Effect of Information and Telephone-Guided Access to Community Support for People with Chronic Kidney Disease: Randomised Controlled Trial

Background: Implementation of self-management support in traditional primary care settings has proved difficult, encouraging the development of alternative models which actively link to community resources. Chronic kidney disease (CKD) is a common condition usually diagnosed in the presence of other co-morbidities. This trial aimed to determine the effectiveness of an intervention to provide information and telephone-guided access to community support versus usual care for patients with stage 3 CKD. Methods and Findings: In a pragmatic, two-arm, patient level randomised controlled trial 436 patients with a diagnosis of stage 3 CKD were recruited from 24 general practices in Greater Manchester. Patients were randomised to intervention (215) or usual care (221). Primary outcome measures were health related quality of life (EQ-5D health questionnaire), blood pressure control, and positive and active engagement in life (heiQ) at 6 months. At 6 months, mean health related quality of life was significantly higher for the intervention group (adjusted mean difference = 0.05; 95% CI = 0.01, 0.08) and blood pressure was controlled for a significantly greater proportion of patients in the intervention group (adjusted odds ratio = 1.85; 95% CI = 1.25, 2.72). Patients did not differ significantly in positive and active engagement in life. The intervention group reported a reduction in costs compared with control. Conclusions: An intervention to provide tailored information and telephone-guided access to community resources was associated with modest but significant improvements in health related quality of life and better maintenance of blood pressure control for patients with stage 3 CKD compared with usual care. However, further research is required to identify the mechanisms of action of the intervention

A922 Sequential measurement of 1 hour creatinine clearance (1-CRCL) in critically ill patients at risk of acute kidney injury (AKI)

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Building a measurement framework of burden of treatment in complex patients with chronic conditions: a qualitative study

David T Eton,1 Djenane Ramalho de Oliveira,2,3 Jason S Egginton,1 Jennifer L Ridgeway,1 Laura Odell,4 Carl R May,5 Victor M Montori1,61Division of Health Care Policy and Research, Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA; 2College of Pharmacy, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil; 3Medication Therapy Management Program, Fairview Pharmacy Services LLC, Minneapolis, MN, USA; 4Pharmacy Services, Mayo Clinic, Rochester, MN, USA; 5Faculty of Health Sciences, University of Southampton, Southampton, UK; 6Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, MN, USABackground: Burden of treatment refers to the workload of health care as well as its impact on patient functioning and well-being. We set out to build a conceptual framework of issues descriptive of burden of treatment from the perspective of the complex patient, as a first step in the development of a new patient-reported measure.Methods: We conducted semistructured interviews with patients seeking medication therapy management services at a large, academic medical center. All patients had a complex regimen of self-care (including polypharmacy), and were coping with one or more chronic health conditions. We used framework analysis to identify and code themes and subthemes. A conceptual framework of burden of treatment was outlined from emergent themes and subthemes.Results: Thirty-two patients (20 female, 12 male, age 26–85 years) were interviewed. Three broad themes of burden of treatment emerged including: the work patients must do to care for their health; problem-focused strategies and tools to facilitate the work of self-care; and factors that exacerbate the burden felt. The latter theme encompasses six subthemes including challenges with taking medication, emotional problems with others, role and activity limitations, financial challenges, confusion about medical information, and health care delivery obstacles.Conclusion: We identified several key domains and issues of burden of treatment amenable to future measurement and organized them into a conceptual framework. Further development work on this conceptual framework will inform the derivation of a patient-reported measure of burden of treatment.Keywords: conceptual framework, patient-centered, medication therapy management, adherence, questionnaire, minimally disruptive medicin

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

David T Eton,1,2 Jennifer L Ridgeway,1,2 Jason S Egginton,1,2 Kristina Tiedje,3 Mark Linzer,4,5 Deborah H Boehm,4 Sara Poplau,6 Djenane Ramalho de Oliveira,7 Laura Odell,8 Victor M Montori,1,9 Carl R May,10 Roger T Anderson11 1Division of Health Care Policy and Research, Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA; 2Robert D and Patricia E Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN, USA; 3Department of Sociology and Anthropology, Université Lumière Lyon 2, Lyon, France; 4Division of General Internal Medicine, Hennepin County Medical Center, Minneapolis, MN, USA; 5University of Minnesota Medical School, University of Minnesota, Minneapolis, MN, USA; 6Minneapolis Medical Research Foundation, Minneapolis, MN, USA; 7Department of Social Pharmacy, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil; 8Pharmacy Services, Mayo Clinic, Rochester, MN, USA; 9Knowledge and Evaluation Research Unit, Mayo Clinic, Rochester, MN, USA; 10Faculty of Health Sciences and NIHR CLAHRC Wessex, University of Southampton, Southampton, UK; 11School of Medicine, University of Virginia, Charlottesville, VA, USA 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. Keywords: treatment burden, conceptual framework, adherence, questionnaire, self-management, multi-morbidit