An introduction to implementation science in rehabilitation medicine

Abstract

The fundamental goal of research that develops and tests rehabilitation interventions is to improve the health, function, and quality of life of patients with disabling health conditions. Rehabilitation medicine frequently uses multicomponent interventions delivered by multidisciplinary teams. This care may also occur over time across a continuum of care (eg, acute care, postacute care, outpatient clinics). Thus, research-developed rehabilitation interventions may be challenging to implement and sustain in routine care settings, particularly for disabling health conditions that persist over time. The field of implementation science has emerged in direct response to these challenges by supporting more rapid, consistent implementation of evidence-based practices in routine care through carefully designed, systematic implementation efforts. Implementation science aims to elucidate the factors that influence implementation success (ie, barriers and facilitators), to identify and evaluate implementation strategies likely to facilitate successful implementation, and to study the underlying mechanisms through which implementation strategies produce their effects on implementation outcomes. This article introduces the field of implementation science and provides an overview of the PM&R special issue on implementation science. The article presents core implementation science concepts and approaches and discusses their application to specific evidence-based rehabilitation interventions that are underused in treating disabling health conditions. The successful application of implementation science methods offers the promise of improved adoption of evidence-based rehabilitation practices to optimize patient outcomes and help maximize realization of their societal value and benefits.

INTRODUCTION

Disabling health conditions can impair individuals’ functioning, well-being, and quality of life. For example, common musculoskeletal conditions such as low back pain and lower extremity osteoarthritis are leading causes of disability worldwide.¹ Nearly all adults are expected to experience at least partial transient disability from a musculoskeletal condition at some point, whereas others experience more persistent and pronounced declines in function.¹ Severe loss of function can also occur after injury. For example, an acute brain injury following a stroke can significantly reduce one’s ability to participate in daily activities.^2,3 The enormous burden of disabling health conditions is an important societal problem associated with excess mortality, morbidity, and reduced quality of life.

Rehabilitation research has produced numerous interventions that can reduce disability and improve quality of life. For the management of musculoskeletal conditions, several effective rehabilitative interventions (eg, exercise programs, manual therapies) are recommended as first-line treatment in major clinical practice guidelines (eg, from the American College of Rheumatology, the American College of Physicians, and the World Health Organization).^4-6 Strong evidence also supports the use of inpatient rehabilitation to reduce mortality and improve functional outcomes in patients hospitalized for disabling conditions (eg, stroke, spinal cord injury).^7-9 Indeed, a rich portfolio of rehabilitation interventions have the potential to significantly improve function and quality of life among individuals with disabling health conditions. Unfortunately, these interventions are rarely self-implementing and their widespread use in routine care is unlikely in the absence of intentional implementation efforts. Thus, there is a need to understand why some rehabilitation interventions are adopted into routine care whereas others are not, why these interventions succeed better in some clinical settings but not others, and what can be done to increase the likelihood of successful implementation. The field of implementation science has emerged in direct response to these challenges by supporting more rapid, consistent implementation of evidence-based practices in routine care through carefully designed, systematic implementation efforts.

This article is part of a PM&R special issue on implementation science. We present core implementation science concepts and approaches and explain how they can be applied to increase adoption of evidence-based rehabilitation practices. First, we introduce the field of implementation science and discuss why it is relevant to rehabilitation clinicians and researchers. Second, we describe core implementation science methods for those wishing to critically appraise implementation research and apply its findings and/or incorporate aspects of implementation science in their own research. Third, because the American Board of Physical Medicine and Rehabilitation has a quality improvement requirement for continuing certification, we discuss how implementation science can strengthen quality improvement initiatives. The PM&R special issue on implementation science also provides numerous examples from the rehabilitation medicine field that illustrate core implementation science concepts and approaches.^10-21

WHAT IS IMPLEMENTATION SCIENCE?

