Multi-disciplinary Participatory Design of a Process to Deliver a CKD Diagnosis in Primary Care (EPIK)
2021년 9월 14일 업데이트: Julie Wright-Nunes, University of Michigan
This study will use an adapted education worksheet to support patient-centered chronic kidney disease (CKD) communication, shared decision making, and patient engagement and will test its impact on intermediate patient modifiable characteristics in a primary care practice with patients who have pre-dialysis CKD.
The study team will enroll up to 100 patients with chronic kidney disease (CKD) from a primary care clinic to start. Patients will receive the intervention, which consists of the physicians using the education worksheet during appointments with patients, and patients and providers will complete surveys about its use and to measure impact on knowledge and other areas related to patient outcomes.
Once initial user testing is complete, the study team plans to submit an amendment to expand on this trial and incorporate comparison sites. This will be submitted and receive IRB approval prior to participant involvement.
The study hypothesis is that patients who receive the intervention will have greater knowledge about their CKD diagnosis, higher satisfaction with provider communication, and higher scores related to managing CKD to keep themselves healthy compared to control populations.
연구 개요
상세 설명
Amendment on 12/2018: The enrollment numbers were updated to include the control group.
Clarification 9/2021: After initial feasibility was assessed, the initial site was used additionally to enroll for the "second arm", rather than a new site as originally intended. A second site was then used for the control population.
연구 유형
중재적
등록 (실제)
78
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
Michigan
-
Canton, Michigan, 미국, 48187
- Canton Health Center
-
Northville, Michigan, 미국, 48168
- Northville Health Center
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- 18 years old or older
- Have an estimated glomerular filtration rate (eGFR) of less than 60 ml/min/1.73 m2
- Able to read and understand English without an interpreter
- Diagnosed with chronic kidney disease on record
Exclusion Criteria:
- Patients with renal transplant or on dialysis
- Patients who have documented or provider known cognitive impairment or vision impairment that will prohibit meaningful interaction with education activation worksheet
- Patients who are not aware of their CKD diagnosis
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위화되지 않음
- 중재 모델: 요인 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Participatory design and intervention
Patients in this arm will receive the intervention of using an education worksheet during their appointment with their provider.
They will be asked to complete post intervention surveys (for feasibility and feedback prior to actual trial enrollment).
Providers and staff at this site have been involved in the design of the intervention process, to make it streamlined and efficient for application in practice.
|
Patients who screen positive for CKD and give written informed consent to be a part of the study will have their chart flagged for the medical assistant and provider to give the education worksheet intervention.
The education worksheet has been developed to be used as an electronic tool within the Electronic Medical Record.
The provider will review it with the patient during the visit.
A paper copy will print out for the patient at the end of the visit.
다른 이름들:
|
|
실험적: Intervention Only
This arm include new patients at the initial site that also received the intervention of using an education worksheet during their appointment and filled out post intervention surveys.
Some of these providers/staff were not involved in the initial design of the intervention.
|
Patients who screen positive for CKD and give written informed consent to be a part of the study will have their chart flagged for the medical assistant and provider to give the education worksheet intervention.
The education worksheet has been developed to be used as an electronic tool within the Electronic Medical Record.
The provider will review it with the patient during the visit.
A paper copy will print out for the patient at the end of the visit.
다른 이름들:
|
|
간섭 없음: Usual Care
A second site included usual care, which did not include the intervention.
Participants were given post visit surveys similar to those in the two other study / intervention arms.
This site served as a usual care comparison.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Level of objective understanding of CKD as measured by the Kidney Knowledge Survey (KiKS)
기간: Length of doctor's appointment, e.g., 1-2 hours
|
This will measure objective kidney disease knowledge, based on a score of 0-100, where 0 means poor level of kidney knowledge, and 100 means good level of kidney knowledge.
The KiKS was developed by Dr. Wright.
|
Length of doctor's appointment, e.g., 1-2 hours
|
|
Level of perceived understanding of CKD as measured by the Perceived Kidney Knowledge Survey (PiKS)
기간: Length of doctor's appointment, e.g., 1-2 hours
|
This will measure subjective kidney knowledge.
Score range is 1-4, where 1 is low level of perceived kidney knowledge, and 4 is high level of perceived kidney knowledge.
