None listed
Conditions
Brief summary
About 1 in 3 stroke survivors experience an emergency presentation or unplanned readmission within 90 days of discharge from hospital. Unplanned readmissions are associated with poorer quality of life, depression and poorer functional status. In addition to the impact of hospitalisation on survivors and their families, there is a substantial economic impact. While the factors precipitating an unplanned readmission are complex, common precipitating factors include: poorer mental health, poorer functional status, and infections. These factors are related to poor preparation of survivors and their carers for the transition from hospital to home; and a lack of ongoing support to assist with self-managing the sequelae of stroke. Methods: Randomised controlled trial to assess the impact of an innovative dischagre support program comprising (a) standardised goal setting prior to hospital discharge plus (b) integrated e-health self-management support, to reduce unplanned presentations/ readmissions among survivors of stroke within 90 days. Significance: This will be the first adequately powered and rigorous trial of an e-health intervention to improve discharge care and support. Findings will be important nationally and internationally, for all adults discharged from hospital with a newly-acquired disability, not just survivors of stroke.
Interventions
In hospital component (All participants before randomisation): Participants have their baseline assessments completed either in hospital, or shortly after discharge by phone, with the hospital clinicians or clinician researchers if e-consent given. For the baseline assessment, consented participants are asked questions about their medical history, current health status and preference for receiving SMS or email communication by a trained clinician researcher. The clinician researcher, using the R
In hospital component (All participants before randomisation): Participants have their baseline assessments completed either in hospital, or shortly after discharge by phone, with the hospital clinicians or clinician researchers if e-consent given. For the baseline assessment, consented participants are asked questions about their medical history, current health status and preference for receiving SMS or email communication by a trained clinician researcher. The clinician researcher, using the ReCAPS structured goal setting menu designed for this project, will assist recruited participants to identify two to five goals for recovery including at least one focused on preventing another stroke that they want to work towards achieving over 12 weeks. They will record the participants goal statement e.g. "to lose weight". This interview, including goal identification, will take about an hour to complete. All participants are informed that a Monash University researcher will contact them via phone (or video-conference) in the first 7-14 days after their discharge from hospital to clarify their goals. The participants indicate their preferred day and time of the day (e.g. morning, afternoon, evening) for this telephone/video call. Within 7-14 days of discharge: A researcher from Monash University will contact all participants to ask them questions about their hospital stay (discharge satisfaction [PREPARED] and longer-term unmet needs [LUNS] questionnaires) and reconfirm willingness to participate. Using the standardised ReCAPS goal setting package, the researcher will assist the participant to restructure each of their stated goals to ensure they meet SMART requirements i.e. specific, measurable, achievable, realistic and time-bound. This interview may take 60 minutes to complete and can be undertaken over 2 sessions, if the participant wishes. All participants are provided with a summary copy of their SMART goals. Participants are then randomly assigned to receive one of the two support programs for 12 weeks. The number of support messages will vary depending on which group the participant has been allocated. Within 7 days following the 7-14 day phone/video call ALL participants receive a welcome message “Hi #PREF_NAME, welcome to the ReCAPS study. We will be contacting you using this number. Please add 'ReCAPS' to your contacts. Thanks ReCAPS team”. Intervention group: Participants are given an opportunity to review and prioritise their goals with the the clinician researcher. They may revise or add new goals to a maximum of 5, if original goals are no longer relevant. The LUNS questionnaire helps to identify unmet needs and may be used in discussion between the clinician researcher and the participant in revising or prioritising their goals, and/or tailoring relevant messages. Based on the participant’s finalised goals, the researcher will personalise (use preferred name where possible) and tailor (aligned to stage of readiness and baseline characteristics including disability level, where relevant) the program of electronic messages and schedule them to be sent over the 12 week intervention period. The format and content of the messages are the same regardless of whether sent via SMS or email. The number of messages sent will be dependent on the number of goals established. The maximum number of contacts will be twice daily. In general, intervention participants will only receive one message per day, but on two occasions they may also receive one of the follow-up reminder (administrative) messages. We will monitor the number of participants who engage with SMS/email by responding to messages requesting a response, “Would you like to speak to someone for further information? Or confirm, by reply SMS or email, that you have received our messages.”; the number of times web-links are accessed; the number of ‘STOP’ messages received; number of help desk enquiries. The satisfaction survey administered on completion will capture participants’ feedback as to whether they did not read the messages and if so how many weeks after starting the program this happened and their reasons for not continuing to read messages. If a participant in either group responds “STOP” they will receive the following message: “Thanks for contacting the ReCAPS team. One of our staff will contact you within 2 business days to clarify your request to stop receiving messages.” Follow-up assessments (all participants): conducted over the telephone, or by videocall, around week 13 post randomisation whereby health outcome and resource use (cost) questionnaires will be administered. At around 52 weeks post randomisation, the EQ-5D and health care resource utilisation questionnaire will be administered over the phone to enable cost-effectiveness analysis.
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Eligible patients will: (i) be aged 18 years or older; (ii) have a confirmed acute stroke; (iii) be discharged directly to a home setting from a participating Stroke Service within 10-14 days of admission; (iv) have access to the internet (can be via public access i.e. local library) or a mobile phone; (v) self-identify as users of SMS/email technology; (vi) be able to communicate in English; (vii) have a Modified Rankin Score of 0-4; (viii) ability to provide own consent and (ix) be likely to survive to 90 days post randomisation, i.e. not being palliated or have illnesses such as terminal cancer.
Exclusion criteria
a) Unlikely to survive to 90 days post randomisation i.e. not being palliated or have illnesses such as terminal cancer; or b) discharged to another hospital/institution or in-hospital rehabilitation following acute care; c) Site Principle Investigator deems participant inappropriate due to requirement for surgical intervention within 12-weeks of discharge from hospital
Outcome results
None listed