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 (alpha 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<.001). Patients with lower health literacy, less adherence to medications, and more financial difficulties reported higher PETS scores (Ps<.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.

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

PurposePatients 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 methodsInterviews (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.ResultsFive 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.ConclusionPatients 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.

PurposeThe 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 methodsSemi-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.ResultsMost 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.ConclusionThe 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.

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 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 hemoglobin A1c (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.

PurposeHaving 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 methodsThis 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.ResultsMost 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”.ConclusionGood 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.

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.

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.