Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000062921
Ethics application status
Approved
Date submitted
17/12/2019
Date registered
24/01/2020
Date last updated
27/02/2020
Date data sharing statement initially provided
24/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Experience of Transfers to Rehabilitation Services
Scientific title
Understanding the experience of patients and families transfer to rehabilitation services
Secondary ID [1] 299898 0
Nil
Universal Trial Number (UTN)
Trial acronym
EXTRAS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stroke 315318 0
Condition category
Condition code
Physical Medicine / Rehabilitation 313621 313621 0 0
Other physical medicine / rehabilitation
Stroke 314043 314043 0 0
Haemorrhagic
Stroke 314044 314044 0 0
Ischaemic

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is an observational project that will utilise a mixed methods approach, where demographic, clinical and questionnaire data will be synthesised with content analysis of semi-structured interviews to provide a well-rounded understanding of patient and whanau experiences of transitions of care to and from inpatient rehabilitation, and stroke care in general, before and after the opening of Ward 51 (the upcoming Integrated Stroke and Adult Rehabilitation Unit) at ADHB.
Phase 1 occurs within the existing structure and processes for ADHB Rehabilitation Services. Under this structure patients will have acute hospital care, then be transferred into Rehabilitation Services. Patients who are eligible for participation will be invited to take part in this study, and will complete their participation before Phase 2 begins. Phase 2 will occur after the opening of Ward 51, the new Integrated Stroke and Rehabilitation Unit. Under this structure, patients with stroke will enter Ward 51 on arrival to hospital, receive their hyperacute, acute and rehabilitation care in the unit, and will then discharge home with community rehabilitation services in place. Participants recruited during this phase will experience a different care transition process than participants recruited during Phase 1.

There are two groups of patients and whanau who will be potentially eligible for participation, defined below.
Group 1: Stroke patients who transfer from the ADHB acute stroke service to ADHB inpatient rehabilitation, and their whanau.
Group 2: Non-stroke patients who transfer from any other ward or hospital to ADHB inpatient rehabilitation.

The main comparison of interest is between Group 1 patients recruited in Phase 1 and Phase 2. The primary outcome is the change inpatient experience for stroke patients who transfer to ADHB inpatient rehabilitation from ADHB acute stroke services. This will involve a transfer to Rangitoto ward during Phase 1, and will occur within Ward 51 during Phase 2.

Patients and whanau who consent to participation will be asked to complete brief surveys around 1 week after beginning inpatient rehabilitation. This will take up to 30 minutes. They will also be invited to discuss their experiences of transitioning to rehabilitation with a member of the research team. This discussion can take only a few minutes or as long as the participant wants. This discussion will be audio recorded and participants will be provided with a transcription of the discussion which they can revise or correct before it is included in the analysis. Patients will also be asked to complete brief surveys around 2 weeks after leaving the hospital. They can choose to do this over the phone or in person at a location of their choice. If they choose to return to hospital their transport will be provided at no cost to them.

Clinicians involved in inpatient stroke care will be emailed a link to an anonymous online survey regarding their perceptions of coordination of care. They will consent by choosing to complete the survey, which is expected to take around 5 minutes. Clinicians will be invited to complete this survey once before Ward 51 opens, and once more after it opens, with no linkage between data collected at these two time points.
Intervention code [1] 316168 0
Not applicable
Comparator / control treatment
Non-Stroke participants receiving rehabilitation at ADHB.

These participants will transition from acute wards into inpatient rehabilitation services at ADHB during Phase 1 and Phase 2 of this study.
Control group
Active

Outcomes
Primary outcome [1] 322090 0
The primary outcome is patients' Care Transition Measure score, which is a measure of patient experience of continuity of care at discharge from hospital. (1,2)

1. Coleman EA, Mahoney E, Parry C. Assessing the quality of preparation for posthospital care from the patient's perspective: the care transitions measure. Medical care. 2005;43(3):246-255.
2. Coleman EA, Smith JD, Frank JC, Eilertsen TB, Thiare JN, Kramer AM. Development and testing of a measure designed to assess the quality of care transitions. Int J Integr Care. 2002;2:e02.
Timepoint [1] 322090 0
Within 2 weeks after discharge from hospital.
Secondary outcome [1] 377300 0
Secondary outcome 1: A brief in-house questionnaire will be used to understand patient and whanau experiences of their transition into inpatient rehabilitation.

