Validating a tool to measure spiritual beliefs, needs and resources in serious illness: The I-SPIRIT.

BACKGROUND: Seriously ill patients rely on spiritual and existential beliefs to support coping and approach crucial treatment and healthcare decisions. Yet, we lack gold standard, validated approaches to gathering information on those spiritual beliefs. Therefore, we developed I-SPIRIT, a spiritual needs and beliefs inventory for those with serious illness (IIR-10-050). METHODS: In prior work to develop measure content, we interviewed a total of 74 participants: 20 patients (veterans with Stage IV cancer, CHF, COPD, ESRD), 19 caregivers, 14 chaplains, 10 social workers, 12 nurses, and 5 physicians. Using directed content analyses, we identified over 50 attributes of spiritual experience comprising five domains: overall importance of spirituality; affiliations and practices; impact on decisions; spiritual needs; and spiritual resources. We then translated these attributes into individual items with Likert response scales. In the quantitative validation of I-SPIRIT, we administered the instrument and a battery of comparison measures to 249 seriously ill veterans. The comparison measures captured general spiritual well-being, religious coping, and emotional functioning. Convergent and discriminant validity was examined with the FACIT-sp (faith, meaning, and purpose), BMMRS (religious/spirituality), POMS and PHQ-8 (emotional function), and FACT-G (quality of life). We administered the I-SPIRIT a week later, for test-retest reliability. RESULTS: Psychometric analyses yielded a final I-SPIRIT Tool including 30 items. Results demonstrated reliability and validity and yielded a tool with three main components: Spiritual Beliefs (seven items); Spiritual Needs (nine items); and Spiritual Resources (14 items). The Spiritual Beliefs items include key practices and affiliations, and impact of beliefs on healthcare. Higher levels of Spiritual Needs were associated with higher anxiety and depression. CONCLUSION: The I-Spirit measures relevance of spirituality, spiritual needs and spiritual resources and demonstrates validity, reliability, and acceptability for patients with serious illness.

Qualitative Analysis of Barriers and Facilitators to Glaucoma Medication Adherence in a Randomized Controlled Trial Intervention.

OBJECTIVE: In the Medication Adherence In Glaucoma To Improve Care trial, 200 veterans with medically-treated glaucoma were randomized to an intervention designed to improve glaucoma medication adherence or to usual care. In the 6 months after intervention, the mean proportion of doses taken on schedule was higher for participants in the intervention group compared with controls (0.85 vs. 0.62, P < 0.001). The purpose of this study was to use a mixed-methods approach to compare barriers and facilitators with adherence among participants through qualitative analysis of structured interviews. DESIGN: This is an analysis of interviews conducted from patients participating in a clinical trial. PARTICIPANTS: Participants from the intervention arm were separated into quartiles based on medication adherence according to the electronic monitor to sample from high and low responders to the intervention. We interviewed 23 participants; 11 participants with low adherence and 12 with high adherence. METHODS: Interviews were conducted over telephone and transcribed. Staff members used grounded theory to conduct content analysis and code the transcribed interviews. The iterative process produced categories of common barriers and facilitators for medication adherence. MAIN OUTCOME MEASURES: The frequency of responses addressing common barriers and facilitators were compared between participants with high and low adherence. RESULTS: In the lowest- and highest-adherence groups, a difficult schedule was the most cited barrier for regular drop usage (63.6% and 58.3%, respectively). In the lowest and highest-adherence groups, the most cited facilitator for adherence was use of the smart bottle (100% and 91.7%, respectively). In the lowest-adherence group, 72.7% of participants cited that improved ability to administer drops was a benefit from the intervention. In the highest-adherence group, 75% of participants cited increased disease knowledge and formation of habits as facilitators from the intervention. Of the 22 of 23 participants who mentioned the smart bottle, 100% cited that they had increased adherence and would continue using the smart bottle. CONCLUSIONS: Using dosing reminders and personalized patient education may be important avenues for addressing difficulties with adhering to an eye drop schedule to improve glaucoma self-management. FINANCIAL DISCLOSURE(S): The author(s) have no proprietary or commercial interest in any materials discussed in this article.

How Medication Adherence Affects Disease Management in Veterans with Glaucoma: Lessons Learned from a Clinical Trial.

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.

Improved Glaucoma Medication Adherence in a Randomized Controlled Trial.

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.

Health Literacy and Success with Glaucoma Drop Administration.

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.

Randomized controlled trial of an education-based intervention to improve medication adherence: Design considerations in the medication adherence in glaucoma to improve care study.

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.

The Association of an Upper Extremity Functional Survey and Glaucoma Medication Administration Success.

