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Mindfulness-based interventions (MBIs) have been shown to improve chronic pain and associated conditions like depression, anxiety, and sleep disorders. However, there is limited research on how Veterans with chronic pain apply mindfulness skills to manage pain in daily life. This cross-sectional study examined the association between applied mindfulness practice, pain, and several pain-related conditions among 1,737 Veterans with chronic pain prior to enrollment in a trial of two MBIs. Applied mindfulness practice was assessed using the Applied Mindfulness Process Scale (AMPS). Outcomes included pain interference, pain intensity, pain catastrophizing, fatigue, sleep disturbance, anxiety, depression, PTSD, physical function, and social participation. Higher overall AMPS scores, as well as the positive and negative emotional regulation subscales of the AMPS, were associated with less pain interference and catastrophizing, as well as better outcomes for all pain-related conditions. The positive emotional regulation subscale had the strongest associations with outcomes. There was no significant association between the AMPS and pain intensity. Results suggest applied mindfulness practice, especially positive emotional regulation, may improve pain and functioning. In addition, the AMPS shows promise as a process measure of mindfulness skills applied in daily life. Additional research is needed to examine different aspects of mindfulness in the context of MBIs. PERSPECTIVE: This article describes the relationship between applied mindfulness practice and pain-related outcomes, prior to a mindfulness-based intervention, using a novel measure of mindfulness practice. These findings underscore the importance of measuring applied mindfulness practice prior to and during clinical interventions to treat chronic pain.
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OBJECTIVE: To assess the effects of an evidence-based family caregiver training program (implementation of Helping Invested Families Improve Veteran Experiences Study [iHI-FIVES]) in the Veterans Affairs healthcare system on Veteran days not at home and family caregiver well-being. DATA SOURCES AND STUDY SETTING: Participants included Veterans referred to home- and community-based services with an identified caregiver across 8 medical centers and confirmed family caregivers of eligible Veterans. STUDY DESIGN: In a stepped wedge cluster randomized trial, sites were randomized to a 6-month time interval for starting iHI-FIVES and received standardized implementation support. The primary outcome, number of Veteran "days not at home," and secondary outcomes, changes over 3 months in measures of caregiver well-being, were compared between pre- and post-iHI-FIVES intervals using generalized linear models including covariates. DATA COLLECTION/EXTRACTION METHODS: Patient data were extracted from the electronic health record. Caregiver data were collected from 2 telephone-based surveys. PRINCIPAL FINDINGS: Overall, n = 898 eligible Veterans were identified across pre-iHI-FIVES (n = 327) and post-iHI-FIVES intervals (n = 571). Just under one fifth (17%) of Veterans in post-iHI-FIVES intervals had a caregiver enroll in iHI-FIVES. Veteran and caregiver demographics in pre-iHI-FIVES intervals were similar to those in post-iHI-FIVES intervals. In adjusted models, the estimated rate of days not at home over 6-months was 42% lower (rate ratio = 0.58 [95% confidence interval: 0.31-1.09; p = 0.09]) post-iHI-FIVES compared with pre-iHI-FIVES. The estimated mean days not at home over a 6-month period was 13.0 days pre-iHI-FIVES and 7.5 post-iHI-FIVES. There were no differences between pre- and post-iHI-FIVES in change over 3 months in caregiver well-being measures. CONCLUSIONS: Reducing days not at home is consistent with effectiveness because more time at home increases quality of life. In this study, after adjusting for Veteran characteristics, we did not find evidence that implementation of a caregiver training program yielded a reduction in Veteran's days not at home.
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OBJECTIVE: To assess whether a team collaboration strategy (CONNECT) improves implementation outcomes of a family caregiver skills training program (iHI-FIVES). DATA SOURCES AND STUDY SETTING: iHI-FIVES was delivered to caregivers at eight Veterans Affairs (VA) medical centers. Data sources were electronic health records, staff surveys, and interviews. STUDY DESIGN: In a stepped wedge cluster randomized trial, sites were randomized to a 6-month time interval start date for iHI-FIVES launch. Sites were then randomized 1:1 to either (i) CONNECT, a team collaboration training strategy plus Replicating Effective Programs (REP), brief technical support training for staff, or (ii) REP only (non-CONNECT arm). Implementation outcomes included reach (proportion of eligible caregivers enrolled) and fidelity (proportion of expected trainings delivered). Staff interviews and surveys assessed team function including communication, implementation experience, and their relation to CONNECT and iHI-FIVES implementation outcomes. DATA COLLECTION/EXTRACTION METHODS: The sample for assessing implementation outcomes included 571 Veterans referred to VA home- and community-based services and their family caregivers eligible for iHI-FIVES. Prior to iHI-FIVES launch, staff completed 65 surveys and 62 interviews. After the start of iHI-FIVES, staff completed 52 surveys and 38 interviews. Mixed methods evaluated reach and fidelity by arm. PRINCIPAL FINDINGS: Fidelity was high overall with 88% of expected iHI-FIVES trainings delivered, and higher among REP only (non-CONNECT) compared with CONNECT sites (95% vs. 80%). Reach was 18% (average proportion of reach across eight sites) and higher among non-CONNECT compared with CONNECT sites (22% vs. 14%). Qualitative interviews revealed strong leadership support at high-reach sites. CONNECT did not influence self-reported team function. CONCLUSIONS: A team collaboration strategy (CONNECT), added to REP, required more resources to implement iHI-FIVES than REP only and did not substantially enhance reach or fidelity. Leadership support was a key condition of implementation success and may be an important factor for improving iHI-FIVES reach with national expansion.
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OBJECTIVE: To examine the relationship between site-level adaptation and early adoption of Caregivers Finding Important Resources, Support, and Training (FIRST) training during national implementation across diverse Veteran Health Administration (VA) medical centers. DATA SOURCES AND STUDY SETTING: We enrolled and evaluated 25 VA medical centers (VAMCs). Along with administrative data on site characteristics, we examined site-reported data on adaptations and intervention adoption, defined as ≥4 training classes delivered to ≥5 caregivers at 6 months from April through October 2022. STUDY DESIGN: A type III hybrid implementation-effectiveness cluster randomized controlled trial, randomized VAMCs 1:1 to receive foundational (low-touch) implementation support (n = 12) or the addition of enhanced (high-touch) implementation support (n = 13). DATA COLLECTION/EXTRACTION METHODS: At key implementation phases, VAMCs were asked to report adaptations including content, contextual modifications (format, setting, personnel, and population), and training of providers. We describe site-level adaptations by arm and by organizational characteristics that included VAMC complexity level, staffing, rurality, and organizational readiness to change. We used qualitative comparative analysis to identify unique adaptations that contributed to intervention adoption at 6 months. PRINCIPAL FINDINGS: VAMCs randomized to receive enhanced support reported slightly more adaptations than those randomized to foundational support. At 6 months, VAMCs with two or more adaptations adopted Caregivers FIRST at a higher rate than those with fewer adaptations (90% vs. 44%). Staffing adaptations (e.g., who delivered the intervention), format and content (e.g., modified delivery pace), and referring provider training were unique adaptations to adopting sites. CONCLUSIONS: Site-level adaptations were diverse and occurred more frequently in sites with early adoption of Caregivers FIRST. Future research should identify best practices of supporting and monitoring intervention adaptation. Understanding the role of adaptation in early adoption success could assist other healthcare systems in implementing interventions for caregivers.
