Clinical trial NCT02925871: The Missing Link- Development and Feasibility Evaluation of Person-centred Transitions From the Stroke Unit to the Home
Official title: The Missing Link- Development and Feasibility Evaluation of Person-centred Transitions From the Stroke Unit to the Home - a Co-design Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: stroke
rehabilitation
interdisciplinary health team
patient-centered care
care transition
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Kamprad Family Foundation
name: Swedish Council for Working Life and Social Research
First posted: 2016-10-06
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim is to design, implement and evaluate new person-centred transitions between stroke units and the home. The development of person-centred transition will be performed together by people with stroke, significant others, stroke unit staff and interdisciplinary teams.

Phase 1, a prospective observational study of current transitions from stroke units to rehabilitation in the home without coordination. The aim is to identify factors that are facilitators or barriers to transitions, patient and caregiver outcomes, use of health care during the first year after stroke. In phase 2, a co-design process of new person-centred transitions will be carried out by people with stroke, significant others, stroke unit staff and interdisciplinary home rehabilitation teams. In phase 3 new person-centred transitions will be implemented and evaluated in a feasibility study.

Detailed description: A phased approach, as recommended for development and evaluation of complex interventions, will be used. In phase 1 the current transitions from stroke units to the home environment will be explored and facilitators / barriers to coordinated person-centred safe transitions will be identified. Knowledge generated in phase 1 will inform phase 2; a co-design process of new coordinated person-centred car transitions conducted by people with stroke, significant others and staff from stroke units and interdisciplinary home rehabilitation teams together. Knowledge from phase 1 and phase 2 will inform phase 3; implementation and feasibility evaluation of the new care transitions.

Phase 1 Aims: Explore current state of care transitions combined with rehabilitation in the home, identify facilitators and barriers to person-centred transitions, current patient and caregiver outcome, satisfaction, and resource use of health services during the first year after stroke.

Design: prospective longitudinal observational study.

1. Participants: people with mild/moderate stroke, referred from stroke units to home rehabilitation and their significant others will be asked to participate before discharge from the stroke unit.

   Data collection: Baseline data on medical and socio-demographic aspects and functioning will be collected from the medical records. Data on satisfaction with the transition process will be collected after discharge from the stroke unit. At 3, and 12 months people with stroke will be assessed regarding disability, perceived impact of stroke, participation in social activities, health related quality of life, perceived needs of health services and satisfaction with services received using reliable validated measures and structured interviews. Data on caregiver burden, life satisfaction and informal care will be collected from significant others. Data on use of health care will be obtained from the register at Region Stockholm.

   Analyses: Statistical analyses to identify factors at baseline associated with satisfactory transitions, and associations between perceived quality of transitions and patient and significant other outcomes at 3 and 12 months.
2. Participants: staff of stroke units and interdisciplinary home rehabilitation teams.

   Data collection: Focus group interviews with staff of stroke units on experiences of identifying candidates for home rehabilitation, the planning and decisions; and with the interdisciplinary teams on experiences of preparation for rehabilitation in the home and establishing new contacts with people referred for home rehabilitation.

   Analyses: Grounded theory.
3. Participants: Strategic samples of people with stroke based on satisfaction with transition and their significant others.

Data collection: Semistructured individual interviews on the experiences of the transition from the stroke unit to the home and the initiation of the home rehabilitation.

Analyses: Grounded theory.

Phase 2 Aims: Develop new person-centred coordinated transitions. Design: Workshops with all stakeholders using a collaborative design process which include reflection, analysis, and description of the problem, visualization to get a common picture, modelling and/or prototyping.

Participants: People with stroke, significant others, staff from stroke units and interdisciplinary home rehabilitation teams in a series of five workshops.

Data collection: field-notes, diaries and documentation of the design process.

Phase 3 Aims: Implement and evaluate the new person-centred transitions between stroke units and the home in a feasibility study regarding satisfaction with the transitions, patient and caregiver outcomes and use of health care during the first year after stroke and explore experiences of the new transitions from all stakeholders involved.

a) Design: cluster non-randomized controlled feasibility study. Participants: people with mild/moderate stroke, referred from stroke units to home rehabilitation and their significant others will be asked to participate before discharge from the stroke unit. The intervention will be implemented at a geriatric stroke unit and an acute stroke unit at Danderyd Hospital and two corresponding home rehabilitatin teams in Stockholm, Sweden. The controls will be recruited from an acute stroke unit at Karolinska University Hospital in Stockholm, Sweden. In total, 50 persons will be consecutively included, 25 from the intervention site and 25 from the control site. In addition, staff of the participating stroke units and interdisciplinary teams will be recruited.

Data collection: Data on feasibility, operationalised as fidelity and acceptability, of the intervention will be collected by participant observations, interviews, and data from the healthcare record. Data on likely effectiveness will be collected using questionnaires and registry data:

1. Sociodemographic and disease-related data will be collected from hospital records and cognitive function, depression, and fatigue in structured interviews. One week after discharge data will be collected on the primary outcome satisfaction with the transition process, and the secondary outcomes patient health literacy, medication adherence, fatigue, depresion symptoms. At 3 months, data will be collected on health literacy, medication adherence, fatigue, depresion symptoms, self-efficacy, perceived stroke recovery, activities of daily living, and satisfaction with care. All data will be collected using validated questionnaires.
2. Semi-structured interviews will be held with a purposive sampling of about 10 patients, and about 10 healthcare professionals. For people with stroke, the interviews will be conducted one-week after discharge. For professionals, the interviews will be conducted 1 to 3 months after start of intervention.

a) Analyses: Patients in the intervention group will be compared to control group using intention-to-treat analysis.

b) Analyses: Qualitative content analysis

Eligibility criteria: Inclusion criteria:

* patients who have had a first time or recurrent stroke, and who will be discharged home from the participating stroke units and referred to a rehabilitation team in primary healthcare for continued rehabilitation in the home.

