with Rankin score of 2 (good recovery) and those with scores of 3 (residual disability) between the 2 groups at 26 weeks (21 [32%] versus 26 [37%]; P=NS). There was a steady and comparable decline in anxiety and depression in both groups during the 6-month period of follow-up (Table 4). The Quality of Life scores improved significantly in both groups (P<0.005) between week 4 and week 26. There was a trend toward higher scores in patients receiving multidisciplinary care at 12 weeks that was significant by 26 weeks (Table 4).

View this table: [in this window] [in a new window]   Table 4. Longitudinal Assessments of Activities of Daily Living, Handicap, Anxiety, Depression, and Quality of Life in Stroke Survivors

The mean duration of physiotherapy and occupational therapy received by patients in both groups was comparable at 12 weeks and 26 weeks (Table 5). Nearly all of the therapy received by patients in the first 6 months of stroke was provided during their inpatient stay; postdischarge therapy accounted for <10% of the input in both groups. Patients in both groups received intensive physiotherapy [mean 2.0 (1.5) versus 1.9 (1.6) h/d] and occupational therapy [mean 0.6 (0.4) versus 0.5 (0.4) h/d] input during the active phase of their rehabilitation program. However, the mean amount of therapy received per day of the entire hospital stay was small because of dilution caused by the time spent awaiting supported discharge or institutionalization in both groups.

View this table: [in this window] [in a new window]   Table 5. Duration of Therapy Input in Hours (Mean and SD) Received by Stroke Patients Undergoing Rehabilitation

	Discussion

Top Abstract Introduction Subjects and Methods Results Discussion References

 
This prospective randomized controlled study of one team using an integrated care pathway versus another team using standard care showed that the ICP method of stroke care did not reduce the length of inpatient stroke rehabilitation. There were no significant differences in the duration of therapy received by patients compared with conventional multidisciplinary care. Mortality, institutionalization, and the combined end point of mortality and institutionalization were comparable between the 2 groups. Both groups showed consistent improvements in functional ability and anxiety and depression levels, which were comparable at 6 months. It appeared that ICP management had little advantage over established multidisciplinary care in the setting of the study.

Objective evaluation of processes of care is methodologically difficult because of dependence on clinical practice, susceptibility to inadvertent bias, and lack of validated measures to detect small changes in stroke recovery. The development and piloting of the ICP methodology before the evaluation in this study enabled differences from conventional multidisciplinary care to be defined and reduced errors caused by practice effects or staff preference. Crossover of interventions was minimized by using 2 different teams in 2 different ward areas to implement the 2 different strategies. Sample size calculations were based on objective data from previous studies on the unit and the primary outcome measure (length of hospital stay) reflected the key objective of ICP management.^{5 6} Comparisons of mood and quality of life up to 6 months after stroke were undertaken to ensure that subtle differences in outcome were not missed because of the insensitivity of more commonly used measures to detect minor changes in stroke outcome.^{23 24}

Stroke management involves the expertise of several disciplines, which can result in poor coordination or inefficiencies in patient treatment.^{25 26} This can be avoided by the use of ICP methodology, which ensures that important areas of treatment are not overlooked and unnecessary delays are prevented by timely intervention.^{5 6 9} However, the success of ICP management seen in previous "before and after" studies^{13 14 27 28} is not supported by randomized controlled trial data. This may be because stroke rehabilitation units have specialized multidisciplinary input, which reduces the need for additional information, planning, or coordination that an ICP may offer.²⁹ ICPs are based on the premise that patients will have predictable recovery, whereas stroke patients show considerable variability in the timing, nature, and order of recovery. Other explanations for the lack of benefit include the dependence on external influences such as accommodation, personal support, and services provided by other organizations that may not share the priorities of the treating unit.

There is some evidence in this study to suggest that conventional multidisciplinary care may be better than ICP management. The median change in Barthel Index between week 4 and 12 was significantly greater in this group of patients, which suggested that flexibility in goal setting and interventions based on continuing patient assessment may hasten (but not increase the extent) of functional recovery. Quality of Life scores showed significantly greater improvement in patients receiving multidisciplinary care, suggesting that a less structured approach in which patients may dictate the pace of their rehabilitation may play a role in their perceptions of well-being. The use of ICP required the appointment of an additional staff member to coordinate it, thus costing more to achieve a similar or less favorable outcome.

There is considerable enthusiasm to introduce successful cost containment and quality improvement methods such as Integrated Care Pathways and Case Management into diverse clinical settings. There are no doubts that these techniques will be effective and reduce costs in several clinical areas, especially those in which care has been coordinated poorly in the past. However, implementation of change without robust evidence may be counterproductive, especially if organized care already exists. This study emphasizes the need for caution in introducing inadequately tested patient management strategies into the complex area of healthcare provision at the expense of proven strategies.

View larger version (61K): [in this window] [in a new window]   Figure 1. Appendix

	Acknowledgments

 
The project was funded by the NHS R&D Executive North Thames Research Implementation Committee (Project No. B6.58). Dr Perez was funded by a NHS Health Technology Assessment grant.

Received December 16, 1999; revision received May 9, 2000; accepted May 9, 2000.

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This Article Abstract Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Request Permissions Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Sulch, D. Articles by Kalra, L. Search for Related Content PubMed PubMed Citation Articles by Sulch, D. Articles by Kalra, L. Related Collections Health policy and outcome research Resource utilization Rehabilitation, Stroke