Making sense of diabetes medication decisions: a mixed methods cluster randomized trial using a conversation aid intervention.

PURPOSE: To determine the effectiveness of a shared decision-making (SDM) tool versus guideline-informed usual care in translating evidence into primary care, and to explore how use of the tool changed patient perspectives about diabetes medication decision making. METHODS: In this mixed methods multicenter cluster randomized trial, we included patients with type 2 diabetes mellitus and their primary care clinicians. We compared usual care with or without a within-encounter SDM conversation aid. We assessed participant-reported decisions made and quality of SDM (knowledge, satisfaction, and decisional conflict), clinical outcomes, adherence, and observer-based patient involvement in decision-making (OPTION12-scale). We used semi-structured interviews with patients to understand their perspectives. RESULTS: We enrolled 350 patients and 99 clinicians from 20 practices and interviewed 26 patients. Use of the conversation aid increased post-encounter patient knowledge (correct answers, 52% vs. 45%, p = 0.02) and clinician involvement of patients (Mean between-arm difference in OPTION12, 7.3 (95% CI 3, 12); p = 0.003). There were no between-arm differences in treatment choice, patient or clinician satisfaction, encounter length, medication adherence, or glycemic control. Qualitative analyses highlighted differences in how clinicians involved patients in decision making, with intervention patients noting how clinicians guided them through conversations using factors important to them. CONCLUSIONS: Using an SDM conversation aid improved patient knowledge and involvement in SDM without impacting treatment choice, encounter length, medication adherence or improved diabetes control in patients with type 2 diabetes. Future interventions may need to focus specifically on patients with signs of poor treatment fit. CLINICAL TRIAL REGISTRATION: ClinicalTrial.gov: NCT01502891.

Finalizing a measurement framework for the burden of treatment in complex patients with chronic conditions.

PURPOSE: The workload of health care and its impact on patient functioning and well-being is known as treatment burden. The purpose of this study was to finalize a conceptual framework of treatment burden that will be used to inform a new patient-reported measure of this construct. PATIENTS AND METHODS: Semi-structured interviews were conducted with 50 chronically ill patients from a large academic medical center (n=32) and an urban safety-net hospital (n=18). We coded themes identifying treatment burden, with the themes harmonized through discussion between multiple coders. Four focus groups, each with five to eight participants with chronic illness, were subsequently held to confirm the thematic structure that emerged from the interviews. RESULTS: Most interviewed patients (98%) were coping with multiple chronic conditions. A preliminary conceptual framework using data from the first 32 interviews was evaluated and was modified using narrative data from 18 additional interviews with a racially and socioeconomically diverse sample of patients. The final framework features three overarching themes with associated subthemes. These themes included: 1) work patients must do to care for their health (eg, taking medications, keeping medical appointments, monitoring health); 2) challenges/stressors that exacerbate perceived burden (eg, financial, interpersonal, provider obstacles); and 3) impacts of burden (eg, role limitations, mental exhaustion). All themes and subthemes were subsequently confirmed in focus groups. CONCLUSION: The final conceptual framework can be used as a foundation for building a patient self-report measure to systematically study treatment burden for research and analytical purposes, as well as to promote meaningful clinic-based dialogue between patients and providers about the challenges inherent in maintaining complex self-management of health.

Perspectives on physical activity among immigrants and refugees to a small urban community in Minnesota.

Immigrants and refugees to the United States exhibit relatively low levels of physical activity, but reasons for this disparity are poorly understood. 16 gender and age-stratified focus groups were conducted among 127 participants from heterogenous immigrant and refugee groups (Cambodian, Mexican, Somali, Sudanese) in a small Minnesota urban community. We found many similarities in perceived barriers and facilitators to physical activity between heterogeneous immigrant and refugee groups. While the benefits of physical activity were widely acknowledged, lack of familiarity and comfort with taking the first steps towards being physically active were the most significant barriers to physical activity. Participants described being motivated by social support from family, friends, and communities to be physically active. Our findings suggest that shared experiences of immigration and associated social, economic, and linguistic factors influence how physical activity is understood, conceptualized and practiced.

