Deriving and validating a brief measure of treatment burden to assess person-centered healthcare quality in primary care: a multi-method study.

BACKGROUND: In primary care there is a need for more quality measures of person-centered outcomes, especially ones applicable to patients with multiple chronic conditions (MCCs). The aim of this study was to derive and validate a short-form version of the Patient Experience with Treatment and Self-management (PETS), an established measure of treatment burden, to help fill the gap in quality measurement. METHODS: Patient interviews (30) and provider surveys (30) were used to winnow items from the PETS (60 items) to a subset targeting person-centered care quality. Results were reviewed by a panel of healthcare providers and health-services researchers who finalized a pilot version. The Brief PETS was tested in surveys of 200 clinic and 200 community-dwelling MCC patients. Surveys containing the Brief PETS and additional measures (e.g., health status, medication adherence, quality of care, demographics) were administered at baseline and follow-up. Correlations and t-tests were used to assess validity, including responsiveness to change of the Brief PETS. Effect sizes (ES) were calculated on mean differences. RESULTS: Winnowing and panel review resulted in a 34-item Brief PETS pilot measure that was tested in the combined sample of 400 (mean age = 57.9 years, 50% female, 48% white, median number of conditions = 5). Reliability of most scales was acceptable (alpha > 0.70). Brief PETS scores were associated with age, income, health status, and quality of chronic illness care at baseline (P < .05; rho magnitude range: 0.16-0.66). Furthermore, Brief PETS scores differentiated groups based on marital and education status, presence/absence of a self-management routine, and optimal/suboptimal medication adherence (P < .05; ES range: 0.25-1.00). Declines in patient-reported physical or mental health status over time were associated with worsening PETS burden scores, while improvements were associated with improving PETS burden scores (P < .05; ES range: 0.04-0.44). Among clinic patients, 91% were willing to complete the Brief PETS as part of their clinic visits. CONCLUSIONS: The Brief PETS (final version: 32 items) is a reliable and valid tool for assessing person-centered care quality related to treatment burden. It holds promise as a means of giving voice to patient concerns about the complexity of disease management.

Validating the Patient Experience with Treatment and Self-Management (PETS), a patient-reported measure of treatment burden, in people with diabetes.

AIMS: To validate a comprehensive general measure of treatment burden, the Patient Experience with Treatment and Self-Management (PETS), in people with diabetes. METHODS: We conducted a secondary analysis of a cross-sectional survey study with 120 people diagnosed with type 1 or type 2 diabetes and at least one additional chronic illness. Surveys included established patient-reported outcome measures and a 48-item version of the PETS, a new measure comprised of multi-item scales assessing the burden of chronic illness treatment and self-care as it relates to nine domains: medical information, medications, medical appointments, monitoring health, interpersonal challenges, health care expenses, difficulty with health care services, role activity limitations, and physical/mental exhaustion from self-management. Internal reliability of PETS scales was determined using Cronbach's alpha. Construct validity was determined through correlation of PETS scores with established measures (measures of chronic condition distress, medication satisfaction, self-efficacy, and global well-being), and known-groups validity through comparisons of PETS scores across clinically distinct groups. In an exploratory test of predictive validity, step-wise regressions were used to determine which PETS scales were most associated with outcomes of chronic condition distress, overall physical and mental health, and medication adherence. RESULTS: Respondents were 37-88 years old, 59% female, 29% non-white, and 67% college-educated. PETS scales showed good reliability (Cronbach's alphas ≥0.74). Higher PETS scale scores (greater treatment burden) were correlated with more chronic condition distress, less medication convenience, lower self-efficacy, and worse general physical and mental health. Participants less (versus more) adherent to medications and those with more (versus fewer) health care financial difficulties had higher mean PETS scores. Medication burden was the scale that was most consistently associated with well-being and patient-reported adherence. CONCLUSION: The PETS is a reliable and valid measure for assessing perceived treatment burden in people coping with diabetes.

Healthcare provider relational quality is associated with better self-management and less treatment burden in people with multiple chronic conditions.

