Advancing Rehabilitation Paradigms for Older Adults in Skilled Nursing Facilities: An Effectiveness-Implementation Hybrid Type 1 Clinical Trial Protocol

Abstract

Objective

Skilled nursing facility rehabilitation is commonly required to address hospital-associated deconditioning among older adults with medical complexity. In skilled nursing facilities, standard-of-care rehabilitation focuses on low-intensity interventions, which are not designed to sufficiently challenge skeletal muscle and impart functional improvements. In contrast, a high-intensity resistance training approach (IntenSive Therapeutic Rehabilitation for Older NursinG homE Residents; i-STRONGER) in a single-site pilot study resulted in better physical function among patients in skilled nursing facilities. To extend this work, an effectiveness-implementation hybrid type 1 design, cluster-randomized trial will be conducted to compare patient outcomes between 16 skilled nursing facilities utilizing i-STRONGER principles and 16 Usual Care sites.

Methods

Clinicians at i-STRONGER sites will be trained to deliver i-STRONGER as a standard of care using an implementation package that includes a clinician training program. Clinicians at Usual Care sites will continue to provide usual care. Posttraining, changes in physical performance (eg, gait speed, Short Physical Performance Battery scores) from patients’ admission to discharge will be collected over a period of 12 months. The Reach, Effectiveness, Adoption, Implementation, and Maintenance framework will be used to evaluate i-STRONGER effectiveness and factors underlying successful i-STRONGER implementation. Effectiveness will be evaluated by comparing changes in physical function between study arms. Reach (proportion of patients treated with i-STRONGER), adoption (proportion of clinicians utilizing i-STRONGER), implementation (i-STRONGER fidelity), and maintenance (i-STRONGER sustainment) will be concurrently quantified and informed by clinician surveys and focus groups.

Impact

This effectiveness-implementation hybrid type 1 cluster-randomized trial has the potential to shift rehabilitation care paradigms in a nationwide network of skilled nursing facilities, resulting in improved patient outcomes and functional independence. Furthermore, evaluation of the facilitators of, and barriers to, implementation of i-STRONGER in real-world clinical settings will critically inform future work evaluating and implementing best rehabilitation practices in skilled nursing facilities.

Introduction

Each year, approximately 1.35 million patients receive skilled nursing facility (SNF) rehabilitation to address hospital-associated functional deficits.¹ SNF “usual care” rehabilitation prioritizes generic strength, aerobic, and mobility training² with minimal emphasis on individualized interventions that sufficiently challenge strength and physical function.^3,4 Consequently, over 64% of patients are discharged from SNFs at functional levels that predispose them to adverse events,^5,6 including rehospitalization,^6,7 failing health,^6–8 disability,⁶ institutionalization,^6,7 and death.⁹ Impaired physical function is a modifiable predictor of these deleterious events,^10,11 warranting the implementation of progressive SNF rehabilitation interventions that optimize physical function more effectively.

IntenSive Therapeutic Rehabilitation for Older skilled NursinG homE Residents (i-STRONGER) is a progressive, high-intensity rehabilitation approach designed by the University of Colorado Anschutz Medical Campus (UC-AMC) research team to address shortcomings of rehabilitation posthospitalization.³ i-STRONGER promotes low-repetition, high-resistance activities in a multicomponent intervention³ designed to physiologically overload the skeletal muscle and improve physical function in older adults.^12,13 Published work demonstrates that i-STRONGER is safe and feasible and leads to improved physical function among patients receiving SNF care.^3,14 Although i-STRONGER has been shown to be safe and effective, critical contextual factors must be targeted (eg, organizational system and team dynamics, perceptions of intervention effectiveness, risk-averse culture)^15,16 to overcome unique barriers to practice change in SNFs. Therefore, additional work is needed to integrate i-STRONGER as a standard of care in SNFs while concurrently measuring and addressing implementation barriers.

Purpose

We will conduct an effectiveness-implementation hybrid type 1 cluster-randomized trial across multiple SNFs to evaluate large-scale i-STRONGER effectiveness and implementation. Sixteen SNFs will be trained to deliver i-STRONGER as the new standard of care (i-STRONGER sites) and will be compared to 16 SNFs that continue to provide usual care (Usual Care sites).

Methods

Brief Overview of Study Design

The effectiveness-implementation hybrid type 1 design¹⁷ prioritizes evaluating i-STRONGER effectiveness while simultaneously evaluating factors affecting real-time implementation. The Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework, a robust and validated implementation science framework,^18–21 will be used to evaluate i-STRONGER effectiveness and implementation success. i-STRONGER effectiveness (defined as improvement in patients’ physical function) will be determined by comparing changes in patients’ gait speed (primary outcome) from admission to discharge between study arms. The remaining RE-AIM domains will be evaluated to determine implementation success: reach (proportion of patients who are eligible for i-STRONGER receiving i-STRONGER), adoption (proportion of clinicians using i-STRONGER routinely), implementation (fidelity to core i-STRONGER principles, measured using standardized fidelity checklists assessed in real-time during patient treatment; see Supplemental Document 1), and maintenance (sustained fidelity to core i-STRONGER principles, measured using standardized fidelity checklists assessed in real-time during patient treatment). Qualitative data from interviews and focus groups will be collected to evaluate barriers to and facilitators of clinician adoption and i-STRONGER implementation and maintenance.