Purpose/Aim: To determine if an upper extremity functional survey may identify which patients will have eye drop administration difficulty. Materials and Methods: Participants with glaucoma treated at a Veterans Affairs Eye Clinic who did not self-report 100% medication adherence were enrolled in a cross-sectional study. Participants were scored on their observed ability to place a drop into the eye (accuracy) and express no more than one drop from the bottle (efficiency). Successful execution of both of these conditions was defined as good drop technique. Participants also completed the QuickDASH, a validated upper extremity functional survey, with higher scores indicating worse disability. We hypothesized participants with lower QuickDASH scores would have an increased probability of observed success with drop administration measures. Diagnoses of upper extremity co-morbidities were abstracted from participants' medical records and clustered into diagnostic groups of either neurologic or musculoskeletal etiologies. Results: When observed, 80 of 94 participants displayed successful accuracy, 58 of 94 participants displayed successful efficiency, and 50 of 94 participants displayed good drop technique. Accuracy with eye drop performance was not related to QuickDASH scores (odds ratio (OR) [probability of successful administration per 10-point decrease in QuickDASH score]: 1.14, 95% CI: 0.89-1.45, p = .29). Success with drop administration efficiency was strongly associated with QuickDASH score (OR: 1.27, 95% CI: 1.04-1.54, p = .02), as was good drop technique (OR: 1.28, 95% CI: 1.05-1.56, p = .01), with lower (better) QuickDASH scores associated with better drop technique. There were no associations between upper extremity neurologic or musculoskeletal co-morbidities and observed good drop technique. The presence of either a neurologic or musculoskeletal upper extremity co-morbidity in a participant's medical record was associated with a higher QuickDASH score. Conclusions: The QuickDASH survey may identify patients with eye drop administration difficulties so this population receives focused drop technique education and management strategies. Abbreviations: CPRS: Computerized Patient Records System; MSK: musculoskeletal; UE: upper extremity; VA: Veterans Affairs.

The Relationship of Self-Report and Medication Possession With Glaucoma Medication Administration Success.

PURPOSE: Many glaucoma eye drop users cannot successfully self-administer drops, and observing patients' drop technique can be time-consuming. We sought to examine the association of patient self-reported efficacy of eye drop technique and medication possession data as potential surrogate measures for actual drop administration success. PATIENTS AND METHODS: In total, 137 adults with medically treated glaucoma were enrolled from a University eye clinic (n=54) or a Veteran Affairs (VA) eye clinic (n=83). All participants were asked, "How confident are you that you can get the medication into your eye?" Medication possession ratio (MPR), defined as the amount of eye drop available divided by the amount prescribed, was calculated for VA study site participants for 6 months. The main outcome was the correct eye drop technique, defined as the ability to get drops into the eye and to put only 1 drop into the eye at a time. RESULTS: Among 117 participants who were "very confident" they could administer eye drops correctly, 95 participants (81%) displayed the correct drop technique. Of those who reported being less than "very confident" (n=18), 11 participants (61%) displayed correct drop technique (the Fisher exact test, P=0.07). For the VA sample, 20 participants with MPR<1.2, 20 participants with MPR=1.2 to 1.8, and 23 participants with MPR>1.8 displayed correct eye drop technique (the Fisher exact test, P=0.18). CONCLUSIONS: Self-reported administration success and MPR are not strongly associated with successful eye drop administration. Thus, direct observation of patients' drop instillation may be the most effective means of determining patient efficacy.

How Views of the Organization of Primary Care Among Patients with Hypertension Vary by Race or Ethnicity.

INTRODUCTION: We assessed potential racial or ethnic differences in the degree to which veterans with pharmaceutically treated hypertension report experiences with their primary care system that are consistent with optimal chronic illness care as suggested by Wagner's Chronic Care Model (CCM). MATERIALS AND METHODS: A cross-sectional analysis of the results of the Patient Assessment of Chronic Illness Care (PACIC), which measured components of the care system suggested by the CCM and was completed at baseline by participants in a hypertension disease management clinical trial. Participants had a recent history of uncontrolled systolic blood pressure. RESULTS: Among 377 patients, non-Hispanic African American veterans had almost twice the odds of indicating that their primary care experience is consistent with CCM features when compared with non-Hispanic White patients (odds ratio (OR) = 1.86; 95% confidence interval (CI) = 1.16-2.98). Similar statistically significant associations were observed for follow-up care (OR = 2.59; 95% CI = 1.49-4.50), patient activation (OR = 1.80; 95% CI = 1.13-2.87), goal setting (OR = 1.65; 95% CI = 1.03-2.64), and help with problem solving (OR = 1.62; 95% CI = 1.00-2.60). CONCLUSIONS: Non-Hispanic African Americans with pharmaceutically treated hypertension report that the primary care system more closely approximates the Wagner CCM than non-Hispanic White patients.

Linkage between theory-based measurement of organizational readiness for change and lessons learned conducting quality improvement-focused research.