Implementation science is defined as “the study of methods to promote the systematic uptake of research findings and other evidence-based practices into routine practice to improve quality and effectiveness of health services.”²² A 2020 article by Curran et al., defines implementation research in simple terms as the study of how to best help people and places ‘do the thing’ that works (eg, evidence-based rehabilitation interventions); this involves the use of implementation strategies, which are defined as ‘the stuff we do’ to help people and places ‘do the thing’ that works.”²³ The field of implementation science has developed in response to low levels of implementation: published studies estimate that only 30% of efficacious interventions are fully implemented into routine care, and it can take 17 years to embed an efficacious intervention into practice.^24,25 A first step in moving evidence-based practices into routine care is often the identification of barriers to implementation. After identifying local barriers to implementation, a set of responsive implementation strategies are selected and tailored to address the barriers and improve implementation outcomes. Multiple implementation strategies are often delivered as part of an integrated package or bundle to target the diverse barriers and needs of interest holders involved in routine care (eg, patients, clinicians, health system leaders). The effectiveness of implementation bundles is then evaluated by measuring implementation outcomes such as adoption, sustainment, and spread.^26,27

Rehabilitation researchers can make critical contributions to implementation science and practice. Rehabilitation clinicians bring essential skills to the health care continuum in the management of disabling conditions, including a multidisciplinary, team-based approach and expertise in symptom management, function optimization, intervention tailoring, goal setting, and a keen focus on quality of life. Rehabilitation for complex chronic conditions is often guided by field-specific frameworks. For example, the World Health Organization’s International Classification of Functioning, Disability and Health framework, is helpful for understanding how a disabling condition involves body structures and functions (eg, neurological, musculoskeletal, cognitive), activities (eg, functional limitations such as reduced ability to walk briskly or poor balance); and participation (eg, restriction of activities of daily living or instrumental activities of daily living such as bathing, walking 2–3 blocks, climbing stairs).^28-30 Thus, the design of rehabilitation interventions for disabling health conditions requires collaboration between researchers and clinicians to carefully consider intervention components that have the correct therapeutic targets to optimize function and other clinical outcomes.^31-33 Similarly, rehabilitation clinicians can work with implementation scientists to identify appropriate implementation strategies to target key barriers to initial adoption of complex multidisciplinary and multicomponent rehabilitation interventions. This is also important when interventions must be sustained over long periods of time (eg, ongoing rehabilitation after limb loss,¹⁵ stroke rehabilitation^13,34 or traumatic brain injury³⁵) across multiple care settings (eg, acute care, postacute care, outpatient clinics). Thus, rehabilitation researchers are well suited to contribute to understanding of barriers to additional implementation outcomes such as sustainability.

CORE CONCEPTS IN IMPLEMENTATION SCIENCE

According to the prevailing translational research pipeline,^36,37 foundational knowledge from basic science research (ie, discovery) is translated through clinical research into evidence-based rehabilitation interventions that can improve outcomes in routine clinical care. As shown in Figure 1, implementation research typically occurs after clinical research, to promote and facilitate the adoption of evidence-based rehabilitation interventions in routine care. In Table 1, we compare “clinical research” to “implementation research” to clarify the main distinctions between these categories of research activity.⁴² However, there is growing consensus that implementation efforts should begin earlier—designing rehabilitation interventions with dissemination and implementation in mind—to accelerate the transition from clinical research to widespread use of promising rehabilitation interventions in routine care.^38,39

FIGURE 1.

Pipeline of research to develop and implement rehabilitation interventions. Figure 1 shows part of the prevailing translational research pipeline,^36,37 focusing on the link from developing rehabilitation interventions through clinical research and moving evidence-based rehabilitation interventions into routine clinical care through implementation research. There is a strong case for beginning implementation efforts earlier (eg, identifying implementation barriers while developing and refining rehabilitation interventions during clinical research) to accelerate the transition between clinical research and use of promising rehabilitation interventions in routine care.^38,39

TABLE 1.

Comparison of clinical research to implementation research.

Key concept	Clinical research	Implementation research
Innovation under study	Rehabilitation intervention or other clinical innovation (eg, prognostic or decision-support tools)	Discrete implementation strategies or bundle of strategies. See also, Figure 2.
Hypothesis	Rehabilitation intervention is more effective than usual care or control for clinical outcomes.	Implementation strategy bundle is more effective than implementation as usual; Tailored bundle of implementation strategies is more effective than nontailored implementation bundle for implementation outcomes.
Target(s) of innovation	Therapeutic target(s) including one or more components of body structures and functions (eg, neurological, musculoskeletal, cognitive), activities, or participation.	Barriers or facilitators that relate to one or more components of the rehabilitation intervention, the clinicians involved with implementation of the rehabilitation intervention, the care setting where implementation is occurring, the health care system, etc.
Primary goal	Develop, test, or refine rehabilitation interventions	Develop, test, or refine implementation strategies
Outcome measurement	Clinical outcomes such as performancebased or self-reported measures of function/disability or other patient reported outcomes such as pain, stress, quality of life.	Implementation outcomes proposed by Proctor et al.,26,27 including acceptability, appropriateness, feasibility, adoption, implementation cost, fidelity, penetration (or reach), and sustainability (or maintenance). See also, Figure 3.
Context	To test rehabilitation intervention in ideal conditions (efficacy) or real-world conditions (effectiveness)	To understand implementation in real world, routine care settings, knowing that this may vary from one health care system to another
Typical unit of randomization	Patient	Provider, clinic, or health care system

