Browsing by Author "Woolson, Sandra"

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    ItemOpen Access
    A telehealth-delivered intervention to extend the veteran HIV treatment cascade for cardiovascular disease prevention: V-EXTRA-CVD study protocol for a randomized controlled trial.
    (HIV research & clinical practice, 2023-12) Musoke, Lewis; Bosworth, Hayden B; Dickson, Christina; Gentry, Pamela; Strawbridge, Elizabeth; Subramaniam, Soumya; Gierisch, Jennifer; Smith, Valerie; Woolson, Sandra; Pura, John; Amutuhaire, Willington; Naggie, Susanna; Schexnayder, Julie; Hall, Karen; Longenecker, Chris T; Harris, Nadine M; Rogers, Chantrice; Van Epps, Puja; for V-EXTRA-CVD Group
    Background: Veterans living with HIV have up to twice the risk of atherosclerotic cardiovascular disease (ASCVD) compared to those without HIV.Objective: Our study seeks to test a non-physician led virtual self-management implementation strategy to reduce ASCVD risk among people living with HIV (PWH). We aim to conduct a randomized control trial among PWH (n = 300) with a diagnosis of hypertension (HTN) who are enrolled in Veterans Health Administration (VHA) clinics, on suppressive antiretroviral therapy (ART), randomized 1:1 to intervention vs. education control for a 12-month duration.Methods: Using human centered design approach, we have adapted a previous 5-component telehealth focused, non-physician led intervention to a Veteran population. The education control arm receives enhanced education in addition to usual care. The primary outcome is 6 mmHg reduction in systolic BP over 12-month in the intervention arm compared to the control arm. The secondary outcome is a 12-month difference in non-HDL cholesterol. While each component of our intervention has an evidence base, they have not been tested together in an HIV context.Conclusion: The proposed multicomponent intervention has the potential to improve cardiovascular outcomes in PWH using novel virtual care methods in a patient centered care approach.
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    COVID-19 vaccination intention and activation among health care system employees: A mixed methods study.
    (Vaccine, 2022-08) Vasudevan, Lavanya; Bruening, Rebecca; Hung, Anna; Woolson, Sandra; Brown, Adrian; Hastings, Susan N; Linton, Tammy; Embree, Genevieve; Hostler, Christopher J; Mahanna, Elizabeth; Okeke, Nwora Lance; Bosworth, Hayden; Sperber, Nina R

    Background

    Achieving high COVID-19 vaccination rates among employees is necessary to prevent outbreaks in health care settings. The goal of the study was to produce actionable and timely evidence about factors underlying the intention and decisions to obtain the COVID-19 vaccine by employees.

    Methods

    The study was conducted from December 2020 - May 2021 with employees from a VA health care system in Southeastern US. The study used a convergent mixed methods design comprising two main activities: a cross-sectional survey conducted prior to COVID-19 vaccine distribution, and semi-structured interviews conducted 4-6 months after vaccine distribution. Data were collected about participant characteristics, vaccination intention prior to distribution, vaccination decision post-distribution, determinants of vaccination intention and decision, activating factors, sources of information and intervention needs. Data from the survey and interviews were analyzed separately and integrated narratively in the discussion.

    Results

    Prior to vaccine distribution, 77% of employees wanted to be vaccinated. Post vaccine distribution, we identified 5 distinct decision-making groups: 1) vaccine believers who actively sought vaccination and included those sometimes described as "immunization advocates", 2) go along to get along (GATGA) individuals who got vaccinated but did not actively seek it, 3) cautious acceptors who got the COVID-19 vaccine after some delay, 4) fence sitters who remained uncertain about getting vaccinated, and 5) vaccine refusers who actively rejected the COVID-19 vaccine. Participants identifying with Black or multiple races were more likely to express hesitancy in their vaccination intention.

