Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
30 participants
INTERVENTIONAL
2026-07-31
2026-09-30
Brief Summary
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The main questions the researchers aim to answer are:
* Do the steps for identifying eligible participants work?
* Do the steps for administering CKD Topics work?
* Do the steps to administer survey questions work?
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Detailed Description
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This study only has one arm, the intervention arm. The intervention, CKD Topics, will be administered as a quality improvement intervention.
Future Directions: This open pilot will inform procedural changes in an upcoming pilot stepped wedge feasibility trial.
Conditions
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Study Design
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NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Arm 1 is Clinical Visit Agenda Setting Tool Intervention
The study team will implement a structured clinical visit agenda-setting (SAS) intervention customized for advanced chronic kidney disease, called Chronic Kidney Disease (CKD) Topics.
Chronic Kidney Disease Structured Agenda-Setting Tool
Chronic Kidney Disease (CKD) Topics is a novel clinical visit agenda-setting intervention developed through participatory research methods for people with CKD living in rural areas. CKD Topics includes 8 structured discussion topic areas with the option for patients to consider and indicate their priority topic areas and take notes before, during, and after a clinical visit.
Interventions
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Chronic Kidney Disease Structured Agenda-Setting Tool
Chronic Kidney Disease (CKD) Topics is a novel clinical visit agenda-setting intervention developed through participatory research methods for people with CKD living in rural areas. CKD Topics includes 8 structured discussion topic areas with the option for patients to consider and indicate their priority topic areas and take notes before, during, and after a clinical visit.
Eligibility Criteria
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Inclusion Criteria
* Care partners, clinicians and staff supporting these CKD patients who are willing and able to provide informed consent
* English-speaking
* Able to provide informed consent
* Patient must be attending outpatient visits \*(in-person and/or telehealth allowable).
Exclusion Criteria
* Non-English-speaking patients and/or care partners
* Patients on dialysis
* Individuals unable or unwilling to provide informed consent
18 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Dartmouth College
OTHER
Dartmouth-Hitchcock Medical Center
OTHER
Responsible Party
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Catherine Hylas Saunders
Principal Scientist, Assistant Professor of Medicine and of Health Policy and Clinical Practice
Locations
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Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Countries
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Central Contacts
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Catherine H. Saunders, Assistant Professor of Medicine and of Health Policy, PhD, MPH
Role: CONTACT
References
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Brashers DE, Haas SM, Neidig JL. The patient self-advocacy scale: measuring patient involvement in health care decision-making interactions. Health Commun. 1999;11(2):97-121. doi: 10.1207/s15327027hc1102_1.
Clayman ML, Pandit AU, Bergeron AR, Cameron KA, Ross E, Wolf MS. Ask, understand, remember: a brief measure of patient communication self-efficacy within clinical encounters. J Health Commun. 2010;15 Suppl 2(Suppl 2):72-9. doi: 10.1080/10810730.2010.500349.
Frankel RM, Salyers MP, Bonfils KA, Oles SK, Matthias MS. Agenda setting in psychiatric consultations: an exploratory study. Psychiatr Rehabil J. 2013 Sep;36(3):195-201. doi: 10.1037/prj0000004. Epub 2013 Jul 1.
Gramling R, Stanek S, Ladwig S, Gajary-Coots E, Cimino J, Anderson W, Norton SA; AAHPM Research Committee Writing Group; Aslakson RA, Ast K, Elk R, Garner KK, Gramling R, Grudzen C, Kamal AH, Lamba S, LeBlanc TW, Rhodes RL, Roeland E, Schulman-Green D, Unroe KT. Feeling Heard and Understood: A Patient-Reported Quality Measure for the Inpatient Palliative Care Setting. J Pain Symptom Manage. 2016 Feb;51(2):150-4. doi: 10.1016/j.jpainsymman.2015.10.018. Epub 2015 Nov 17.
Hemming K, Haines TP, Chilton PJ, Girling AJ, Lilford RJ. The stepped wedge cluster randomised trial: rationale, design, analysis, and reporting. BMJ. 2015 Feb 6;350:h391. doi: 10.1136/bmj.h391. No abstract available.
Makoul G, Krupat E, Chang CH. Measuring patient views of physician communication skills: development and testing of the Communication Assessment Tool. Patient Educ Couns. 2007 Aug;67(3):333-42. doi: 10.1016/j.pec.2007.05.005. Epub 2007 Jun 18.
Saunders CH, Durand MA, Kirkland KB, MacMartin MA, Barnato AE, Elwyn G. Psychometric assessment of the consideRATE questions, a new measure of serious illness experience, with an online simulation study. Patient Educ Couns. 2022 Jul;105(7):2581-2589. doi: 10.1016/j.pec.2022.01.002. Epub 2022 Jan 22.
Saunders CH, Durand MA, Scalia P, Kirkland KB, MacMartin MA, Barnato AE, Milne DW, Collison J, Bennett A, Wasp G, Nelson E, Elwyn G. "It helps us say what's important..." Developing Serious Illness Topics: A clinical visit agenda-setting tool. Patient Educ Couns. 2023 Aug;113:107764. doi: 10.1016/j.pec.2023.107764. Epub 2023 Apr 18.
Saunders CH, Durand MA, Scalia P, Kirkland KB, MacMartin MA, Barnato AE, Milne DW, Collison J, Jaggars A, Butt T, Wasp G, Nelson E, Elwyn G. User-Centered Design of the consideRATE Questions, a Measure of People's Experiences When They Are Seriously Ill. J Pain Symptom Manage. 2021 Mar;61(3):555-565.e5. doi: 10.1016/j.jpainsymman.2020.08.002. Epub 2020 Aug 16.
Sierpe A, Yen RW, Stevens G, Van Citters AD, Elwyn G, Saunders CH. Agenda-setting in the clinical encounter: A systematic review protocol. PLoS One. 2024 Oct 24;19(10):e0312613. doi: 10.1371/journal.pone.0312613. eCollection 2024.
Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
Wild MG, Wallston KA, Green JA, Beach LB, Umeukeje E, Wright Nunes JA, Ikizler TA, Steed J, Cavanaugh KL. The Perceived Medical Condition Self-Management Scale can be applied to patients with chronic kidney disease. Kidney Int. 2017 Oct;92(4):972-978. doi: 10.1016/j.kint.2017.03.018. Epub 2017 May 18.
Other Identifiers
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STUDY02002598_2
Identifier Type: -
Identifier Source: org_study_id
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