Note: Adapted from Bauer et al.⁴²

The conduct of “hybrid” clinical trials can expedite progress along the translational pipeline by combining clinical effectiveness and implementation research aims.^43,44 Hybrid trials include trials assessing clinical intervention effectiveness while gathering information on implementation barriers and facilitators as a secondary goal (hybrid type 1); trials evaluating clinical intervention effectiveness and implementation bundle effectiveness simultaneously (hybrid type 2); and trials aimed primarily at testing implementation bundles while also measuring clinical outcomes for established clinical interventions that are being tested in a new setting (hybrid type 3).

Within “implementation research” are several categories or phases of implementation studies. Early “preimplementation” studies are conducted to document quality and implementation gaps and identify the root causes of these gaps. By identifying implementation barriers and facilitators, researchers can select responsive implementation strategies and design implementation strategy bundles that target multiple barriers. Preimplementation studies are typically followed by a series of trials (ranging from small pilot studies to large multisite trials) that develop and test the effectiveness of implementation strategy bundles on implementation outcomes. Implementation trials can be conducted in a sequence similar to the Food and Drug Administration four-phase framework employed for clinical trials of drugs and vaccines as shown in Figure 1.⁴⁵ The sequence begins with small Phase 1 pilot projects that develop or refine an improvement or implementation program and assess basic feasibility within a single facility. This is followed by Phase 2 efficacy-oriented implementation studies conducted in a small number of clinical sites under idealized conditions (eg, selective recruitment, high levels of research team support and involvement). If Phase 2 studies reveal acceptable efficacy of the implementation bundle, larger effectiveness-oriented, pragmatic Phase 3 studies are conducted to evaluate the implementation bundle under routine, real-world conditions in a diverse range of settings. If continued implementation effectiveness is supported, Phase 4 “postmarketing” research monitors ongoing implementation effectiveness in a low-cost, observational manner as the implementation bundle is deployed across an entire health system, region, or country.

Core concepts and approaches employed while designing and conducting preimplementation studies and implementation trials include (1) implementation science theories, models, and frameworks; (2) typologies of implementation strategies and methods for developing, selecting, and specifying these strategies; (3) a diverse array of implementation outcomes and approaches to outcome measurement, all of which are employed using (4) a range of study designs selected to address the multiple aims of implementation studies that can achieve (5) equitable implementation outcomes. These core implementation science concepts and approaches are discussed next.

Theories, models, and frameworks

A challenge for implementation science is its frequent use of complex bundles of multiple implementation strategies to address an equally complex array of barriers. Implementation science relies on a rich collection of theories, models, and frameworks to help researchers and clinicians understand, organize, and communicate the complex processes of implementation.^46-48 A systematic review published in 2012 identified 61 distinct theories and frameworks from the field of dissemination and implementation research.⁴⁹ Although a comprehensive review of this large (and still growing) body of theories and frameworks is outside the scope of this article, it is important to introduce three of the main framework categories: process, determinant, and evaluative. Process frameworks aim to describe and/or guide the process of implementing research into practice, for example, the Knowledge-to-Action framework and implementation mapping.^50-52 Determinant frameworks are particularly helpful in early phases of implementation when clinicians or researchers aim to identify the determinants (ie, barriers and facilitators) of successful implementation, for example, the Consolidated Framework for Implementation Research and the Theoretical Domains Framework.^53,54 Determinants may occur at several ecological levels (eg, patient, provider, health system, or community factors) and determinant frameworks can help to systematically evaluate barriers and facilitators from multiple perspectives.⁵⁵ Evaluative frameworks are important when evaluating the effectiveness of implementation strategies on implementation outcomes (eg, Reach, Effectiveness, Adoption, Implementation, and Maintenance framework, Proctor Conceptual Model).^26,56-58 In Table 2 we list several common implementation science models and frameworks and provide examples of their use to inform implementation of rehabilitation interventions.