    Conclusion

    The findings of our study highlight distinct decision-making profiles associated with COVID-19 vaccination among employees of a VA health care system, and provide tailored recommendations to reduce vaccine hesitancy in this population.
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    Health Literacy and Success with Glaucoma Drop Administration.
    (Ophthalmology. Glaucoma, 2022-01) Kang, J Minjy; Chatterjee, Ayan; Rosdahl, Jullia A; Bosworth, Hayden B; Woolson, Sandra; Olsen, Maren; Sexton, Malina; Kirshner, Miriam; Muir, Kelly W

    Purpose

    To assess the relationship between health literacy and successful glaucoma drop administration.

    Design

    Substudy of a single-site interventional randomized controlled trial.

    Participants

    Veterans receiving care at the Durham Veterans Affairs Eye Clinic who had a diagnosis of open-angle glaucoma were recruited if they endorsed poor drop adherence.

    Methods

    Participants underwent a health literacy evaluation using the Rapid Estimate of Adult Literacy in Medicine (REALM) as well as a qualitative assessment of eye drop administration technique using 3 different criteria: (1) the drop was instilled in the eye, (2) only 1 drop was dispensed, and (3) the bottle was not potentially contaminated. A multivariate logistic regression model was used to assess the association of REALM score and successful drop administration, adjusting for age, disease severity, and Veterans Administration Care Assessment Needs (CAN) score.

    Main outcome measures

    Successful drop administration.

    Results

    Of the 179 participants with REALM scores and observed drop administration, 78% read at a high school level (HSL) or more and 22% read at less than HSL. Of the 179 participants, 87% (n = 156) successfully instilled the drop into the eye (criterion 1). A greater proportion of participants who read at HSL or more successfully instilled the drop in the eye compared with those reading at less than HSL (90.6% vs. 75.0%; P = 0.02). Rates of success with criterion 1 were similar across different levels of visual field severity. Care Assessment Needs scores were not statistically significant between those who did and those did not have successful overall drop technique.

    Conclusions

    Poor health literacy may be associated with decreased successful drop instillation in the eye in patients with glaucoma. Screening for and considering health literacy in developing interventions to improve glaucoma self-management may improve treatment adherence in a vulnerable population.
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    How Medication Adherence Affects Disease Management in Veterans with Glaucoma: Lessons Learned from a Clinical Trial.
    (Ophthalmic research, 2023-01) Buehne, Kristen L; Rosdahl, Jullia A; Hein, Aaron M; Woolson, Sandra; Olsen, Maren; Kirshner, Miriam; Sexton, Malina; Bosworth, Hayden B; Muir, Kelly W

    Introduction

    We conducted a secondary, real-world clinical assessment of a randomized controlled trial to determine how a glaucoma medication adherence intervention impacted the clinical outcomes of participants at 12 months post-randomization. Participants included veterans at a VA eye clinic with medically treated glaucoma who reported poor adherence and their companions, if applicable.

    Methods

    The treatment group received a glaucoma education session with drop administration instruction and virtual reminders from a "smart bottle" (AdhereTech) for their eye drops. The control group received a general eye health class and the smart bottle with the reminder function turned off. Medical chart extraction determined if participants in each group experienced visual field progression, additional glaucoma medications, or a recommendation for surgery or laser due to inadequate intraocular pressure control over the 12 months following randomization. The main outcome measure was disease progression, defined as visual field progression or escalation of glaucoma therapy, in the 12 months following randomization.

    Results

    Thirty-six versus 32% of the intervention (n = 100) versus control (n = 100) groups, respectively, experienced disease intensification. There was no difference between the intervention and control groups in terms of intensification (intervention vs. control group odds ratio: 1.20; 95% confidence interval: [0.67, 2.15]), including when age, race, and disease severity were accounted for in the logistic regression model. Those whose study dates included time during the COVID-19 pandemic were evenly distributed between groups.

