The PAtient Preference Analysis of Yearly Follow-up After PCI (PAPAYA)
The purpose of this study is to determine the preference of patients regarding the approach for follow-up after percutaneous coronary intervention (PCI) procedures. We hypothesize that patients prefer questionnaires for annual follow-up assessment when compared to telephone or email.
Coronary Artery Disease
|Study Type:||Observational [Patient Registry]|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration:||1 Year|
|Official Title:||What Patients Really Want - Patient Preferences Regarding Annual Follow-up After Medical Interventions: The PAPAYA Study|
- Assessment of preferred approach for annual follow-up after PCI [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Least preferred approach for follow up [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Maximum acceptable number of questions to be answered [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||July 2013|
|Study Completion Date:||September 2014|
|Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
Rationale: Assessment and reporting of long-term clinical follow-up after medical interventions is essential for transparency of medical care and its quality improvement. However follow-up adherence is a serious challenge in clinical trials. Taking the patient preference of the mode of follow-up into account is likely to enhance trial adherence, reduce withdrawals, and facilitate a longer follow-up duration. No data on patient preference of annual follow-up have been reported.
Objective: To investigate the patient preference of approach to obtain follow-up information after percutaneous coronary intervention (PCI)
Study design: Single-center, prospective, observational registry
Study population: All patients enrolled in the percutaneous coronary intervention studies TWENTE trial (a broad study population reflecting real-world PCI patients) and DUTCH PEERS trial (an all-comers population), who were treated at Thoraxcentrum Twente in Enschede between June 2008 and May 2012
Intervention: All subjects will receive a questionnaire with questions regarding their preference with regards to the approach of acquiring follow-up information after PCI.
Main study endpoints:
- The primary endpoint is the patient preference on how to be approached for annual follow-up after PCI procedures.
Secondary endpoints include
- least preferred approach of follow-up
- the preferred number of follow-up moments per year
- the from the patients' perspective maximum acceptable number of questions to be answered
- the assessment of potential relationships between the most and least preferred approach of assessment and patient age, gender urgency of PCI treatment, and history of previous revascularizations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02189070
|Medisch Spectrum Twente|
|Principal Investigator:||Clemens von Birgelen, MD,PhD,Prof||Thorax Centrum Twente|