Jesús Díaz OTD, OTR/L

Background. Type 1 diabetes (T1D) is a chronic condition affecting nearly 1.9 million people in the United States. Young adults (YAs) with T1D face unique challenges in managing their condition, experiencing poorer health and well-being than other age groups. The current study is evaluating the Resilient, Empowered, Active Living (REAL) intervention, previously shown to improve glucose levels and quality of life among YAs with diabetes, using telehealth delivery (REAL-T) to expand reach and accessibility. This paper reports on the methodology and baseline participant characteristics of the REAL-T study.

Methods. REAL-T is a two-arm randomized controlled trial that recruited 18–30 year olds with T1D via clinics and social media advertising. Data collection, which was adapted to be fully remote due to COVID-19, occurs every three months for one year. Participants receive either usual care or a 6-month telehealth occupational therapy intervention. The primary outcome is glycated hemoglobin (A1c); secondary outcomes include diabetes distress, quality of life, and continuous glucose monitor-derived measures.

Results. The study enrolled a diverse sample of 209 YAs with T1D. Analysis of baseline data indicates equivalence between the intervention and control groups. Study participants have notably higher diabetes distress and poorer mental well-being than similar populations.

Conclusion. The REAL-T study successfully adapted to remote implementation during the COVID-19 pandemic. By examining long-term outcomes, mediating pathways, and cost-effectiveness, the study will contribute knowledge of the impact of tailored interventions for YAs with T1D, designed to reduce disparities and improve health and well-being in this population.

Telehealth delivery of Lifestyle Redesign®, an occupational therapy intervention framework addressing health and quality of life among people with chronic conditions, is understudied. The objective of this study was to evaluate the effectiveness, satisfaction, and engagement of telehealth Lifestyle Redesign for young adults with diabetes. Using process data from two randomized controlled trials, we compared in-person and telehealth intervention effects. Among telehealth clients, effectiveness was assessed using pre-post changes in occupational performance, occupational satisfaction, and health management; a survey captured telehealth satisfaction. Attendance and engagement in in-person versus telehealth therapy were compared. Preliminary results indicate telehealth clients had significant increases in occupational performance, occupational satisfaction, and health management (all p < .02), and high levels of telehealth satisfaction. Intervention engagement (p = .59) and attendance (p = .42) were similar across treatment modalities. Telehealth delivery of Lifestyle Redesign occupational therapy is feasible and potentially efficacious, and continued advocacy is needed to ensure access to occupational therapy through telehealth.

This chapter will address diabetes and the related issues that the occupational therapy practitioner can address in primary care. The chapter will outline the basic role of the primary care physician, as well as the evaluation techniques and intervention strategies employed by the occupational therapy practitioner.

This chapter presents findings from a study analyzing occupational therapy intervention outcomes to elucidate the relationship between lifestyle changes and pressure ulcer development. The complexities of lifestyle and behavior changes contributed to different patterns which impacted the development and progression of pressure ulcers. The four identified patterns included positive pressure ulcer changes accompanied by positive lifestyle and behavior changes, negative or no pressure ulcer changes accompanied by positive lifestyle and behavior changes, positive pressure ulcer changes accompanied by minor or no lifestyle or behavior changes, and negative or no pressure ulcer changes accompanied by minor or no lifestyle changes. Community-based occupational therapy practice provides an opportunity to comprehensively address important lifestyle factors impacting pressure ulcer development.

Keywords. occupational therapy, lifestyle, behavior, pressure ulcer, community-based practice

Background/Aims. Research is needed to identify promising recruitment strategies to reach and engage diverse young adults in diabetes clinical research. The aim of this study was to examine the relative strengths and weaknesses of three recruitment strategies used in a diabetes self-management clinical trial: social media advertising (Facebook), targeted mailing, and in-person solicitation of clinic patients.

Methods. Strategies were compared in terms of (1) cost-effectiveness (i.e. cost of recruitment/number of enrolled participants), (2) ability to yield participants who would not otherwise be reached by alternative strategies, and (3) likelihood of participants recruited through each strategy to adhere to study procedures. We further explored the appeal (overall and among age and gender subgroups) of social media advertisement features.

Results. In-person recruitment of clinic patients was overall the most cost-effective strategy. However, differences in demographic, clinical, and psychosocial characteristics of participants recruited via different strategies suggest that the combination of these approaches yielded a more diverse sample than would any one strategy alone. Once successfully enrolled, there was no difference in study completion and intervention adherence between individuals recruited by the three recruitment strategies.

