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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
University of Pittsburgh
About
Eligibility
Locations
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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

    First Posted
    September 6, 2006
    Last Updated
    May 26, 2017
    Sponsor
    University of Pittsburgh
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    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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