    Conclusions

    A multifaceted intervention that improved medication adherence for glaucoma for 6 months did not affect the clinical outcomes measured at 12 months post-randomization. Twelve months may not be long enough to see the clinical effect of this intervention or more than 6 months of intervention are needed.
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    ItemOpen Access
    Implementation of a group physical therapy program for Veterans with knee osteoarthritis.
    (BMC musculoskeletal disorders, 2020-02) Allen, Kelli D; Sheets, Brandon; Bongiorni, Dennis; Choate, Ashley; Coffman, Cynthia J; Hoenig, Helen; Huffman, Kim; Mahanna, Elizabeth P; Oddone, Eugene Z; Van Houtven, Courtney; Wang, Virginia; Woolson, Sandra; Hastings, Susan N
    BACKGROUND:A previous randomized clinical trial found that a Group Physical Therapy (PT) program for knee osteoarthritis yielded similar improvements in pain and function compared with traditional individual PT. Based on these findings the Group PT program was implemented in a Department of Veterans Affairs Health Care System. The objective of this study was to evaluate implementation metrics and changes in patient-level measures following implementation of the Group PT program. METHODS:This was a one-year prospective observational study. The Group PT program involved 6 weekly sessions. Implementation metrics included numbers of referrals and completed sessions. Patient-level measures were collected at the first and last PT sessions and included the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC; self-report of pain, stiffness and function (range 0-96)) and a 30-s chair rise test. RESULTS:During the evaluation period, 152 patients were referred, 80 had an initial session scheduled, 71 completed at least one session and 49 completed at least 5 sessions. The mean number of completed appointments per patient was 4.1. Among patients completing baseline and follow-up measures, WOMAC scores (n = 33) improved from 56.8 (SD = 15.8) to 46.9 (SD = 14.0); number of chair rises (n = 38) completed in 30 s increased from 10.4 (SD = 5.1) to 11.9 (SD = 5.0). CONCLUSIONS:Patients completing the Group PT program in this implementation phase showed clinically relevant improvements comparable to those observed in the previous clinical trial that compared group and individual PT for knee osteoarthritis. These results are important because Group PT can improve efficiency and access compared with individual PT. However, there were some limitations with respect to attendance and completion rates, and program adaptations may be needed to optimize these implementation metrics. Larger, longer-term studies are required to more fully evaluate the effectiveness of this program.
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    Improved Glaucoma Medication Adherence in a Randomized Controlled Trial.
    (Ophthalmology. Glaucoma, 2022-01) Muir, Kelly W; Rosdahl, Jullia A; Hein, Aaron M; Woolson, Sandra; Olsen, Maren K; Kirshner, Miriam; Sexton, Malina; Bosworth, Hayden B

    Purpose

    To test the effectiveness of an intervention designed to improve glaucoma medication adherence.

    Design

    Randomized, controlled trial at a Veterans Affairs (VA) eye clinic.

    Participants

    Veterans with medically treated glaucoma who reported poor adherence and their companions if applicable.

    Methods

    Participants, and their companions if applicable, were randomized to receive an intervention to improve medication adherence that included glaucoma education, personalized disease management suggestions, and a reminder aid, or the control arm that received education regarding general eye health.

    Main outcome measures

    The average proportion of prescribed glaucoma medication doses taken on schedule over the 6 months after randomization according to an electronic monitor between participants in the 2 arms.

    Results

    The mean proportion of prescribed doses taken on schedule was higher in the intervention group compared with controls (0.85 vs. 0.62, P < 0.0001). The difference in proportions between the 2 groups did not vary in regressions models adjusted for companion status, frequency of dosing, and race. The longitudinal model indicated that the intervention group had significantly higher adherence during the first month after randomization and continued to stay higher through 6 months (month by treatment interaction, P = 0.003).

    Conclusions

    A multifaceted intervention can help improve glaucoma medication adherence.
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    ItemOpen Access
    Randomized controlled trial of an education-based intervention to improve medication adherence: Design considerations in the medication adherence in glaucoma to improve care study.
    (Clinical trials (London, England), 2021-06) Rosdahl, Jullia A; Hein, Aaron M; Bosworth, Hayden B; Woolson, Sandra; Olsen, Maren; Kirshner, Miriam; Hung, Anna; Muir, Kelly W

    Background

    Glaucoma treatment requires patients to follow daily, often times complex, eye drop regimens, but adherence is poor for many patients, putting them at risk for irreversible vision loss. A comprehensive approach is needed to address the challenges in the self-management of glaucoma. The purpose of this study is to improve glaucoma medication adherence in Veterans with medically treated glaucoma using an education-based intervention.

    Methods/design

    This study is a single-site randomized controlled trial enrolling 200 Veterans and their companions, if companions are involved in their care. It has two arms: an intervention group and a control group. Participants in the intervention group receive an educational session with a non-physician interventionist and are provided with an AdhereTech smart bottle with the reminder functions activated. The control group is designed as an attention control such that they have a session on general eye health and are provided with a smart bottle but without the reminder functions activated. The primary outcome is the proportion of prescribed doses taken on schedule over 6 months following randomization according to the smart bottle. Secondary outcomes include intensification of glaucoma treatment, cost of intervention delivery, and cost-effectiveness of the intervention over 12 months.

    Discussion

    The education-based intervention that we are testing is comprehensive in scope, to encompass a variety of barriers to adherence that glaucoma patients encounter, but personalized to address issues facing individual patients. Particular attention was given to feasibility in the real-world setting, as the high throughput of patients and lack of reimbursement for educational encounters in ophthalmology would limit implementation of a resource-intensive intervention.
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    Relationship between electronically measured medication adherence and vision-related quality of life in a cohort of patients with open-angle glaucoma.
    (BMJ open ophthalmology, 2018-01) Thompson, Atalie C; Woolson, Sandra; Olsen, Maren K; Danus, Susanne; Bosworth, Hayden B; Muir, Kelly W

    Objective

    To investigate whether electronically measured medication adherence is associated with vision-related quality of life (VRQoL) in patients with open-angle glaucoma.

    Methods and analysis

    This is a 3-year prospective cohort study of 79 subjects with open-angle glaucoma at a Veterans Affairs medical centre. Participants returned a medication event monitoring system (MEMS) for their glaucoma eye-drops and had at least two visits with glaucoma during the study period. Those taking less than 80% of prescribed glaucoma medication doses were considered to be non-adherent. Subjects were interviewed using the National Eye Institute's Visual Function Questionnaire-25 (VFQ-25) at baseline and after 3 years.

    Results

    Thirty per cent (n=24/79) of participants took less than 80% of prescribed doses of their glaucoma medications at baseline. Patients who did not adhere to their medications at baseline had lower mean composite VFQ-25 scores at baseline (70.66±20.50 vs 75.91±19.12, standardised mean difference=0.27) and after 3 years (71.68±21.93 vs 76.25±21.67, standardised mean difference=0.21). Visual acuity (P=0.03), but not visual field severity (P=0.13) or medication adherence (P=0.30), was significantly associated with composite VFQ-25 score in an adjusted model.

    Conclusions

    Subjects who were non-adherent to their glaucoma medications at baseline as assessed by a MEMS device reported lower VRQoL than adherent subjects at baseline and after 3 years. However, visual acuity was significantly associated with VRQoL. Future studies should assess whether improved adherence to eye-drops impacts VRQoL in patients with glaucoma.
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    STepped exercise program for patients with knee OsteoArthritis (STEP-KOA): protocol for a randomized controlled trial.
    (BMC musculoskeletal disorders, 2019-05) Allen, Kelli D; Bongiorni, Dennis; Caves, Kevin; Coffman, Cynthia J; Floegel, Theresa A; Greysen, Heather M; Hall, Katherine S; Heiderscheit, Bryan; Hoenig, Helen M; Huffman, Kim M; Morey, Miriam C; Ramasunder, Shalini; Severson, Herbert; Smith, Battista; Van Houtven, Courtney; Woolson, Sandra