A focus group study of healthy eating knowledge, practices, and barriers among adult and adolescent immigrants and refugees in the United States.

BACKGROUND: Immigrants and refugees to the United States exhibit lower dietary quality than the general population, but reasons for this disparity are poorly understood. In this study, we describe the meanings of food, health and wellbeing through the reported dietary preferences, beliefs, and practices of adults and adolescents from four immigrant and refugee communities in the Midwestern United States. METHODS: Using a community based participatory research approach, we conducted a qualitative research study with 16 audio-recorded focus groups with adults and adolescents who self-identified as Mexican, Somali, Cambodian, and Sudanese. Focus group topics were eating patterns, perceptions of healthy eating in the country of origin and in the U.S., how food decisions are made and who in the family is involved in food preparation and decisions, barriers and facilitators to healthy eating, and gender and generational differences in eating practices. A team of investigators and community research partners analyzed all transcripts in full before reducing data to codes through consensus. Broader themes were created to encompass multiple codes. RESULTS: Results show that participants have similar perspectives about the barriers (personal, environmental, structural) and benefits of healthy eating (e.g., 'junk food is bad'). We identified four themes consistent across all four communities: Ways of Knowing about Healthy Eating ('Meanings;' 'Motivations;' 'Knowledge Sources'), Eating Practices ('Family Practices;' 'Americanized Eating Practices' 'Eating What's Easy'), Barriers ('Taste and Cravings;' 'Easy Access to Junk Food;' 'Role of Family;' Cultural Foods and Traditions;' 'Time;' 'Finances'), and Preferences for Intervention ('Family Counseling;' Community Education;' and 'Healthier Traditional Meals.'). Some generational (adult vs. adolescents) and gender differences were observed. CONCLUSIONS: Our study demonstrates how personal, structural, and societal/cultural factors influence meanings of food and dietary practices across immigrant and refugee populations. We conclude that cultural factors are not fixed variables that occur independently from the contexts in which they are embedded.

Medical humanitarianism in the United States: alternative healthcare, spirituality and political advocacy in the case of Our Lady Guadalupe Free Clinic.

Exclusionary practices in dominant market-based systems are recognized as contributing to global health inequities. Undocumented immigrants are particularly vulnerable to unequal access to healthcare. Humanitarian NGOs strive to respond meaningfully to these health inequities among migrants and undocumented immigrants. Few studies describe the work of humanitarian NGOs that advocate for the right to health of undocumented immigrants in high-income countries. This paper discusses immigration, health, and human rights while examining solidarity, spirituality, and advocacy using a U.S.-based example of medical humanitarianism: the 'Our Lady of Guadalupe Free Clinic.' In 2011, the Free Clinic began in the basement of a Catholic parish in Minnesota in response to the lack of access to medical services for undocumented immigrants. Run by a local grassroots organization, it is held every six weeks and offers free primary healthcare to Latino immigrants and the uninsured. In this article, we examine the tricky relationship between humanitarianism and human rights in the U.S. Using ethnography, we draw on participant observation and interviews with 30 clinic volunteers, including health professionals, administrators, language interpreters, and spiritual leaders. The study was conducted September 2012-December 2013 in southern Minnesota. We examine how notions of solidarity, spirituality, and advocacy structure faith-based medical humanitarianism in the U.S. and explore the underlying tensions between the humanitarian mandate, spiritual teachings (social justice, solidarity), and political advocacy. Examining a moment of "crisis" in the Clinic, our study shows that volunteers experience the alliance between spirituality and advocacy with uneasiness. While a spiritual calling may initially motivate volunteers to serve, an embrace of human rights advocacy is important in a sustained effort to provide humanitarian medical care to individuals who fall outside of the political and moral community in the U.S.

