## Protocol Section
### Identification Module
**NCT ID:** NCT04887779

**Brief Title:** Pathologist Lung Transplant Study

**Official Title:** Pathologist Led Intervention To Improve Psychological Outcomes and Adherence in Lung Transplant Patients

#### Organization Study ID Info
**ID:** STUDY19060024
#### Organization
**Class:** OTHER
**Full Name:** University of Pittsburgh
### Status Module
#### Completion Date
**Date:** 2022-08-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-02-21

**Type:** ACTUAL

**Last Update Submit Date:** 2022-02-03

**Overall Status:** WITHDRAWN

#### Primary Completion Date
**Date:** 2022-06-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2021-12

**Type:** ESTIMATED

**Status Verified Date:** 2022-02

#### Study First Post Date
**Date:** 2021-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2021-05-11
**Study First Submit QC Date:** 2021-05-13
**Why Stopped:** personale shortage
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Pittsburgh

#### Responsible Party

**Investigator Affiliation:** University of Pittsburgh

**Investigator Full Name:** Blake Gibson

**Investigator Title:** Psychiatry Resident at UPMC Western Psychiatric Hospital

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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 Module

**Conditions:**

- Adherence, Patient

- Psychological

- Coping Skills

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

**Intervention Model Description:** Prospective, no blinding or randomization

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patient viewing ex-planted organ and microscopy with pathologist

**Intervention Names:**

- Behavioral: Pathologist intervention

**Label:** Intervention

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Intervention

**Description:** viewing explanted organ and microscopy

**Name:** Pathologist intervention

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Basel Assessment of Adherence to Immunosuppressive Medication Scale (BAASIS©)

**Time Frame:** one day after intervention and assessment for change one month later

**Description:** 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.

**Measure:** Client Satisfaction Questionnaire (CSQ-8)

**Time Frame:** one day after intervention and assessment for change one month later

#### Secondary Outcomes

**Description:** Assess if patient has gained more understanding of their condition. No specific scale used, assessed by interview.

**Measure:** Patient understanding

**Time Frame:** one day after intervention and assessment for change one month later

**Description:** Discussing patient's overall experience. No specific scale used, assessed by interview.

**Measure:** Patient experience

**Time Frame:** one day after intervention and assessment for change one month later

### Eligibility Module

**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 Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Pittsburgh

**Country:** United States

**Facility:** UPMC Presbyterian Hospital

**State:** Pennsylvania

**Zip:** 15213

#### Overall Officials

**Official 1:**

**Affiliation:** University of Pittsburgh Medical Center Western Psychiatric Hospital

**Name:** Blake Gibson, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24
