Clinical trial NCT04887779: Pathologist Lung Transplant Study
Official title: Pathologist Led Intervention To Improve Psychological Outcomes and Adherence in Lung Transplant Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Adherence, Patient
Psychological
Coping Skills
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2021-05-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, no blinding or randomization
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Basel Assessment of Adherence to Immunosuppressive Medication Scale (BAASIS©)
timeFrame: one day after intervention and assessment for change one month later
measure: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: one day after intervention and assessment for change one month later
Secondary outcomes:
measure: Patient understanding
timeFrame: one day after intervention and assessment for change one month later
measure: Patient experience
timeFrame: one day after intervention and assessment for change one month later
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Presbyterian Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh Medical Center Western Psychiatric Hospital
name: Blake Gibson, MD
role: PRINCIPAL_INVESTIGATOR
References: