Clinical Impact of MI on Inhaled Antibiotic Adherence in Cystic Fibrosis

Belfast Health and Social Care Trust22 enrolled

Overview

Adherence to treatment is a major challenge in cystic fibrosis (CF). Motivational Interviewing (MI) is increasingly used to address this, but its effectiveness is unknown. We investigated the clinical impact of an MI intervention, delivered by a specifically trained pharmacist, on adherence to inhaled antibiotics (IA). Adults with CF were recruited through the Regional CF Centre. A pharmacist trained in MI delivered three recorded MI sessions over 2 months, with follow up at 3, 4 and 6 months. Demographics, ppFEV1, BMI, adherence (IA collection rates) and additional antibiotic use were collected during the study and for 6 months prior. Treatment Quality and Satisfaction (TQSM), self-reported adherence (Moriskey Medication Adherence Scale-8 (MMAS-8)), Quality Of Life (CF Questionnaire-Revised (CFQ-R)) and sputum Pseudomonas aeruginosa (Pa) density were assessed at each study visit. Statistical analysis compared outcomes pre and post-intervention and variation during the intervention period.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Cystic Fibrosis

Interventions

Motivational InterviewingBEHAVIORAL

A pharmacist trained in MI delivered three recorded MI sessions over 2 months, with follow up at 3, 4 and 6 months.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male or female patients with a documented diagnosis of CF aged ≥18 years on the date of informed consent 2. Known chronic infection with Pa, as defined by the Leeds criteria 3. Has been prescribed inhaled colomycin and/or tobramycin and/or aztreonam for a minimum of 3 months prior to study enrolment 4. Able to provide written informed consent 5. Able to understand and comply with protocol requirements and instructions 6. Has been identified by the physician during routine appointments as having difficulties with adherence to their inhaled therapies Exclusion Criteria: 1. Patients that do not expectorate sputum spontaneously 2. Inability to complete questionnaires

Outcomes

Primary Outcomes

Inhaled Antibiotic collection percentage

Change in adherence to Inhaled Antibiotic measured by collection from pharmacy in 6 months before intervention and at end of intervention

Time frame: 6 months preceding intervention compared to end of 6 month intervention period

Secondary Outcomes

Percent Predicted Forced Expiratory Volume in 1 second (ppFEV1)

Change in ppFEV1 from start of study to end of study (6 months)

Time frame: 6 months

Body Mass Index (BMI)

Change in BMI from start of study to end of study (6 months)

Time frame: 6 months

Need for additional Intra-venous or oral antibiotics

change in additional antibiotic days from 6 months preceding the intervention to end of intervention period

Time frame: 6 months

Treatment quality and satisfaction (TQSM)

Change in TQSM from start to end of intervention period

Time frame: 6 months

Self reported adherence using "Moriskey Medication Adherence 8" questionnaire (MMAS-8)

Change in MMAS-8 from start to end of intervention period

Time frame: 6 months

Density of Pseudomonas growth in sputum

Change in density of pseudomonas growth from start to end of intervention period

Time frame: 6 months

Quality of life measured by CFQ-R

Data from ClinicalTrials.gov

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