Based on our review of the literature, we conclude that a validated patient reported experience measure that addresses transitions within hospital is not yet available. We therefore have designed in-house patient and whanau questionnaires. The questionnaire is based on contemporary multli-dimensional concepts of continuity of care (1,2)

1. Uijen AA, Heinst CW, Schellevis FG, et al. Measurement properties of questionnaires measuring continuity of care: a systematic review. PLoS One. 2012;7(7):e42256.
2. Haggerty JL, Reid RJ, Freeman GK, Starfield BH, Adair CE, McKendry R. Continuity of care: a multidisciplinary review. BMJ. 2003;327(7425):1219-1221.
Timepoint [1] 377300 0
Within 1 week after transfer to inpatient rehabilitation.
Secondary outcome [2] 378599 0
Secondary outcome 2: A patient and whanau semi-structured interview will be used to understand personal and relational dimensions of continuity of care.
Timepoint [2] 378599 0
Within 1 week after transfer to inpatient rehabilitation.
Secondary outcome [3] 378600 0
Secondary outcome 3: The Satisfaction with Stroke Care questionnaire (1) will be used to understand stroke patients satisfaction with in-hospital care.

1. Boter H, De Haan RJ, Rinkel GJ. Clinimetric evaluation of a Satisfaction-with-Stroke-Care questionnaire. J Neurol. 2003;250(5):534-541.
Timepoint [3] 378600 0
Within 2 weeks after discharge from hospital.
Secondary outcome [4] 378601 0
Secondary outcome 4: An online version of The Care Coordination Survey (1) will be used to understand clinicians’ evaluations of care coordination.

Citation: 1. Weston CM, Yune S, Bass EB, et al. A Concise Tool for Measuring Care Coordination from the Provider's Perspective in the Hospital Setting. J Hosp Med. 2017;12(10):811-817.
Timepoint [4] 378601 0
Clinicians will be surveyed 4-6 months before Ward 51 and within 4-6 months after Ward 51 starts.
Secondary outcome [5] 378605 0
Secondary outcome 4: The Caregivers’ Satisfaction with Stroke (1) Questionnaire will be used to understand whanau satisfaction with in-hospital care.

1. Cramm JM, Strating MM, Nieboer AP. Validation of the caregivers' satisfaction with Stroke Care Questionnaire: C-SASC hospital scale. J Neurol. 2011;258(6):1008-1012.
Timepoint [5] 378605 0
Within 2 weeks after discharge from hospital.

Eligibility
Key inclusion criteria
Patients:
i. Patients with stroke aged at least 18 years of age
ii. Patients without stroke aged 18-65 years requiring intensive inpatient rehabilitation

Family/Supporters:
i. Nominated by consented patient participants.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i. Patients with severe cognitive or communication deficit which precludes the ability to consent to research
ii. Patients receiving end of life care or discharging to hospice care

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The questionnaires planned for this study all involve Likert scales for each item, and give total scores of 57 or 60 points. The total score for each respondent will be entered into analyses using parametric methods (ANOVA, t-test). While the responses to each questionnaire are made using ordinal Likert scales, the total score for each questionnaire can be treated as a continuous variable for the purposes of analysis.

a. Continuity of inpatient care
A 2x2 ANOVA will be used to compare mean total scores for the two phases of the study (pre- Ward 51, post-Ward 51) and two groups of patients (stroke, non-stroke). The same approach will be used to compare mean total scores from whanau respondents for the two phases of the study and two groups (stroke, non-stroke).

b. Care Transition Measure
A 2x2 ANOVA will be used to compare mean total scores for the two phases of the study (pre-Ward 51, post-Ward 51) and two groups of patients (stroke, non-stroke). The same approach will be used to compare mean total scores from whanau respondents for the two phases of the study and two groups (stroke, non-stroke).

c. Satisfaction with Stroke Care, SASC-19 and C-SASC
Two-tailed independent samples t-tests will be used to compare mean total scores for the two phases of the study (pre-WARD 51, post-WARD 51) separately for patients (SASC-19) and whanau (C-SASC). The same approach will be used to compare mean total scores for the ‘hospital’ and ‘home’ sub-scales. The sub-scale scores will also be used to binarise respondents into “satisfied” or “unsatisfied” with pre- and post-discharge stroke care using established cut-off scores.