Exclusion criteria:

* unable to give informed consent, due to e.g., severe aphasia or dementia.

Primary outcomes:
measure: Care Transition Measure
timeFrame: 1 week after discharge from hospital stroke unit
Secondary outcomes:
measure: Health Literacy Questionnaire
timeFrame: 1 week and 3 months after inclusion
measure: Stroke Impact Scale, perceived recovery (patient)
timeFrame: 1 week and 3 months after inclusion
measure: The Medication Adherence Report Scale (patient)
timeFrame: 1 week and 3 months after inclusion
measure: General Self-Efficacy Scale (patient)
timeFrame: 3 months after inclusion
measure: Caregiver Burden Scale (significant other)
timeFrame: 3 months after inclusion
measure: EuroQol-5D Visual Analogue Scale (significant other)
timeFrame: 3 months after inclusion
measure: Life Satisfaction Checklist, item 1 (significant other)
timeFrame: 3 months after inclusion
Other outcomes:
measure: Fatigue visual analogue scale (patient)
timeFrame: 1 week and 3 months after inclusion
measure: Patient Health Questionnaire-2 (patient)
timeFrame: 1 week and 3 months after inclusion
measure: Barthel Index (patient)
timeFrame: 1 week and 3 months after inclusion
Locations:
city: Huddinge
country: Sweden
facility: Karolinska University Hospital
city: Stockholm
country: Sweden
facility: Danderyd hospital
Study officials:
affiliation: Karolinska Institutet, Department of Neurobiology, Care Sciences and Society
name: Charlotte Ytterberg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Flink M, Lindblom S, Tistad M, Laska AC, Bertilsson BC, Warlinge C, Hasselstrom J, Elf M, von Koch L, Ytterberg C. Person-centred care transitions for people with stroke: study protocol for a feasibility evaluation of codesigned care transition support. BMJ Open. 2021 Dec 23;11(12):e047329. doi: 10.1136/bmjopen-2020-047329.
citation: Lindblom S, Ytterberg C, Elf M, Flink M. Perceptive Dialogue for Linking Stakeholders and Units During Care Transitions - A Qualitative Study of People with Stroke, Significant Others and Healthcare Professionals in Sweden. Int J Integr Care. 2020 Mar 25;20(1):11. doi: 10.5334/ijic.4689.
citation: Lindblom S, Flink M, Sjostrand C, Laska AC, von Koch L, Ytterberg C. Perceived Quality of Care Transitions between Hospital and the Home in People with Stroke. J Am Med Dir Assoc. 2020 Dec;21(12):1885-1892. doi: 10.1016/j.jamda.2020.06.042. Epub 2020 Jul 29.
citation: Lindblom S, Flink M, Elf M, Laska AC, von Koch L, Ytterberg C. The manifestation of participation within a co-design process involving patients, significant others and health-care professionals. Health Expect. 2021 Jun;24(3):905-916. doi: 10.1111/hex.13233. Epub 2021 Mar 17.
citation: Lindblom S, Tistad M, Flink M, Laska AC, von Koch L, Ytterberg C. Referral-based transition to subsequent rehabilitation at home after stroke: one-year outcomes and use of healthcare services. BMC Health Serv Res. 2022 May 3;22(1):594. doi: 10.1186/s12913-022-08000-7.
citation: Lindblom S, Ytterberg C, Flink M, Carlsson AC, Stenberg U, Tistad M, von Koch L, Laska AC. The Use of Teach Back at Hospital Discharge to Support Self-Management of Prescribed Medication for Secondary Prevention after Stroke-Findings from A Feasibility Study. Healthcare (Basel). 2023 Jan 30;11(3):391. doi: 10.3390/healthcare11030391.
citation: Flink M, Lindblom S, von Koch L, Carlsson AC, Ytterberg C. Health literacy is associated with less depression symptoms, higher perceived recovery, higher perceived participation, and walking ability one year after stroke - a cross-sectional study. Top Stroke Rehabil. 2023 Dec;30(8):865-871. doi: 10.1080/10749357.2023.2178133. Epub 2023 Feb 21.
citation: Hess Engstrom A, Flink M, Lindblom S, von Koch L, Ytterberg C. Association between general self-efficacy and health literacy among stroke survivors 1-year post-discharge: a cross-sectional study. Sci Rep. 2024 Mar 27;14(1):7308. doi: 10.1038/s41598-024-57738-z.
citation: Lindblom S, Flink M, von Koch L, Laska AC, Ytterberg C. Feasibility, Fidelity and Acceptability of a Person-Centred Care Transition Support Intervention for Stroke Survivors: A Non-Randomised Controlled Study. Health Expect. 2024 Oct;27(5):e70057. doi: 10.1111/hex.70057.
citation: Hess Engstrom A, Lindblom S, Flink M, Soderberg S, von Koch L, Ytterberg C. Stroke survivors' health literacy is not associated with caregiver burden: a cross-sectional study. Sci Rep. 2025 Feb 8;15(1):4720. doi: 10.1038/s41598-025-89523-x.