Shared decision making in the safety net: where do we go from here?

BACKGROUND: Shared decision making (SDM) is an interactive process between clinicians and patients in which both share information, deliberate together, and make clinical decisions. Clinics serving safety net patients face special challenges, including fewer resources and more challenging work environments. The use of SDM within safety net institutions has not been well studied. METHODS: We recruited a convenience sample of 15 safety net primary care clinicians (13 physicians, 2 nurse practitioners). Each answered a 9-item SDM questionnaire and participated in a semistructured interview. From the transcribed interviews and questionnaire data, we identified themes and suggestions for introducing SDM into a safety net environment. RESULTS: Clinicians reported only partially fulfilling the central components of SDM (sharing information, deliberating, and decision making). Most clinicians expressed interest in SDM by stating that they "selected a treatment option together" with patients (8 of 15 in strong or complete agreement), but only a minority (3 of 15) "thoroughly weighed the different treatment options" together with patients. Clinicians attributed this gap to many barriers, including time pressure, overwhelming visit content, patient preferences, and lack of available resources. All clinicians believed that lack of time made it difficult to practice SDM. CONCLUSIONS: To increase use of SDM in the safety net, efficient SDM interventions designed for this environment, team care, and patient engagement in SDM will need further development. Future studies should focus on adapting SDM to safety net settings and determine whether SDM can reduce health care disparities.

Factors that lessen the burden of treatment in complex patients with chronic conditions: a qualitative study.

PURPOSE: Patients with multiple chronic conditions (multimorbidity) often require ongoing treatment and complex self-care. This workload and its impact on patient functioning and well-being are, together, known as treatment burden. This study reports on factors that patients with multimorbidity draw on to lessen perceptions of treatment burden. PATIENTS AND METHODS: Interviews (n=50) and focus groups (n=4 groups, five to eight participants per group) were conducted with patients receiving care in a large academic medical center or an urban safety-net hospital. Interview data were analyzed using qualitative framework analysis methods, and themes and subthemes were used to identify factors that mitigate burden. Focus groups were held to confirm these findings and clarify any new issues. This study was part of a larger program to develop a patient-reported measure of treatment burden. RESULTS: Five major themes emerged from the interview data. These included: 1) problem-focused strategies, like routinizing self-care, enlisting support of others, planning for the future, and using technology; 2) emotion-focused coping strategies, like maintaining a positive attitude, focusing on other life priorities, and spirituality/faith; 3) questioning the notion of treatment burden as a function of adapting to self-care and comparing oneself to others; 4) social support (informational, tangible, and emotional assistance); and 5) positive aspects of health care, like coordination of care and beneficial relationships with providers. Additional subthemes arising from focus groups included preserving autonomy/independence and being proactive with providers. CONCLUSION: Patients attempt to lessen the experience of treatment burden using a variety of personal, social, and health care resources. Assessing these factors in tandem with patient perceptions of treatment burden can provide a more complete picture of how patients fit complex self-care into their daily lives.

Lessons learned from the conduct of a multisite cluster randomized practical trial of decision aids in rural and suburban primary care practices.

