Patient Partnership Tools to Support Medication Safety in Community-Dwelling Older Adults: Protocol for a Nonrandomized Stepped Wedge Clinical Trial.

BACKGROUND: Preventable harms from medications are significant threats to patient safety in community settings, especially among ambulatory older adults on multiple prescription medications. Patients may partner with primary care professionals by taking on active roles in decisions, learning the basics of medication self-management, and working with community resources. OBJECTIVE: This study aims to assess the impact of a set of patient partnership tools that redesign primary care encounters to encourage and empower patients to make more effective use of those encounters to improve medication safety. METHODS: The study is a nonrandomized, cross-sectional stepped wedge cluster-controlled trial with 1 private family medicine clinic and 2 public safety-net primary care clinics each composing their own cluster. There are 2 intervention sequences with 1 cluster per sequence and 1 control sequence with 1 cluster. Cross-sectional surveys will be taken immediately at the conclusion of visits to the clinics during 6 time periods of 6 weeks each, with a transition period of no data collection during intervention implementation. The number of visits to be surveyed will vary by period and cluster. We plan to recruit patients and professionals for surveys during 405 visits. In the experimental periods, visits will be conducted with two partnership tools and associated clinic process changes: (1) a 1-page visit preparation guide given to relevant patients by clinic staff before seeing the provider, with the intention to improve communication and shared decision-making, and (2) a library of short educational videos that clinic staff encourage patients to watch on medication safety. In the control periods, visits will be conducted with usual care. The primary outcome will be patients' self-efficacy in medication use. The secondary outcomes are medication-related issues such as duplicate therapies identified by primary care providers and assessment of collaborative work during visits. RESULTS: The study was funded in September 2019. Data collection started in April 2023 and ended in December 2023. Data was collected for 405 primary care encounters during that period. As of February 15, 2024, initial descriptive statistics were calculated. Full data analysis is expected to be completed and published in the summer of 2024. CONCLUSIONS: This study will assess the impact of patient partnership tools and associated process changes in primary care on medication use self-efficacy and medication-related issues. The study is powered to identify types of patients who may benefit most from patient engagement tools in primary care visits. TRIAL REGISTRATION: ClinicalTrials.gov NCT05880368; https://clinicaltrials.gov/study/NCT05880368. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/57878.

Primary care teams' reported actions to improve medication safety: a qualitative study with insights in high reliability organising.

BACKGROUND: Our aim was to understand actions by primary care teams to improve medication safety. METHODS: This was a qualitative study using one-on-one, semistructured interviews with the questions guided by concepts from collaborative care and systems engineering models, and with references to the care of older adults. We interviewed 21 primary care physicians and their team members at four primary care sites serving patients with mostly low socioeconomic status in Southwest US during 2019-2020. We used thematic analysis with a combination of inductive and deductive coding. First, codes capturing safety actions were incrementally developed and revised iteratively by a team of multidisciplinary analysts using the inductive approach. Themes that emerged from the coded safety actions taken by primary care professionals to improve medication safety were then mapped to key principles from the high reliability organisation framework using a deductive approach. RESULTS: Primary care teams described their actions in medication safety mainly in making standard-of-care medical decisions, patient-shared decision-making, educating patients and their caregivers, providing asynchronous care separate from office visits and providing clinical infrastructure. Most of the actions required customisation at the individual level, such as limiting the supply of certain medications prescribed and simplifying medication regimens in certain patients. Primary care teams enacted high reliability organisation principles by anticipating and mitigating risks and taking actions to build resilience in patient work systems. The primary care teams' actions reflected their safety organising efforts as responses to many other agents in multiple settings that they could not control nor easily coordinate. CONCLUSIONS: Primary care teams take many actions to shape medication safety outcomes in community settings, and these actions demonstrated that primary care teams are a reservoir of resilience for medication safety in the overall healthcare system. To improve medication safety, primary care work systems require different strategies than those often used in more self-contained systems such as hospital inpatient or surgical services.

A Multisite Qualitative Analysis of Perceived Roles in Medication Safety: Older Adults' Perspectives.

Older adults and caregivers play an essential role in medication safety; however, self-perception of their and health professionals' roles in medication safety is not well-understood. The objective of our study was to identify the roles of patients, providers, and pharmacists in medication safety from the perspective of older adults. Semi-structured qualitative interviews were held with 28 community-dwelling older adults over 65 years who took five or more prescription medications daily. Results suggest that older adults' self-perceptions of their role in medication safety varied widely. Older adults perceived that self-learning about their medications and securing them are critical to avoiding medication-related harm. Primary care providers were perceived as coordinators between older adults and specialists. Older adults expected pharmacists to inform them of any changes in the characteristics of medications to ensure medications were taken correctly. Our findings provide an in-depth analysis of older adults' perceptions and expectations of their providers' specific roles in medication safety. Educating providers and pharmacists about the role expectations of this population with complex needs can ultimately improve medication safety.

