{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,19]],"date-time":"2026-10-19T15:40:28Z","timestamp":1792424428086,"version":"4.5.0"},"reference-count":34,"publisher":"American Medical Association (AMA)","issue":"10","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Netw Open"],"abstract":"<jats:sec>\n                    <jats:title>Importance<\/jats:title>\n                    <jats:p>Effective interventions are needed to support the cocreation of diabetes care plans that are sensible, desirable, and feasible for the people living with diabetes (ie, care that fits).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To investigate whether an agenda-setting kit (ASK) added to usual primary care improves fit of care and glycemic control in adults with type 2 diabetes (T2D).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design, Setting, and Participants<\/jats:title>\n                    <jats:p>\n                      This single-center, clinician-level cluster randomized clinical trial was conducted from February 16, 2023, to July 26, 2024, with a 6-month follow-up, at a federally qualified health center in New Haven, Connecticut. Eligible clinicians were primary care physicians, nurse practitioners, and physician assistants who prescribed medication to treat patients with T2D. Eligible patients were English- or Spanish-speaking adults aged 18 years or older with T2D and hemoglobin (Hb) A\n                      <jats:sub>1c<\/jats:sub>\n                      level greater than 8%. Patients were excluded if their clinician determined that an HbA\n                      <jats:sub>1c<\/jats:sub>\n                      level 8% or lower was inconsistent with goals of care. Data were analyzed from November 7, 2024, to August 13, 2026.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Intervention<\/jats:title>\n                    <jats:p>Clinicians were randomized 1:1 to the ASK plus usual primary care group (intervention group) or usual primary care only (control group). The ASK intervention consisted of 14 conversation cards about life with diabetes and its treatment. Prior to the clinical encounter, patients were asked to select 0 to 3 cards they wanted to prioritize for discussion.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Main Outcomes and Measures<\/jats:title>\n                    <jats:p>\n                      The primary outcome was the 6-month change from baseline in illness intrusiveness measured with the Illness Intrusiveness Ratings Scale (IIRS; range: 13-91, with higher scores indicating greater intrusiveness) and HbA\n                      <jats:sub>1c<\/jats:sub>\n                      level. Secondary outcomes included changes in treatment burden measured with the Treatment Burden Questionnaire (TBQ; range: 0-150, with higher scores indicating greater burden), diabetes distress measured with the 17-Item Diabetes Distress Scale (DDS-17; scores: indicate little or no distress [&amp;amp;lt;2.0], moderate distress [2.0-2.9], and high distress [\u22653.0]), and visit satisfaction.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Eleven clinicians (6 [54.5%] female) were included in the trial along with 143 of their patients. The mean (SD) patient age was 56 (12) years; 87 participants (60.8%) were female and 88 (61.5%) reported Spanish as their primary language. Six-month survey data were available for 65 of 74 patients (87.8%) in the intervention group and 58 of 69 (84.0%) in the control group; data on HbA\n                      <jats:sub>1c<\/jats:sub>\n                      level were available for 71 (95.9%) and 65 (94.2%), respectively. At 6 months, mean (SD) IIRS scores were 32.1 (15.1) and 37.1 (18.7) in the intervention and control groups (adjusted mean difference, \u22123.9; 95% CI, \u221210.4 to 2.6). The mean (SD) HbA\n                      <jats:sub>1c<\/jats:sub>\n                      levels were 8.8% (1.8) in the intervention group and 9.1% (1.8) in the control group (adjusted mean difference, \u22120.2%; 95% CI, \u22120.9% to 0.5%). Mean (SD) TBQ scores in the intervention and control groups were 41.2 (44.8) and 46.8 (44.4) (adjusted mean difference, 1.0; 95% CI, \u221216.6 to 18.6), and mean (SD) DDS-17 scores were 2.0 (1.0) and 2.3 (1.0) (adjusted mean difference, \u22120.1; 95% CI, \u22120.4 to 0.2). Clinician-reported satisfaction was greater in the intervention group; patient satisfaction did not differ between groups.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions and Relevance<\/jats:title>\n                    <jats:p>In this cluster randomized clinical trial of adults with T2D, use of the ASK with usual primary care was associated with greater clinician satisfaction but not with improvements in patients\u2019 fit of care or glycemic control over 6 months. Larger studies should evaluate interventions that not only identify patients\u2019 priorities and treatment burdens but also better support clinicians in addressing them.