- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00374010
Improving Patient-clinician Communication About End-of-life Care
May 26, 2017 updated by: University of Pittsburgh
Improving Patient-clinician Communication Among End-stage Renal Disease African Patients and Their Families
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
congruence between patient and surrogate at one week after intervention
Time Frame: one week post intervention
|
one week post intervention
|
|
patient and surrogate satisfaction with communication
Time Frame: one week post intervention
|
one week post intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mi-Kyung Song, PhD, University of Pittsburgh School of Nursing
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2005
Primary Completion (Actual)
June 1, 2007
Study Completion (Actual)
December 1, 2008
Study Registration Dates
First Submitted
September 6, 2006
First Submitted That Met QC Criteria
September 7, 2006
First Posted (Estimate)
September 8, 2006
Study Record Updates
Last Update Posted (Actual)
May 31, 2017
Last Update Submitted That Met QC Criteria
May 26, 2017
Last Verified
March 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0412044
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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