General design
This is a prospective randomised controlled trial to evaluate the effectiveness of the SCOHP for improving the psychosocial health of those who have experienced stroke and their carers. The SCOHP will be delivered as an 8-week individualised support program, with an additional booster session, and will be compared to usual care. Assessments will take place at baseline, 3, 6, and 12 months. The study protocol was approved by the St Vincent’s Hospital Human Research Ethics Committee (HREC-A 019/14). An executive steering committee (all authors) oversees project planning, conduct and ongoing data collation.
Setting
The study will be conducted at the neurology unit of St Vincent’s Hospital, a large metropolitan teaching hospital in Melbourne, Australia. Between 2011 and 2012, 737 patients were admitted to St Vincent’s Hospital, with a principal diagnosis of stroke. The stroke unit at St Vincent’s Hospital, Melbourne will enable planned recruitment of 168 participants for the SCOHP program over a 2-year period.
Participants
A total of 84 patients diagnosed with stroke, and 84 carers of these patients, will be recruited into the RCT. For the purposes of this study, stroke is defined as cerebral infarction or parenchymal haemorrhage confirmed by medical records. The following criteria are to be met for inclusion into the RCT: (1) diagnosis of stroke for patient or self-nominated carer of a stroke patient; (2) 18 years or older; (3) ability to converse in English without an interpreter or professional assistance; (4) absence of developmental disability or amnestic syndrome impairing their ability to learn from the intervention; and (5) absence of serious comorbid illness, including severe forms of aphasia, as identified by the nurse unit manager, and cognitive impairment, as identified from medical notes scoring lower than 24 on the Mini-Mental State Examination (MMSE) [27]. As the OHP adopts a holistic approach to managing chronic disease, patients may enter the program at any stage along the continuum of care.
Power was calculated to detect a medium effect size of Cohen’s d = 0.50. This was chosen as a clinically meaningful effect size that may be compared with previous RCT research in the area of chronic disease management programs [28]. Calculations assumed two primary outcomes (health-related quality of life and General Self-Efficacy Scale (GSE) scores), four assessment points (baseline, 3-month, 6-month, and 12-month), a study-wide type I error rate (α) of .05, and hence a type II error rate (β) of 0.20 (power of 0.80), a correlation of post-treatment scores with baseline measurements (ρ) of 0.81, and a two-tailed statistical test [29]. To detect an effect size of Cohen’s d = 0.50, 53 participants in each of the control and intervention groups will be required. Allowing for up to 20 % attrition, a total of 168 participants, or 42 carers and stroke survivors in control and intervention groups will be recruited.
Study procedures
Recruitment
Potential patients who have been diagnosed with stroke and/or their carer will be identified by clinical staff (e.g. neurologist, nurse) and provided with a study flyer. Patients and/or carers will be asked permission for a researcher to approach them to discuss the program in more detail. If agreeable, they will be approached, informed and formally consented by the research assistant. Study fliers will also be posted online through community organisations and will include contact details for the research team. Participants from the community may contact researchers directly to request further information. Planned recruitment will occur over an 18-month period (see Fig. 1).
Consent
The process of consent will be in accordance with the Declaration of Helsinki. Nurse unit managers were consulted to determine a patient’s eligibility for the study. Senior clinicians and the research team were consulted in instances when it was unclear if an individual met the inclusion criteria. All eligible patients and carers will be fully informed that they are being asked to participate in an RCT. The procedures involved in the study, and the chances of being assigned randomly to one of two groups will be explained verbally and via an information sheet approved by the hospital’s Human Research Ethics Committee. A signed consent form will be obtained from each participant. Participants will be made aware of their right to withdraw from the study at any time without any effects on their clinical management.
Randomisation and blinding
Using a computer-generated block randomisation sequence created by a researcher independent of the study, participants will be allocated to treatment or control group. The allocation sequence will be generated using random numbers and participants will be randomised progressively as they consent. Patients and carers will be randomized as dyads. Patients or carer will be randomized alone if they are not participating as a dyad. Due to the nature and length of the intervention, it is not possible to blind either participant or investigator to the treatment allocation.
