Improving Patient-clinician Communication About End-of-life Care
Primary Purpose
End-stage Renal Disease
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Patient-Centered Advance Care Planning
Sponsored by
About this trial
This is an interventional treatment trial for End-stage Renal Disease focused on measuring end-of-life decision making, advance care planning
Eligibility Criteria
Inclusion Criteria:
- have been on either center-hemodialysis or home-peritoneal dialysis
- are cognitively intact,i.e., able to communicate, able to understand information, able to make choices and give rationale,
- have an individual who can be present during the intervention as a surrogate decision maker,
- are over 18 years of age, and
- are able to communicate in English. Surrogates must be over 18 years of age and be able to communicate in English.
Sites / Locations
Outcomes
Primary Outcome Measures
congruence between patient and surrogate at one week after intervention
patient and surrogate satisfaction with communication
Secondary Outcome Measures
Full Information
NCT ID
NCT00374010
First Posted
September 6, 2006
Last Updated
May 26, 2017
Sponsor
University of Pittsburgh
1. Study Identification
Unique Protocol Identification Number
NCT00374010
Brief Title
Improving Patient-clinician Communication About End-of-life Care
Official Title
Improving Patient-clinician Communication Among End-stage Renal Disease African Patients and Their Families
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pittsburgh
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The specific aims are:
to evaluate the feasibility and acceptability of PC-ACP among African American patients with End-stage Renal Disease and their surrogates and
to examine preliminary effects of PC-ACP on patient and surrogate outcomes (patients' perceived quality of communication, surrogates' level of comfort in decision making for the patient, patients' difficulty in making choices, patient-surrogate congruence in goals of care, and patients' and surrogates' psychosocial/spiritual receptiveness) at one week following receipt of the intervention.
Detailed Description
Despite the increasing emphasis placed on patient-clinician communication about end of life care, efforts to guide the patient to make an informed end-of-life treatment decision often fail. Past efforts to enhance end-of-life discussions were insufficient to create treatment decisions that were consistent with the patient's values and the surrogate's ability to make end-of-life decisions for his/her loved one when required. The importance of effective end-of-life discussions has been documented extensively, yet systematic explorations of the effects of such dialogue with African Americans are nearly absent from the literature. The proposed study is designed to test the ability of an hour-long intervention, Patient-Centered Advance Care Planning (PC-ACP), to enhance clinicians' communication about end-of-life care with patients and surrogates. The specific aims are (1) to evaluate the feasibility and acceptability of PC-ACP among African American patients with End-stage Renal Disease and their surrogates and (2) to examine preliminary effects of PC-ACP on patient and surrogate outcomes (patients' perceived quality of communication, surrogates' level of comfort in decision making for the patient, patients' difficulty in making choices, patient-surrogate congruence in goals of care, and patients' and surrogates' psychosocial/spiritual receptiveness) at one week following receipt of the intervention. A randomized, controlled, pre and post study will be conducted. Subjects (patient-surrogate dyads) will be randomized to PC-ACP or to a usual care control group. Data to assess feasibility, clinical and sociodemographic data, and baseline measures of patient and surrogate outcomes will be collected when subjects enter the study. Measures of the patient and surrogate outcomes and data to assess acceptability of the intervention will be administered at one week follow up. Findings from this study are critical to strengthening PC-ACP and designing a randomized controlled trial to test its efficacy for improving the quality of patient-clinician communication and the quality of decision making for future medical care with African American patients, in comparison with non-Hispanic Whites.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-stage Renal Disease
Keywords
end-of-life decision making, advance care planning
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Patient-Centered Advance Care Planning
Intervention Description
The PC-ACP is a scheduled interview with the dyad, delivered by a trained nurse facilitator. It consists of 5 stages and lasts about an hour:
Representational assessment (10 - 15 minutes);
Exploring concerns related to planning for future medical decision-making (10 - 15 minutes);
Creating conditions for conceptual change (5 minutes);
Introducing replacement information using a disease-specific Statement of Treatment Preferences document (15 minutes); and
Summary (3 - 5 minutes)
Primary Outcome Measure Information:
Title
congruence between patient and surrogate at one week after intervention
Time Frame
one week post intervention
Title
patient and surrogate satisfaction with communication
Time Frame
one week post intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
have been on either center-hemodialysis or home-peritoneal dialysis
are cognitively intact,i.e., able to communicate, able to understand information, able to make choices and give rationale,
have an individual who can be present during the intervention as a surrogate decision maker,
are over 18 years of age, and
are able to communicate in English. Surrogates must be over 18 years of age and be able to communicate in English.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mi-Kyung Song, PhD
Organizational Affiliation
University of Pittsburgh School of Nursing
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Improving Patient-clinician Communication About End-of-life Care
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