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INTRODUCTION: The timely translation of evidence-based programs into real-world clinical settings is a persistent challenge due to complexities related to organizational context and team function, particularly in inpatient settings. Strategies are needed to promote quality improvement efforts and implementation of new clinical programs. OBJECTIVE: This study examines the role of CONNECT, a complexity science-based implementation intervention to promote team readiness, for enhancing implementation of the 'Assisted Early Mobility for Hospitalized Older Veterans' program (STRIDE), an inpatient, supervised walking program. DESIGN: We conducted a stepped-wedge cluster randomized trial using a convergent mixed-methods design. Within each randomly assigned stepped-wedge sequence, Veterans Affairs Medical Centers (VAMCs) were randomized to receive standardized implementation support only or additional training via the CONNECT intervention. Data for the study were obtained from hospital administrative and electronic health records, surveys, and semi-structured interviews with clinicians before and after implementation of STRIDE. SETTING: Eight U.S. VAMCs. PARTICIPANTS: Three hundred fifty-three survey participants before STRIDE implementation and 294 surveys after STRIDE implementation. Ninety-two interview participants. INTERVENTION: CONNECT, a complexity-science-based intervention to improve team function. MAIN OUTCOME MEASURES: The implementation outcomes included STRIDE reach and fidelity. Secondary outcomes included validated measures of team function (i.e., team communication, coordination, role clarity). RESULTS: At four VAMCs randomized to CONNECT, reach was higher (mean 12.4% vs. 3.8%), and fidelity was similar to four non-CONNECT VAMCs. VAMC STRIDE delivery teams receiving CONNECT reported improvements in team function domains, similar to non-CONNECT VAMCs. Qualitative findings highlight CONNECT's impact and the influence of team characteristics and contextual factors, including team cohesion, leadership support, and role clarity, on reach and fidelity. CONCLUSION: CONNECT may promote greater reach of STRIDE, but improvement in team function among CONNECT VAMCs was similar to improvement among non-CONNECT VAMCs. Qualitative findings suggest that CONNECT may improve team function and implementation outcomes but may not be sufficient to overcome structural barriers related to implementation capacity.
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BACKGROUND: There is increasing recognition of the importance of maximizing program-setting fit in scaling and spreading effective programs. However, in the context of hospital-based mobility programs, there is limited information on how settings could consider local context and modify program characteristics or implementation activities to enhance fit. To fill this gap, we examined site-initiated adaptations to STRIDE, a hospital-based mobility program for older Veterans, at eight Veterans Affairs facilities across the United States. METHODS: STRIDE was implemented at eight hospitals in a stepped-wedge cluster randomized trial. During the pre-implementation phase, sites were encouraged to adapt program characteristics to optimize implementation and align with their hospital's resources, needs, and culture. Recommended adaptations included those related to staffing models, marketing, and documentation. To assess the number and types of adaptations, multiple data sources were reviewed, including implementation support notes from site-level support calls and group-based learning collaborative sessions. Adaptations were classified based on the Framework for Reporting Adaptations and Modifications-Enhanced (FRAME), including attention to what was adapted, when, why, and by whom. We reviewed the number and types of adaptations across sites that did and did not sustain STRIDE, defined as continued program delivery during the post-implementation period. RESULTS: A total of 25 adaptations were reported and classified across seven of the eight sites. Adaptations were reported across five areas: program documentation (n = 13), patient eligibility criteria (n = 5), program enhancements (n = 3), staffing model (n = 2), and marketing and recruitment (n = 2). More than one-half of adaptations were planned. Adaptations were common in both sustaining and non-sustaining sites. CONCLUSIONS: Adaptations were common within a program designed with flexible implementation in mind. Identifying common areas of planned and unplanned adaptations within a flexible program such as STRIDE may contribute to more efficient and effective national scaling. Future research should evaluate the relationship between adaptations and program implementation.
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BACKGROUND: Recruitment for clinical trials and large-scale studies is challenging, especially for patients with complex conditions like chronic pain. Email recruitment has the potential to increase efficiency, to reduce costs, and to improve access for underrepresented patient populations. The objective of this study was to examine the effectiveness, efficiency, and equitability of email versus postal mail recruitment for the Learning to Apply Mindfulness to Pain (LAMP) study, a three-site clinical trial of mindfulness-based interventions for chronic pain. METHODS: Patients with chronic pain diagnoses were recruited from three United States Department of Veterans Affairs (VA) facilities using the VA electronic health record (EHR). Recruitment materials were sent using either postal mail (n = 7986) or email (n = 19,333). Patients in the email recruitment group were also mailed introductory postcards before any emails. Mailing addresses and email addresses were obtained from the EHR. Effectiveness was measured by the response rate of patients who logged into the secure LAMP study website. Efficiency was measured by the number of days from when the recruitment materials were sent to when patients logged into the LAMP portal as well as the estimated costs of each recruitment approach. To assess equitability, we examined whether email recruitment was less effective for underrepresented populations, based on demographic information from the EHR. RESULTS: Effectiveness-unadjusted response rates were greater for email versus postal-mail recruitment (18.9% versus 6.3%), and adjusted response rates were over three times greater for email recruitment (RR = 3.5, 95% CI 3.1-3.8) based on a multivariable analysis controlling for age, gender, race, ethnicity, rurality, and site. Efficiency-email recruitment had a significantly lower mean response time (1 day versus 8 days) and a lower cost. Equity-email recruitment led to higher response rates for all subpopulations, including older, non-White, Hispanic, rural, and female Veterans. CONCLUSIONS: Email recruitment is an effective, efficient, and equitable way to recruit VA patients to large-scale, chronic pain clinical trials. TRIAL REGISTRATION: Clinical Trial Registration Number: NCT04526158. Patient enrollment began on December 4, 2020.
