Overview

This trial is active, not recruiting.

Condition end-stage renal disease
Treatment patient-centered advance care planning
Phase phase 2
Sponsor University of Pittsburgh
Start date January 2005
End date June 2007
Trial size 42 participants
Trial identifier NCT00374010, 0412044

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (investigator, outcomes assessor)
Primary purpose treatment

Primary Outcomes

Measure
congruence between patient and surrogate at one week after intervention
time frame: one week post intervention
patient and surrogate satisfaction with communication
time frame: one week post intervention

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. have been on either center-hemodialysis or home-peritoneal dialysis 2. are cognitively intact,i.e., able to communicate, able to understand information, able to make choices and give rationale, 3. have an individual who can be present during the intervention as a surrogate decision maker, 4. are over 18 years of age, and 5. are able to communicate in English. Surrogates must be over 18 years of age and be able to communicate in English.

Additional Information

Official title Improving Patient-Clinician Communication Among End-Stage Renal Disease African Patients and Their Families
Principal investigator Mi-Kyung Song, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2008.
Information provided to ClinicalTrials.gov by University of Pittsburgh.