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Clinical Trials/NCT05646589
NCT05646589
Completed
Not Applicable

Implementation and Evaluation of a Person-centred Care Transition Support for People With Stroke/TIA

Karolinska Institutet3 sites in 1 country213 target enrollmentNovember 21, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Karolinska Institutet
Enrollment
213
Locations
3
Primary Endpoint
Care Transition Measure
Status
Completed
Last Updated
3 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 21, 2022
End Date
September 15, 2025
Last Updated
3 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Charlotte Ytterberg

Lecturer, associate professor (docent)

Karolinska Institutet

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.

Outcomes

Primary Outcomes

Care Transition Measure

Time Frame: 1 week after discharge from hospital

Questionnaire that assesses perceived quality in care transitions. The total score (0-100) reflects the overall perceived quality of the care transition, with lower scores indicating a poor quality care transition, and higher scores indicating a higher quality care transition

Secondary Outcomes

  • The Medication Adherence Report Scale (patient)(1 week, 3 and 12 months after inclusion)
  • General Person-centred Care Questionnaire(1 week, 3 and 12 months after inclusion)
  • Stroke Impact Scale, perceived recovery (patient)(inclusion, 1 week, 3 and 12 months after inclusion)
  • EuroQol 5D(1 week and 12 months after inclusion)
  • Stroke Patient Education Retention(1 week, 3 and 12 months after inclusion)
  • Satisfaction with care and rehabilitation(1 week, 3 and 12 months after inclusion)
  • Health Literacy Survey(1 week, 3 and 12 months after inclusion)
  • General Self-Efficacy Scale(12 months after inclusion)
  • Caregiver Burden Scale (significant other)(3 months after inclusion)
  • Life Satisfaction Checklist, item 1 (significant other)(3 months after inclusion)
  • Health Literacy Questionnaire(1 week, 3 and 12 months after inclusion)
  • EuroQol 5D (significant other)(3 months after inclusion)

Study Sites (3)

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