PURPOSE: Having multiple chronic conditions (MCCs) can lead to appreciable treatment and self-management burden. Healthcare provider relational quality (HPRQ) - the communicative and interpersonal skill of the provider - may mitigate treatment burden and promote self-management. The objectives of this study were to 1) identify the associations between HPRQ, treatment burden, and psychosocial outcomes in adults with MCCs, and 2) determine if certain indicators of HPRQ are more strongly associated than others with these outcomes. PATIENTS AND METHODS: This is a cross-sectional survey study of 332 people with MCCs. Patients completed a 7-item measure of HPRQ and measures of treatment and self-management burden, chronic condition distress, self-efficacy, provider satisfaction, medication adherence, and physical and mental health. Associations between HPRQ, treatment burden, and psychosocial outcomes were determined using correlational analyses and independent samples t-tests, which were repeated in item-level analyses to explore which indicators of HPRQ were most strongly associated with the outcomes. RESULTS: Most respondents (69%) were diagnosed with ≥3 chronic conditions. Better HPRQ was found to be associated with less treatment and self-management burden and better psychosocial outcomes (P<0.001), even after controlling for physical and mental health. Those reporting 100% adherence to prescribed medications had higher HPRQ scores than those reporting less than perfect adherence (P<0.001). HPRQ items showing the strongest associations with outcomes were "my healthcare provider spends enough time with me", "my healthcare provider listens carefully to me", and "I have trust in my healthcare provider". CONCLUSION: Good communication and interpersonal skills of healthcare providers may lessen feelings of treatment burden and empower patients to feel confident in their self-management. Patient trust in the provider is an important element of HPRQ. Educating healthcare providers about the importance of interpersonal and relational skills could lead to more patient-centered care.

Pilot Feasibility Study of a Digital Storytelling Intervention for Immigrant and Refugee Adults With Diabetes.

Purpose The purpose of this pilot feasibility project was to examine the potential effectiveness of a digital storytelling intervention designed through a community-based participatory research (CBPR) approach for immigrants and refugees with type 2 diabetes mellitus (T2DM). Methods The intervention was a 12-minute culturally and linguistically tailored video consisting of an introduction, 4 stories, and a concluding educational message. A structured interview was used to assess the intervention for acceptability, interest level, and usefulness among 25 participants with T2DM (15 Latino, 10 Somali) across 5 primary care clinical sites. After watching the video, participants rated their confidence and motivation about managing T2DM as a result of the intervention. Baseline A1C and follow-up values (up to 6 months) were abstracted from medical records. Results All participants reported that the intervention got their attention, was interesting, and was useful; 96% reported that they were more confident about managing their T2DM than before they watched the video, and 92% reported that the video motivated them to change a specific behavior related to T2DM self-management. The mean baseline A1C level for the intervention participants was 9.3% (78 mmol/mol). The change from baseline to first follow-up A1C level was -0.8% (-10 mmol/mol) ( P < .05). Conclusions Implementation of a digital storytelling intervention for T2DM among immigrant populations in primary care settings is feasible and resulted in self-rated improvement in psychosocial constructs that are associated with healthy T2DM self-management behaviors, and there was some evidence of improvement in glycemic control. A large-scale efficacy trial of the intervention is warranted.

Diabetes Outcome and Process Measures Among Patients Who Require Language Interpreter Services in Minnesota Primary Care Practices.

Immigrants and refugees are less likely to meet diabetes management goals than the general US population. Those with limited English proficiency (LEP) and who need interpreter services (IS) for health care encounters, maybe at higher risk for encountering barriers to optimal diabetes management, and while most receive diabetes care in primary care settings, little is known about the association between IS need and diabetes outcomes. This study aims to determine adherence with diabetes process and outcomes measures among LEP patients in primary care settings, and is a retrospective cohort study of patients with type II diabetes at two large primary care networks in Minnesota from January 1, 2012 through December 31, 2013. Diabetes outcome measure goals were defined as hemoglobin A1C <8%, LDL-C <100 mg/dL, and blood pressure <140/90 mmHg. Process measure goals were defined as hemoglobin A1C measured within the previous 6 months and LDL cholesterol (LDL-C) measured within the previous 12 months. Compared to non-IS patients (N = 11,970), IS patients (N = 1486) were more likely to meet guideline outcome recommendations for blood pressure (Adjusted odds ratio [OR] 2.02; 95% confidence interval [CI] 1.70, 2.40), hemoglobin A1C (OR 1.23; 95% CI 1.08, 1.40), and LDL-C (OR 1.40; 95% CI 1.2, 1.62). Older IS patients and male IS patients were less likely to meet recommendations for hemoglobin A1C (OR 0.70; 95% CI 0.48, 1.02; OR 0.66; CI 0.54, 0.79; respectively) and LDL-C (OR 0.81; 95% CI 0.55, 1.17; OR 0.47; CI 0.39, 0.57; respectively). Healthcare system solutions need to bridge gaps from process to outcomes among LEP patients who require IS in primary care settings.