Aims and Hypotheses

Aim 1 will determine if patients receiving i-STRONGER demonstrate greater physical function improvement from admission to discharge compared with patients receiving usual care, as measured by gait speed (primary outcome), the Short Physical Performance Battery (SPPB; secondary outcome), rehospitalization rates (secondary outcome), and the Modified Barthel Index (mBI; tertiary outcome). We hypothesize that patients receiving i-STRONGER will demonstrate (1) greater gait speed improvements, (2) greater SPPB score improvements, (3) decreased rehospitalization rates at 30 days postdischarge, and (4) greater mBI score improvements, compared with patients receiving usual care.

Aim 2 uses the RE-AIM framework²² to optimize successful implementation and maintenance while identifying processes, mechanisms, and determinants that explain variations in successful implementation. We hypothesize that (1) reach will be demonstrated with >80% of all patients who are eligible to be treated with i-STRONGER; (2) adoption barriers and facilitators will be identified using stakeholder focus groups involving rehabilitation clinicians; (3) implementation will be supported by >85% fidelity to core i-STRONGER principles during research support periods; and (4) maintenance will be demonstrated by >75% of facilities demonstrating >80% fidelity 6 months after research support has ended.

Study Population

Older adults admitted to SNFs following an acute hospitalization will be targeted. Patient-specific inclusion/exclusion criteria for data analyses are outlined in Fig. 1. Patients will not be required to provide informed consent, as they will receive rehabilitation within the scope of practice and provided as the standard of care at each SNF. All demographic and clinical data will be collected in accordance with the Centers for Medicare and Medicaid Services Minimum Data Set guidelines²³ or as part of the facility standard of practice as approved under the Data Use Agreement between UC-AMC and Aegis Therapies and by the Colorado Multiple Institutional Review Board.

Figure 1.

Patient- and site-level characteristics. ^aPatient-level criteria that will be used to determine eligibility for the final analysis. ^bPreferred site characteristics targeted during site recruitment and enrollment.

Study Setting, Site Enrollment, and Randomization

The UC-AMC Team is partnering with Aegis Therapies for this study and will recruit from their national network of contracted SNF sites. Sites demonstrating preferred characteristics (Fig. 2) will be approached by Aegis Therapies leadership to determine interest. Preferred characteristics were selected to maximize site retention, ensure capacity for i-STRONGER delivery, and achieve the required patient sample size. Recruitment will be ongoing, targeting 32 enrolled SNFs to obtain a target sample size of 2880 patients (1440 patients receiving i-STRONGER at i-STRONGER trained SNFs; 1440 patients receiving usual care at Usual Care SNFs). A blocked, 1:1 randomization scheme will be used and stratified by SNF staff size (large sites: ≥7 clinicians, small sites: <7 clinicians) to maximize balance. Sites will be enrolled across rolling waves (Wave 1: approximately 8 sites, subsequent Waves to be determined), with 4–6 months between waves.

Figure 2.

Study timeline.

Clinician Enrollment

All rehabilitation clinicians (physical therapists and assistants, occupational therapists and assistants) will be expected to participate in their respective training, fidelity, and/or reliability assessments as part of site enrollment. Additionally, clinicians will provide informed consent to participate in research-specific activities (eg, surveys, focus groups).

Study Timeline

Study preparation, including site recruitment, enrollment, and training, will take place during a 12-month pre-experimental phase (Fig. 2). Sites will then participate in a 12-month experimental phase, followed by a 6-month maintenance phase for i-STRONGER sites only.

During the pre-experimental phase, clinicians at all sites will be trained to collect and document functional outcomes as part of a non-research, Aegis Therapies-wide initiative to standardize documentation and integrate these measures into the electronic medical record (EMR). Baseline contextual factors (eg, site characteristics, culture, clinician demographics) will be assessed via surveys and/or interviews. Additionally, clinicians at i-STRONGER sites will receive training in implementing i-STRONGER as the standard of care at their facilities.

i-STRONGER-site clinicians will deliver i-STRONGER to patients during experimental and maintenance phases, and regular fidelity assessments will be conducted during routine patient care to ensure adherence to core i-STRONGER principles (eg, high-intensity dosing; additional details in “Fidelity and Quality Assurance” and in Supplemental Document 1). Patient and clinician data will be collected during experimental and maintenance phases to determine i-STRONGER effectiveness, implementation, and maintenance, respectively. Finally, we will use a mixed-methods approach to evaluate processes, clinician-specific characteristics, and site-specific contexts that explain variations in effectiveness, as well as barriers to and facilitators of successful clinician adoption, implementation, and maintenance.

Impracticality of Blinding

Randomization occurs at the site level. Given training needs, masking site assignment from the UC-AMC Team is impossible. Clinicians will assess patients using standardized functional measures and deliver rehabilitation according to the standard of care at each SNF. Clinicians and patients will not be aware of the approach used in the other study arm.

I-STRONGER Intervention

Following participation in a 10-week online training program (Supplemental Document 2), clinicians at i-STRONGER sites will implement i-STRONGER as the new standard of care without altering rehabilitation volume (ie, weekly rehabilitation minutes, dictated primarily by patient need). The core i-STRONGER principle involves dosing therapeutic tasks to 80% of a patient’s one-repetition maximum, or an 8-repetition maximum,³ wherein exercise is dosed at an intensity such that patients cannot perform more than 8 repetitions with proper form. The point at which patients cannot complete additional repetitions without significant compensation is defined as “failure.” This level of challenge is necessary to impart strength gains that translate to functional improvement.²⁴

i-STRONGER principles are highly translatable beyond traditional strength training tasks to activities of daily living, instrumental activities of daily living, gait, and balance training. When repetition counts are not applicable (eg, walking, timed tasks), i-STRONGER principles target an “80% goal,” where clinicians create challenging enough scenarios via added resistance, environmental obstacles, or cognitive load to ensure patients are successful for no more than 80% of the task.³ Similarly, this level of challenge is critical to stimulate strength gains and translate to functional improvement.²⁴ Clinicians are trained to tailor i-STRONGER interventions to patient-specific activity limitations, participation restrictions, and goals. Gustavson et al.³ provide structured examples of i-STRONGER application; however, this trial will take a more pragmatic approach than previous work and allow the application of principles to any therapeutic activities, rather than dictating shared time across specific interventions.

Usual Care

Usual Care clinicians will not receive recommendations informing rehabilitative strategies. Instead, clinicians will continue usual care and receive training on appropriately collecting and documenting primary (ie, gait speed) and secondary (ie, SPPB) outcome measures for comparison purposes. To characterize usual care and its level of therapeutic intensity compared with i-STRONGER, randomly selected treatment sessions will be observed and assessed for dosing techniques at Usual Care sites; the volume of rehabilitation will be unaltered and tracked for productivity comparisons.

To limit group contamination, participating Aegis Therapies leadership and clinicians will be instructed to limit information transfer between Usual Care and i-STRONGER sites regarding research activities, and only general, non-study-specific communication will be approved for distribution to local community members. Furthermore, in instances where clinician cross-coverage across study arms is unavoidable (eg, emergency coverage for short staffing), clinicians from Usual Care SNFs who provide coverage support to i-STRONGER SNFs will not receive training in and/or resources related to i-STRONGER application to prevent awareness of or potential integration of principles into Usual Care practice.

Study Outcomes

Study outcomes are listed by aim and timepoint in Table 1. Methods of collection are described in “Data Collection and Management” and Table 1.

Table 1.

Study Outcomes by Aim and Timepoint^a

RE-AIM Domain and Related Outcomes		Aim	Description	Collection Timepoint
Effectiveness	Gait Speed Change, m/sb	1	Change in usual walking speed from patient admission to discharge, captured using a 4-meter walk test	Experimental Phase: Patient Admission and Discharge
	SPPB Score Change, points	1	Change in the composite measure of gait speed chair stand performance, and balance performance from patient admission to discharge	Experimental Phase: Patient Admission and Discharge
	mBI Score Change, points	1	Change in the ADL performance from patient admission to discharge	Experimental Phase: Patient Admission and Discharge
	Rehospitalization Rate, %	1	Proportion of i-STRONGER-eligible patients who are re-hospitalized within 30 days of SNF discharge	Experimental Phase: Patient Discharge
Reach	i-STRONGER Reach, %	2	Proportion of i-STRONGER-appropriate patients who are treated with i-STRONGER	End of Experimental Phase: Compiled EMR Extraction
	Influential Patient Characteristics	2	Demographic and comorbidity-related characteristics of i-STRONGER-appropriate patients as compared to those that are not i-STRONGER-appropriate	Experimental Phase: Monthly EMR Extraction, Midpoint and Post-Experimental Focus Groups
	Patient-specific Barriers	2	Patient-specific reasons for declining i-STRONGER participation	Experimental Phase: Midpoint and Post-Experimental Focus Groups
Adoption	i-STRONGER Adoption, %	2	Proportion of clinicians using i-STRONGER with ≥75% of i-STRONGER-appropriate patients	End of Experimental Phase: Compiled Monthly Clinician Surveys
	Characteristics Influencing Adoption	2	Demographic, site-specific, and role-specific characteristics of clinicians who adopt or do not adopt i-STRONGER	Pre-Experimental Phase: Baseline Surveys
Implementation	i-STRONGER Fidelity, %	2	Proportion of therapeutic tasks dosed according to i-STRONGER-defined high-intensity (i.e., achieving failure within ideal training zone)	End of Experimental Phase: Compiled Fidelity Checklist Scores
	Clinician Productivity	2	Average monthly productivity (billable hours/total work hours) and average percent time with patients (billable clinical hours/total work hours)	End of Experimental Phase: Administrative Data Review
	Factors Influencing i-STRONGER Fidelity	2	Barriers and facilitators to i-STRONGER fidelity and descriptions of i-STRONGER adaptations	Experimental Phase: Midpoint and Post-Experimental Focus Groups
Maintenance	i-STRONGER Fidelity, %	2	Proportion of therapeutic tasks dosed according to i-STRONGER-defined high-intensity (i.e., achieving failure within ideal training zone)	End of Maintenance Phase: Maintenance-specific Fidelity Checklist Scores
	Factors Influencing i-STRONGER Fidelity	2	Barriers and facilitators to i-STRONGER fidelity and descriptions of i-STRONGER adaptations	Maintenance Phase: Maintenance Clinician Focus Group