Conclusions. Ultimately, the utility of a recruitment strategy is defined by its ability to effectively attract people representative of the target population who are willing to enroll in and complete the study. Leveraging a variety of recruitment strategies appears to produce a more representative sample of young adults, including those who are less engaged in diabetes care.

Purpose. Medically underserved adults with spinal cord injury (SCI) remain at high risk of incurring medically serious pressure injuries even after receiving education in prevention techniques. The purpose of this research is to identify circumstances leading to medically serious pressure injury development in medically underserved adults with SCI during a lifestyle-based pressure injury prevention program, and provide recommendations for future rehabilitation approaches and intervention design.

Methods. This study entailed a qualitative secondary case analysis of treatment notes from a randomized controlled trial. Participants were 25 community-dwelling, medically underserved adults with SCI who developed medically serious pressure injuries during the course of the intervention of the RCT.

Results and conclusions. Among the 25 participants, 40 unique medically serious pressure injuries were detected. The six themes related to medically serious pressure injury development were: (1) lack of rudimentary knowledge pertaining to wound care; (2) equipment and supply issues; (3) comorbidities; (4) non-adherence to prescribed bed rest; (5) inactivity; and (6) circumstances beyond the intervention’s reach. Together, these factors may have undermined the effectiveness of the intervention program. Modifications, such as assessing health literacy levels of patients prior to providing care, providing tailored wound care education, and focusing on equipment needs, have potential for altering future rehabilitation programs and improving health outcomes.

Keywords. Spinal cord injuries, pressure injury, lifestyle, intervention, cultural diversity

Importance. Primary health care is rapidly developing as an occupational therapy practice area. Yet, to date, little evidence supports occupational therapy’s feasibility and efficacy in primary care settings.

Objective. To report on the implementation and preliminary clinical outcomes of a Lifestyle Redesign® (LR)–occupational therapy (LR–OT) diabetes management intervention in a primary care clinic.

Design. Patients were randomized to be offered LR–OT or to a no-contact comparison group (data not reported). We assessed implementation outcomes using mixed methods.

Setting. Safety-net primary care clinic.

Participants. Clinic providers and staff; English- or Spanish-speaking clinic patients ages 18–75 yr with diabetes and a current hemoglobin A1c (HbA1c) ≥ 9.0%.

Intervention. Eight 1-hr individual sessions of LR–OT focused on diabetes management.

Outcomes and Measures. Clinical and health behavior outcomes were assessed via electronic medical record (EMR) review and self-report surveys of patients receiving LR–OT at initial evaluation and discharge. We assessed implementation outcomes (acceptability, appropriateness, feasibility, fidelity, efficiency, and timeliness) using patient and staff surveys, interviews, focus groups, and observations.

Results. Seventy-three patients were offered LR–OT: 51 completed one or more sessions, and 38 completed the program. Clinical outcomes among program completers indicate beneficial changes in HbA1c, diabetes self-care, and health status. Implementation challenges included a need for patient and staff education, securing adequate workspace, and establishing a referral process. Factors contributing to implementation success included strong buy-in from clinic leadership, colocation, and shared EMR documentation.

Conclusions and Relevance. LR–OT is a feasible approach to enhancing service delivery and clinical outcomes in primary care.

What This Article Adds. This study provides insight into factors that may create challenges or contribute to the success of implementing occupational therapy services within primary health care settings. In addition, this study provides preliminary evidence of occupational therapy’s effectiveness in improving clinical outcomes among ethnically diverse, low-income patients with diabetes in a safety-net primary care setting.

Background. Pressure injuries negatively impact quality of life and participation for individuals with spinal cord injury (SCI).

Objective. To examine the factors that may protect against the development of medically serious pressure injuries in adults with SCI.

Methods. A qualitative analysis was conducted using treatment notes regarding 50 socioeconomically disadvantaged individuals who did not develop medically serious pressure injuries during a 12-month pressure injury prevention intervention program.

Results. Eight types of potentially protective factors were identified: meaningful activity, motivation to prevent negative health outcomes, stability/resources, equipment, communication and self-advocacy skills, personal traits, physical factors, and behaviors/activities.

Conclusions. Some protective factors (e.g., personal traits) may be inherent to certain individuals and nonmodifiable. However, future interventions for this population may benefit from a focus on acquisition of medical equipment and facilitation of sustainable, health-promoting habits and routines. Substantive policy changes may be necessary to facilitate access to adequate resources, particularly housing and equipment, for socioeconomically disadvantaged individuals with SCI. Further research is needed to understand the complex interplay of risk and protective factors for pressure injuries in adults with SCI, particularly in underserved groups.