Development and validation of the Patient Experience with Treatment and Self-management (PETS): a patient-reported measure of treatment burden.

PURPOSE: The purpose of this study was to develop and validate a new comprehensive patient-reported measure of treatment burden-the Patient Experience with Treatment and Self-management (PETS). METHODS: A conceptual framework was used to derive the PETS with items reviewed and cognitively tested with patients. A survey battery, including a pilot version of the PETS, was mailed to 838 multi-morbid patients from two healthcare institutions for validation. RESULTS: A total of 332 multi-morbid patients returned completed surveys. Diagnostics supported deletion and consolidation of some items and domains. Confirmatory factor analysis supported a domain model for scaling comprised of 9 factors: medical information, medications, medical appointments, monitoring health, interpersonal challenges, medical/healthcare expenses, difficulty with healthcare services, role/social activity limitations, and physical/mental exhaustion. Scales showed good internal consistency (α range 0.79-0.95). Higher PETS scores, indicative of greater treatment burden, were correlated with more distress, less satisfaction with medications, lower self-efficacy, worse physical and mental health, and lower convenience of healthcare (Ps < 0.001). Patients with lower health literacy, less adherence to medications, and more financial difficulties reported higher PETS scores (Ps < 0.01). CONCLUSION: A comprehensive patient-reported measure of treatment burden can help to better characterize the impact of treatment and self-management burden on patient well-being and guide care toward minimally disruptive medicine.

Shared decision making and medication therapy management with the use of an interactive template.

OBJECTIVES: To evaluate the preliminary efficacy, feasibility, and acceptability of a template-based intervention to facilitate shared decision making (SDM) in medication therapy management (MTM) consultations; and to examine the type and number of drug therapy problems (DTPs) discussed and how resolution was communicated to patients' primary care providers (PCPs). SETTING: An internal medicine clinic at a large safety-net hospital. PRACTICE DESCRIPTION: Hennepin County Medical Center is an urban safety net hospital serving an ethnically-diverse population with about 50 percent of patients enrolled in Medicaid. Within its internal medicine clinic, the study setting, over 100 clinicians participate in the primary care of approximately 25,000 discrete patients. PRACTICE INNOVATION: This is the first study to use a template format to facilitate SDM with pharmacists in MTM consultations. The template approach is more flexible than the use of decision aids, facilitating discussion around various issues. INTERVENTIONS: Patients completed template-guided interventions with pharmacists trained in SDM. EVALUATION: We analyzed the electronic health record used during the intervention, as well as post-appointment surveys administered to patients and pharmacists, for indications of SDM efficacy, feasibility, and acceptability. RESULTS: Twenty patients and four pharmacists participated in the study. Free-text comments demonstrated that both patients and pharmacists appreciated the intervention, although some pharmacists had concerns including consultation length and SDM applicability. On average, two DTPs were identified per consultation and were most commonly related to appropriate compliance (30% of DTPs), appropriate indication (26%), medication effectiveness (23%), and safety (21%). CONCLUSION: Using a template to facilitate SDM within MTM consultations appears to be effective, feasible, and acceptable. DTP identification exemplifies a potential application of template-guided SDM. These results will be used to inform future work refining the intervention and developing robust comparative analyses.

Regional Variation in Diabetic Outcomes by Country-of-Origin and Language in an Urban Safety Net Hospital.

