Pathologist Lung Transplant Study

Psychological Clinical Trial

Official title:

Pathologist Led Intervention To Improve Psychological Outcomes and Adherence in Lung Transplant Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04887779
• Other study ID #: STUDY19060024
• Status: Withdrawn
• Phase: N/A
• Start date: December 2021
• Est. completion date: August 1, 2022

Study information

• Verified date: February 2022
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adherence, Patient
• Coping Skills
• Psychological

Intervention

Behavioral:
• Pathologist intervention
viewing explanted organ and microscopy

Locations

Country	Name	City	State
United States	UPMC Presbyterian Hospital	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Patient understanding	Assess if patient has gained more understanding of their condition. No specific scale used, assessed by interview.	one day after intervention and assessment for change one month later
Secondary	Patient experience	Discussing patient's overall experience. No specific scale used, assessed by interview.	one day after intervention and assessment for change one month later