^a ADL = activities-of-daily-living; EMR = Electronic Medical Record; i-STRONGER = IntenSive Therapeutic Rehabilitation for Older skilled NursinG homE Residents; mBI = Modified Barthel Index; RE-AIM = Reach, Effectiveness, Adoption, Implementation, and Maintenance Framework; SNF = Skilled Nursing Facility; SPPB = Short Physical Performance Battery; UC-AMC = University of Colorado Anschutz Medical Campus.

^b Primary effectiveness outcome.

Primary Effectiveness Outcome

The primary outcome evaluating i-STRONGER effectiveness will be the change in patients’ self-selected gait speed from admission to discharge. Gait speed (meters/second) will be collected using a 4-meter walk test as part of standardized administration of the SPPB.¹⁹ Gait speed was selected as the primary outcome because it is (1) predictive of disability risk, healthcare utilization, and mortality^25,26; (2) strongly correlated to muscle strength^27,28; (3) valid and reliable^29,30; and (4) well tolerated by patients with varying conditions and degrees of health.^31–33

Secondary Effectiveness Outcomes

The SPPB, a reliable and valid measure of lower-extremity mobility,^26,34 will serve as a secondary effectiveness outcome. A composite SPPB score will be calculated across 3 domains: static balance, gait speed, and functional lower-extremity strength. Each domain is scored on an ordinal scale from 0 (severe disability) to 4 (limited-to-no disability), with a maximum score of 12 points.^26,34 The SPPB is responsive to change³⁵ and predictive of disability, institutionalization, and mortality in older adults.²⁶

Rehospitalization rates within 30 days of patient discharge will serve as a secondary, system-level effectiveness outcome. The proportion of patients who are eligible for i-STRONGER who are hospitalized within 30 days post-SNF discharge will be quantified and compared with those at Usual Care sites.

Tertiary Effectiveness Outcome

Changes in patients’ mBI scores will be assessed as a tertiary effectiveness outcome. The mBI assesses performance of basic activities of daily living (eg, toileting, feeding, transfers).^36,37

Reach, Adoption, Implementation, and Maintenance Outcomes

Reach will be quantified as the proportion of patients who are eligible for i-STRONGER who receive i-STRONGER treatment. This will be collected via clinician-reported i-STRONGER fields within the EMR that denote whether ≥50% of each treatment session was dosed to failure. Adoption will be quantified as the proportion of clinicians who report using i-STRONGER principles with ≥75% of patients who are eligible for i-STRONGER via a monthly survey that will be completed throughout the experimental phase. Implementation and maintenance will be quantified as the proportion of tasks dosed to failure during real-time patient treatment observation, assessed using a standardized fidelity checklist at quarterly touchpoints in the experimental phase (implementation) or in the final month of the maintenance phase (maintenance). Given the critical nature of fidelity monitoring, additional details on the fidelity monitoring process are outlined in “Fidelity and Quality Assurance” and in Tables 1 and 2. Qualitative data from stakeholder focus groups and interviews will be used to inform and explain quantitative RE-AIM outcomes, including barriers to and facilitators of adoption, implementation, and maintenance.

Table 2.