The PiKS was developed by Dr. Wright.
|
Length of doctor's appointment, e.g., 1-2 hours
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Level of positive perception of patient-provider communication as measured by the Patient Communication Assessment Tool (CAT)
기간: Length of doctor's appointment, e.g., 1-2 hours
|
This assesses the quality of physician to patient and physician's staff to patient communication.
Score range is 1-5, where 1 means negative perception of communication and 5 means positive perception of communication.
|
Length of doctor's appointment, e.g., 1-2 hours
|
|
Level of mental anxiety/stress related to condition as measured by the adapted NDBCSS scale
기간: Length of doctor's appointment, e.g., 1-2 hours
|
The 19-item NDBCSS (Newly Diagnosed Breast Cancer Stress Scale) is adapted to form the 21-item scale in the patient survey to measure stress associated with CKD.
The score range is 1-4, where 1 means high level of stress associated with CKD and 4 means low level of stress associated with CKD.
|
Length of doctor's appointment, e.g., 1-2 hours
|
|
Level of energy/fatigue and emotional well-being as measured by the SF-36 mental health component
기간: 4 weeks
|
The SF-36 mental health component is a 9-item scale that measures energy/fatigue and emotional well-being in the past 4 weeks.Score range is 0-100, where 0 means poor emotional well-being and low energy and 100 means good emotional well-being and high energy.
|
4 weeks
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Level of positive assessment of care as measured by the Patient Assessment of Care for Chronic Conditions (PACIC) scale
기간: 6 months
|
This is a 11-item scale evaluating patient assessment of the quality of care that patients received in the past 6 months.
Score range is 1-5, where 1 means poor assessment of quality of care and 5 means good assessment of quality of care.
|
6 months
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Julie Wright-Nunes, MD, MPH, University of Michigan
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2017년 6월 5일
기본 완료 (실제)
2020년 9월 11일
연구 완료 (실제)
2020년 9월 11일
연구 등록 날짜
최초 제출
2017년 2월 20일
QC 기준을 충족하는 최초 제출
2017년 3월 13일
처음 게시됨 (실제)
2017년 3월 20일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 9월 21일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 9월 14일
마지막으로 확인됨
2021년 9월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
만성 신장 질환에 대한 임상 시험
-
Hospital Clinic of BarcelonaAstraZeneca완전한CTO(Chronic Total Occlusion)를 위한 PCI(Percutaneous Coronary Intervention)를 받을 예정인 환자스페인
-
L2 Bio, LLCFDAMap; Akan Biosciences, Inc.아직 모집하지 않음Crohn & amp;#39; s | Crohn & amp;#39; s Disease (CD)
-
University Hospital, Basel, Switzerland아직 모집하지 않음
-
UNC Lineberger Comprehensive Cancer CenterFogarty International Center of the National Institute of Health모집하지 않고 적극적으로
-
Vanderbilt University Medical CenterTakeda Pharmaceuticals U.S.A., Inc.모집하지 않고 적극적으로염증성 장질환(IBD) | 궤양성 대장염(UC) | Crohn & amp;#39; s Disease (CD)미국
-
Kaohsiung Medical University아직 모집하지 않음폐 선암종 | 폐암(진단) | Condition/Disease
-
Nandakumar NarayananNational Institute of Neurological Disorders and Stroke (NINDS)초대로 등록
Education worksheet에 대한 임상 시험
-
Chia-Tzu Line완전한
-
Emine ErginSaglik Bilimleri Universitesi아직 모집하지 않음
-
Academisch Medisch Centrum - Universiteit van Amsterdam...모집하지 않고 적극적으로월경통 | 생리주기 | 생리통 | 모바일 건강 | 심한 월경 출혈 | 생리통 | 생리통(월경통) | 일상 생활 | 월경 건강 개입 | 모바일 건강 기술(mHealth)네덜란드
-
Second Affiliated Hospital, School of Medicine,...완전한
-
University of SheffieldUniversity of Liverpool; University of Manchester; University of Melbourne모집하지 않고 적극적으로
-
University of OxfordBeijing Normal University; Beijing Stars and Rain Education Institute for Autism완전한아동 학대 | 부모-자녀 관계 | 자폐 스펙트럼 장애 | 육아 | 아동 행동 문제 | 가족 관계 | 정신 건강 문제중국