    Background

    Physical therapy (PT) and other exercise-based interventions are core components of care for knee osteoarthritis (OA), but both are underutilized, and some patients have limited access to PT services. This clinical trial is examining a STepped Exercise Program for patients with Knee OsteoArthritis (STEP-KOA). This model of care can help to tailor exercise-based interventions to patient needs and also conserve higher resource services (such as PT) for patients who do not make clinically relevant improvements after receiving less costly interventions.

    Methods / design

    Step-KOA is a randomized trial of 345 patients with symptomatic knee OA from two Department of Veterans Affairs sites. Participants are randomized to STEP-KOA and Arthritis Education (AE) Control groups with a 2:1 ratio, respectively. STEP-KOA begins with 3 months of access to an internet-based exercise program (Step 1). Participants not meeting response criteria for clinically meaningful improvement in pain and function after Step 1 progress to Step 2, which involves bi-weekly physical activity coaching calls for 3 months. Participants not meeting response criteria after Step 2 progress to in-person PT visits (Step 3). Outcomes will be assessed at baseline, 3, 6 and 9 months (primary outcome time point). The primary outcome is the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC), and secondary outcomes are objective measures of physical function. Linear mixed models will compare outcomes between the STEP-KOA and AE control groups at follow-up. We will also evaluate patient characteristics associated with treatment response and conduct a cost-effectiveness analysis of STEP-KOA.

    Discussion

    STEP-KOA is a novel, efficient and patient-centered approach to delivering exercise-based interventions to patients with knee OA, one of the most prevalent and disabling health conditions. This trial will provide information on the effectiveness of STEP-KOA as a novel potential model of care for treatment of OA.

    Trial registration

    Clinicaltrials.gov, NCT02653768 (STepped Exercise Program for Knee OsteoArthritis (STEP-KOA)), Registered January 12, 2016.
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    Within-Trial Cost-Effectiveness of an Adherence-Enhancing Educational Intervention for Glaucoma.
    (American journal of ophthalmology, 2022-12) Williams, Andrew M; Theophanous, Christos; Muir, Kelly W; Rosdahl, Jullia A; Woolson, Sandra; Olsen, Maren; Bosworth, Hayden B; Hung, Anna

    Purpose

    To assess the within-trial cost-effectiveness of a behavioral intervention to improve glaucoma medication adherence.

    Design

    Prospective cost-effectiveness analysis of randomized, controlled trial data.

    Methods

    The study setting was a Veterans Affairs (VA) eye clinic. The patient population comprised veterans with medically treated glaucoma and self-reported poor adherence. Participants were randomized to a personalized educational session with a reminder bottle to promote medication adherence or to a control session on general eye health. Costs were assessed from the perspective of the VA payor at 6 months using the VA Managerial Cost Accounting System. Probabilistic sensitivity analyses were conducted using bootstrapped samples. The main outcome measures were the proportion of participants attaining ≥80% adherence as measured by electronic monitor, total intervention and medical resource costs, and incremental cost-effectiveness ratios comparing intervention to control at 6 months.

    Results

    Of 200 randomized participants, 95 of 100 assigned to the intervention and 97 of 100 assigned to the control had adherence outcomes at 6 months, and the proportion of adherent patients was higher in the intervention group compared to control (0.78 vs 0.40, P < .0001). All participants had costs at 6 months. The total cost at 6 months was $1,149,600 in the intervention group (n = 100) compared to $1,298,700 in the control group (n = 100). Thus, in a hypothetical cohort of 100 patients, the intervention was associated with cost savings (-$149,100) and resulted in 38 additional patients achieving medication adherence.

    Conclusions

    An adherence-enhancing behavioral intervention was effective and cost saving at 6 months.