Data Monitoring and Quality Assurance Protocol^a

Strategy	Responsible Party	Target Domains	Description	Frequency	Benchmark
RE-AIM Monitoring Activities
i-STRONGER knowledge checks	Rehabilitation clinicians	Implementation	Clinicians (including all new hires during project participation) must complete in-module knowledge checks during the training process to demonstrate understanding of i-STRONGER core principles.	Pre-Experimental phase: 8 in-module knowledge checks and a final exam	Clinicians must score ≥ 85% on critical knowledge checks.
i-STRONGER treatment fidelity assessment	UC-AMC team and i-STRONGER champion	Implementation	i-STRONGER Champions will assess i-STRONGER fidelity among clinician colleagues during real-time patient treatment sessions to ensure consistent and accurate i-STRONGER application. A standardized fidelity assessment checklist will be used which quantifies the proportion of tasks that are dosed to failure according to i-STRONGER principles. i-STRONGER Champions will undergo their own fidelity assessments with the UC-AMC Team prior to conducting them with peers.	Pre-Experimental phase: twice per clinician after completion of i-STRONGER training as a prerequisite to data collection Experimental phase: twice per clinician quarterly as both an implementation strategy and outcome (implementation)	Scores indicating <85% of tasks are dosed to the point of failure will warrant repeat assessment. Sites will not be able to begin the Experimental phase until all clinicians meet this benchmark.
Monthly clinician surveys	Rehabilitation clinicians	Adoption	i-STRONGER clinicians will complete a monthly survey indicating the proportion of their caseload with which they are using i-STRONGER principles.	Monthly during the Experimental phase	N/A
Monthly champion surveys	i-STRONGER champion	Adoption, Implementation	i-STRONGER Champions will complete a monthly survey describing influencing factors affecting their site’s i-STRONGER adoption and implementation.	Monthly during the Experimental phase	N/A; factors will be discussed during Champion meetings.
Research Therapist Facilitator chart audit reports	Research Therapist Facilitator	Reach, Cross-discipline concordance	The Research Therapist Facilitator will regularly review completeness of responses regarding each patient's i-STRONGER eligibility. This review allows immediate determination of cross-discipline (ie, physical therapy/occupational therapy) concordance regarding patient appropriateness, which can be remedied in real-time and enables real-time insight into Reach.	Experimental phase: Reports generated biweekly, then tapered to monthly or bi-monthly pending site performance; feedback provided to clinicians on concordance ≥3 days per wk	100% of notes must indicate patient appropriateness for i-STRONGER, and physical therapy, and occupational therapy teams must demonstrate 100% agreement regarding patient appropriateness for i-STRONGER. Cross-discipline discrepancies in i-STRONGER-appropriateness must be remedied within 72 h of note date.
Quality Assurance Strategies
Usual care treatment assessments	UC-AMC team	Quality assurance	Usual Care will be evaluated virtually by UC-AMC Team members. A standardized treatment assessment checklist will be used to identify whether interventions are dosed using i-STRONGER principles (ie, to failure).	1–2 times during the Experimental phase	N/A; scores will be documented to characterize Usual Care treatment rather than used as a benchmark.
SPPB training and knowledge checks	UC-AMC team	Quality assurance	SPPB training will be conducted with physical therapists and physical therapist assistants at each i-STRONGER and Usual Care site to maximize consistency of outcomes collection across clinicians; training consists of additional self-paced, online modules describing SPPB protocols, interpretation, and documentation.	Pre-Experimental phase: 3 in-module knowledge checks and a final exam	Clinicians must score ≥ 85% on all knowledge checks.
SPPB reliability assessments	UC-AMC team and outcomes champions	Quality assurance	Outcomes Champions will assess the reliability of SPPB total scores and gait speed among all physical therapist and physical therapist assistant colleagues to ensure that SPPB is being administered according to standardized directions and results are interpreted appropriately. Outcomes Champions will undergo their own reliability assessments with the UC-AMC Team prior to conducting them with peers.	Pre-Experimental phase: twice per clinician following i-STRONGER training Experimental phase: twice per clinician quarterly	Clinicians must score within 10% of Outcomes Champions for both SPPB total score (points) and gait speed time (in seconds).
Research Therapist Facilitator outcome measure reports	Research Therapist Facilitator and outcomes champions	Quality assurance	The Research Therapist Facilitator will regularly review completion of SPPB and mBI in all patient evaluation and discharge notes finalized within 72 h of review. This report will be communicated directly to the Outcomes Champion for remediation to limit data missingness.	Experimental phase: ≥3 days per wk	100% of finalized patient notes must include SPPB and mBI scores. Missing SPPB and mBI data must be remedied within 72 h of note date.

^a i-STRONGER = IntenSive Therapeutic Rehabilitation for Older skilled NursinG homE Residents; SPPB = Short Physical Performance Battery; UC-AMC = University of Colorado Anschutz Medical Campus.

Implementation Approach

A robust and comprehensive implementation approach will foster high levels of i-STRONGER reach, adoption, implementation, and maintenance to support i-STRONGER effectiveness. Each implementation strategy, informed by the Expert Recommendations for Implementing Change,³⁸ is outlined in Table 3. Notable strategies include (1) electing Champions at all sites, who will champion training engagement, outcome documentation, and/or i-STRONGER application; (2) integrating required EMR fields to document outcome measures, patient safety for participating in i-STRONGER, and whether ≥50% of treatment sessions were dosed to failure according to i-STRONGER principles; and (3) internal auditing of data completeness, patient reach, and the frequency at which clinicians indicate i-STRONGER use via an Aegis Therapies Research Therapist Facilitator. Given this study’s pragmatic approach, adaptations to i-STRONGER implementation processes are permissible and will be tracked; however, sites must adhere to the core principle of therapeutic dosing to achieve patient failure using 8-repetition-maximum or ≤80% success principles.