BACKGROUND: The decision aids for diabetes (DAD) trial explored the feasibility of testing the effectiveness of decision aids (DAs) about coronary prevention and diabetes medications in community-based primary care practices, including rural clinics that care for patients with type 2 diabetes. METHODS: As originally designed, we invited clinicians in eight practices to participate in the trial, reviewed the patient panel of clinicians who accepted our invitation for potentially eligible patients, and contacted these patients by phone, enrolling those who accepted our invitation. As enrollment failed to meet targets, we recruited four new practices. After discussing the study with the clinicians and receiving their support, we reviewed all clinic panels for potentially eligible patients. Clinicians were approached to confirm participation and patient eligibility, and patients were approached before their visit to provide written informed consent. This in-clinic approach required study coordinators to travel and stay longer at the clinics as well as to screen more patient records for eligibility. The in-clinic approach was associated with better recruitment rates, lower patient retention and outcome completion rates, and a better intervention effect. RESULTS: We drew four lessons: 1) difficulties identifying potentially eligible patients threaten the viability of practical trials of DAs; 2) to improve the recruitment yield, recruit clinicians and patients for the study at the clinic, just before their visit; 3) approaches that improve recruitment may be associated with reduced retention and survey response; and 4) procedures that involve working closely with the practice may improve recruitment and may also affect the quality of the implementation of the interventions. CONCLUSION: Success in practice-based trials in usual primary care including rural clinics may require the smallest possible research footprint on the practice while implementing a streamlined protocol favoring in-clinic, in-person interactions with clinicians and patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT01029288.

Shared decision making for patients with type 2 diabetes: a randomized trial in primary care.

BACKGROUND: Patient-centered diabetes care requires shared decision making (SDM). Decision aids promote SDM, but their efficacy in nonacademic and rural primary care clinics is unclear. METHODS: We cluster-randomized 10 practices in a concealed fashion to implement either a decision aid (DA) about starting statins or one about choosing antihyperglycemic agents. Each practice served as a control group for another practice implementing the other type of DA. From April 2011 to July 2012, 103 (DA=53) patients with type 2 diabetes participated in the trial. We used patient and clinician surveys administered after the clinical encounter to collect decisional outcomes (patient knowledge and comfort with decision making, patient and clinician satisfaction). Medical records provided data on metabolic control. Pharmacy fill profiles provided data for estimating adherence to therapy. RESULTS: Compared to usual care, patients receiving the DA were more likely to report discussing medications (77% vs. 45%, p<.001), were more likely to answer knowledge questions correctly (risk reduction with statins 61% vs. 33%, p=.07; knowledge about options 57% vs. 33%, p=.002) and were more engaged by their clinicians in decision making (50. vs. 28, difference 21.4 (95% CI 6.4, 36.3), p=.01). We found no significant impact on patient satisfaction, medication starts, adherence or clinical outcomes, in part due to limited statistical power. CONCLUSION: DAs improved decisional outcomes without significant effect on clinical outcomes. DAs designed for point-of-care use with type 2 diabetes patients promoted shared decision making in nonacademic and rural primary care practices. TRIAL REGISTRATION: NCT01029288.

'They leave at least believing they had a part in the discussion': understanding decision aid use and patient-clinician decision-making through qualitative research.

OBJECTIVE: This study explores how patient decision aids (DAs) for antihyperglycemic agents and statins, designed for use during clinical consultations, are embedded into practice, examining how patients and clinicians understand and experience DAs in primary care visits. METHODS: We conducted semistructured in-depth interviews with patients (n=22) and primary care clinicians (n=19), and videorecorded consultations (n=44). Two researchers coded all transcripts. Inductive analyses guided by grounded theory led to the identification of themes. Video and interview data were compared and organized by themes. RESULTS: DAs used during consultations became flexible artifacts, incorporated into existing decision making roles for clinicians (experts, authority figures, persuaders, advisors) and patients (drivers of healthcare, learners, partners). DAs were applied to different decision making steps (deliberation, bargaining, convincing, case assessment), and introduced into an existing knowledge context (participants' literacy regarding shared decision-making (SDM) and DAs). CONCLUSION: DAs' flexible use during consultations effectively provided space for discussion, even when SDM was not achieved. DAs can be used within any decision-making model. PRACTICE IMPLICATIONS: Clinician training in DA use and SDM practice may be needed to facilitate DA implementation and promote more ideal-type forms of sharing in decision making.

Mexican and Somali immigrant breastfeeding initiation and counseling: a qualitative study of practices.