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Dolor Crónico , Correo Electrónico , Selección de Paciente , Humanos , Dolor Crónico/terapia , Dolor Crónico/diagnóstico , Femenino , Masculino , Persona de Mediana Edad , Estados Unidos , Anciano , United States Department of Veterans Affairs , Registros Electrónicos de Salud , Servicios Postales , AdultoRESUMEN
OBJECTIVE: The aims of this scoping review were to summarize the evidence regarding sex, racial, ethnic, geographic, and socioeconomic disparities in post-acute rehabilitation following total hip arthroplasty (THA) and knee arthroplasty (TKA). METHODS: Literature searches were conducted in Ovid MEDLINE, EMBASE, CINAHL, Web of Science, and PEDro. Studies were included if they were original research articles published 1993 or later; used data from the US; included patients after THA and/or TKA; presented results according to relevant sociodemographic variables, including sex, race, ethnicity, geography, or socioeconomic status; and studied utilization of post-acute rehabilitation as an outcome. RESULTS: Twelve studies met the inclusion criteria. Five examined disparities in inpatient rehabilitation and found that Black patients and women experience longer lengths of stay after arthroplasty, and women are less likely than men to be discharged home after inpatient THA rehabilitation. Four studies examined data from skilled nursing facilities and found that insurance type and dual eligibility impact length of stay and rates of community discharge but found conflicting results regarding racial disparities in skilled nursing facility utilization after TKA. Five studies examined home health data and noted that rural agencies provide less care after TKA. Results regarding racial disparities in home health utilization after arthroplasty were conflicting. Six studies of outpatient rehabilitation noted geographic differences in timing of outpatient rehabilitation but mixed results regarding race differences in outpatient rehabilitation. CONCLUSION: Current evidence indicates that sex, race, ethnicity, geography, and socioeconomic status are associated with disparities in post-acute rehabilitation use after arthroplasty. IMPACT: Rehabilitation providers across the post-acute continuum should be aware of disparities in the population of patients after arthroplasty and regularly assess social determinants of health and other factors that may contribute to disparities. Customized care plans should ensure optimal timing and amount of rehabilitation is provided, and advocate for patients who need additional care to achieve the desired functional outcome.
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Background: Family caregivers are family members or friends of care recipients who assist with activities of daily living, medication management, transportation, and help with finances among other activities. As a result of their caregiving, family caregivers are often considered a population at risk of experiencing increased stress, isolation, and loneliness. During the COVID-19 pandemic in the US, social isolation and decrease in social activities were a top concern among older adults and their family caregivers. Using secondary analysis of survey data as part of a multi-site implementation trial of a caregiver skills training program, we describe differences in caregiver experiences of loneliness before and during the COVID-19 pandemic. Methods: Health and wellbeing surveys of family caregivers were collected on 422 family caregivers of veterans before and during COVID-19. Logistic regression modeling examined whether the loneliness differed between caregiver groups pre vs during COVID-19, using the UCLA 3-item loneliness measure. Rapid directed qualitative content analysis of open-ended survey questions was used to explore the context of how survey responses were affected by the COVID-19 pandemic. Results: There were no significant differences in loneliness between caregivers pre vs during COVID-19. In open-ended responses regarding effects of COVID-19, caregivers described experiencing loneliness and social isolation; why they were unaffected by the pandemic; and how caregiving equipped them with coping strategies to manage negative pandemic-related effects. Conclusion: Loneliness did not differ significantly between pre vs during COVID-19 caregivers. Future research could assess what specific characteristics are associated with caregivers who have resiliency, and identify caregivers who are more susceptible to experiencing loneliness. Understanding caregiver loneliness could assist other healthcare systems in developing and implementing caregiver support interventions.