Table 3.

Expert Recommendations for Implementing Change³⁸ Strategies^a

ERIC Strategy	Study-Specific Strategy	Description	Rationale
Assess for readiness and Identify barriers and facilitators	Focus groups with i-STRONGER site leadership (Pre-Experimental phase)	i-STRONGER leadership will participate in pretraining focus groups.	Pretraining focus groups will allow the research team to identify immediate site needs and anticipated barriers to training engagement to facilitate training success.
Train and educate stakeholders and Make training dynamic	Online training in i-STRONGER principles (Pre-Experimental phase)	Clinicians will complete an online, self-paced training course in i-STRONGER implementation, which includes 9 training modules and a posttraining knowledge assessment. In total, training takes approximately 8 h to complete, distributed over the 10-wk training period.	Online training allows for concurrent training at multiple, remote sites. Interactive patient cases allow for real-world integration with practice of didactic concepts and will allow for monitoring of clinician competency to identify clinicians in need of additional training.
Develop/distribute educational materials	Decision-making and communication aids (All phases)	Resources/tools designed to optimize i-STRONGER fidelity improve inter-clinician communication and documentation and enhance clinician-patient communication will be distributed to i-STRONGER clinicians.	Decision-making aids will assist with patient screening and i-STRONGER application. Communication aids will address challenges with continuity of care, previously identified as a barrier, as well as motivational interviewing strategies to increase patient engagement.
Identify and prepare champions and Provide clinical supervision and Use Train-the-trainer strategies	Site champion(s) selection and training (Pre-Experimental phase)	Site Champion(s) will be internally selected and trained to help oversee intervention fidelity and outcomes documentation.	i-STRONGER champions will mentor clinicians in efficient and accurate application of i-STRONGER. Outcomes Champions will also oversee the administration of outcome measure administration and documentation. Site Champions will also inform the UC-AMC Team of implementation barriers and critical adaptations.
Conduct ongoing training and Conduct educational outreach visits	Regular research team/clinician team meetings and external expert facilitation via case discussions (All phases)	Asynchronous and synchronous case discussions and Champion meetings will occur regularly. Onsite visits will also occur, when possible, to promote i-STRONGER fidelity.	Frequent contact with clinical teams will facilitate engagement in i-STRONGER training and implementation and allow for team–based problem-solving to optimize i-STRONGER fidelity.
Audit and provide feedback and Develop and implement tools for quality monitoring and Facilitate relay of clinical data to providers	Research Therapist Facilitator data monitoring (Pre-Experimental and Experimental phase)	Using a clinical data dashboard, the Research Therapist Facilitator will monitor real-time variables critical for implementation success, including reach and outcome measure documentation. Required variables, such as prompts assessing i-STRONGER eligibility, will be added as entries within the EMR to ensure completeness.	Real-time monitoring of implementation data allows intervention from both Site Champions and the UC-AMC Team to improve i-STRONGER application, consistency, and accuracy in patient care.

^a EMR = electronic medical record; ERIC = Expert Recommendations for Implementing Change; i-STRONGER = IntenSive Therapeutic Rehabilitation for Older skilled NursinG homE Residents; UC-AMC = University of Colorado Anschutz Medical Campus.

Data Collection and Management

Patient-Level Data Collection

Upon SNF admission, patient demographics and characteristics (eg, comorbidities) will be documented in the EMR; these are routinely collected Minimum Data Set variables.²³ Comorbidity data, eg, the average number or type of active comorbidities per patient in each study arm, will be used to objectively describe and compare degrees of medical complexity across groups. At discharge, rehospitalization will be captured via posthospitalization Centers for Medicare and Medicaid Services data under the provision of the National Institute of Aging distribution of Centers for Medicare and Medicaid Services data through the MedRIC HaAD Enclave. Outcome measures will be documented in the EMR by clinicians at admission and discharge as part of routine care. Clinicians at all sites will receive training and reinforcement (eg, handouts, job aids) to support administration and documentation of study outcomes to limit missing data. Due to limitations in EMR field integration, i-STRONGER dosing documentation will not be standardized; however, required EMR fields will indicate whether ≥50% of a patient treatment session was dosed to failure using i-STRONGER principles, which will allow for further follow-up as needed when dosing indicators are low. Patient-level data will be extracted from the EMR and securely transferred to the UC-AMC Team throughout the 12-month experimental phase.