Defining and enhancing collaboration between community pharmacists and primary care providers to improve medication safety.

INTRODUCTION: Over 4 billion prescriptions are dispensed each year to patients in the United States, with the number of prescriptions continuing to increase. There is a growing recognition of pharmacists' potential in improving medication safety in community settings, in collaboration with primary care providers (PCPs). However, the nature of collaboration has not been well defined, and barriers and strategies are not articulated. AREA COVERED: For this narrative review, published studies were retrieved from PubMed between January 2000 and December 2020. Search terms included "patient safety," "medication safety," "collaboration," "primary care physician," and "community pharmacy." Resulting articles were categorized as follows: defining collaboration, types of collaboration, and barriers and solutions to collaboration. EXPERT OPINION: It is important to understand the factors within a community pharmacy setting that limit or facilitate community pharmacists' participation in medication safety activities. Strategies such as medication review are a common form of collaboration. Barriers to collaboration include misconceptions regarding roles and differences in access to clinical information and community pharmacy practice variability. Future recommendations include increasing training and utilization of pharmacists/PCP teams, increasing community pharmacists' practice in emerging roles, and expanding the community pharmacist role in transitions of care from the hospital to the community.

Ambulatory Medication Safety in Primary Care: A Systematic Review.

PURPOSE: To review the literature on medication safety in primary care in the electronic health record era. METHODS: Included studies measured rates and outcomes of medication safety in patients whose prescriptions were written in primary care clinics with electronic prescribing. Four investigators independently reviewed titles and analyzed abstracts with dual-reviewer review for eligibility, characteristics, and risk of bias. RESULTS: Of 1464 articles identified, 56 met the inclusion criteria. Forty-three studies were noninterventional and 13 included an intervention. The majority of the studies (30) used their own definition of error. The most common outcomes were potentially inappropriate prescribing/medications (PIPs), adverse drug events (ADEs), and potential prescribing omissions (PPOs). Most of the studies only included high-risk subpopulations (39), usually older adults taking > 4 medications. The rate of PIPs varied widely (0.19% to 98.2%). The rate of ADEs was lower (0.47% to 14.7%). There was poor correlation of PIP and PPO with documented ADEs leading to physical harm. CONCLUSIONS: This literature is limited by its inconsistent and highly variable outcomes. The majority of medication safety studies in primary care were in high-risk populations and measured potential harms rather than actual harms. Applying algorithms to primary care medication lists significantly overestimates rate of actual harms.

Patient Research Interest Differences by Gender and Race/Ethnicity: A North Texas Primary Care Practice-Based Research Network (NorTex) Study.

BACKGROUND: Recruiting and increasing participation of women and racial/ethnic groups remains an ongoing struggle despite the National Institutes of Health Revitalization Act mandating the inclusion of these populations. This study examined gender and racial/ethnic differences in research interest in participating in Practice-Based Research Network studies focused on cardiovascular disease (CVD), diabetes, cancer, and mental health research. METHODS: A total of 1348 participants and 18 NorTex clinics from the North Texas Primary Care Registry Project (NRP) database were included in this cross-sectional study. Participants who signed up through the registry to participate in future research projects and self-reported as non-Hispanic White, Hispanic, or non-Hispanic Black were included. Research interest in heart disease, high cholesterol, high blood pressure and heart failure were categorized as CVD; depression and anxiety were categorized as mental health; diabetes and cancer research were coded as single item dependent variables. RESULTS: Of registry participants, 72% were female, 34.5% were Black, and 24.4% were Hispanic. Of participants, 70% (n = 942) were interested in CVD research, the leading area of interest. Mental health research (56.3%, n = 755) was the second highest area of interest, while cancer had the least interest (38.4%, n = 515). After controlling for age, smoking, and having a diagnosis of the medical condition, gender did not predict interest in CVD, diabetes, cancer, or mental health research. However, race/ethnicity significantly predicted interest in diabetes and cancer research. CONCLUSION: Results indicate there are racial/ethnic differences in interest in specific research topics among our registry participants. This information may be helpful to develop successful recruitment strategies.