TABLE 2.

Examples of implementation science models and frameworks.

Model or framework	Categorya	Applied papers
KTA	Process	KTA was illustrated by Campione et al. through discussing the dissemination and implementation of a diagnostic clinical practice guideline for lymphedema secondary to cancer among physical therapists and physical therapist assistants.11
PRISM59	Process determinant	PRISM was applied in Johnson et al. in a learning community to assess determinants of a novel clinical decision support tool for physical therapy triage in acute care hospitals; this framework also informed the design and fit of implementation strategies to the local context.17
i-PARIHS60	Process determinant	i-PARIHS was applied in Touchett et al. to identify determinants of adoption of a catheter-associated urinary tract infection intervention for a spinal cord injury population and to guide adaptation for implementation in this setting.14
CFIR54	Determinant	CFIR was applied in Roseen et al. to analyze interview transcripts and identify determinants (ie, barriers and facilitators) to adoption of guideline-recommended nonpharmacologic treatments for low back pain in primary care clinics at a safety net hospital.21
TDF53	Determinant	TDF was applied in Tierney-Hendricks et al. to identify determinants to adoption of a cognitive assessment protocol implemented in an outpatient rehabilitation setting, among occupational therapists (OT) and speech-language pathologists (SLP).19
ERIC taxonomy40	Implementation strategies	The ERIC taxonomy was applied in Stout et al. to select implementation strategies for implementing a cancer rehabilitation navigation program in oncology care delivery.12
FRAME61 and FRAME-IS62	Adaptation	Used in Touchett et al. to document adaptation of a urinary tract infection intervention program developed in other populations for a spinal cord injury population with catheter-associated urinary tract infections.14
RE-AIM57,58	Evaluation	RE-AIM was applied in Tierney-Hendricks et al. to measure the reach and adoption of a cognitive assessment protocol in occupational therapy and speech language pathology outpatient practices.19
PCM26,27,56	Evaluation	See Figure 3

Abbreviations: CFIR, Consolidated Framework for Implementation Research; ERIC, Expert Recommendations for Implementing Change taxonomy of implementation strategies (See Figure 2); FRAME, Framework for Adaptations and Modifications-Enhanced; FRAME-IS, Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies; iPARIHS, integrated Promoting Action on Research Implementation in Health Services; KTA, Knowledge-to-Action framework; PCM, Proctor Conceptual Model of implementation outcomes (See Figure 3); PRISM, Practical, Robust Implementation and Sustainability Model; RE-AIM, Reach, Effectiveness, Adoption, Implementation, and Maintenance; TDF, Theoretical Domains Framework.

^aFurther detail on models and frameworks is provided in Nilsen et al.⁴⁶ and Tabak et al.⁴⁸

Implementation strategy typologies, selection, and reporting

Examples of implementation strategies depicted in the Expert Recommendations for Implementing Change (ERIC) taxonomy of implementation strategies are shown in Figure 2.^40,41 Careful selection of specific implementation strategies to combine in a multicomponent, often multilevel bundle is critical to implementation success. This selection relies on knowledge of the relevant implementation barriers and facilitators. Although published literature discusses common barriers and facilitators to implementation of evidence-based rehabilitation interventions,^63,64 local preimplementation observational studies are often needed to identify the specific pattern of implementation barriers present in a particular setting. Researchers, implementation practitioners, and clinicians can employ a range of methods to identify and prioritize local barriers and facilitators including interviews, focus groups, and process mapping.^65-67 Once the barriers are defined, implementation strategies can be selected and tailored to target the identified barriers.⁵⁰ Using language to describe implementation strategies that is consistent with established typologies, such as the ERIC taxonomy of implementation strategies, is important for replication.^40,41 Systematic documentation and reporting of how implementation bundles are operationalized in implementation research is also essential for ensuring these implementation bundles can be reproduced in new settings.^68-70

FIGURE 2.

