Pathologist Lung Transplant Study

NCT04887779 | Withdrawn DMC

• 1 other identifier: STUDY19060024
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Adherence, Patient; Psychological; Coping Skills

Outcome Measures

Primary Outcomes (2)

• Basel Assessment of Adherence to Immunosuppressive Medication Scale (BAASIS©)

  The Basel Assessment of Adherence to Immunosuppressive Medication Scale (BAASIS©) was developed to assess adherence to immunosuppressive drugs in adult and adolescent transplant recipients. Initiation starts when a patient takes his/her first dose of medication. This is a binary event (yes/no). Implementation of the dosing regimen refers to "the extent to which a patient's actual dosing corresponds to the prescribed dosing regimen, from initiation until the last dose is taken" and implies a dosing history. Discontinuation refers to "the moment that the patient discontinues his/her medication regimen" and is assessed as a time to event. Persistence is thus the duration between time of initiation and the moment the last dose is taken. Any yes response demonstrates issues with medication adherence.

  one day after intervention and assessment for change one month later

• Client Satisfaction Questionnaire (CSQ-8)

  The Client Satisfaction Questionnaire is an 8 item measure of client satisfaction. An "overall score" is calculated by summing the respondent's rating (item rating) score for each scale item. Scores therefore range from 8 to 32, with higher values indicating higher satisfaction. with services with both a parent intervention versus averages of lung transplant patients.

  one day after intervention and assessment for change one month later

Secondary Outcomes (2)

• Patient understanding

  one day after intervention and assessment for change one month later

• Patient experience

  one day after intervention and assessment for change one month later

Study Arms (1)

Intervention

EXPERIMENTAL

Patient viewing ex-planted organ and microscopy with pathologist

Behavioral: Pathologist intervention

Interventions

Pathologist intervention BEHAVIORAL

viewing explanted organ and microscopy

Intervention

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Blake Gibson, MD

  University of Pittsburgh Medical Center Western Psychiatric Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychiatry Resident at UPMC Western Psychiatric Hospital

Model Details: Prospective, no blinding or randomization

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: May 14, 2021
• Study Start: December 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: August 1, 2022
• Last Updated: February 21, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)