Chronic kidney disease (CKD) is a serious and growing public health problem. The purpose of this study is to find out if an educational worksheet, called the Encounter Decision Intervention (EDI), combined with health coaching helps CKD patients improve their blood pressure and other health outcomes. The research team hypothesizes that the intervention group will have greater improvement in CKD outcomes than the control group.
Patients that meet eligibility criteria and are seen in a clinic assigned to the control group will be given a Control-Encounter Decision Intervention (Control-EDI) about kidney disease in general (not tailored to the patient) by their primary care provider. Eligible patients that agree to participate and give consent will complete enrollment, 1, 6, and 12 month follow-up visits. Eligible patients that are seen in a clinic assigned to the intervention group will be given a personalized Intervention-EDI by their primary care provider. Following this, eligible patients that agree to participate and give consent will complete the enrollment visit, and have a baseline call with a health coach. In addition to the 1, 6, 12 month follow-up visits these patients will also have approximately 4-6 phone calls with the health coach between the baseline visit and 11 months after enrollment. In both groups the study team will be collecting medical information and assessments regarding their health; blood sample and urine samples at baseline and 12 months; approximately 4-6 phone calls; as well as surveys at various time points. In order to reduce in-person human subject activity due to the Coronavirus disease 2019 (COVID-19) pandemic, participants in both groups receive an at home blood pressure monitor so that systolic- \& diastolic-BP data can be collected at all 4 time points (baseline, 1, 6, 12 months). Additionally, we have increased the window tolerance for data collection by a few months for greater flexibility. We also collect survey data from patients' providers to assess their perception of the intervention's usefulness after patients complete their follow-up study visits. The provider survey data collection will occur up to one year, with an anticipated 100 participating providers. In addition to the 320 patients already enrolled, the study is expected to include a total of 420 participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
320
Patients in the control group will receive Control-EDI from their primary care provider during clinic visit. Subsequent patient CKD education and follow-up will be provider dependent. Patients will be called and reminded of their study visits at 1, 6, 12 months to complete study measures, BP checks, and give urine and blood samples (baseline and 12-month visit only).
Patients in the intervention group will receive a personalized Intervention-EDI from their primary care provider during visit, which will include their most recent BP, their urine protein level and most recent eGFR. There is also a space for their provider to type in a sentence about specific goals for the patient. Health coaches will conduct a baseline call and 4-6 coaching calls, based on patient's needs, over an 11-month period. There are 4 topic areas related to blood pressure and CKD that will be the focus of the calls. Coaches will also have pre-determined and vetted educational resources to provide patients if needed. Additionally, patients will be called and reminded of their study visits at 1, 6, 12 months to complete study measures, BP checks, and give urine and blood samples (baseline and 12-month visit only).
University of Michigan / Domino's Farms
Ann Arbor, Michigan, United States
University of Michigan / Briarwood Family Medicine
Ann Arbor, Michigan, United States
University of Michigan / Brighton Health Center
Brighton, Michigan, United States
University of Michigan / Canton Health Center
Canton, Michigan, United States
University of Michigan / Chelsea Health Center
Chelsea, Michigan, United States
University Health Center - GMAP/Gen Med
Detroit, Michigan, United States
University Health Center - Med Peds
Detroit, Michigan, United States
University of Michigan / Dexter Health Center
Dexter, Michigan, United States
University of Michigan / Livonia Health Center
Livonia, Michigan, United States
University of Michigan / Northville Health Center
Northville, Michigan, United States
...and 1 more locations
Change in Systolic Blood Pressure between baseline and 12 months
Changes in systolic blood pressure between baseline and 12 months will be compared between the intervention group and control group.
Time frame: Baseline, 12 months
Change in Diastolic Blood Pressure between baseline and 12 months
Changes in diastolic blood pressure between baseline and 12 months will be compared between the intervention group and control group.
Time frame: Baseline, 12 months
Slope of systolic BP between baseline and 12 months using all available BP values
BP will be collected at 4 time points - baseline, 1, 6, 12 months. This will be compared between the intervention group and control group.
Time frame: Baseline up to 12 months
Slope of diastolic BP between baseline and 12 months using all available BP values
BP will be collected at 4 time points - baseline, 1, 6, 12 months. This will be compared between the intervention group and control group.
Time frame: Baseline up to 12 months
CKD knowledge measured by the Kidney Knowledge Survey (KiKS)
This is a 28-item questionnaire measuring objective CKD disease knowledge and includes questions about goals, cardiovascular risk, and anti-hypertensive medications. Patients will answer the questions with a yes or no answer and their score will be based on how many responses were correct. This number will be converted to a percentage.