Nine categories of implementation strategies. Examples of discrete implementation strategies are shown in each box according to the nine categories of the Expert Recommendations for Implementing Change Taxonomy of implementation strategies; Further detail provided in Powell et al.⁴⁰ and Kirchner et al.⁴¹

Fidelity of the rehabilitation intervention can be an important consideration in implementation research. Although maintaining rehabilitation intervention fidelity is an important goal in clinical research, particularly in tightly controlled efficacy trials, inflexible interventions may not be acceptable or optimal for highly diverse routine care settings. Thus, a core tenant of pragmatic implementation for complex health interventions is that an intervention will likely need to be adapted or tailored to suit each unique care setting. Guiding and monitoring adaptation of rehabilitation interventions is important in pragmatic effectiveness clinical trials that test rehabilitation interventions in real-world settings. The Framework for Adaptations and Modifications-Enhanced (FRAME) can help specify what components of a rehabilitation intervention have changed to meet local needs.⁶¹ Although implementation strategies are distinct from rehabilitation interventions, they too may need to be adapted or tailored to achieve optimal outcomes in a particular context. Researchers can guide and monitor adaptations of implementation strategies using the Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies (FRAME-IS).⁶²

Another tool for managing the challenge of designing and tailoring rehabilitation interventions or implementation strategies is the “core function/form” framework.^71,72 This framework helps clinicians and researchers distinguish between the underlying purpose (core function) of an activity versus the options (forms) available to operationalize or achieve each function. In clinical research, this framework helps to distinguish between the primary mechanism(s) of action for a given rehabilitation intervention (core function) and the intervention delivery options for carrying out that mechanism (forms). For example, a rehabilitation intervention may have a core function of increasing muscle strength that can be achieved through multiple forms of strength training. Thus, several “forms” are typically available to carry out each core function without any loss of fidelity. Similarly, when applied to implementation strategies, if limited clinician knowledge of a rehabilitation intervention is a known barrier there may be several forms of educational interventions (eg, educational meetings, learning collaboratives) available to operationalize the education core function to address the clinician knowledge gap.

Researchers can partner with community members and other interest holders to identify the core functions integral to successful implementation as well as the specific forms optimally matched to different settings with their unique contextual factors. A fundamental feature of implementation research is reliance on the expertise, commitment and buy-in from a broad range of groups and interest holders involved in care delivery, including health system leaders, the front-line clinicians and staff implementing the rehabilitation intervention, the patients who will receive the intervention, and others.^73,74 Applying principles from community-based participatory research⁷⁵ is essential to conduct successful preimplementation studies as well as the full range of implementation trials, from a pilot study in a single clinic to implementation across multiple clinics and health systems.

Implementation outcome selection and measurement

A seminal paper by Proctor et al. introduced eight core implementation outcomes: acceptability, adoption, appropriateness, cost, feasibility, fidelity, penetration, and sustainability.^26,27 These outcomes are defined in Figure 3. Quantitative measurement tools have been developed to evaluate some of these outcomes, such as acceptability, appropriateness, and feasibility.⁷⁶ Additional guidance for use of quantitative measurement tools to measure implementation outcomes (and implementation determinants) can be found elsewhere.^77-81

FIGURE 3.

Eight implementation outcomes defined for rehabilitation research. Definitions adapted from the Proctor Conceptual Model for implementation outcomes.^26,27

Although implementation research is primarily interested in implementation outcomes (eg, adoption or sustainability of a rehabilitation intervention), the ultimate goal is to achieve improved clinical outcomes via successful implementation of evidence-based rehabilitation interventions. For example, we anticipate successful implementation of an evidence-based exercise program for older adults with chronic low back pain will result in less pain, better mobility, and an increased ability to perform activities of daily living. Figure 4 illustrates the relationship between rehabilitation interventions and implementation strategies and the mediating effect of implementation outcomes on clinical outcomes.

FIGURE 4.

