Clinical Impact of MI on Inhaled Antibiotic Adherence in Cystic Fibrosis

Assessing the Clinical Impact of Motivational Interviewing on Inhaled Antibiotic Adherence in Cystic Fibrosis

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).

Study Overview

• Status: Completed
• Conditions: Cystic Fibrosis
• Intervention / Treatment: Behavioral: Motivational Interviewing

Detailed Description

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
• Enrollment (Actual): 22
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention cohort; All participants were entered into the intervention cohort to receive the Motivational Interviewing intervention	Behavioral: Motivational Interviewing; A pharmacist trained in MI delivered three recorded MI sessions over 2 months, with follow up at 3, 4 and 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months preceding intervention compared to end of 6 month intervention period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Predicted Forced Expiratory Volume in 1 second (ppFEV1)	Change in ppFEV1 from start of study to end of study (6 months)	6 months
Body Mass Index (BMI)	Change in BMI from start of study to end of study (6 months)	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	6 months
Treatment quality and satisfaction (TQSM)	Change in TQSM from start to end of intervention period	6 months
Self reported adherence using "Moriskey Medication Adherence 8" questionnaire (MMAS-8)	Change in MMAS-8 from start to end of intervention period	6 months
Density of Pseudomonas growth in sputum	Change in density of pseudomonas growth from start to end of intervention period	6 months
Quality of life measured by CFQ-R	Change in quality of life from start to end of intervention period	6 months

Collaborators and Investigators

• Sponsor: Belfast Health and Social Care Trust
• Collaborators: Queen's University, Belfast

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2014
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): May 17, 2017

Study Registration Dates

• First Submitted: July 10, 2019
• First Submitted That Met QC Criteria: July 10, 2019
• First Posted (Actual): July 12, 2019

Study Record Updates

• Last Update Posted (Actual): July 12, 2019
• Last Update Submitted That Met QC Criteria: July 10, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: 14074DD-AS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No