Time frame: Baseline up to 12 months
Medication Adherence Self-Efficacy Scale-Revised (MASES-R)
This is a 13-item measure with the answers on a Likert scale of 1 (not at all sure) to 4 (extremely sure). The higher the score the higher the self-efficacy, with a range from 13-52.
Time frame: Baseline up to 12 months
Morisky Medication Adherence Scale (MMAS - 8)
This scale is to quantify adherence to pharmacological treatments by 8 items. Levels of adherence are based on the following scores: \<6 = low adherence; 6-\<8 = medium adherence; 8 = high adherence.
Time frame: Baseline up to 12 months
Visit Time with provider
Length of time provider spends with the patient. This will be compared between the intervention group and control group.
Time frame: Enrollment visit (baseline)
Total time in clinic
Length of time between patient check-in and check-out. This will be compared between the intervention group and control group.
Time frame: Enrollment visit (baseline)
Patient Motivation by the Treatment Self-Regulation Questionnaire scale (TSRQ)
This contains a 17-item questionnaire in which the participants select scores from 1-7 or does not apply. A number of 1 = not at all and a score of 7 = considered very true, and zero = not applicable.
Time frame: Baseline up to 12 months
Satisfaction with CKD care based on Communication Assessment Tool (CAT)
This is a 15-item questionnaire that assesses the quality of physician to patient communication completed by the patients. There are 5 answers to choose from; poor, fair, good, very good, and excellent. The Score range is 1-5, where 1 means negative perception of communication and 5 means positive perception of communication.
Time frame: Baseline up to 12 months
Satisfaction with CKD care based on Consultation Care Measure (CCM)
This is a 21-item questionnaire that is completed by the patients, and select from the the 4 choices: very strongly agree, strongly agree, agree, and neutral/disagree. Each answer is worth one point on a Likert scale with a higher score meaning more satisfied.
Time frame: Baseline up to 12 months
Perceptions of health coaching for the intervention group
During health coach phone calls, participants will be asked 37 questions about their perceptions of the health coach program, including how much their participation in CHECK-D helped participants change various behaviors. Participant responses will be used to examine various measures of reliability and validity during the analyses of data acquired though this survey.
Time frame: Baseline up to 12 months
Self-efficacy for disease self-management based on The Perceived Kidney/Dialysis Self-Management Scale (PKDSMS)
This is an 8-item scale regarding self-efficacy where each statement is rated on the level of agreement from 1-5. 1 is disagree and 5 is agree.
Time frame: Baseline up to 12 months
Self-reported Blood Pressure-Related Behaviors Survey
This is a 5-item survey about knowledge and behaviors regarding sodium in the diet.
Time frame: Baseline up to 12 months
Provider Adoption based on EMR query and patient survey
Provider adoption will be measured by the percentage of enrolled patients whose providers used the EDI with them during their visit. Data will be collected by EMR query and a 1-item question in the patient survey.
Time frame: Baseline
Provider Fidelity measured by EMR query
Provider fidelity will be measured by the percentage of enrolled patients in the intervention clinics whose providers entered 1-2 patient specific goals in the EDI. This will be collected through EMR query.
Time frame: Baseline
Provider Perception of Usefulness by provider survey
Provider perception of usefulness will be measured by a survey of 2-3 questions about how useful they thought it was.
Time frame: After all patient follow-ups, up to one year
Change in serum creatinine
Change in Serum Creatinine between baseline and 12-months
Time frame: Baseline, 12 months
Change in urine protein-creatinine ratio
Change in urine protein-creatinine ratio between baseline and 12-months
Time frame: Baseline, 12 months
Change in estimated glomerular filtration rate (eGFR)
Change in estimated glomerular filtration rate (eGFR) between baseline and 12-months
Time frame: Baseline, 12 months
Change in EMR-recorded blood pressure between baseline and 12 months
Changes in blood pressure recorded in the EMR from baseline to 12 months will be compared between the intervention group and control group
Time frame: Baseline up to 12 months
Change in study visit blood pressure supplemented with EMR blood pressure if missing
Changes in blood pressure collected during study visits from baseline to 12 months will be compared between the intervention group and control group, with EMR data used to supplement missing values
Time frame: Baseline up to 12 months
Change in blood pressure using the combined dataset of all study visit and EMR blood pressure values
Changes in blood pressure from baseline to 12 months will be analyzed using a combined dataset that includes all available study visit and EMR blood pressure values
Time frame: Baseline up to 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.