A randomised controlled trial evaluating the effectiveness of a self-management programme for adolescents with a chronic illness

This study aims to investigate the effectiveness of a modified adolescent friendly version of an adult self-management program (Flinders Program™). The study will be a two site, longitudinal, randomised controlled trial, using both quantitative and qualitative research methods and conducted within the two national university teaching paediatric hospitals of the Sydney Children’s Hospital Network in Sydney, Australia. Intervention: Following baseline data collection and randomisation, participants in the intervention group will receive a 12 month nurse led modified version of the Flinders Program™ plus standard care. The Flinders Program™ is a validated, internationally recognised program that is designed for adults. Developed from the South Australia HealthPlus coordinated care trial at Flinders University, Adelaide, Australia. It is a structured, generic, individualized program that incorporates the use of specific standardized tools. The program involves the application of three key specific assessment tools: the Partners in Health Scale, Cue and Response Interview, and the Problems & Goals Assessment which are founded on the principals of self-management. These assessment tools provide a formal, systematic approach to assessing self-management skills and problems and support goal setting that lead to the development of a self-management care plan incorporating mutually agreed issues and goals which the participant has agreed to work towards over 6-9 months with monitoring and review on a day and time agreed between the patient and health professional. The study design will include a baseline collection period, followed by sequential, individual randomisation to control or intervention. The intervention group and control groups will be continually recruited and exposed to the intervention plus standard care and/or standard care with baseline and follow up observations collected until target numbers achieved as per power analysis. Participants in the intervention group will receive the Flinders Program™ which will be delivered individually, using a combination of face-to-face and Telehealth sessions by members of the research team who have been trained in the delivery of the Flinders Program™. The intervention will consists of a total of 4 sessions, with an initial session (90 minutes in duration), then 3 x follow up sessions (60 minutes duration) at 3, 6 and 12 months from the initial session. The initial face-to-face session will be undertaken in a private room in a clinic environment within a tertiary paediatric referral hospital. Outline of initial self-management support session: 1. Introduction (5 mins) 2. Partners in Health Scale (10 mins) 3. Cue and Response Interview (25 mins) 4. Discussion to identify agreed issues for the care plan (10 mins) 5. Problems and Goals Assessment (25 mins) defines the problem/s from the adolescents perspective and clearly identifies the goal/s that they agree to work towards. 6. Complete the self-management care plan (10 mins) 7. Wrap up and identify next steps (5 mins) Follow up sessions: Formal follow up sessions will be offered (a total of three sessions at 3, 6 and 12 months) in person, via email or Telehealth modality including PEXIP video conferencing or telephone depending on the participants preference. It is envisaged that email modality will be used to make it easier to deliver session specific questionnaires to participants prior to Telehealth or telephone sessions and it would be unlikely that the follow up session would be delivered via email interaction alone. Between the delivery of the initial session and 3 months follow up, participants will receive intensive follow up consisting of a maximum of 3 phone calls (every 3 weeks), on a date a time agreed between the nurse and the patient. On clinical experience it is anticipated that the medium duration of the follow up phone calls will be 25 minutes each. Participants will receive a booster session at 6 months to maintain engagement, monitor progress and to provide feedback and motivation to help them achieve their self-management goals. The 6 month booster session will involve participants completing the Partners in Health Scale designed specifically to measure self-management behaviours. Measures of illness control and data on planned hospital admissions will be obtained from the electronic medical records by the research team. There is a final follow up session at 12 months. Telehealth sessions will follow the same structure as the face-to-face sessions and dependent on the goals of the participant. No educational materials will be provided to participants in either the initial or follow up sessions. Outline of Self-management support follow up sessions: 1. Brief Introduction (5 mins) 2. Review progress from last visit (5 mins) 3. Partners in Health Scale (5 mins) 4. Cue and Response Interview (10 mins) 5. Discussion to identify any new agreed issues for the care plan (10 mins) 6. Problems and Goals Assessment (15 mins) 7. Update the self-management care plan (5 mins) 8. Wrap up (negotiate date/time for next appointment) and identify next steps (5 mins) Study fidelity: Training of the intervention providers has been undertaken. Research staff have completed the Flinders training workshop conducted over two days, by the lead research nurse who is an Accredited Flinders Trainer and were assessed as competent against current Flinders competency standards. The training was guided by validated manuals with electronic copies of all training resources and PowerPoint presentation to ensure reproducibility and fidelity of the intervention program. In addition a self-report evaluation checklist was developed by the research team specifically for the study to guide each interview and to assess fidelity ensuring that all key points are covered during each consultation. The self-report checklist is completed immediately after the consultation by the health professional delivering the intervention and emailed to the research nurse coordinator. Follow up quality assurance checks will also be completed by the research team as part of the study after each consultation. Information around attendance, aspects of the program covered in the first and subsequent sessions, length of consultation visits and records of all face to face consultations and phone contact and the development of a care plan. The Department of Adolescent Medicine consists of a multidisciplinary team of health professionals, providing quality healthcare to adolescents within a paediatric healthcare setting. The intervention will be delivered by two clinical Nurse Consultants (CNC) who are highly skilled and experienced paediatric nurses who combined have more than 15 years experience in working with the target population. The lead research nurse is an accredited Flinders Trainer and a current PhD candidate. There is also a research Fellow and academic lead who is also an Adolescent Medicine Physician with extensive clinical and research experience. All members of the team are licensed to use the Flinders Program.