d. Interviews
The brief semi-structured interviews regarding continuity of inpatient care will be audio recorded and transcribed by the principal investigator. The transcriptions will be reviewed by the principal investigator and members of the research team The interview transcripts will be imported into NVivo for analysis. Data will be coded using the key dimensions and factors that form the conceptual framework for the interview, with additional free codes developed where needed. In order to establish a shared understanding and interpretation of the coding framework, all three researchers will begin by coding the same four transcripts. These coded transcripts will be compared and any variance in interpretation of data and application of codes was discussed to arrive at a mutual decision. The remaining transcripts will be independently coded by two researchers (Ben Scrivener, Dr Smith). Excerpts used in reporting will be de-identified. Interview data will be aggregated and interpreted separately for Maori, Pasifika, and non-Maori. Within each of these groups, data will be aggregated and interpreted separately for patients with and without stroke, and for whanau of patients with and without stroke. Alexis Cameron will be involved in the interpretation and reporting of data collected from Maori and Pasifika participants.

Key results and themes identified during the analysis of questionnaire and interview data will be synthesised, depicted as infographics, and sent to participants. Participants will be invited to provide their feedback before the interpretation of the data is finalized, with amendments and additions made based on the feedback provided.

e. Care Coordination Survey
We estimate that approximately 25 clinicians are likely to provide responses to this questionnaire on each occasion. Analyses will assume independence between the two groups of respondents, acknowledging this as a potential limitation. The maximum score for the questionnaire is 60 (all 12 items scored at 5 points). A sample of 25 clinicians at each time point provides > 80% power to detect a 10-point change in average total score, with a standard deviation of 12 points, using a two-tailed independent samples t-test with a = 0.05.


Statistical power
The main effect of interest is an effect of phase on stroke patients’ scores before and after Ward 51 becomes operational. Assuming that at least 50 patients with stroke will be recruited during each phase of the project, we will have 80% power to detect an effect size of 0.58, which reflects a difference in mean total score of 7 points on the continuity of inpatient care measure, the Care Transition Measure, and the SASC, with a standard deviation of 12 points and a = 0.05. This sample size will also provide 80% power to detect a difference of 0.4 in the proportion of patients and whanau who are “satisfied” with the stroke care they received, using binarised SASC-19 and C-SASC sub-scale data, as described above.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/02/2020
Actual
21/02/2020
Date of last participant enrolment
Anticipated
11/01/2021
Actual
Date of last data collection
Anticipated
1/03/2021
Actual
Sample size
Target
400
Accrual to date
2
Final
Recruitment outside Australia
Country [1] 22147 0
New Zealand
State/province [1] 22147 0
Auckland

Funding & Sponsors
Funding source category [1] 304362 0
Charities/Societies/Foundations
Name [1] 304362 0
Auckland DHB Charitable Trust (A+ Trust)
Country [1] 304362 0
New Zealand
Primary sponsor type
Hospital
Name
Auckland DHB
Address
2 Park Rd
Grafton
Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 304643 0
None
Name [1] 304643 0
Address [1] 304643 0
Country [1] 304643 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304804 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 304804 0
Ethics committee country [1] 304804 0
New Zealand
Date submitted for ethics approval [1] 304804 0
16/12/2019
Approval date [1] 304804 0
13/02/2020
Ethics approval number [1] 304804 0
20/CEN/10

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98266 0
Mr Benjamin Scrivener
Address 98266 0
Allied Health, Level 11, Support Building, Auckland City Hospital
2 Park Road,
Grafton
Auckland 1023
Country 98266 0
New Zealand
Phone 98266 0
+6421825460
Fax 98266 0
Email 98266 0
[email protected]
Contact person for public queries
Name 98267 0
Benjamin Scrivener
Address 98267 0
Allied Health, Level 11, Support Building, Auckland City Hospital
2 Park Road,
Grafton
Auckland 1023
Country 98267 0
New Zealand
Phone 98267 0
+6421825460
Fax 98267 0
Email 98267 0
[email protected]
Contact person for scientific queries
Name 98268 0
Benjamin Scrivener
Address 98268 0
Allied Health, Level 11, Support Building, Auckland City Hospital
2 Park Road,
Grafton
Auckland 1023
Country 98268 0
New Zealand
Phone 98268 0
+6421825460
Fax 98268 0
Email 98268 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6592Ethical approval    The HDEC ethics approval will be uploaded once ava... [More Details]



Results publications and other study-related documents

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