Intervention: SCOHP
The SCOHP is delivered at a nominated place of convenience by the participant i.e. home, hospital, community health centre. Dyads have the option of either receiving the intervention independently or together. The SCOHP comprises a modular format of eight sequential sessions plus a booster, based on a structured workbook. Participants are encouraged throughout the program to identify areas of stroke- or carer-related health concerns on which they would like to focus. Sessions are approximately 1 hour in duration and held weekly, apart from the ‘booster’ session, which is held 3 months after session 8. Learning is cumulative with each session designed to build on the previous session including tasks to complete between sessions, i.e. journaling and coping strategies (e.g. breathing exercises).
In summary, session 1 introduces SCOHP within the six domains of the ‘Optimal Health Wheel’: social, physical, emotional, intellectual, employment and spiritual as documented in the workbook. This session provides participants with the opportunity to explore and understand stroke self-management behaviour from a holistic perspective. Sessions 2 and 3 initiate development of a health plan exploring the implications and potential complications of stroke in terms of strengths and vulnerabilities, and understanding and monitoring disease impact (e.g. emotional burden and physical weakness). Session 4 focuses on medication management and metabolic monitoring. Session 5 expands the health plan to include key stroke partnerships and supports in the community and online (e.g. www.strokefoundation.com.au). Change enhancement is the focus in session 6, in terms of understanding past events and establishing new proactive avenues for change. The aim of session 7 is goal setting via creative problem solving and planning around the complexities of stroke. To cement a shift in focus of the person’s illness from being ‘dependent on’ services to being ‘supported by’ services, session 8 strategises stroke advanced care planning that incorporates wellbeing maintenance and sustainability. The goal of the ‘booster session’ (session 9) is to review health plans, consolidate progress, and reflect on achievements towards health-related goals.
A health professional (e.g. nurse, psychologist) trained in the approach (2-day workshop plus regular supervision and fidelity checks) will facilitate each session. The facilitator will draw on carer and stroke-specific information in concordance with individual circumstances. Examples include the relationship between depression and caregiving or physical impairments of stroke, availability of stroke and carer supports in the community, and coping strategies for addressing anxiety and stress related to new roles and circumstances. The emphasis is on collaboration between facilitator and participant to arrive at goals for the program that stem from the participant’s main concerns and needs. The facilitator will encourage participants to identify their early warning signs of stress and illness and integrate healthy coping strategies to prevent the build-up of stress. Facilitators may also discuss and arrange referrals for other services in conjunction with the multidisciplinary team depending on participant needs. Additionally, facilitators will work with the multidisciplinary team to coordinate visits. Participants in rural and regional areas will have the option of participating in sessions via phone or Skype.
Control
The comparison group will receive usual care and no SCOHP intervention. As participants will be recruited from a variety of settings (hospital outpatients, community organisations) we anticipate variation in standard care received. To capture this variation, all participants will complete the Health Care Utilisation Questionnaire (HCUQ) [30] at each time point. Participants in the control group will have the option of completing the SCOHP at the end of the trial once evaluation is complete.
Outcome measurements
Table 2 details the primary and secondary outcome measures and time points for carers and stroke survivors. Participants complete the measures independently unless a specific request is made for assistance e.g. due to vision or motor skill impairment. Primary outcome measures for both stroke survivors and carers are quality of life and self-efficacy. Health-related quality of life will be assessed using the (AQoL-6D) [25], which consists of six dimensions of health and a global ‘utility’ score and the EuroQol-5D (EQ-5D) [26]. Self-efficacy is to be assessed using the General Self-Efficacy Scale (GSE) [31] a measure of perceived self-efficacy in response to daily challenges and stressful life events. Secondary measures for both stroke survivors and carers are: coping strategies as measured using an abbreviated version of the COPE inventory, the Brief COPE [32]; symptom severity and caseness of depression and anxiety disorders as assessed using the Hospital Anxiety and Depression Scale (HADS) [33]; a 10-item measure of the Big Five personality dimensions (BFI-10) [34]; effect of an individual’s mental health on their ability to function via the Work and Social Adjustment Scale (WSAS) [35]; treatment expectancy and rationale credibility of the clinical study as assessed with the Credibility/Expectancy Questionnaire (CEQ) [36]; perceived satisfactoriness of treatment as assessed using the Treatment Evaluation Inventory-Short Form (TEI-SF) [37]; and health care utilisation and its economic impact assessed by the Health Care Utilisation Questionnaire (HCUQ) [30]. Stroke survivors will also be assessed for cognitive and emotional responses to stroke using the Brief Illness Perceptions Questionnaire (BIPQ) [38]. In addition, carers will be assessed for carer strain using the Modified Caregiver Strain Index (MCSI) [39] and carer satisfaction as assessed by the Carer Assessment of Satisfaction Index (CASI) [40].
Due to the potential for variability of ‘usual care’ in the control group, key aspects of usual care will be assessed with the HCUQ. Furthermore, medical records will be reviewed to determine stroke diagnostic information and clinical indices including the Modified Rankin Scale (MRS), which measures the degree of disability/dependence after a stroke.
Program assessment and treatment fidelity
The SCOHP facilitators will be trained in program delivery, receive a structured manual/protocol and monthly group supervision with the clinical investigators (with individual supervision provided as needed in between group sessions). The purpose of supervision will be to discuss problems in study procedures and ensure standardised activity. The SCOHP sessions will be audio recorded with a random selection rated by independent assessors in compliance with the SCOHP protocol. Variations from the protocol will be identified and relayed to the facilitator. Facilitators will complete a summary of each session using a standard template and send these notes to the research team. Session notes will include OHP topics covered, participant concerns raised, and needs for supervision. Additionally, content of sessions regarding participant requirement and concerns will be discussed at supervision meetings.
Post-intervention focus groups will be held for clinicians and participants. Participants will be informed during consent (both written and verbal) of the option to participate in focus groups, and that the purpose is to ascertain an in-depth understanding of their experiences of the study, advantages and disadvantages of conducting the study/program in their services (for clinicians), and recommendations for components to include or exclude from the SCOHP. It will be made clear to participants when consenting that the number of focus groups will be limited; such that they will only be run until data saturation is achieved. It is envisioned that data saturation will be reached after 2 to 3 focus groups, each containing 8 to 12 individuals. To increase objectivity, focus group facilitators will be independent researchers who were not OHP facilitators. The pragmatic data analysis approach of Halcomb and Davidson [42] will be used for the purpose of focus group data analysis. In summary, identifying key passages and words will be independently analyzed, coded, and categorized (classifying key passages and words within themes) drawing on pragmatic thematic analysis to form emergent themes.
Statistical analyses
Intention-to-treat analyses will be employed to prevent overestimation of efficacy. Categorical variables will be analysed using chi-squared tests (or Fisher’s exact test for small samples). A mixed-effects model, repeated measures (MMRM) approach will be used to examine the longitudinal profile of continuous variables at 3, 6 and 12 months post-baseline. For all MMRM analyses, baseline scores will be used as covariates and the models will include prespecified fixed effects of treatment, clinician, and time, and treatment-by-time and treatment-by-clinician interactions.
Secondary analyses using analysis of covariance will be conducted to compare change scores during treatment and follow-up phases for primary, secondary, and process outcomes using the fixed, continuous covariate of baseline score as well as the categorical fixed effects of treatment group, clinician, and treatment-by-clinician interactions.
Although the attrition rate is not expected to vary by treatment condition, we will attempt to identify key predictors of attrition status (i.e. demographic and baseline clinical characteristics) and test for differences between conditions. Assuming the data are missing at random, several procedures offer effective approaches that may attenuate attrition. Maximum likelihood models (i.e. MMRM), with time as a random variable, allow the use of all available data from all assessments, reducing bias and increasing power [43]. In addition, multiple imputation procedures that utilise the expectation-maximization (EM) algorithm with bootstrap estimates of standard errors will be used to address attrition. The application of these procedures can provide unbiased estimates, even in the face of substantial missing data [44].
A full economic evaluation will occur alongside the proposed RCT. Healthcare outcomes and costs will be compared between participants in the control and interventional conditions. Healthcare system (medical record) and self-reported information via the HCUQ [30] will be used to generate analyses. The utility measurements of participant quality of life will be assessed using AQoL-6D [25] developed in Australia and the EQ-5D-3L [26] developed in Europe. The potential long-term (lifetime) impact on cost and effectiveness of intervention beyond the trial period will be extrapolated using the Markov process modelling method.