Improving Patient-clinician Communication About End-of-life Care

NCT00374010 | Completed Phase 2

• 1 other identifier: 0412044
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief Summary

The specific aims are:

1. 1.to evaluate the feasibility and acceptability of PC-ACP among African American patients with End-stage Renal Disease and their surrogates and
2. 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.

Conditions

End-stage Renal Disease

Keywords

end-of-life decision making; advance care planning

Outcome Measures

Primary Outcomes (2)

• congruence between patient and surrogate at one week after intervention

  one week post intervention

• patient and surrogate satisfaction with communication

  one week post intervention

Interventions

Patient-Centered Advance Care Planning BEHAVIORAL

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mi-Kyung Song, PhD

  University of Pittsburgh School of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2006
• First Posted: September 8, 2006
• Study Start: January 1, 2005
• Primary Completion: June 1, 2007
• Study Completion: December 1, 2008
• Last Updated: May 31, 2017

Record last verified: 2008-03