NCT Number: NCT07221604
The goal of this open pilot is to practice using an intervention and surveys before a larger pilot stepped wedge clinical trial. The intervention the researchers plan to use is Chronic Kidney Disease (CKD) Topics, and it is a structured clinical agenda-setting intervention (SAS), or a customized list of discussion topics. The people the researchers are practicing using the SAS with have advanced CKD (stages 4-5), and many of them live in rural areas. The researchers will practice administering CKD Topics, along with survey questions. By doing the open pilot, the researchers will learn if they need to modify the steps they plan to take in the larger trial.
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?
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Cheshire Medical Center/Dartmouth-Hitchcock, Keene, New Hampshire, United States
In this open pilot, the researchers will administer a novel structured agenda-setting tool (SAS) called Chronic Kidney Disease (CKD) Topics. The researchers will determine if their procedures for screening eligible participants, administering the intervention, and administering outcome and other questionnaires are appropriate. Learnings from the open pilot will feed forward into procedures in a larger planned pilot stepped wedge feasibility trial.
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Day 1
Our primary outcome will be feasibility, assessed by the proportion of patients who received the intervention.
Time frame: Day 1
As measured by participant enrollment in Redcap.
Time frame: Day 1
Patient Self-Advocacy Scale (PSAS); a 12-item validated scale assessing the latent construct of perceived self-advocacy for patients.
Time frame: Day 1
Patient self-efficacy measured using the Ask, Understand, Remember Assessment, (AURA); a validated 4-item assessment of self-efficacy completed by patients.
Time frame: Day 1
Patient demonstration of self-management using the Perceived Medical Condition Self-Management Scale; an 8-item instrument validated to assess self-management among CKD patients; correlated with treatment adherence.
Time frame: Day 1
The 10-item version, PEPPI is a valid and reliable measure of older patients' perceived self-efficacy in interacting with physicians. This instrument may be useful in measuring the impact of empowerment interventions to increase older patients' personal sense of effectiveness in obtaining needed health care
Time frame: Day 1
Serious illness experience measured by the consideRATE questions; a validated 8-item, plain language (2nd grade) patient-reported experience measure (PREM) with Likert-like response options for patients, and care partners.
Time frame: Day 1
Respect experience assessment measured by the "Heard and understood" tool. Heard and Understood is a validated Single-item PREM with Likert-like response options for patients.
Contact information is provided by the study sponsor or research team.
Anne E. Dade, Research Associate, MPP
CONTACT
Catherine H. Saunders, Assistant Professor of Medicine and of Health Policy, PhD, MPH
CONTACT
Dartmouth-Hitchcock Medical Center
Other
Setting the Agenda: An Open Pilot of a Structured Clinical Visit Agenda-Setting Intervention for Rural-Residing People With Advanced Chronic Kidney Disease
Acronym: ASK
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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