The PRINCE Study Design

Background

One of the key strategies in improving care for people with COPD is the provision of a pulmonary rehabilitation programme (PR). We know that PR programmes are effective but we do not know what the impact of providing these in a structured format in primary care is. The NICE guidelines for the management of COPD (2004) emphasise the need for patients to have access to such multidisciplinary teams and that rehabilitation programmes should be based in primary care. At present such access is the exception rather than the rule.

The PRINCE study is a randomised trial designed to examine these issues. In the intervention arm, participants received a specially designed structured education PR programme facilitated by the Practice Nurse and a Physiotherapist, in primary care which was compared to “care as usual” group.

In the broader context of chronic disease management, the research explored the impact of structured education programmes on patient self-management. The research also explored the impact of training and participation in the PR programme on practice nurse’s and physiotherapist’s knowledge and skills. If this is shown to improve, the research has the potential to expand practice nurses knowledge and expertise in COPD management. If successful, this study may have wider implications for the management of other chronic diseases in primary care.

The study began in Jan 2008 (with preliminary work in 2007) and is anticipated to be completed by Dec 2012.

Aims

The primary aim of the PRINCE study is to evaluate the effectiveness of a structured education pulmonary rehabilitation programme (SEPRP), delivered at the level of the general practice, on the health status of people with COPD. The trial has four main objectives:

  1. To develop a comprehensive SEPRP specifically orientated toward delivery by GP practice nurses to people with COPD in their local communities.
  2. To evaluate the effectiveness of the SEPRP within the context of a cluster randomised trial.
  3. To understand participants’ perceptions and experiences of ‘COPD’, its impact on their lives and their approach to self-management.
  4.  To evaluate the cost effectiveness of the provision of a SEPRP for people with COPD.

This research is designed to examine the potential of delivering structured PR programmes in the community.

Outcome Measures

Primary
The primary outcome measure of the study is the health status as measured by the Chronic Respiratory Questionnaire (CRQ). The questionnaire has four domains: dyspnoea, fatigue, emotional function and mastery.

Secondary

  1. Incremental Shuttle Walking Test
  2. Self-Efficacy for Managing Chronic Disease 6-Item Scale [26]
  3. Economic analysis specific:
    1. EuroQol EQ-5D [27]
    2. Utilisation of health care Service Utilisation of health care Service

Design

The PRINCE Trial is a two-group, single blind cluster randomised trial conducted in the primary care setting in Ireland. The study took place taking in 13 counties North Western, West and Midlands of Ireland in 32 General Practices. Randomisation to control and intervention was at the level of the General Practice. Participants allocated to the intervention group received a SEPRP and those allocated to the control group received usual care. The PR programme was delivered by a practice nurse and physiotherapist in GP sites. Blinded outcome assessment was undertaken at baseline and at twelve-fourteen weeks after completion of the programme. A comparison of outcomes between intervention and control sites was made to examine if differences exist and, if so, to what extent between control and experimental groups. Randomisation to the PRINCE study began in September, 2009 and final outcome assessment was completed in February 2011.

What was involved?

  • The PRINCE Research Team recruited 32 eligible and consenting General Practices in North Western, Western and Midlands of Ireland.
  • With support of the GP Practices, the PRINCE Team identified a minimum of 13 participants per practice with moderate to severe COPD, using Spirometry.
  • Eligible participants were invited to attend a health assessment (baseline) of their exercise ability.
  • Practices then were randomisation to either the intervention or control group.

The intervention involved the delivery of a Pulmonary Rehabilitation programme at community level as follows:

  • The PR programme was for 16 hours, delivered over an 8 week period (2 hours per week).
  • The PR programme was facilitated by a practice nurse (of the practice) and a physiotherapist (of the Primary Care Team of the practice or a member of the research team).
  • The programme was followed up by:
    • A follow-up phone call from the practice nurse 4 weeks after completion of the programme
    • A 1 hour group follow up group session facilitated by the practice nurse at 10 weeks after completion of the programme
    • A final Health Assessment with all participants 3 months after completion of the programme
  • A standardised curriculum and programme materials were developed by the research team for use in the intervention. The PR curriculum has been developed in accordance with best practice guidelines for managing COPD.
  • Practice nurses in Intervention Practices underwent 3 days of formal training and the Physiotherapist underwent a 1 day formal training programme led by the research team to enable them to facilitate the delivery of the PR programme in a standardised way.
  • Practice nurses in the control sites were invited to attend the PNPP training after data collection was completed.

Who do I contact to find out more?

Should you require any more information or have any queries, please contact Collette Kirwan (project manager) at 091-495421 or collette.kirwan@nuigalway.ie