Organizations have different levels of readiness to implement change in the patient care process. The Hypertension Telemedicine Nurse Implementation Project for Veterans (HTN-IMPROVE) is an example of an innovation that seeks to enhance delivery of care for patients with hypertension. We describe the link between organizational readiness for change (ORC), assessed as the project began, and barriers and facilitators occurring during the process of implementing a primary care innovation. Each of 3 Veterans Affairs medical centers provided a half-time nurse and implemented a nurse-delivered, telephone-based self-management support program for patients with uncontrolled hypertension. As the program was starting, we assessed the ORC and factors associated with ORC. On the basis of consensus of medical center and research partners, we enumerated implementation process barriers and facilitators. The primary ORC barrier was unclear long-term commitment of nursing to provide continued resources to the program. Three related barriers included the need to address: (1) competing organizational demands, (2) differing mechanisms to integrate new interventions into existing workload, and (3) methods for referring patients to disease and self-management support programs. Prior to full implementation, however, stakeholders identified a high level of commitment to conduct nurse-delivered interventions fully using their skills. There was also a significant commitment from the core implementation team and a desire to improve patient outcomes. These facilitators were observed during the implementation of HTN-IMPROVE. As demonstrated by the link between barriers to and facilitators of implementation anticipated though the evaluation of ORC and what was actually observed during the process of implementation, this project demonstrates the practical utility of assessing ORC prior to embarking on the implementation of significant new clinical innovations.

Open-label randomized trial of titrated disease management for patients with hypertension: Study design and baseline sample characteristics.

Despite the availability of efficacious treatments, only half of patients with hypertension achieve adequate blood pressure (BP) control. This paper describes the protocol and baseline subject characteristics of a 2-arm, 18-month randomized clinical trial of titrated disease management (TDM) for patients with pharmaceutically-treated hypertension for whom systolic blood pressure (SBP) is not controlled (≥140mmHg for non-diabetic or ≥130mmHg for diabetic patients). The trial is being conducted among patients of four clinic locations associated with a Veterans Affairs Medical Center. An intervention arm has a TDM strategy in which patients' hypertension control at baseline, 6, and 12months determines the resource intensity of disease management. Intensity levels include: a low-intensity strategy utilizing a licensed practical nurse to provide bi-monthly, non-tailored behavioral support calls to patients whose SBP comes under control; medium-intensity strategy utilizing a registered nurse to provide monthly tailored behavioral support telephone calls plus home BP monitoring; and high-intensity strategy utilizing a pharmacist to provide monthly tailored behavioral support telephone calls, home BP monitoring, and pharmacist-directed medication management. Control arm patients receive the low-intensity strategy regardless of BP control. The primary outcome is SBP. There are 385 randomized (192 intervention; 193 control) veterans that are predominately older (mean age 63.5years) men (92.5%). 61.8% are African American, and the mean baseline SBP for all subjects is 143.6mmHg. This trial will determine if a disease management program that is titrated by matching the intensity of resources to patients' BP control leads to superior outcomes compared to a low-intensity management strategy.

Perspectives of patients on factors relating to adherence to post-acute coronary syndrome medical regimens.

PURPOSE: Poor adherence to cardioprotective medications after acute coronary syndrome (ACS) hospitalization is associated with increased risk of rehospitalization and mortality. Clinical trials of multifaceted interventions have improved medication adherence with varying results. Patients' perspectives on interventions could help researchers interpret inconsistent outcomes. Identifying factors that patients believe would improve adherence might inform the design of future interventions and make them more parsimonious and sustainable. The objective of this study was to obtain patients' perspectives on adherence to medical regimens after experiencing an ACS event and their participation in a medication adherence randomized control trial following their hospitalization. PATIENTS AND METHODS: Sixty-four in-depth interviews were conducted with ACS patients who participated in an efficacious, multifaceted, medication adherence randomized control trial. Interview transcripts were analyzed using the constant comparative approach. RESULTS: Participants described their post-ACS event experiences and how they affected their adherence behaviors. Patients reported that adherence decisions were facilitated by mutually respectful and collaborative provider-patient treatment planning. Frequent interactions with providers and medication refill reminder calls supported improved adherence. Additional facilitators included having social support, adherence routines, and positive attitudes toward an ACS event. The majority of patients expressed that being active participants in health care decision-making contributed to their health. CONCLUSION: Our findings demonstrate that respectful collaborative communication can contribute to medication adherence after ACS hospitalization. These results suggest a potential role for training health-care providers, including pharmacists, social workers, registered nurses, etc, to elicit and acknowledge the patients' views regarding medication treatment in order to improve adherence. Future research is needed with providers to understand how they elicit and acknowledge patients' views, particularly in the face of nonadherence, and with patients to understand how to empower them to share their opinions with their providers.