Causal model connecting clinical research and implementation research. Figure illustrates the relationship between rehabilitation interventions and implementation strategies, including the mediating effect of implementation outcomes on clinical outcomes. A shows the theoretical relationship between rehabilitation intervention components (components a–e) and clinical outcomes (outcomes 1–3) shown as circles and rings, respectively. For example, clinicians expect that 1 or more components of an effective exercise intervention will improve a specific clinical outcome (eg, increased strength). B shows the theoretical relationship between implementation strategy components (components f–i) and implementation outcomes (outcomes 4–7) shown as squares and square frames, respectively. For example, optimizing a referral mechanism in an electronic health record to a rehabilitation intervention may have an effect on referral rates (ie, adoption) to the rehabilitation intervention. C shows that implementation strategies that achieve successful implementation outcomes for effective clinical interventions will, ultimately, mediate better clinical outcomes. This is represented by the matching of the appropriate implementation strategy with implementation outcomes (square within square frame) or clinical intervention component with clinical outcome (circle within ring). For more information on implementation strategies and implementation outcomes see Figures 2 and 3, respectively.

The adaptability of implementation bundles and the heterogeneity across sites participating in trials serve to highlight the importance of measuring intermediate factors (mediators) and baseline contextual factors such as site characteristics (determinants, effect modifiers) that may explain how implementation strategy bundles achieve their effects. Several methods (eg, intervention mapping exercises, causal mediation analyses) may be applied to elucidate or quantify the mechanisms (ie, mediators) of implementation strategy effects on implementation or clinical outcomes.^82-84 These methods can help determine whether implementation strategies that involve provider education achieve better adoption of rehabilitation interventions via increases in provider knowledge or self-efficacy, and whether improvements in provider knowledge and self-efficacy produce better clinical outcomes. Similarly, causal inference methods can be applied to understand heterogeneity of implementation strategy effects on implementation outcomes in identifiable subgroups, that is, effect modification.^85,86 Elucidating the underlying mechanisms of implementation strategies, or the subgroups most likely to benefit, can inform how to target and adapt them for future use. For subgroups for which a strategy is not effective, it is helpful to know if alternative or more intensive strategies will be effective.

Study design types

Implementation bundles are evaluated via studies employing a rich array of study designs, including experimental and hybrid effectiveness-implementation designs—described in the ‘Core concepts in implementation science’ section—as well as quasi-experimental and observational designs. A comprehensive review of study designs in implementation science can be found elsewhere.^87,88 Effectiveness-oriented implementation trials are often conducted in health systems interested in achieving near-term improvements in implementation outcomes in addition to supporting the production of scientific knowledge. However, the goal of “near-term improvement” often precludes use of conventional intervention-control designs (which prevent control sites from receiving the benefits of the implementation bundle under study). These considerations have contributed to interest in quasi-experimental designs such as stepped-wedge study designs and others offering basic experimental control and internal validity while supporting practice and improvement goals.^88-90

Implementing with health equity in mind

Imbalances in disability outcomes can be observed for several health conditions across sociodemographic groups such as age, gender, and race/ethnicity.^91-93 Addressing inequities in use of rehabilitation interventions can ensure equitable outcomes among individuals with disabling health conditions. For example, lower-income, less-educated, and non-White Americans are less likely to receive rehabilitation services such as physical therapy, occupational therapy, and chiropractic care for low back pain.⁹⁴ Other targets for improving receipt of rehabilitative care include sustainability of care for long-term disability (eg, following a spinal cord injury) and access to affordable durable medical equipment.^95-97 Without designing implementation strategies to explicitly include underserved populations, implementation efforts may perpetuate or worsen disparities.^98,99 This is a concern for rehabilitation interventions, which have, in some cases, been marketed to the public as an “add-on” service for patients who can afford it rather than an essential service. In other cases, rehabilitation interventions may be prematurely withdrawn due to logistical constraints or limitations of health insurance. Patients, particularly those with limited resources, may also find it hard to sustain engagement in rehabilitation for in-person rehabilitation due to logistical barriers (eg, transportation, time away from work, child care) or challenges in provider interactions (eg, communication and cognitive barriers resulting from a disabling health condition). As telehealth delivery (ie, telerehabilitation) becomes widely available, those responsible for implementation also need to consider equitable delivery.¹⁰⁰ To date, implementation of rehabilitation services is most robust in higher-income and more-educated, predominately White neighborhoods.¹⁰¹ Choosing and engaging clinical sites that serve underserved neighborhoods is an important step in implementation research that can address health disparities while improving overall implementation. Additional theories and frameworks have been developed in underserved populations to help address health disparities.^102,103

