The PAtient Preference Analysis of Yearly Follow-up After PCI (PAPAYA)

Thorax Centrum Twente

Status: Completed

Conditions: Coronary Artery Disease

Study type: Observational

Funder types: Other

Identifiers

NCT02189070

K13-28

Details and patient eligibility

About

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.

Full description

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

  1. least preferred approach of follow-up
  2. the preferred number of follow-up moments per year
  3. the from the patients' perspective maximum acceptable number of questions to be answered
  4. 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

Enrollment: 2,566 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients enrolled in the TWENTE trial and DUTCH PEERS trial (an all-comers population, who were treated at Thoraxcentrum Twente in Enschede between June 2008 and May 2012

Exclusion criteria

• Patients who had withdrawn their consent for participation in the TWENTE and DUTCH PEERS trials, respectively. Patients who passed away during follow-up could obviously not be approached for further questioning.

Trial design

2,566 participants in 2 patient groups

Responders

Description:

Responding participants

Non-responders

Description:

Non-responding participants