Feedback Reports and e-Learning in Primary Care Spirometry (FRESCO)

• ClinicalTrials.gov Identifier: NCT00962455
• Recruitment Status: Completed
• First Posted: August 20, 2009
• Last Update Posted: August 20, 2009
• Sponsor: Radboud University Medical Center
• Collaborators: Quartz Transmural Centre for the Helmond Region; Elkerliek Hospital
• Information provided by: Radboud University Medical Center

Tracking Information

• First Submitted Date: August 17, 2009
• First Posted Date: August 20, 2009
• Last Update Posted Date: August 20, 2009
• Study Start Date: November 2007
• Actual Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: August 19, 2009): Proportion of spirometry tests with ≥2 acceptable blows according to 2005 ERS/ATS criteria that were also repeatable for both FEV1 and FVC [ Time Frame: 12 months prospective follow-up ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: August 19, 2009)

• Proportions of tests with ≥2 acceptable blows according to 2005 ERS/ATS criteria [ Time Frame: 12 months prospective follow-up ]
• Proportions of spirometry tests with ≥2 blows meeting 2005 ERS/ATS end-of-test criteria [ Time Frame: 12 months prospective follow-up ]
• Proportions of spirometry tests with A to C grade according to scholastic-type quality grading system by Ferguson et al (2000) [ Time Frame: 12 months prospective follow-up ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Feedback Reports and e-Learning in Primary Care Spirometry
• Official Title: Feedback Reports and E-learning to Support Spirometry Test Performance in Dutch Family Practices
• Brief Summary: Spirometry is a biomedical test to measure lung function in subject who (may) have a chronic respiratory condition. Performing the test requires a certain level of training and experience from the health care professional who conducts the test, and sufficient cooperation of the patient. Although the test is widely used in primary care in many countries, the quality of the test performance seems limited and needs improvement in order to avoid false-positive and false-negative test interpretations. In this study, the researchers investigated whether a combination of e-learning and bimonthly written performance feedback to family practice nurses and assistance regarding their spirometry tests improves the rate of adequate tests.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor)

Condition

• Respiratory Tract Diseases
• Pulmonary Disease, Chronic Obstructive
• Asthma

Intervention

• Other: e-learning & performance feedback
  Initial e-learning by studying CD-Rom 'Spirometry Fundamentals', followed by repeated periodic performance feedback on spirometry test quality
• Other: usual practice
  Usual practice regarding spirometry execution in family practice

Study Arms

• Experimental: e-learning & performance feedback
  Initial e-learning by studying CD-Rom 'Spirometry Fundamentals', followed by repeated periodic performance feedback on spirometry test quality
  Intervention: Other: e-learning & performance feedback
• Active Comparator: Usual practice
  Usual practice regarding spirometry execution in family practice
  Intervention: Other: usual practice

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 19, 2009): 1135
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: April 2009
• Actual Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria for Family Practices:

• collaboration with Elkerliek Hospital Helmond through regional integrated care support service ('QUARTZ')
• purchased spirometer through this support service
• have implemented spirometry as a part of routine patient care

Inclusion Criteria for Patients:

• registered in one of the participating family practices
• performed a spirometry test as a part of routine care during the observation period of the study

Exclusion Criteria for Patients:

• age < 10 years

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 10 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Netherlands

Administrative Information

• NCT Number: NCT00962455
• Other Study ID Numbers: UMCN-CARA-0001113
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Tjard Schermer, senior researcher, Radboud University Nijmegen MC, Dept of Primary and Community Care
• Original Responsible Party: Same as current
• Current Study Sponsor: Radboud University Medical Center
• Original Study Sponsor: Same as current

Collaborators

• Quartz Transmural Centre for the Helmond Region
• Elkerliek Hospital

Investigators

• Principal Investigator: Tjard R Schermer, PhD; Radboud University Medical Center
• Principal Investigator: Alan J Crockett, PhD; The University of Adelaide
• Principal Investigator: Willem Pieters, MD, PhD; Elkerliek Hospital

• PRS Account: Radboud University Medical Center
• Verification Date: August 2009