SYNERGY OF IMPLEMENTATION SCIENCE WITH QUALITY IMPROVEMENT

In addition to facilitating implementation research, use of implementation science methods and approaches can enhance the practice of implementation, which may align well with quality improvement or improvement science activities.^104,105 Within rehabilitation departments, quality improvement initiatives are common and are often required as part of continuing medical education.^106-108 Synthesis and synergy across the quality improvement and implementation science fields can improve achievement of their shared goal of improving patient outcomes in rehabilitation medicine settings.¹⁰⁹ For example, implementation science offers guidance on sustainment and scale-up and spread as well as evaluation of heterogeneous, site-tailored implementation strategy bundles. In turn, improvement science offers specific tools to achieve site-specific tailoring through rapid-cycle, iterative improvement methods.^104,105 Thus, partnering of improvement and implementation scientists who have complementary skills can enhance implementation efforts.^110-113 Learning health systems, which routinely gather information on patient reported outcomes in rehabilitative medicine settings, can also facilitate collaborations between implementation and improvement scientists that result in rapid, efficient implementation of evidence-based rehabilitation practices.¹⁰

DISCUSSION

In this article we have highlighted the value of implementation science for researchers and clinicians working in rehabilitation medicine. We introduced the field of implementation science, provided information on core concepts and approaches, and discussed how implementation science can be used in quality improvement efforts. We highlighted applied examples of implementation science methods within a broader rehabilitation medicine context. Additional guidance on implementation research being conducted within specific subfields of rehabilitative medicine is also available, for example, traumatic brain injury,³⁵ stroke rehabilitation,³⁴ and cancer rehabilitation.^12,114,115

The development of rehabilitation interventions often follows the typical translational research pipeline through which novel clinical interventions are developed and tested for efficacy in controlled settings and subsequently tested for effectiveness in real-world settings.^36,37 Rehabilitation scientists have begun to recognize the importance of subsequent phases of research within the pipeline, that is, health services research and implementation research.^116,117 There is a strong case for beginning implementation efforts earlier, that is, designing rehabilitation interventions with dissemination and implementation in mind, to accelerate the transition between clinical research and use of promising rehabilitation interventions in routine care.^38,39 Rehabilitation researchers can partner with implementation scientists to conduct hybrid effectiveness-implementation studies (described previously) to expedite progress along the research-implementation pipe-line.^43,44 For example, in a hybrid type 1 study, a conventional clinical effectiveness study incorporates exploratory data collection on implementation barriers and facilitators. Several funding mechanisms are available to support this research (eg, National Institutes of Health R21 and R01 funding announcements; PAR-25-143 and PAR-25-144, respectively). Guidance on the essential elements of an implementation science grant proposal is also available to help develop competitive proposals.^118-120

The field of implementation science encompasses dissemination as well as implementation. Although we focused on implementation research, activity is also needed in dissemination research, defined as the scientific study of targeted distribution of information and intervention materials specific to clinical practice or public health audiences.¹²¹ Dissemination efforts can address biases or naiveté about an evidence-based practice that may impede adoption.^11,122 This appears particularly relevant for rehabilitation approaches that are complex and time consuming. Some approaches to rehabilitation may already be widely available or acceptable (eg, exercise programs or physical therapy for low back pain). However, other promising interventions may be underused in a given context. For example, although tai chi is recommended for fall prevention and knee osteoarthritis in the United States,^4,123 it is not well integrated into health care systems, rehabilitation clinics, or training institutions where “routine medical care” is taught. Thus, dissemination research is important for achieving more widespread awareness and acceptability of evidence-based rehabilitation interventions while preparing for implementation in a particular setting.

Although our article primarily emphasized methods needed to increase implementation of evidence-based rehabilitation practices, deimplementation efforts are also important to reduce use of services or treatments that are harmful, ineffective or low value.¹²⁴ For example, several services (eg, imaging) and treatments (eg, passive therapeutic modalities, epidural injections) have been characterized as “low-value” for low back pain, but remain popular among patients and providers.^20,125-127 Implementation science theories, models, and frameworks can be employed within deimplementation efforts to address overuse.¹²⁸ Deimplementation strategies include redesigning workflows, providing feedback to clinicians on their treatment patterns, and developing methods to educate patients who seek out low-value care.¹²⁹ Deimplementation and implementation efforts may need to occur simultaneously (ie, practice substitution¹³⁰), allowing patients to receive evidence-based high-value treatments in place of low-value approaches.