Adherence to diabetic care guidelines among US immigrants remains low. This study assesses adherence to diabetic care guidelines by country-of-origin and language among a limited English-proficient (LEP) population. Timely completion of diabetic measures and acceptable levels of hemoglobin A1c (A1c), low density lipoprotein (LDL) cholesterol, and blood pressure (BP) were compared between LEP and English-proficient (EP) patients in this 2013 retrospective cohort study of adult diabetics. More LEP patients met BP targets (83 vs. 68 %, p < 0.0001) and obtained LDL targets (89 vs. 85 %, p = 0.0007); however, they had worse LDL control (57 vs. 62 %, p = 0.0011). Ethiopians and Somalians [adjusted OR (95 % CI) = 0.44 (0.30, 0.63)] were less likely than Latin Americans to meet BP goals. LEP patients outperformed EP peers on several diabetic outcomes measures with important variation between groups. These data highlight the success of a safety net hospital in improving diabetes management among diverse populations.

Shared Decision Making for Antidepressants in Primary Care: A Cluster Randomized Trial.

IMPORTANCE: For antidepressants, the translation of evidence of comparative effectiveness into practice is suboptimal. This deficit directly affects outcomes and quality of care for patients with depression. To overcome this problem, we developed the Depression Medication Choice (DMC) encounter decision aid, designed to help patients and clinicians consider the available antidepressants and the extent to which they improved depression and other issues important to patients. OBJECTIVE: Estimate the effect of DMC on quality of the decision-making process and depression outcomes. DESIGN, SETTING, AND PARTICIPANTS: We conducted a cluster randomized trial of adults with moderate to severe depression considering treatment with an antidepressant. Primary care practices in 10 rural, suburban, and urban primary care practices across Minnesota and Wisconsin were randomly allocated to treatment of depression with or without use of the DMC decision aid. INTERVENTION: Depression Medication Choice, a series of cards, each highlighting the effect of the available options on an issue of importance to patients for use during face-to-face consultations. MAIN OUTCOMES AND MEASURES: Decision-making quality as judged by patient knowledge and involvement in decision making, patient and clinician decisional comfort (Decisional Conflict Scale) and satisfaction, encounter duration, medication adherence, depression symptoms, and the Patient Health Questionnaire for depression (PHQ-9). RESULTS: We enrolled 117 clinicians and 301 patients (67% women; mean [SD] age, 44 [15] years; mean [SD] PHQ-9 score, 15 [4]) into the trial. Compared with usual care (UC), use of DMC significantly improved patients' decisional comfort (DMC, 80% vs UC, 75%; P = .02), knowledge (DMC, 65% vs UC, 56%; P = .03), satisfaction (risk ratio [RR], from 1.25 [P = .81] to RR, 2.4 [P = .002] depending on satisfaction domain), and involvement (DMC, 47% vs UC, 33%; P<.001). It also improved clinicians' decisional comfort (DMC, 80% vs UC, 68%; P < .001) and satisfaction (RR, 1.64; P = .02). There were no differences in encounter duration, medication adherence, or improvement of depression control between arms. CONCLUSIONS AND RELEVANCE: The DMC decision aid helped primary care clinicians and patients with moderate to severe depression select antidepressants together, improving the decision-making process without extending the visit. On the other hand, DMC had no discernible effect on medication adherence or depression outcomes. By translating comparative effectiveness into patient-centered care, use of DMC improved the quality of primary care for patients with depression. TRIAL REGISTRATION: clinicaltrials.gov Identifier: 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.

Does Integrated Care Affect Healthcare Utilization in Multi-problem Refugees?

A history of trauma is common in refugee populations and appropriate treatment is frequently avoided. Using a convenience sample of 64 patients in a Somali primary care clinic, a culture and trauma specific intervention was developed to address retention into appropriate treatment. One goal of the intervention was to improve the rate of engagement in psychotherapy after a mental health referral and to test the effect of psychotherapy on health care utilization using a staged primary care clinical tool. Forty-eight percent of patients given a mental health referral engaged in psychotherapy. Patients engaging in psychotherapy had higher baseline utilization and over 12 months trended towards less emergency room use and more primary care. Our findings suggest that the intervention improved referral and retention in mental health therapy for East African refugee women.

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.