Breastfeeding is highly beneficial to mothers and children. Yet even among women who intend to breastfeed their babies, it is not always initiated or sustained. We decided to examine whether cultural beliefs affect breastfeeding practices. Specifically, we looked at those of immigrant Mexican and Somali women who gave birth at a community hospital in southeastern Minnesota and those of the nurses and lactation educators who supported them. To study this, we conducted focus groups with health professionals (N=10) and in-person interviews with Somali and Mexican mothers (N=9). Although the mothers in this study stated their intention to breastfeed, our data show they faced significant challenges to early breastfeeding initiation and exclusive breastfeeding, including their belief that they did not initially produce enough milk. We found the nurses' and lactation educators' discomfort with counseling people from another background as well as language differences and lack of cultural understanding were also barriers to early breastfeeding initiation and exclusive breastfeeding. This study highlights how the beliefs of new mothers and the attitudes of nurses and educators can affect breastfeeding outcomes.

The impact of decision aids to enhance shared decision making for diabetes (the DAD study): protocol of a cluster randomized trial.

BACKGROUND: Shared decision making contributes to high quality healthcare by promoting a patient-centered approach. Patient involvement in selecting the components of a diabetes medication program that best match the patient's values and preferences may also enhance medication adherence and improve outcomes. Decision aids are tools designed to involve patients in shared decision making, but their adoption in practice has been limited. In this study, we propose to obtain a preliminary estimate of the impact of patient decision aids vs. usual care on measures of patient involvement in decision making, diabetes care processes, medication adherence, glycemic and cardiovascular risk factor control, and resource utilization. In addition, we propose to identify, describe, and explain factors that promote or inhibit the routine embedding of decision aids in practice. METHODS/DESIGN: We will be conducting a mixed-methods study comprised of a cluster-randomized, practical, multicentered trial enrolling clinicians and their patients (n = 240) with type 2 diabetes from rural and suburban primary care practices (n = 8), with an embedded qualitative study to examine factors that influence the incorporation of decision aids into routine practice. The intervention will consist of the use of a decision aid (Statin Choice and Aspirin Choice, or Diabetes Medication Choice) during the clinical encounter. The qualitative study will include analysis of video recordings of clinical encounters and in-depth, semi-structured interviews with participating patients, clinicians, and clinic support staff, in both trial arms. DISCUSSION: Upon completion of this trial, we will have new knowledge about the effectiveness of diabetes decision aids in these practices. We will also better understand the factors that promote or inhibit the successful implementation and normalization of medication choice decision aids in the care of chronic patients in primary care practices. TRIAL REGISTRATION: NCT00388050.

Impact of direct-to-consumer predictive genomic testing on risk perception and worry among patients receiving routine care in a preventive health clinic.

OBJECTIVE: To assess the impact of direct-to-consumer (DTC) predictive genomic risk information on perceived risk and worry in the context of routine clinical care. PATIENTS AND METHODS: Patients attending a preventive medicine clinic between June 1 and December 18, 2009, were randomly assigned to receive either genomic risk information from a DTC product plus usual care (n=74) or usual care alone (n=76). At intervals of 1 week and 1 year after their clinic visit, participants completed surveys containing validated measures of risk perception and levels of worry associated with the 12 conditions assessed by the DTC product. RESULTS: Of 345 patients approached, 150 (43%) agreed to participate, 64 (19%) refused, and 131 (38%) did not respond. Compared with those receiving usual care, participants who received genomic risk information initially rated their risk as higher for 4 conditions (abdominal aneurysm [P=.001], Graves disease [P=.04], obesity [P=.01], and osteoarthritis [P=.04]) and lower for one (prostate cancer [P=.02]). Although differences were not significant, they also reported higher levels of worry for 7 conditions and lower levels for 5 others. At 1 year, there were no significant differences between groups. CONCLUSION: Predictive genomic risk information modestly influences risk perception and worry. The extent and direction of this influence may depend on the condition being tested and its baseline prominence in preventive health care and may attenuate with time.