The Missing Link- Development and Evaluation of Person-centred Transitions From the Stroke Unit to the Home "MissingLink"

Recruiting

Phase N/A Results N/A

Trial Description

There is strong evidence that early supported discharge and continued rehabilitation at home (ESD) delivered by an interdisciplinary team reduces deaths or dependency in activities in daily living after stroke. Despite recommendations in national guidelines ESD is only implemented in few places in Sweden. There are interdisciplinary teams that supply rehabilitation in the home but the coordinated transition is lacking. Such rehabilitation is not evidence based. The key components of a coordinated transition to achieve the benefits of ESD are not known. The aim is to design, implement and evaluate new person-centred transitions between stroke units and the home to achieve full ESD. 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 to form a full ESD service and evaluated in a cluster randomised controlled trial.

Detailed Description

Project 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 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 evaluation of the missing link.
Phase 1 Aims: Explore current state of 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.
1. Design: prospective longitudinal observational 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. Power calculations indicate the inclusion of 300 participants with stroke. 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 with the Care Transition Measure (CTM) 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 Stockholms Läns Landsting. Analyses: Statistical analyses to identify factors at baseline associated with satisfactory transitions (CTM), and associations between perceived quality of transitions (CTM) and patient and significant other outcomes at 3 and 12 months.
2. Data: Medical records will be reviewed on the planning and decisions regarding transitions e.g., criteria for referral to home rehabilitation, timing and planning, information exchange between stroke unit and interdisciplinary home rehabilitation teams, and use of decision support. Analyses: Quantitative content analyses.c) 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: Thematic analyses with constant comparisons. d) 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: Thematic analyses with constant comparisons.
Phase 2 Aims: Create prototype for a new person-centred coordinated safe transition process.
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. The design process comprises six phases: 1. Engage; establish relationship between the participants. 2. Plan; generate ideas and goals. 3. Explore; learning about experiences of the transition from the stroke unit to the home. 4. Develop; turning ideas into context specific improvements. 5. Decide; choose what improvements to make, and how to make them. 6. Change; put the decided improvements into action i.e., phase 3. The improvements may involve decision support for the staff, the patient and significant others and information and support with or without support by information technology.
Phase 3 Aims: Implement the new transitions between stroke units and the home, a) evaluate new person-centred transitions from stroke unit to home rehabilitation compared to transitions without coordination in a feasibility cluster randomised controlled trial 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.
Design: a) Cluster randomized controlled feasibility study. Interdisciplinary home rehabilitation teams collaborating with the participating stroke units at Karolinska University hospital and Danderyd hospital will be randomised to deliver either the new person-centred transitions or initiation of rehabilitation in the home as usual. Based on core aspects of person-centred transitions identified in phase I and phase 2 and transition designs developed in phase 2 the interface to coordinate the transitions between the stroke-unit and each interdisciplinary team will be identified and organised. Participants: people with mild to moderate stroke, referred to receive rehabilitation at home in participating stroke units, their significant others, staff of the participating stroke units and interdisciplinary teams. Data on satisfaction with the transition process will be collected with the CTM 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 Stockholms Läns Landsting. Analyses comparing outcomes of people who receive the new person-centred transitions and transition as usual will be performed intention to treat. Analyses will include health economic aspects of the new transitions. b) In addition, open ended questions will be asked to the participants with stroke and the significant others pertaining to their experiences of the new person-centred transition and the rehabilitation in the home environment. Members of the participating interdisciplinary teams and staff of the participating stroke units will be interviewed regarding their experiences. The answers will be audio recorded and transcribed verbatim. Analyses: Thematic applied analyses using constant comparisons will be applied to transcripts of the interviews to identify experiences of the ESD and specifically the person-centred transition of the staff in the stroke units and the participating interdisciplinary teams.

Conditions

Trial Design

  • Observation: Cohort
  • Perspective: Prospective
  • Sampling: Probability Sample

Trial Population

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.

Outcomes

Type Measure Time Frame Safety Issue
Primary Care Transition Measure, questionnaire 3 months post-stroke No

Sponsors