Context/Objective. Medically serious pressure injuries (MSPrIs), a common complication of spinal cord injury (SCI), have devastating consequences on health and well-being and are extremely expensive to treat. We aimed to test the efficacy of a lifestyle-based intervention designed to reduce incidence of MSPrIs in adults with SCI.

Design. A randomized controlled trial (RCT), and a separate study wing involving a nonrandomized standard care control group.

Setting. Rancho Los Amigos National Rehabilitation Center, a large facility serving ethnically diverse, low income residents of Los Angeles County.

Participants. Adults with SCI, with history of one or more MSPrIs over the past 5 years: N=166 for RCT component, N=66 in nonrandomized control group.

Interventions. The Pressure Ulcer Prevention Program, a 12-month lifestyle-based treatment administered by healthcare professionals, largely via in-home visits and phone contacts.

Outcome Measures. Blinded assessments of annualized MSPrI incidence rates at 12 and 24 months, based on: skin checks, quarterly phone interviews with participants, and review of medical charts and billing records. Secondary outcomes included number of surgeries and various quality-of-life measures.

Results. Annualized MSPrI rates did not differ significantly between study groups. At 12 months, rates were .56 for intervention recipients, .48 for randomized controls, and .65 for nonrandomized controls. At follow-up, rates were .44 and .39 respectively for randomized intervention and control participants.

Conclusions. Evidence for intervention efficacy was inconclusive. The intractable nature of MSPrI threat in high-risk SCI populations, and lack of statistical power, may have contributed to this inability to detect an effect.

Trial Registration. ClinicalTrials.gov NCT01999816.

Objective. To assess the efficacy of a manualized occupational therapy (OT) intervention (Resilient, Empowered, Active Living with Diabetes [REAL Diabetes]) to improve glycemic control and psychosocial well-being among ethnically diverse young adults with low socioeconomic status (SES) who have type 1 or type 2 diabetes.

Research Design and Methods. Eighty-one young adults (age 22.6 ± 3.5 years; hemoglobin A_1c [HbA_1c] = 10.8%/95 mmol/mol ± 1.9%/20.8 mmol/mol) were randomly assigned to the REAL Diabetes intervention group (IG) or an attention control group (CG) over 6 months. IG participants received biweekly sessions guided by a manual composed of seven content modules; CG participants received standardized educational materials and biweekly phone calls. Blinded assessors collected data at baseline and 6 months. The primary outcome was HbA_1c; secondary outcomes included diabetes self-care, diabetes-related quality of life (QOL), diabetes distress, depressive symptoms, and life satisfaction. Change scores were analyzed using Wilcoxon rank sum tests.

Results. Intent-to-treat analyses showed that IG participants showed significant improvement in HbA_1c (-0.57%/6.2 mmol/mol vs. +0.36%/3.9 mmol/mol, P = 0.01), diabetes-related QOL (+0.7 vs. +0.15, P = 0.04), and habit strength for checking blood glucose (+3.9 vs. +1.7, P = 0.05) as compared with CG participants. There was no statistically significant effect modification by sex, ethnicity, diabetes type, recruitment site, or SES. No study-related serious adverse events were reported.

Conclusions. The REAL Diabetes intervention improved blood glucose control and diabetes-related QOL among a typically hard-to-reach population, thus providing evidence that a structured OT intervention may be beneficial in improving both clinical and psychosocial outcomes among individuals with diabetes.

This paper describes the case of an after-school program, focused on providing enrichment opportunities for neighborhood youth, jointly administered through an academic division and residential community within a large urban research university. The program, originally conceived as an activity-based after-school program for middle school youth, expanded in scope in response to both community and student needs. The resident faculty fellow in this community served as a liaison between the academic division and office of residential education, helping maintain continuity and facilitating effective student leadership of the program. In this case, we detail the origins and evolution of the program, including strategies used to resolve challenges that arose over several years of program implementation.

Objective. Prior research has documented caregiving difficulties in families of children with autism spectrum disorder (ASD). However, Latino families may encounter unique challenges. The purpose of this study was to understand the caregiving experiences of Latino families with children with ASD, including daily activities, coping strategies, and service utilization.

Method. Fifteen Latino parents of children with ASD were interviewed. The interviews were transcribed for analysis to identify themes of experiences unique to this population.

Results. Latino families of children with ASD encounter many similar issues as non-Latino families but also unique issues that affect service utilization. Four themes were identified: dealing with the diagnosis, dealing with stigma and isolation from family and community, understanding the role of mothers in changing family routines, and utilizing services.