Primary care clinics can be a source of exposure to virulent Clostridium (now Clostridioides) difficile: An environmental screening study of hospitals and clinics in Dallas-Fort Worth region.

C. difficile is an endospore-forming pathogen, which is becoming a common cause of microbial health-care associated gastrointestinal disease in the United States. Both healthy and symptomatic patients can shed C. difficile spores into the environment, which can survive for long periods, being resistant to desiccation, heat, and disinfectants. In healthcare facilities, environmental contamination with C. difficile is a major concern as a potential source of exposure to this pathogen and risk of disease in susceptible patients. Although hospital-acquired infection is recognized, community-acquired infection is an increasingly recognized health problem. Primary care clinics may be a significant source of exposure to this pathogen; however, there are limited data about presence of environmental C. difficile within clinics. To address the potential for primary care clinics as a source of environmental exposure to virulent C. difficile, we measured the frequency of environmental contamination with spores in clinic examination rooms and hospital rooms in Dallas-Fort Worth (DFW) area of Texas. The ribotypes and presence of toxin genes from some environmental isolates were compared. Our results indicate primary care clinics have higher frequencies of contamination than hospitals. After notification of the presence of C. difficile spores in the clinics and an educational discussion to emphasize the importance of this infection and methods of infection prevention, environmental contamination in clinics was reduced on subsequent sampling to that found in hospitals. Thus, primary care clinics can be a source of exposure to virulent C. difficile, and recognition of this possibility can result in improved infection prevention, potentially reducing community-acquired C. difficile infections and subsequent disease.

Incidental computer tomography radiologic findings through research participation in the North Texas Healthy Heart Study.

BACKGROUND: Although variation exists in the classification and practice of managing clinical findings in research, emerging views suggest that researchers bear some responsibility in the management of incidental findings. This study contributes to the documentation of the population characteristics and prevalence of medical findings incidental to research participation, specifically findings related to coronary calcium scores and computed tomography (CT) scans that investigated cardiovascular disparities in an asymptomatic population. METHODS: A total of 571 asymptomatic adult participants were recruited in the North Texas Healthy Heart Study. Participants completed a 16-slice CT scan of the heart and abdomen. Findings of radiology reports and 3 years of follow-up documentation were reviewed. RESULTS: A total of 246 clinically apparent findings were identified in 169 asymptomatic participants (32.9% of participants who completed a CT scan). Another 245 participants (48%) had findings of unknown significance, a total of 307 findings. At least 4 cases in this study led to a clinically significant intervention. CONCLUSION: Although CT scans were completed for research purposes, study procedures resulted in the diagnosis and treatment of individuals who were previously asymptomatic. Potential clinical benefits in imaging research are moderated by considerations regarding possible harm and costs resulting from uncertain findings and the use of CT scans for nonclinical purposes. The continued development of protocols for the handling of incidental findings in research and the establishment of guidelines are needed to ensure that research procedures mirror the best interests of participants.

Improving accuracy of medication identification in an older population using a medication bottle color symbol label system.

BACKGROUND: The purpose of this pilot study was to evaluate and refine an adjuvant system of color-specific symbols that are added to medication bottles and to assess whether this system would increase the ability of patients 65 years of age or older in matching their medication to the indication for which it was prescribed. METHODS: This study was conducted in two phases, consisting of three focus groups of patients from a family medicine clinic (n = 25) and a pre-post medication identification test in a second group of patient participants (n = 100). Results of focus group discussions were used to refine the medication label symbols according to themes and messages identified through qualitative triangulation mechanisms and data analysis techniques. A pre-post medication identification test was conducted in the second phase of the study to assess differences between standard labeling alone and the addition of the refined color-specific symbols. The pre-post test examined the impact of the added labels on participants' ability to accurately match their medication to the indication for which it was prescribed when placed in front of participants and then at a distance of two feet. RESULTS: Participants appreciated the addition of a visual aid on existing medication labels because it would not be necessary to learn a completely new system of labeling, and generally found the colors and symbols used in the proposed labeling system easy to understand and relevant. Concerns were raised about space constraints on medication bottles, having too much information on the bottle, and having to remember what the colors meant. Symbols and colors were modified if they were found unclear or inappropriate by focus group participants. Pre-post medication identification test results in a second set of participants demonstrated that the addition of the symbol label significantly improved the ability of participants to match their medication to the appropriate medical indication at a distance of two feet (p < 0.001) and approached significant improvement when placed directly in front of participants (p = 0.07). CONCLUSIONS: The proposed medication symbol label system provides a promising adjunct to national efforts in addressing the issue of medication misuse in the home through the improvement of medication labeling. Further research is necessary to determine the effectiveness of the labeling system in real-world settings.