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial Registration<\/jats:title>\n                    <jats:p>\n                      ClinicalTrials.gov Identifier:\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/study\/NCT05553912\">NCT05553912<\/jats:ext-link>\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1001\/jamanetworkopen.2026.39032","type":"journal-article","created":{"date-parts":[[2026,10,19]],"date-time":"2026-10-19T15:00:30Z","timestamp":1792422030000},"page":"e2639032","source":"Crossref","is-referenced-by-count":0,"title":["A Conversation Tool to Enhance Care for People With Type 2 Diabetes"],"prefix":"10.1001","volume":"9","author":[{"given":"Kasia J.","family":"Lipska","sequence":"first","affiliation":[{"name":"Department of Internal Medicine, Section of Endocrinology and Metabolism, Yale School of Medicine, New Haven, Connecticut"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Megan E.","family":"Branda","sequence":"additional","affiliation":[{"name":"Division of Clinical Trials and Biostatistics, Mayo Clinic, Rochester, Minnesota"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne W.","family":"Camp","sequence":"additional","affiliation":[{"name":"Fair Haven Community Health Center, New Haven, Connecticut"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Melissa","family":"Montosa","sequence":"additional","affiliation":[{"name":"Fair Haven Community Health Center, New Haven, Connecticut"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rozalina G.","family":"McCoy","sequence":"additional","affiliation":[{"name":"Division of Endocrinology, Diabetes, and Nutrition, Department of Medicine, University of Maryland School of Medicine, Baltimore"},{"name":"University of Maryland Institute for Health Computing, North Bethesda"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Victor V.","family":"Montori","sequence":"additional","affiliation":[{"name":"Knowledge and Evaluation Research Unit, Division of Endocrinology, Department of Medicine, Mayo Clinic, Rochester, Minnesota"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Felipe","family":"Larios","sequence":"additional","affiliation":[{"name":"Knowledge and Evaluation Research Unit, Division of Endocrinology, Department of Medicine, Mayo Clinic, Rochester, Minnesota"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Victor M.","family":"Montori","sequence":"additional","affiliation":[{"name":"Knowledge and Evaluation Research Unit, Division of Endocrinology, Department of Medicine, Mayo Clinic, Rochester, Minnesota"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"10","published-online":{"date-parts":[[2026,10,19]]},"reference":[{"key":"zoi261054r1","doi-asserted-by":"publisher","first-page":"138","DOI":"10.1186\/1477-7525-11-138","article-title":"The Diabetes Self-Management Questionnaire (DSMQ): development and evaluation of an instrument to assess diabetes self-care activities associated with glycaemic control.","volume":"11","author":"Schmitt","year":"2013","journal-title":"Health Qual Life Outcomes"},{"issue":"3","key":"zoi261054r2","doi-asserted-by":"publisher","first-page":"267","DOI":"10.2337\/ds17-0077","article-title":"Time needed for diabetes self-care: Nationwide Survey of Certified Diabetes Educators.","volume":"31","author":"Shubrook","year":"2018","journal-title":"Diabetes Spectr"},{"issue":"6","key":"zoi261054r3","doi-asserted-by":"publisher","first-page":"591","DOI":"10.1016\/j.jpsychores.2009.05.006","article-title":"Using the illness intrusiveness ratings scale to understand health-related quality of life in chronic disease.","volume":"68","author":"Devins","year":"2010","journal-title":"J Psychosom Res"},{"issue":"1","key":"zoi261054r4","doi-asserted-by":"publisher","first-page":"36","DOI":"10.1007\/s11606-018-4540-5","article-title":"Eliciting the patient\u2019s agenda\u2014secondary analysis of recorded clinical encounters.","volume":"34","author":"Singh Ospina","year":"2019","journal-title":"J Gen Intern Med"},{"issue":"8","key":"zoi261054r5","doi-asserted-by":"publisher","first-page":"2653","DOI":"10.1016\/j.pec.2022.03.026","article-title":"Interrupted opening statements in clinical encounters: a scoping review.","volume":"105","author":"Coyle","year":"2022","journal-title":"Patient Educ Couns"},{"issue":"1","key":"zoi261054r6","doi-asserted-by":"publisher","first-page":"5","DOI":"10.1136\/bmjebm-2021-111871","article-title":"Making care fit manifesto.","volume":"28","author":"Kunneman","year":"2023","journal-title":"BMJ Evid Based Med"},{"issue":"10","key":"zoi261054r7","doi-asserted-by":"publisher","first-page":"1041","DOI":"10.1016\/j.jclinepi.2012.05.005","article-title":"Cumulative