Future implementation efforts in rehabilitation medicine will require growth in the research capacity and infrastructure needed to conduct this work. Obtaining foundational knowledge on implementation science can be achieved through general training resources (eg, online modules from National Institutes of Health’s Training Institute for Dissemination and Implementation Research in Cancer) and rehabilitation-specific resources (eg, Learning Health Systems Rehabilitation Research Network). These tools can be particularly helpful for novice implementation science research staff, trainees, or other collaborators who will work on implementation projects. Partnering with implementation scientists from other clinical fields is another path forward, with this PM&R special issue on implementation science being an important introduction to the landscape of implementation efforts within rehabilitation medicine. Success of large-scale implementation efforts typically requires that health systems have prioritized, and invested in, the implementation effort. This may be facilitated by clear goals or quality metrics for disabling health conditions. Quality metrics for management of disabling conditions may be less institutionalized when compared to those for other common health conditions (eg, hemaglobin A1c for diabetes). Thus, engaging health system leaders, and setting disability specific goals or quality metrics, is an important step in building capacity and aligning health system priorities with implementation efforts. Developing networks of institutions (especially learning health systems¹⁰) to carry out implementation research agendas and sustain basic research infrastructure can support the efficient conduct of multisite pragmatic implementation trials.

CONCLUSIONS AND OVERVIEW OF SPECIAL ISSUE

This article introduces a rich body of implementation science literature available to inform the practice and study of implementation in rehabilitation medicine. In addition to this introductory article, the PM&R special issue on implementation science also features 12 articles illustrating and discussing new and upcoming areas in rehabilitation implementation, dissemination, and deimplementation research. As shown in Table 2, several of these articles apply implementation science theories or frameworks in rehabilitation settings. In a commentary, Annaswamy et al. address the synergy between implementation science and learning health systems, and the importance of both to rehabilitation medicine.¹⁰ In the field of cancer rehabilitation, Campione et al. review the Knowledge-to-Action framework, and illustrate its use to implement a diagnostic clinical practice guideline for lymphedema secondary to cancer.¹¹ Stout et al. describe the use of implementation mapping to develop implementation strategies at multiple levels (eg, health system, clinic, provider) to support adoption of a cancer rehabilitation navigation program.¹² For neurorehabilitation focused clinicians, Hasan et al. introduce initial program theories focused on telerehabilitation for survivors of stroke and explore the mechanisms by which initial program theories facilitate or hinder implementation outcomes.¹³ Touchett et al. describe the use of clinician feedback to adapt an evidence-based decision making tool for catheter-associated urinary tract infections for the spinal cord injury population.¹⁴ For limb loss, Grover et al. follows patients through the health care continuum and propose a multilevel implementation model to improve care and outcomes for patients with limb loss and threatened limb loss.¹⁵ In the field of acute care rehabilitation, Drake et al. evaluate an implementation strategy to increase site readiness in a stepped-wedge cluster randomized trial of an evidence-based supervised walking program for hospitalized older veterans.¹⁶ Johnson et al. describe engaging a multidisciplinary learning community to produce a clinical decision support tool (and potential implementation strategies) to guide the use of physical therapist services in the acute care setting.¹⁷ Similarly, Hinrichs-Kinney engaged an expert panel to conduct implementation mapping to develop strategies to support implementation of high-intensity resistance rehabilitation for older skilled nursing home residents.¹⁸ In outpatient rehabilitation, Tierney-Hendricks et al. evaluates the implementation of a cognitive assessment protocol in occupational therapy and speech language pathology outpatient practices; they also evaluate determinants of clinician adoption and potential implementation strategies.¹⁹ Tai et al. synthesize evidence from 21 low back pain clinical practice guidelines to identify low-value interventions that can be the target of de-implementation efforts.²⁰ Lastly, Roseen et al. report on their development of an interview guide to identify barriers and facilitators to adoption of guideline-recommended nonpharmacologic treatments for low back pain in primary care clinics.²¹

Together, the articles in this special issue offer rich evidence of the complex multidiciplinary and multicomponent nature of rehabilitation medicine and illustrate its value as a novel context for future implementation research. Partnerships between rehabilitation medicine researchers and implementation scientists can help further develop and apply implementation research methods while simultaneously increasing adoption of evidence-based rehabilitation practices to optimize patient outcomes and help maximize realization of their societal value and benefits.