The influence of research compensation options on Practice-based Research Network (PBRN) physician participation: a North Texas (NorTex) PBRN study.

OBJECTIVE: To study the effect of two compensation approaches, continuing medical education (CME) credits (5 hours) or monetary ($150), on the participation rate of a physician needs assessment study. METHODS: Physicians representing family medicine, internal medicine, pediatric, and geriatrics specialties, and practicing in ambulatory primary care clinics affiliated with the North Texas Primary Care (NorTex) PBRN clinics, were recruited to complete a survey relevant to their subspecialty and to conduct a self-audit/abstraction of five medical records. Physicians were recruited from four health care systems, and the recruiting methods varied by system. Study outcome was the rate of study completion by type of incentive. RESULTS: One hundred five of 211 (49.8%) physicians approached to participate gave consent and 84 (39.8%) completed the study. There was no difference in the number of physicians randomly assigned to monetary compared with CME compensation for giving consent to participate (adjusted odds ratio = 1.42, confidence interval = 0.69, 2.93). However, physicians in the monetary compensation group were more likely to complete the study after giving consent (adjusted odds ratio = 4.70, confidence interval = 1.25, 17.58). This monetary effect was also significant from the perspective of all physicians approached initially (adjusted odds ratio = 2.78, confidence interval = 1.16, 6.67). DISCUSSION: This study suggests that future PBRN investigators should receive monetary compensation for the opportunity cost of adding research activities to their already busy practices. This compensation may be especially vital for PBRNs to complete more ambitious projects requiring a significant time commitment from the participating physicians.

Recruiting Practice-based Research Network (PBRN) physicians to be research participants: lessons learned from the North Texas (NorTex) needs assessment study.

INTRODUCTION: The purpose of this study was to examine strategies for recruiting physician subjects in a practice-based research network continuing education research study, using different recruitment methods at four systems, or health plan arrangements. METHODS: The North Texas Primary Care Practice-based Research Network Needs Assessment Study consisted of a survey and five self-directed medical record abstractions. Physicians were recruited to be research subjects from four systems, using different recruitment strategies. χ(2) was used to determine differences in physicians consenting and completing the study between systems. Kruskal-Wallis was used to determine differences in time from first contact to consent and number of contacts required before consent between systems. RESULTS: One hundred five of 211 physicians (49.8%) consented to participate, of which 90 (85.7%) completed the survey. There was a significant difference by system in the number of physicians who consented (P = .04) and number of contacts required pre-consent (P < .001) but not in the number of physicians completing the study or time from first contact to consent. DISCUSSION/CONCLUSIONS: Success of recruiting physicians to be research subjects varied between systems using different recruitment methods. Lessons learned include using clinician champions to make initial contact, establishing a relationship with clinic personnel, distinguishing the research team from a pharmaceutical representative, establishing a preferred contact method, and collecting study materials on a set timeline.

Self-reported racial discrimination, response to unfair treatment, and coronary calcification in asymptomatic adults--the North Texas Healthy Heart study.

BACKGROUND: Accruing evidence supports the hypothesis that psychosocial factors are related to cardiovascular disease. However, a limited number of studies have investigated the pathophysiologic pathways through which these associations occur. The purpose of this study was to assess whether experiences of self-reported racial discrimination and reactions to unfair treatment were associated with coronary artery calcification (CAC), an indicator of subclinical coronary heart disease (CHD). METHODS: This cross-sectional study recruited 571 subjects (45 years and older) who were asymptomatic of CHD from Fort Worth, Texas from 2006 to 2008. Subjects completed a questionnaire, a multi-slice computed tomography scan to assess for CAC presence (measured as Agatston score >0), and serum chemistries. Logistic regression was used to estimate odds ratios (ORs) and 95% confidence intervals (CIs) for the association between self-reported discrimination and CAC. Results were stratified by response to unfair treatment as it was found to significantly modify the relationship between discrimination and CAC. RESULTS: Among those who passively responded to unfair treatment, the odds of having CAC present were approximately 3 times higher for those experiencing discrimination (OR, 2.95; 95% CI, 1.19-7.32) after adjusting for age, gender, race/ethnicity, education, body mass index, hyperlipidemia, smoking status, hypertension, diabetes, and first degree relative with heart disease. CONCLUSIONS: This is the first multi-racial/ethnic study to find racial discrimination associated with CAC, which differs based on how one responds to unfair treatment.