Pathologist Lung Transplant Study

NCT ID: NCT04887779

Last Updated: 2022-02-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-31
• Study Completion Date: 2022-08-01

Brief Summary

Using a prospective qualitative approach, explore whether pathologist intervention is feasible as part of multimodal multidisciplinary care model for transplant patients in effecting psychological dimensions such as experience, satisfaction, or patient's understanding of their disease. Additionally, to examine if this intervention improves medication adherence.

Detailed Description

Specific Aims 1. Create post-transplant pathologist-led intervention Objective 1a: Recruit 10 patients who have undergone lung transplantation primarily for chronic obstructive pulmonary disease (COPD). Use pathologist to show gross/microscopic explanted organs.

Specific Aim 2. Assess the efficacy of intervention pilot Objective 2a: Immediate (within 1 day after pathologist intervention) phone interview to access patient's reaction, feelings, and experience with intervention and understanding of disease.

Objective 2b: 1 month later, phone interview asking questions related to medication adherence, patient experience with intervention and lung transplant overall, and patient understanding of disease. Results will be compared to first interview.

Objective 2c: Analyze Client Satisfaction Questionnaire (CSQ-8) for quality of life, Basel assessment of adherence to immunosuppressive medications scale (BAASIS) as a self report adherence measure, and conduct a mixed methods/grounded theory analysis of qualitative data (patient experience, disease understanding). This analysis will systematically identify themes, and assign these descriptive words.

Specific Aim 3: Finalize intervention protocol based on pilot testing. Objective 3a. Adjust and refine the content and process of intervention protocol based on findings of pilot study Objective 3b. Final changes will assure readiness for large scale study.

Conditions

Adherence, Patient; Psychological; Coping Skills

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention

Patient viewing ex-planted organ and microscopy with pathologist

Group Type: EXPERIMENTAL

Pathologist intervention

Intervention Type: BEHAVIORAL

viewing explanted organ and microscopy

Interventions

Pathologist intervention

viewing explanted organ and microscopy

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Lung transplant patient, transplanted after IRB approval of study -Transplanted primarily for COPD
• English speaking
• within three months of initial transplant (prior to initial discharge)
• > 18 years old

Exclusion Criteria

• Transplant indication other than COPD
• <18 year old
• Non English speaking

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Blake Gibson

Psychiatry Resident at UPMC Western Psychiatric Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Blake Gibson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh Medical Center Western Psychiatric Hospital

Locations

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

STUDY19060024

Identifier Type: -

Identifier Source: org_study_id