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BACKGROUND: Post-traumatic stress disorder (PTSD) and chronic pain are highly prevalent comorbid conditions. Veterans dually burdened by PTSD and chronic pain experience more severe outcomes compared to either disorder alone. Few studies have enrolled enough women Veterans to test gender differences in pain outcomes [catastrophizing, intensity, interference] by the severity of PTSD symptoms. AIM: Examine gender differences in the association between PTSD symptoms and pain outcomes among Veterans enrolled in a chronic pain clinical trial. METHODS: Participants were 421 men and 386 women Veterans with chronic pain who provided complete data on PTSD symptoms and pain outcomes. We used hierarchical linear regression models to examine gender differences in pain outcomes by PTSD symptoms. RESULTS: Adjusted multivariable models indicated that PTSD symptoms were associated with higher levels of pain catastrophizing (0.57, 95% CI [0.51, 0.63]), pain intensity (0.30, 95% CI [0.24, 0.37]), and pain interference (0.46, 95% CI [0.39, 0.52]). No evidence suggesting gender differences in this association were found in either the crude or adjusted models (all interaction p-values<0.05). CONCLUSION: These findings may reflect the underlying mutual maintenance of these conditions whereby the sensation of pain could trigger PTSD symptoms, particularly if the trauma and pain are associated with the same event. Clinical implications and opportunities testing relevant treatments that may benefit both chronic pain and PTSD are discussed.
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Dolor Crónico , Trastornos por Estrés Postraumático , Veteranos , Humanos , Trastornos por Estrés Postraumático/psicología , Trastornos por Estrés Postraumático/epidemiología , Femenino , Masculino , Persona de Mediana Edad , Veteranos/psicología , Dolor Crónico/psicología , Índice de Severidad de la Enfermedad , Adulto , Anciano , Factores Sexuales , Catastrofización/psicología , Dimensión del Dolor , Caracteres SexualesRESUMEN
OBJECTIVE: Translation of knee osteoarthritis (KOA) clinical practice guidelines (CPGs) to practice remains suboptimal. The primary purpose of this systematic review was to describe the use of implementation strategies to promote KOA CPG-recommended care. METHODS: Medline (via PubMed), Embase, CINAHL, and Web of Science were searched from inception to February 23, 2023, and the search was subsequently updated and expanded on January 16, 2024. Implementation strategies were mapped per the Expert Recommendations for Implementing Change taxonomy. Risk of bias (RoB) was assessed using the Cochrane Effective Practice and Organisation of Care criteria. The review was registered prospectively (PROSPERO identifier: CRD42023402383). RESULTS: Nineteen studies were included in the final review. All (100% [n = 4]) studies that included the domains of "provide interactive assistance," "train and educate stakeholders" (89% [n = 16]), "engage consumers" (87% [n = 13]), and "support clinicians" (79% [n = 11]) showed a change to provider adherence. Studies that showed a change to disability included the domains of "train and educate stakeholders," "engage consumers," and "adapt and tailor to context." Studies that used the domains "train and educate stakeholders," "engage consumers," and "support clinicians" showed a change in pain and quality of life. Most studies had a low to moderate RoB. CONCLUSION: Implementation strategies have the potential to impact clinician uptake of CPGs and patient-reported outcomes. The implementation context, using an active learning strategy with a patient partner, restructuring funding models, and integrating taxonomies to tailor multifaceted strategies should be prioritized. Further experimental research is recommended to determine which implementation strategies are most effective.