Clinician-Level Data Collection

Clinician and leadership surveys, interviews, and focus groups will identify barriers to and facilitators of RE-AIM success (eg, i-STRONGER effectiveness, high levels of clinician adoption) at i-STRONGER sites. Surveys will be distributed via email and self-administered digitally. Interviews and focus groups will be performed by an objective, non-biased qualitative research services professional external to the direct UC-AMC Team, or an objective, non-site-lead as necessitated by personnel availability. Surveys and/or focus groups will be completed pretraining, as well as immediately and 6-, 12-, and 18-months posttraining to assess time-specific barriers and facilitators influencing i-STRONGER implementation. At Usual Care sites, baseline survey data will be captured to enable contextual comparisons between groups.

Data Management Overview

UC-AMC Team members will compile patient- and clinician-level data for analysis via UC-AMC-hosted Research Electronic Data Capture.^39,40 Qualitative data will be recorded, transcribed, deidentified, and stored on secured UC-AMC servers.

Aim 1 Analyses

To test i-STRONGER effectiveness, changes in patients’ outcomes (gait speed, SPPB, rehospitalization rate, mBI) will be compared between i-STRONGER and Usual Care sites using a linear mixed model, with fixed effects for time and intervention and a group-by-time interaction. The linear mixed model will include random effects for patient nested within site. We will adjust for the stratification variable (large vs small sites, based on staff size) and test for a group-by-time interaction effect, corresponding to no difference in the mean change of the outcomes between Usual Care and i-STRONGER sites at the end of each wave’s experimental phase.

Aim 2 Analyses

In Aim 2, an explanatory sequential mixed-methods design will be used to evaluate RE-AIM outcomes. Briefly, descriptive statistics will be computed for reach, adoption, implementation, and maintenance calculations as described in “Reach, Adoption, Implementation, and Maintenance Outcomes” and Table 1. Focus group and interview data regarding barriers to and facilitators of RE-AIM domains will be transcribed, validated, and analyzed using rapid and traditional thematic analyses.⁴¹ Data will be coded by at least 2 members of the UC-AMC Team using both emergent and a priori coding aiming to identify barriers to and facilitators of RE-AIM domains^20,42; agreement will be reached through discussion of inter-coder discrepancies. The Atlas.ti qualitative analysis program (version 9; Scientific Software Development, GmbH, Berlin, Germany) will be used to support qualitative analyses. For mixed-methods analyses, we will use side-by-side joint display analysis,⁴³ which integrates mixed-methods data by creating visual diagrams to force comparisons by data type (eg, quantitative adoption data will be compared to and explained by stakeholder-reported barriers to and facilitators of adoption). We will use multiple iterations and triangulation of data to evaluate RE-AIM domains and identify key emergent themes.

Fidelity and Quality Assurance

Comprehensive fidelity and quality assurance protocols (Table 2) will be employed to ensure that (1) i-STRONGER-site clinicians accurately and consistently dose rehabilitation interventions to failure, as assessed using standardized fidelity checklists that will be completed during real-time patient treatment at established timepoints, (2) outcome measures are consistently and appropriately administered, and (3) routine Usual Care practice does not employ i-STRONGER principles fortuitously.

Adverse Event Monitoring

Adverse events denoted in clinical records will be extracted from the EMR and reviewed by the UC-AMC Team. Any unanticipated problems or events falling outside those routinely documented will be reported directly to the UC-AMC Team by site leadership. Once the UC-AMC Team is aware of an adverse event, it will be categorized in terms of expectedness, study relatedness, and severity in a hierarchical manner, as feasible based on available information. Serious, study-related adverse events and unanticipated problems will be reported in accordance with the National Institutes of Aging and Colorado Multiple Institutional Review Board guidelines.

Discussion

Current constraints within SNF rehabilitation and suboptimal physical function outcomes necessitate a paradigm shift in SNF rehabilitation. This study will evaluate the effectiveness of i-STRONGER, an evidence-based multicomponent intervention targeting muscle strength and physical function, across nationwide SNFs. This effectiveness-implementation hybrid type 1 cluster-randomized trial uniquely allows for large-scale evaluation of i-STRONGER in real-world clinical settings. Therefore, findings from this study will be highly generalizable and primed for translation, increasing their potential impact on practice.

An important strength of this study is the pragmatic design, which will expedite the integration of this research into practice. Second, the inclusion of rigorous fidelity assessments will ensure consistent i-STRONGER implementation across multiple SNFs. Additionally, we will prospectively collect data from active Usual Care sites for comparison. Data will be extracted from a single EMR system, enabling the evaluation of a large volume of data. Furthermore, we will use a mixed-methods approach to better understand real-world clinical processes, enabling the generation of future research questions. Finally, clinical meaningfulness and application have been optimized through the involvement of multilevel stakeholders throughout the planning and experimental phases.

