ParTNer-STEPs: Parents in Transition - a Nurse-led Support and Transfer Education Program
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 64
- Locations
- 2
- Primary Endpoint
- Transition readiness (TR)
Study Overview
Brief Summary
OBJECTIVE To improve chronically ill adolescents' transition to adult care by preparing and supporting the parents. The study aim is to improve parents' (of chronically ill adolescents, 16-18 years) transition readiness by offering them a brief transition program.
HYPOTHESIS Young peoples´ self-management skills are mainly developed at home, guided by their parents, rather than in consultations with health professionals.
The investigators hypothesize that a nurse-led transfer intervention focusing on parents' knowledge, skills and attitudes will:
- improve the parents´ readiness for their child's transition to adult health care
- support the parents' gradual handing over of treatment responsibility to the adolescent and, that an improvement in parental transition readiness will
- strengthen the adolescent's self-management skills and increase his/her readiness for transition.
BACKGROUND Transfer from paediatric to adult care for chronically ill adolescents is associated with no-shows and low treatment adherence, as well as anxiety and concerns among parents. Studies show that support for parents results in better transition for both parties.
INTERVENTION
ParTNer-STEPs is a transfer program consisting of three initiatives:
- a website with information about the adult department and legal changes as well as advice from other parents and young people
- online teaching events (web based seminars) for parents
- transfer consultations across the paediatric and adult department
METHOD The intervention will be evaluated in a randomized controlled trial (RCT) study over two years. The project will be carried out in four paediatric outpatient clinics at Rigshospitalet, Copenhagen University Hospital, Denmark: nephrology, hepatology, neurology and rheumatology. Based on a power calculation, the investigators aim to include parents of minimum 62 adolescents. Primary outcome: Parents' transition readiness (TR). Secondary outcomes: Adolescents' TR, self-management skills, and quality of life.
Detailed Description
STUDY DESIGN The study design is a randomized controlled trail (RCT) study in a period of 6 to 18 months before the adolescent is transferred to adult care (depends on when the participant is recruited before transfer) and three months after transfer.
RECRUTMENT Potential participants will be contacted by the paediatric nurses at the four outpatient clinics and briefly informed of the study. If the parents are interested in the project, the project coordinator will provide the parents with oral and written information of the study, including the fact that they can withdraw from the study at any time without consequences for their child's treatment. There will also be provided written information to their adolescent child and the adolescent will also get the opportunity to speak directly to the project coordinator, if they have any questions. Finally, after time to consider their participation in the project, a written consent will be obtained. Under the recruitment process the investigators will carefully consider the risk of coercion, autonomy, and confidentiality.
RANDOMIZATION Randomisation will be conducted after screening and written consent of parents. Randomisation will by conducted by computer-generated (REDCap) random numbers as a dyad (adolescent and parents) with a ratio of 1:1 (using algorithm to stratify by the four outpatient's clinic). The dyads will be randomised into two groups 1) receive the intervention (standard care plus ParTNer-STEPs until their child´s transfer to adult care) or 2) standard care (control group). Once the database has defined a dyad's allocation, no changes can be made. Those randomised to the intervention arm will then receive access to the intervention materials.
SAMPLE-SIZE No previous studies have focused on whether it´s possible to increase parents´ transition readiness score (TR) by offering them a transfer program. A previous cross-sectional study found that parents of chronically ill adolescents have an average TR score of 3.12 (SD 0.68). Based on our clinical experience, advice from the author of the primary outcome questionnaire, and a review of each item in the questionnaire (Medical self-management and transition readiness), the investigators assume that it will be possible to increase the parents' TR score in the intervention group with 0,5 points.
The investigators are planning an RCT study with a continuous response variable from an independent control- and intervention group with 1 control(s) per intervention subject. Based on a previous study the investigators assume the response within each group will be normally distributed with standard deviation 0.68. If the true difference in the intervention and control means is 0.50, the investigators will need to include parents of 31 individual adolescents in each group to be able to reject the null hypothesis that the population means of the intervention and control groups are equal with probability (power) 0.80. The Type I error probability associated with this test of this null hypothesis is 0.05. Thus, the investigators need to recruit a total of parents of at least 62 individual adolescents.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 198 Months to 210 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Parents, stepparents or guardians of chronically ill adolescents, who
- •are aged 16.5-17.5 years (can be recruited up to six months before transfer)
- •have been diagnosed for minimum six months
- •have regular check-ups at the Department of Paediatrics and Adolescent Medicine's nephrology, hepatological, neurological and rheumatological outpatient clinics at Rigshospitalet, Denmark.
- •are transferred to an adult hospital department
- •are mentally and cognitively able to take responsibility for their own treatment
Exclusion Criteria
- •Parents who do not read and speak Danish
- •Parents of adolescents who will be transferred to their family doctor at the age of 18 year.
Outcomes
Primary Outcomes
Transition readiness (TR)
Time Frame: Change from baseline TR at transfer (last consultation in paediatrics)
TR measured by the questionnaire Medical self-management and transition readiness. The questionnaire is validated. The questionnaire consists of 21 identically structured Likert-scaled items assessing the adolescent's awareness of their health condition and ability to make decisions relevant to their health care needs. All items ask participants to respond on a five item Likert-scale (1=strongly disagree, 2=disagree, 3= neither disagree nor agree; 4=agree and 5= strongly agree). Answered by parents (primary) and adolescent (secondary outcome)
Secondary Outcomes
- Uncertainty(Change from baseline uncertainty score at transfer (last consultation in paediatrics))
- Health-related quality of life (HRQoL)(Change from baseline HRQoL at transfer (last consultation in paediatrics))
- Allocation of Responsibility (AoR)(Change from baseline AoR at transfer (last consultation in paediatrics))
- Experiences of transfer(Three months after transfer (follow-up))
- Transfer satisfaction(Three months after transfer (follow-up))
Investigators
Bente Appel Esbensen
Professor, Senior Researcher, RN, MSciN, Ph.D
Glostrup University Hospital, Copenhagen