Clinical trial NCT05646589: A Person-centred Care Transition Support for People With Stroke/TIA
Official title: Implementation and Evaluation of a Person-centred Care Transition Support for People With Stroke/TIA
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stroke
Transient Ischemic Attack
Keywords: clinical trial
complex intervention
care transition
process evaluation
secondary prevention
hospital discharge
health literacy
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Forte
First posted: 2022-12-12
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to test a person-centred care transition support in people with stroke/TIA. The main questions it aims to answer are:

* Does a multi-component care transition intervention have an effect on perceived quality of care transitions, health literacy, collected medications, medication adherence, perceived person-centeredness, functioning, recurrent stroke/TIA, healthcare utilization and caregiver burden?
* What are the experiences of the intervention components and the implementation process?
* How does the intervention get adapted and implemented in practice?
* What contextual moderators and mechanisms of the intervention can likely explain the potential effects of the intervention?

Participants will receive a person-centred care transition support that includes a set of activities targeting how healthcare professionals can improve quality with care transition and support health literacy for self-management of secondary stroke prevention for persons who are to be discharged from hospitals after stroke or TIA.

Researchers will compare participants who receive the person-centred care transition support with participants receiving regular care transitions to see if the person-centred care transition support has any effects on perceived quality of care transitions, health literacy, collected medications, medication adherence, perceived person-centeredness, functioning, recurrent stroke/TIA, healthcare utilization and caregiver burden.

Detailed description: Care transitions following a stroke call for integrated care approaches to reduce death and disability. The proposed research described in this study protocol aims to evaluate the ef-fectiveness of a person-centred multicomponent care transition support and the process in terms of contextual moderators, implementation aspects and mechanisms of impact.

A non-randomized controlled trial design will be used. The intervention includes person-centred dialogue intended to permeate all patient-provider communication, various pedagogical modes of information, a person-centred care and rehabilitation plan, and a bridging e-meeting to prepare patients for homecoming.

Patients with stroke or TIA who are to be discharged from the participating hospitals to home and referred to a neurorehabilitation team for continued rehabilitation will be included. Follow-ups will be conducted at one week, 3 months and 12 months. Data will be collected on the primary outcome of perceived quality of the care transition, and on the secondary outcomes of health literacy, medication adherence, and perceived person-centeredness. Data for process evaluation will be collected through semi-structured interviews, focus groups, partici-patory observations, and the Normalisation Measure Development Questionnaire.

Eligibility criteria: Inclusion Criteria:

* patients who have had a first time ever or recurrent stroke or TIA; who are to be discharged from the participating hospitals to home and referred to a neurorehabilitation team for continued rehabilitation; and who are able to give informed consent by themselves.

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
Secondary outcomes:
measure: The Medication Adherence Report Scale (patient)
timeFrame: 1 week, 3 and 12 months after inclusion
measure: General Person-centred Care Questionnaire
timeFrame: 1 week, 3 and 12 months after inclusion
measure: Stroke Impact Scale, perceived recovery (patient)
timeFrame: inclusion, 1 week, 3 and 12 months after inclusion
measure: Stroke Patient Education Retention
timeFrame: 1 week, 3 and 12 months after inclusion
measure: EuroQol 5D
timeFrame: 1 week and 12 months after inclusion
measure: Health Literacy Survey
timeFrame: 1 week, 3 and 12 months after inclusion
measure: Satisfaction with care and rehabilitation
timeFrame: 1 week, 3 and 12 months after inclusion
measure: General Self-Efficacy Scale
timeFrame: 12 months after inclusion
measure: Caregiver Burden Scale (significant other)
timeFrame: 3 months after inclusion
measure: Life Satisfaction Checklist, item 1 (significant other)
timeFrame: 3 months after inclusion
measure: EuroQol 5D (significant other)
timeFrame: 3 months after inclusion
measure: Health Literacy Questionnaire
timeFrame: 1 week, 3 and 12 months after inclusion
Other outcomes:
measure: Patient Health Questionnaire-2
timeFrame: inclusion, 1 week, 3 and 12 months after inclusion
measure: Fatigue visual analogue scale
timeFrame: inclusion, 1 week, 3 and 12 months after inclusion
measure: Barthel Index
timeFrame: inclusion, 1 week, 3 and 12 months after inclusion
measure: Modified Rankin Scale
timeFrame: 1 week, 3 and 12 months after inclusion
measure: Montreal Cognitive Assessment Scale
timeFrame: inclusion, 3 and 12 months after inclusion
Locations:
city: Stockholm
country: Sweden
facility: Aleris Dalengeriatriken
city: Stockholm
country: Sweden
facility: Danderyd hospital
city: Stockholm
country: Sweden
facility: Södersjukhuset
Study officials:
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: 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: 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: 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: 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, 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, 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, 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: 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.
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.