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Objective: Walk With Ease (WWE) is an effective low-cost walking program. We estimated the budget impact of implementing WWE in persons with knee osteoarthritis (OA) as a measure of affordability that can inform payers' funding decisions. Methods: We estimated changes in two-year healthcare costs with and without WWE. We used the Osteoarthritis Policy (OAPol) Model to estimate per-person medical expenditures. We estimated total and per-member-per-month (PMPM) costs of funding WWE for a hypothetical insurance plan with 75,000 members under two conditions: 1) all individuals aged 45+ with knee OA eligible for WWE, and 2) inactive and insufficiently active individuals aged 45+ with knee OA eligible. In sensitivity analyses, we varied WWE cost and efficacy and considered productivity costs. Results: With eligibility unrestricted by activity level, implementing WWE results in an additional $1,002,408 to the insurance plan over two years ($0.56 PMPM). With eligibility restricted to inactive and insufficiently active individuals, funding WWE results in an additional $571,931 over two years ($0.32 PMPM). In sensitivity analyses, when per-person costs of $10 to $1000 were added with 10-50% decreases in failure rate (enhanced sustainability of WWE benefits), two-year budget impact varied from $242,684 to $6,985,674 with unrestricted eligibility and from -$43,194 (cost-saving) to $4,484,122 with restricted eligibility. Conclusion: Along with the cost-effectiveness of WWE at widely accepted willingness-to-pay thresholds, these results can inform payers in deciding to fund WWE. In the absence of accepted thresholds to define affordability, these results can assist in comparing the affordability of WWE with other behavioral interventions.
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OBJECTIVE: To conduct a business case analysis for Department of Veterans Affairs (VA) program STRIDE (ASsisTed EaRly MobIlization for hospitalizeD older VEterans), which was designed to address immobility for hospitalized older adults. DATA SOURCES AND STUDY SETTING: This was a secondary analysis of primary data from a VA 8-hospital implementation trial conducted by the Function and Independence Quality Enhancement Research Initiative (QUERI). In partnership with VA operational partners, we estimated resources needed for program delivery in and out of the VA as well as national implementation facilitation in the VA. A scenario analysis using wage data from the Bureau of Labor Statistics informs implementation decisions outside the VA. STUDY DESIGN: This budget impact analysis compared delivery and implementation costs for two implementation strategies (Replicating Effective Programs [REP]+CONNECT and REP-only). To simulate national budget scenarios for implementation, we estimated the number of eligible hospitalizations nationally and varied key parameters (e.g., enrollment rates) to evaluate the impact of uncertainty. DATA COLLECTION: Personnel time and implementation outcomes were collected from hospitals (2017-2019). Hospital average daily census and wage data were estimated as of 2022 to improve relevance to future implementation. PRINCIPAL FINDINGS: Average implementation costs were $9450 for REP+CONNECT and $5622 for REP-only; average program delivery costs were less than $30 per participant in both VA and non-VA hospital settings. Number of walks had the most impact on delivery costs and ranged from 1 to 5 walks per participant. In sensitivity analyses, cost increased to $35 per participant if a physical therapist assistant conducts the walks. Among study hospitals, mean enrollment rates were higher among the REP+CONNECT hospitals (12%) than the REP-only hospitals (4%) and VA implementation costs ranged from $66 to $100 per enrolled. CONCLUSIONS: STRIDE is a low-cost intervention, and program participation has the biggest impact on the resources needed for delivering STRIDE. TRIAL REGISTRATION: ClinicalsTrials.gov NCT03300336. Prospectively registered on 3 October 2017.
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Background: Although studies have documented higher rates of chronic pain among women Veterans compared to men Veterans, there remains a lack of comprehensive information about potential contributors to these disparities. Materials and Methods: This study examined gender differences in chronic pain and its contributors among 419 men and 392 women Veterans, enrolled in a mindfulness trial for chronic pain. We conducted descriptive analyses summarizing distributions of baseline measures, obtained by survey and through the electronic health record. Comparisons between genders were conducted using chi-square tests for categorical variables and t-tests for continuous measures. Results: Compared to men, women Veterans were more likely to have chronic overlapping pain conditions and had higher levels of pain interference and intensity. Women had higher prevalence of psychiatric and sleep disorder diagnoses, greater levels of depression, anxiety, post-traumatic stress disorder, fatigue, sleep disturbance, stress and pain catastrophizing, and lower levels of pain self-efficacy and participation in social roles and activities. However, women were less likely to smoke or have a substance abuse disorder and used more nonpharmacological pain treatment modalities. Conclusion: Among Veterans seeking treatment for chronic pain, women differed from men in their type of pain, had greater pain intensity and interference, and had greater prevalence and higher levels of many known biopsychosocial contributors to pain. Results point to the need for pain treatment that addresses the comprehensive needs of women Veterans.Clinical Trial Registration Number: NCT04526158. Patient enrollment began on December 4, 2020.