Conclusion. To meet the unique needs of Latino families, services need to be provided in culturally sensitive context that address children's needs within family units.

Implementation into real-world practice of interventions previously studied in randomized controlled trials is an ongoing challenge. In this article, we describe the methodology we used for the first phase of a project for the implementation and outcomes assessment of an occupational therapy pressure ulcer prevention intervention for people with spinal cord injury in the Veterans Health Administration. This first phase of the project was guided by practice-based evidence research methodology and resulted in an intervention manual tailored to meet the needs of Veterans and the establishment of a system for documenting and monitoring care processes, patient characteristics, and intervention outcomes. This system, in turn, will provide the data-gathering template for the next phase in which the beneficial effects of the intervention will be assessed. We conclude by recommending that clinicians explore the utility of this approach for the implementation of other novel interventions.

Background. Randomized trials of complex, non-pharmacologic interventions implemented in home and community settings, such as the University of Southern California (USC)-Rancho Los Amigos National Rehabilitation Center (RLANRC) Pressure Ulcer Prevention Study (PUPS), present unique challenges with respect to (1) participant recruitment and retention, (2) intervention delivery and fidelity, (3) randomization and assessment, and (4) potential inadvertent treatment effects.

Purpose. We describe the methods employed to address the challenges confronted in implementing PUPS. In this randomized controlled trial, we are assessing the efficacy of a complex, preventive intervention in reducing the incidence of, and costs associated with, the development of medically serious pressure ulcers in people with spinal cord injury.

Methods. Individuals with spinal cord injury recruited from RLANRC were assigned to either a 12-month preventive intervention group or a standard care control group. The primary outcome is the incidence of serious pressure ulcers with secondary endpoints including ulcer-related surgeries, medical treatment costs, and quality of life. These outcomes are assessed at 12 and 24 months after randomization. Additionally, we are studying the mediating mechanisms that account for intervention outcomes.

Results. PUPS has been successfully implemented, including recruitment of the target sample size of 170 participants, assurance of the integrity of intervention protocol delivery with an average 90% treatment adherence rate, and enactment of the assessment plan. However, implementation has been replete with challenges. To meet recruitment goals, we instituted a five-pronged approach customized for an underserved, ethnically diverse population. In intervention delivery, we increased staff time to overcome economic and cultural barriers to retention and adherence. To ensure treatment fidelity and replicability, we monitored intervention protocol delivery in accordance with a rigorous plan. Finally, we have overcome unanticipated assessment and design concerns related to (1) determining pressure ulcer incidence/severity, (2) randomization imbalance, and (3) inadvertent potential control group contamination.

Limitations. We have addressed the most daunting challenges encountered in the recruitment, assessment, and intervention phases of PUPS. Some challenges and solutions may not apply to trials conducted in other settings.

Conclusions. Overcoming challenges has required a multifaceted approach incorporating individualization, flexibility, and persistence, as well as the ability to implement needed mid-course corrections.

Randomized controlled trials (RCTs) are considered the criterion standard in research design for establishing treatment efficacy. However, the rigorous and highly controlled conditions of RCTs can be difficult to attain when conducting research among individuals living with a confluence of disability, low socioeconomic status, and being a member of a racial/ethnic minority group, who may be more likely to have unstable life circumstances. Research on effective interventions for these groups is urgently needed, because evidence regarding approaches to reduce health disparities and improve health outcomes is lacking. In this methodologic article, we discuss the challenges and lessons learned in implementing the Lifestyle Redesign for Pressure Ulcer Prevention in Spinal Cord Injury study among a highly disadvantaged population. These issues are discussed in terms of strategies to enhance recruitment, retention, and intervention relevance to the target population. Recommendations for researchers seeking to conduct RCTs among socioeconomically disadvantaged, ethnically diverse populations are provided.

The manualization of a complex occupational therapy intervention is a crucial step in ensuring treatment fidelity for both clinical application and research purposes. Toward the latter end, intervention manuals are essential for ensuring trustworthiness and replicability of randomized controlled trials that aim to provide evidence of the effectiveness of occupational therapy. In this article, we review the literature on the process of intervention manualization. We then illustrate the prescribed steps through our experience in implementing the University of Southern California/Rancho Los Amigos National Rehabilitation Center's collaborative Pressure Ulcer Prevention Project. In this research program, qualitative research provided the initial foundation for manualization of a multifaceted occupational therapy intervention designed to reduce the incidence of medically serious pressure ulcers in adults with spinal cord injury.