complexity: a functional, patient-centered model of patient complexity can improve research and practice.","volume":"65","author":"Shippee","year":"2012","journal-title":"J Clin Epidemiol"},{"issue":"3","key":"zoi261054r8","doi-asserted-by":"publisher","first-page":"358","DOI":"10.2337\/cd23-0062","article-title":"Feasibility and acceptability of an agenda-setting kit in the care of people with type 2 diabetes: The QBSAFE ASK Feasibility Study.","volume":"42","author":"Haider","year":"2024","journal-title":"Clin Diabetes"},{"issue":"1","key":"zoi261054r9","doi-asserted-by":"publisher","first-page":"196","DOI":"10.1186\/s40814-021-00935-8","article-title":"Quality of life, burden of treatment, safety, and avoidance of future events (QBSAfe) protocol: a pilot study testing an intervention to shift the paradigm of diabetes care.","volume":"7","author":"Clark","year":"2021","journal-title":"Pilot Feasibility Stud"},{"issue":"3","key":"zoi261054r10","doi-asserted-by":"publisher","first-page":"200","DOI":"10.7326\/0003-4819-158-3-201302050-00583","article-title":"SPIRIT 2013 statement: defining standard protocol items for clinical trials.","volume":"158","author":"Chan","year":"2013","journal-title":"Ann Intern Med"},{"issue":"5","key":"zoi261054r11","doi-asserted-by":"publisher","first-page":"483","DOI":"10.1001\/jama.2017.21903","article-title":"Guidelines for inclusion of patient-reported outcomes in clinical trial protocols: The SPIRIT-PRO Extension.","volume":"319","author":"Calvert","year":"2018","journal-title":"JAMA"},{"key":"zoi261054r12","doi-asserted-by":"publisher","first-page":"i5239","DOI":"10.1136\/bmj.i5239","article-title":"CONSORT 2010 statement: extension to randomised pilot and feasibility trials.","volume":"355","author":"Eldridge","year":"2016","journal-title":"BMJ"},{"key":"zoi261054r13","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.e5661","article-title":"Consort 2010 statement: extension to cluster randomised trials.","volume":"345","author":"Campbell","year":"2012","journal-title":"BMJ"},{"issue":"4","key":"zoi261054r14","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2025.5258","article-title":"Engagement in hypertension and diabetes clinical trials at federally qualified health centers: a systematic review.","volume":"8","author":"Byiringiro","year":"2025","journal-title":"JAMA Netw Open"},{"issue":"6","key":"zoi261054r15","doi-asserted-by":"publisher","first-page":"30","DOI":"10.1007\/s11892-019-1149-y","article-title":"Bringing social context into diabetes care: intervening on social risks versus providing contextualized care.","volume":"19","author":"Hessler","year":"2019","journal-title":"Curr Diab Rep"},{"issue":"2","key":"zoi261054r16","doi-asserted-by":"publisher","first-page":"145","DOI":"10.2337\/ds18-0064","article-title":"Social and psychosocial determinants of health associated with uncontrolled diabetes in a federally qualified health center population.","volume":"32","author":"Rivich","year":"2019","journal-title":"Diabetes Spectr"},{"issue":"3","key":"zoi261054r17","doi-asserted-by":"publisher","first-page":"626","DOI":"10.2337\/diacare.28.3.626","article-title":"Assessing psychosocial distress in diabetes: development of the diabetes distress scale.","volume":"28","author":"Polonsky","year":"2005","journal-title":"Diabetes Care"},{"issue":"2","key":"zoi261054r18","doi-asserted-by":"publisher","first-page":"259","DOI":"10.2337\/dc11-1572","article-title":"When is diabetes distress clinically meaningful?: establishing cut points for the Diabetes Distress Scale.","volume":"35","author":"Fisher","year":"2012","journal-title":"Diabetes Care"},{"key":"zoi261054r19","doi-asserted-by":"publisher","first-page":"109","DOI":"10.1186\/1741-7015-12-109","article-title":"Adaptation and validation of the Treatment Burden Questionnaire (TBQ) in English using an internet platform.","volume":"12","author":"Tran","year":"2014","journal-title":"BMC Med"},{"key":"zoi261054r20","doi-asserted-by":"publisher","first-page":"68","DOI":"10.1186\/1741-7015-10-68","article-title":"Development and description of measurement properties of an instrument to assess treatment burden among patients with multiple chronic conditions.","volume":"10","author":"Tran","year":"2012","journal-title":"BMC Med"},{"key":"zoi261054r21","doi-asserted-by":"publisher","first-page":"141","DOI":"10.1080\/10810730.2012.712615","article-title":"Measurement variation across health literacy assessments: implications for assessment selection in research and practice.","volume":"17","author":"Haun","year":"2012","journal-title":"J Health Commun"},{"issue":"5","key":"zoi261054r22","doi-asserted-by":"publisher","first-page":"561","DOI":"10.1007\/s11606-008-0520-5","article-title":"Validation of screening questions for limited health literacy in a large VA outpatient population.","volume":"23","author":"Chew","year":"2008","journal-title":"J Gen Intern Med"},{"issue":"7","key":"zoi261054r23","doi-asserted-by":"publisher","first-page":"943","DOI":"10.2337\/diacare.23.7.943","article-title":"The summary of diabetes self-care activities measure: results from 7 studies and a revised scale.","volume":"23","author":"Toobert","year":"2000","journal-title":"Diabetes Care"},{"issue":"2","key":"zoi261054r24","doi-asserted-by":"publisher","first-page":"311","DOI":"10.1023\/B:QURE.0000018499.64574.1f","article-title":"Is a single-item visual analogue scale as valid, reliable and responsive as multi-item scales in measuring quality of life?","volume":"13","author":"de Boer","year":"2004","journal-title":"Qual Life Res"},{"issue":"1","key":"zoi261054r25","doi-asserted-by":"publisher","first-page":"443","DOI":"10.1186\/s13063-017-2178-y","article-title":"Shared decision making for stroke prevention in atrial fibrillation: study protocol for a randomized controlled trial.","volume":"18","author":"Kunneman","year":"2017","journal-title":"Trials"},{"key":"zoi261054r27","doi-asserted-by":"publisher","first-page":"301","DOI":"10.1186\/1472-6963-13-301","article-title":"Shared decision making for patients with type 2 diabetes: a randomized trial in primary care.","volume":"13","author":"Branda","year":"2013","journal-title":"BMC Health Serv Res"},{"issue":"2","key":"zoi261054r28","doi-asserted-by":"publisher","first-page":"177","DOI":"10.1001\/jama.297.2.177","article-title":"Relationship between adherence to evidence-based pharmacotherapy and long-term mortality after acute myocardial infarction.","volume":"297","author":"Rasmussen","year":"2007","journal-title":"JAMA"},{"issue":"3","key":"zoi261054r29","doi-asserted-by":"publisher","first-page":"229","DOI":"10.1136\/heart.88.3.229","article-title":"Adherence to statin treatment and readmission of patients after myocardial infarction: a six year follow up study.","volume":"88","author":"Wei","year":"2002","journal-title":"Heart"},{"issue":"1","key":"zoi261054r30","doi-asserted-by":"publisher","first-page":"17","DOI":"10.1007\/s11892-025-01576-4","article-title":"Addressing diabetes distress in primary care: where are we now, and where do we need to go?","volume":"25","author":"Kostiuk","year":"2025","journal-title":"Curr Diab Rep"},{"issue":"1","key":"zoi261054r31","doi-asserted-by":"publisher","first-page":"660","DOI":"10.1186\/s12888-024-06125-z","article-title":"The effectiveness of psychological interventions on diabetes distress and glycemic level in adults with type 2 diabetes: a systematic review and meta-analysis.","volume":"24","author":"Zu","year":"2024","journal-title":"BMC Psychiatry"},{"key":"zoi261054r32","doi-asserted-by":"publisher","DOI":"10.1016\/j.pecinn.2022.100097","article-title":"\u201cLess is more\u201d: a design thinking approach to the development of the agenda-setting conversation cards for people with type 2 diabetes.","volume":"1","author":"Lomborg","year":"2022","journal-title":"PEC Innov"},{"key":"zoi261054r33","doi-asserted-by":"publisher","DOI":"10.1016\/j.pec.2023.108084","article-title":"Evaluating the effect of conversation cards on agenda-setting in annual diabetes status visits: a multi-method study.","volume":"119","author":"Munch","year":"2024","journal-title":"Patient Educ Couns"},{"issue":"2","key":"zoi261054r34","doi-asserted-by":"publisher","first-page":"65","DOI":"10.1007\/s10488-010-0319-7","article-title":"Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda.","volume":"38","author":"Proctor","year":"2011","journal-title":"Adm Policy Ment Health"},{"key":"zoi261054r26","unstructured":"CAHPS Clinician & Group Survey. Agency for Healthcare Research and Quality. Accessed September 25, 2020. https:\/\/www.ahrq.gov\/cahps\/surveys-guidance\/cg\/index.html"}],"container-title":["JAMA Network Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/jamanetwork.com\/journals\/jamanetworkopen\/articlepdf\/2855477\/lipska_2026_oi_261054_1791821846.30865.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,10,19]],"date-time":"2026-10-19T15:00:30Z","timestamp":1792422030000},"score":1,"resource":{"primary":{"URL":"https:\/\/jamanetwork.com\/journals\/jamanetworkopen\/fullarticle\/2855477"}},"subtitle":["The QBSafe Cluster Randomized Clinical Trial"],"short-title":[],"issued":{"date-parts":[[2026,10,19]]},"references-count":34,"journal-issue":{"issue":"10","published-print":{"date-parts":[[2026,10,1]]}},"URL":"https:\/\/doi.org\/10.1001\/jamanetworkopen.2026.39032","relation":{},"ISSN":["2574-3805"],"issn-type":[{"value":"2574-3805","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,10,19]]}}}