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OBJECTIVE: To evaluate the impact of physical rehabilitation interventions, supplemented with one or more adherence-enhancing components, on outcomes among adults with hip or knee osteoarthritis or chronic lower back pain. DESIGN: Primary literature search from inception of each database to July 27, 2021, guided by relevant search terms and keywords to search titles and abstracts. All articles meeting eligibility criteria were included for data abstraction. DATA SOURCES: MEDLINE, CINAHL Complete, and Embase. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Randomized and nonrandomized trials evaluating adherence-focused intervention components conducted in addition to an index usual care or usual care-like physical rehabilitation program among adults with hip or knee osteoarthritis or chronic low back pain. Eligible studies included a comparator group of the same index physical rehabilitation intervention without the adjunctive adherence components. Included studies measured outcomes at least 3 months after the rehabilitation course. RESULTS: Of the 10 studies meeting inclusion criteria, 6 interventions were delivered concurrent to an index rehabilitation program and 4 were delivered sequentially. Of the 3 studies that reported a positive effect on long-term adherence, only 1 was a low risk of bias study. There is very limited evidence of a beneficial treatment effect of adjunct adherence interventions on long-term physical function, self-efficacy, or adverse events. CONCLUSION: We found inadequate evidence evaluating adherence-enhancing interventions for the specific promotion of long-term adherence to home rehabilitation programs. Future studies should consider testing interventions specifically built to target behavioral maintenance of home rehabilitation programs.
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BACKGROUND: STRIDE is a supervised walking program designed to address the negative consequences of immobility during hospitalization for older adults. In an 8-hospital stepped wedge randomized controlled trial, STRIDE was associated with reduced odds of hospital discharge to skilled nursing facility. STRIDE has the potential to become a system-wide approach to address hospital-associated disability in Veteran's Affairs; however, critical questions remain about how best to scale and sustain the program. The overall study goal is to compare the impact of two strategies on STRIDE program penetration (primary), fidelity, and adoption implementation outcomes. METHODS: Replicating Effective Programs will be used as a framework underlying all implementation support activities. In a parallel, cluster randomized trial, we will use stratified blocked randomization to assign hospitals (n = 32) to either foundational support, comprised of standard, low-touch activities, or enhanced support, which includes the addition of tailored, high-touch activities if hospitals do not meet STRIDE program benchmarks at 6 and 8 months following start date. All hospitals begin with foundational support for 6 months until randomization occurs. The primary outcome is implementation penetration defined as the proportion of eligible hospitalizations with ≥ 1 STRIDE walks at 10 months. Secondary outcomes are fidelity and adoption with all implementation outcomes additionally examined at 13 and 16 months. Fidelity will be assessed for STRIDE hospitalizations as the percentage of eligible hospital days with "full dose" of the program, defined as two or more documented walks or one walk for more than 5 min. Program adoption is a binary outcome defined as ≥ 5 patients with a STRIDE walk or not. Analyses will also include patient-level effectiveness outcomes (e.g., discharge to nursing home, length of stay) and staffing and labor costs. We will employ a convergent mixed-methods approach to explore and understand pre-implementation contextual factors related to differences in hospital-level adoption. DISCUSSION: Our study results will dually inform best practices for promoting successful implementation of an evidence-based hospital-based walking program. This information may support other programs by advancing our understanding of how to apply and scale-up national implementation strategies. TRIAL REGISTRATION: This study was registered on June 1, 2021, at ClinicalTrials.gov (identifier NCT04868656 ).