The following limitations should be considered. First, the study population is limited to patients requiring no more than minimal assistance to ambulate upon SNF admission; this criterion was selected to ensure consistent collection of a valid, robust, and clinically meaningful physical function outcome (ie, gait speed). The study population also targets older adults, as this group comprises the majority of SNF admissions. These inclusion criteria limit the generalizability of potential findings to younger populations and those with substantial physical function impairments, who may still meaningfully benefit from high-intensity approaches. Although this trial will be implemented across diverse and variable SNFs, all SNFs are regulated by a single organization, which may limit the generalizability of implementation processes. Finally, this study will identify factors influencing i-STRONGER implementation across SNFs, but the results will not provide robust evidence regarding the utility or mechanism of a particular implementation strategy. Thus, future pragmatic trials evaluating variations in implementation strategies will be needed to best guide implementation approaches across diverse clinical contexts.

Overall, this study aims to advance clinical practice by further establishing i-STRONGER as a safe, effective standard of care in SNFs. Study findings have the potential to (1) substantially shift SNF rehabilitation paradigms, (2) optimize patient outcomes via a pragmatic rehabilitation intervention, and (3) critically inform future work aimed at wide-scale i-STRONGER implementation across postacute settings. Lastly, this study will evaluate factors that predict implementation success in diverse and dynamic SNFs, informing future dissemination and implementation efforts.

Author Contributions

Concept/idea/research design: E.H. Beisheim-Ryan, K.A. Butera, L.A. Hinrichs, D.L. Derlein, D.J. Malone, J.S. Holtrop, J.E. Forster, A.M. Gustavson, J.E. Stevens-Lapsley

Writing: E.H. Beisheim-Ryan, K.A. Butera, L.A. Hinrichs, D.L. Derlein, D.J. Malone, J.S. Holtrop, J.E. Forster, A.M. Gustavson, J.E. Stevens-Lapsley

Data collection: E.H. Beisheim-Ryan, K.A. Butera, D.L. Derlein, L.A. Hinrichs

Project management: E.H. Beisheim-Ryan, K.A. Butera, D.L. Derlein, D. Diedrich, A.M. Gustavson, J.E. Stevens-Lapsley

Fund procurement: A.M. Gustavson, J.E. Stevens-Lapsley

Providing facilities / equipment: J.E. Stevens-Lapsley

Providing institutional liaisons: J.E. Stevens-Lapsley

Consultation (including review of manuscript before submitting): E.H. Beisheim-Ryan, K.A. Butera, L.A. Hinrichs, D.L. Derlein, J.S. Holtrop, J.E. Forster, A.M. Gustavson, J.E. Stevens-Lapsley

Funding

This study was funded by a grant from the National Institute on Aging and Eunice Kennedy Shriver National Institute of Child Health and Human Development [R01AG072693]. E.H. Beisheim-Ryan and L.A. Hinrichs received funding from the VA Eastern Colorado Geriatric Research, Education, and Clinical Center Advanced Geriatrics Fellowship. K.A. Butera received funding from the National Institutes of Health/National Center for Advancing Translational Sciences and Colorado Clinical and Translational Science Award [TL1 TR002533]. J.S. Holtrop received funding from the National Institutes of Health and Patient-Centered Outcomes Research Institute; she is an unfunded mentor on grants from the National Institutes of Health, Agency for Healthcare Research and Quality, the United States Department of Veterans Affairs, and American Cancer Society. J.E. Forster received funding from the National Institutes of Health, the Department of Defense, and the United States Department of Veterans Affairs. A.M. Gustavson received funding from the Minneapolis Veterans Affairs Center of Innovation, Center for Care Delivery and Outcomes Research Pilot Grant [CIN 13–406], the National Institutes of Health [T32 AG000279], the Agency for Healthcare Research and Quality and Patient-Centered Outcomes Research Institute [K12HS026379], and the National Institutes of Health/National Center for Advancing Translational Sciences [KL2TR002492]. J.E. Stevens-Lapsley received funding from the National Institutes of Health and the United States Department of Veterans Affairs. The funders played no role in the design, conduct, or reporting of this study.

Ethics Approval

This protocol adheres to SPIRIT guidelines⁴⁴ and was approved by the Colorado Multiple Institutions Review Board (#20–3068); necessary changes will be conducted under their supervision and approval. Clinicians will provide informed consent prior to research participation, while a waiver of consent for patients has been approved. This study is registered with ClinicalTrials.gov (NCT05492240).

Clinical Trial Registration

This study was registered with ClinicalTrials.gov (NCT05492240).

Data Availability Statement

Anticipated study end date is Spring 2025. Data will be available from the corresponding author, J.E. Stevens-Lapsley, upon reasonable request, and following publication of the main study results.

Disclosures and Presentations

The authors completed the ICMJE Form for Disclosure of Potential Conflicts of Interest. D. Diedrich is affiliated with Aegis Therapies as a paid employee. There are no additional conflicts of interest to report.

The views expressed in this article are those of the authors and do not necessarily reflect the position or policy of the Department of Veterans Affairs, the United States government, or any other funding agencies previously listed.

E.H. Beisheim-Ryan presented the details of this protocol during a scientific presentation at the MR3 Network’s Second Annual Scientific Retreat, September 29–30, 2022, Zoom.