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临床试验/NCT04919941
NCT04919941已完成不适用

A Pilot Study of A Guide to Conservative Care

University of Washington2 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2020年8月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
92
试验地点
2
主要终点
Questionnaire on patient-provider discussions of conservative care .

研究概览

简要总结

This is a randomized pilot study to test the feasibility and acceptability of a patient decision aid on conservative care among older patients with advanced CKD and their close persons.

详细描述

Conservative care is an important therapeutic option for patients with advanced chronic kidney disease (CKD) who do not wish to pursue maintenance dialysis. However, most patient educational materials on treatment options for advanced CKD do not include information.

This study is a randomized pilot study to test the acceptability and feasibility of a novel patient decision aid on conservative care, entitled A Guide to Conservative Care, among older patients with advanced CKD and their close persons. The investigators hypothesize that the Guide will be feasible and acceptable to patients and families as reflected in greater discussion of conservative care with health care providers following receipt of the Guide as compared with usual care.

The study will enroll 92 patients aged 75 years and older with advanced CKD and up to 92 of their close persons from University of Washington Medicine and Veterans Affairs Puget Sound Health Care System. Enrolled patients are invited but not required to nominate a close person (defined as a person who assists the patient with his/her advanced CKD) to also participate in the study. Patients and their close persons will be randomized together in a 1:1 fashion to receive either the Guide (i.e. intervention) or usual care (i.e. control). Data from participants will be collected at the time of enrollment, 2-week follow-up and 3-month follow-up.

As a reflection of acceptability and feasibility, the primary outcome measure is difference in rates of discussion of conservative care with a healthcare provider at 3-month follow-up. Increased motivation for patients to discuss of conservative care with their health care providers would reflect that the Guide is acceptable to patients and can be feasibly incorporated by them into their care planning. The investigators will also collect completion and attrition rates at the second and third study visits as additional measures of acceptability and feasibility. Furthermore, the investigators will collect feedback on the Guide and experiences with using the Guide from participants who received the Guide using qualitative interviews at 2-week and 3-month follow-up. The investigators will also explore treatment goals and preferences for advanced CKD using standardized surveys at each study visit.

The investigators will use the information gathered during the study towards further refining the Guide so that it will be ready for distribution at participating study sites and future testing in broader patient populations.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
75 Years 至 —(Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Adults aged ≥75 years
  • •Diagnosis of advanced CKD as defined as having at least 2 outpatient measures of eGFR <25 ml/min/1.73m2 separated by >90 days in the prior year and with at least 1 of these measures of eGFR <20 ml/min/1.73m2
  • •Must be english-speaking
  • •Close persons
  • •Adults aged ≥18 years
  • •Must assist patient with their kidney disease care
  • •Must be English-speaking

排除标准

  • •Patients and Close Person
  • •Unable to provide informed consent

研究组 & 干预措施

Decision aid

Experimental

The intervention is receipt of a patient decision aid on conservative care, entitled A Guide to Conservative Care. This is 12-page printed handout that provides an overview of conservative care. Participants assigned to the intervention group are mailed a copy of the Guide after their initial baseline visit (T1). Participants keep the Guide throughout the duration of the study.

干预措施: A Guide to Conservative Care (Other)

Control

No Intervention

Did not receive the decision aid.

结局指标

主要结局

Questionnaire on patient-provider discussions of conservative care .

时间窗: 3 months

Using a questionnaire, patients will be asked whether they had discussed conservative care with any of their healthcare providers prior to T1 and by T3. Possible responses are "yes", "no" or "unsure." Greater motivation to discuss conservative care with their care providers at T3 after would indicate that the Guide is acceptable to patients and can be feasibly incorporated by them into their care planning.

Attrition

时间窗: 3 months

The proportion of participants in each study arm who withdraw from the study and the reasons why at T2 and T3. Study withdrawal would indicate that the Guide and/or study is unacceptable or burdensome to the participant.

次要结局

  • Treatment Goals(3 months)
  • Guide Questionnaire(2 weeks)
  • Guide Interview(3 months)
  • Treatment Preference(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Susan Wong

Assistant Professor, School of Medicine: Nephrology

University of Washington

研究点 (2)

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