Improving Patient-Clinician Communication About End-of-Life Care

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by University of Pittsburgh.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00374010
First received: September 6, 2006
Last updated: March 27, 2008
Last verified: March 2008

September 6, 2006
March 27, 2008
January 2005
June 2007   (final data collection date for primary outcome measure)
  • congruence between patient and surrogate at one week after intervention [ Time Frame: one week post intervention ] [ Designated as safety issue: No ]
  • patient and surrogate satisfaction with communication [ Time Frame: one week post intervention ] [ Designated as safety issue: No ]
  • congruence between patient and surrogate at one week after intervention
  • patient and surrogate satisfaction with communication
  • patient decisional conflict at one week
  • surrogate decision making confidence at one week
Complete list of historical versions of study NCT00374010 on ClinicalTrials.gov Archive Site
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Improving Patient-Clinician Communication About End-of-Life Care
Improving Patient-Clinician Communication Among End-Stage Renal Disease African Patients and Their Families

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
End-Stage Renal Disease
Behavioral: Patient-Centered Advance Care Planning

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:

  1. Representational assessment (10 - 15 minutes);
  2. Exploring concerns related to planning for future medical decision-making (10 - 15 minutes);
  3. Creating conditions for conceptual change (5 minutes);
  4. Introducing replacement information using a disease-specific Statement of Treatment Preferences document (15 minutes); and
  5. Summary (3 - 5 minutes)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
42
June 2008
June 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT00374010
0412044
No
University of Pittsburgh Office of Research, University of Pittsburgh
University of Pittsburgh
Not Provided
Principal Investigator: Mi-Kyung Song, PhD University of Pittsburgh School of Nursing
University of Pittsburgh
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP