PRISM Race and Communication Pilot RCT

NCT04915079 | Completed Phase 1 Results

• 2 other identifiers: STUDY000114551K23MD015270-01
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot randomized trial of 60 patients to test feasibility, acceptability and efficacy of PRISM to improve resilience and facilitate improved patient-clinician communication in racially minorities patients with serious illness.

Conditions

Discrimination, Racial; Communication; Chronic Illness; Bias, Racial

Outcome Measures

Primary Outcomes (1)

• 10-item Connor-Davidson Resilience Scale (CD-RISC)

  We will measure the change the Connor-Davidson Resilience Scale (CD-RISC 10) between enrollment and at 3-months after randomization. in The 10-item Connor-Davidson Resilience Scale (CD-RISC) is is composed of 10 items from an original 25-item CD-RISC scale. Scores correlate with the full 25-item scale. Respondents rate their agreement with the survey items on a 5-point Likert scale from 0 (not true at all) to 4 (nearly true all the time). It is scored by the sum of all items with a range between 0-40 with higher scores indicating higher patient-reported resilience.

  3 months

Study Arms (2)

PRISM

EXPERIMENTAL

Patients in this arm will be recipients of the PRISM intervention

Behavioral: Promoting Resilience in Stress Management (PRISM)

Usual Care

NO INTERVENTION

Patients in this arm will not receive the PRISM intervention, but will continue to receive usual care the discretion of their treating clinicians.

Interventions

Promoting Resilience in Stress Management (PRISM) BEHAVIORAL

PRISM is a novel resilience resource intervention consisting of five, one-on-one sessions lasting 30-50 minutes targeting specific teachable resilience skills: stress management, problem solving, goal setting, benefit finding, and meaning making. Sessions will occur at a time convenient to the patient with the first session to occur within 1 week of enrollment either while inpatient or if the patient is discharged, in the outpatient setting in-person or by HIPPA-compliant Zoom. After completion, participants will receive weekly "booster" contacts (invitations to practice reviewing certain skills) until the occurrence of a planned patient-clinician conversation, facilitated and arranged by study staff during the 5th session. All participants will receive paper worksheets to practice skills between sessions, plus access to a free, digital PRISM app (available only for patients enrolled in PRISM).

PRISM

Eligibility Criteria

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

You may qualify if:

• Seriously ill adults with median life expectancy of two years or less (e.g. metastatic cancer or inoperable lung cancer, chronic obstructive pulmonary disease (COPD) with forced expiratory volume in 1 second (FEV1) \<35% predicted or oxygen dependence, restrictive lung disease with total lung capacity (TLC) \<50% predicted, New York Heart Association (NYHA) class III or IV heart failure, or Child's class C cirrhosis or Model for End Stage Liver Disease(MELD) \>17)
• Hospitalized at either Harborview Medical Center or University of Washington Medical Center-Montlake
• At least 18 years of age
• English-speaking
• No cognitive impairment precluding completion of surveys or participation in the PRISM sessions

You may not qualify if:

• Younger than 18 years of age
• Non-English speaking
• Ccgnitive impairment that would preclude completion of surveys and participation in the PRISM sessions.

Sponsors & Collaborators

• University of Washington: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

University of Washington - Harborview Medical Center

Seattle, Washington, 98112, United States

Location

MeSH Terms

Conditions

Racism; Communication; Chronic Disease

Condition Hierarchy (Ancestors)

Prejudice; Social Behavior; Behavior; Social Discrimination; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Overall, it was difficult to follow up with our patients for multiple reasons including patients feeling too ill to continue, experiencing significant medical events in the hospital unrelated to the study, or difficulty in reaching participants after discharge (e.g. non-working phone line).

Results Point of Contact

• Title: Crystal Brown
• Organization: University of Washington

crysb@uw.edu

206-744-5018

Study Officials

• Crystal E Brown, MD, MA

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, School of Medicine

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: June 7, 2021
• Study Start: July 19, 2023
• Primary Completion: August 29, 2024
• Study Completion: August 29, 2025
• Last Updated: April 30, 2026
• Results First Posted: April 30, 2026

Record last verified: 2026-04

Locations

US (1)