Ethics and privacy considerations
The study was reviewed and approved by the Repatriation General Hospital Research and Ethics Committee (90/07). Approval to access participant data relating to utilisation of pharmaceutical and medical benefits was provided by Medicare Australia, subject to provision of individually signed consent forms.
Recruitment and screening
Once an older adult and their informal carer agreed to participate in the study, written informed consent was sought from both parties. A modified Zelen randomised consent design
was used. The study team have used this design in a previous study in the same setting.
The modified Zelen design is employed when standard consent procedures may lead to unnecessary confusion or distress.
The initial consent provided a full description of baseline and outcome measures and included a simple description of the intervention. Following allocation, participants assigned to the intervention group were given detailed information about each of the components of the intervention and informed consent to participate was sought. Those assigned to usual care were not re-approached. Proxy consent was sought for those with an appointed guardian or impaired cognition.
Permuted block randomisation was used to achieve balanced treatment allocation.
A random number sequence was generated for the order of treatment allocation within the blocks using the SPSS vl5 RV.UNIFORM function by a statistician external to the trial. Varying block sizes were used. The blocks were randomly arranged within larger sized blocks. Random group allocation was managed by a clinical trials pharmacist at the Repatriation General Hospital. Sequentially numbered, opaque sealed envelopes were used to conceal treatment allocation.
Research staff screened for inclusion criteria, sought informed consent and conducted the baseline assessment. Following completion of the baseline assessment, a research staff member telephoned the clinical trials pharmacist at the hospital; the participant was assigned a unique participant number and allocated to the intervention or control group. While staff performing the outcome assessments were blinded to group allocation, it was not possible to blind participants and staff administering interventions to group allocation.
All participants received usual care at the TC facility. A multidisciplinary team was responsible for comprehensive geriatric assessment, goal setting, care plans and periodic review at regular case conference meetings.
Physiotherapy, occupational therapy and speech therapy were provided in individual and/or group sessions. A pharmacist reviewed patient medications, documented changes during hospital admission and the period of TC and provided education for older adults who were discharged to home. Social workers assisted older adults and their families to make decisions about living arrangements and aged care services and to access legal and social security services if required. An initial medical consultation was provided by a geriatrician but most medical care was provided by a general practitioner and a geriatric medicine advanced trainee who visited the TC facility twice weekly, with telephone support available 24 hours a day via an on-call roster. The geriatricians only met with the patient or carer if clinically indicated after the initial review. Each patient was discussed at a multi-disciplinary case conference in the week after their admission and then was discussed again at four and eight weeks if still in the program. There was a separate weekly discharge planning meeting involving allied health and nursing staff.
The intervention was delivered in addition to usual care and addressed health literacy in relation to participant and carer understanding of the participant’s medical conditions and medications, and encouraged participation in decisions about future health care needs. Issues relating to the participant’s wishes about end of life care were also canvassed. The intervention comprised four components: a Question Prompt List (QPL); medical and nursing meetings; written summary; and telephone call post discharge.
Question Prompt List
Participants and carers received a Question Prompt List (QPL) a week prior to meeting with a geriatrician (see ). A structured list of questions has been shown to enhance patient participation in oncology settings
and their use aims to improve patient and carer involvement in care planning and encourage discussion about sensitive issues such as diminished capacity, long-term care options and end of life care.
Geriatrician and nurse meetings
A checklist was used to guide the consultation with a geriatrician and nurse and as a record of the meeting (see ). The checklist was developed by consultant geriatricians and included the core information components of the Care Transition Intervention, specifically: the reason for hospital admission and comorbid diagnoses, current medications and ‘red flags’ indicative of a worsening condition.
Additional topics were those generally covered as part of a comprehensive geriatric assessment (CGA) and included: depression,falls,continence,cognition,behaviour, nutrition, decision-making capacity, advanced care planning and end of life care. The participants’ and family members’ preferences for discharge destination were elicited and, where appropriate, discussion included information about the risks associated with each of the options and strategies to mitigate those risks. Geriatricians had access to hospital and TC facility records and current medication charts immediately prior to the family meetings and brief nursing notations on the checklist were used to highlight key dates (e.g. orthopaedic review), results of cognitive testing, and clinical observations.
Checklist for geriatrician meeting
Participants received an audio recording of the consultation.
The nurse met with the participant and carer two weeks after the initial consultation to consolidate key educational messages concerning medications and ‘red flags’. Falls prevention, self-care, continence and behaviours associated with dementia were discussed as appropriate. Permission was sought to conduct meetings in aged care facilities for those participants who entered permanent care prior to the scheduled meetings.
Participants and carers received a written summary of the study meetings with the geriatrician and nurse. The personal summary adopted a conversational tone and utilised images and colour to improve readability. It described the medical condition that resulted in hospital admission and other medical diagnoses. The summary also included a reconciled list of medications and a description of the medications’ purposes and possible side effects. Extracts from a de-identified summary are provided as a supplementary file. Participants were encouraged to share their summary with their doctor, formal carers, and family members as appropriate.
Telephone call post discharge
The study nurse telephoned the participant or carer two to three weeks after discharge from the TC facility to enquire about medical follow-up, medication supply and community and aged care services. Participants were asked to rate the usefulness of the QPL (see ), meetings with the geriatrician and nurse, audio-recording and written summary of health conditions and medications.
Components of the coaching intervention
Data collection, measures and outcomes
Baseline measures were recorded prior to randomisation. In addition to demographic details and descriptions of health conditions, the following measures were collected:
interRAI Post-Acute Care (interRAI-PAC)
is one of a suite of standardised instruments developed by an international research consortium known as interRAI (RAI = Resident Assessment Instrument). Development and validation of the RAI for nursing homes was funded by the USA government in 1987 to enable comparison of resident needs across institutions, inform resource allocation, and as a foundation for care improvement.
An assessment of patient performance and clinical characteristics were conducted across a three-day period (and within seven days of admission) by a health professional with interRAI certification. The interRAI-PAC provides summary scores on eight scales: (i) cognitive performance; (ii) communication; (iii) Changes in Health, End-stage disease and Signs and Symptoms scale (CHESS); (iv) depression; (v) Activities of Daily Living (ADL) – short form; (vi) ADL – long form; (vii) pain; (viii) Instrumental Activities of Daily Living (IADL); and Body Mass Index (BMI).
Standardised Mini Mental State Examination (SMMSE)
Assesses verbal memory and attention and is a widely used measure in screening for dementia and delirium. Total scores range from 0-30 with lower scores indicating greater cognitive impairment. Values of 23 or less generally indicate significant impairment.
Charlson Comorbidity Index (CCI)
This is a widely used index of comorbidity and a strong indicator of mortality at one-year follow-up. The index encompasses 19 medical conditions weighted 1–6 with total scores ranging from 0-37.
Higher scores indicate greater disease burden.The CCI has been adapted and validated for use with the International Classification of Disease 9th Revision (ICD-9)and 10th Revisions (ICD-10) and the Australian modification (AM) of the ICD-10. For the current study, the CCI was calculated based on the ICD-10-AM codes at hospital discharge.
Health care utilisation Hospital admissions and Medicare Australia information relating to pharmaceutical and medical benefits was collected for the 12 month period prior to study entry, as a baseline measure of health care utilisation.
The primary outcome for the study is the 15 item Care Transition Measure (CTM-15)
which was completed by participants and carers at the three-month outcome assessment. The CTM-15 assesses the quality of preparation for care transfers. The measure includes four major domains identified through qualitative research to be important to an individual’s experience of a change in care setting, namely: (i) critical understanding; (ii) respect for individual preferences; (iii) preparation for self management; and (iv) a written care plan.
The CTM-15 is scored between 0 and 100, with higher scores indicating a better transition. The tool has been found to discriminate between patients who do, and do not, re-present to hospital for their original condition.
Secondary outcomes were assessed at 3 and 12 months by a research assistant who was blind to group allocation. A summary of primary and secondary outcomes is provided in . Measures include:
Health and aged care service utilisation Hospitalisations and admissions to aged care facilities in the preceding period were recorded at 3 and 12-month assessments and confirmed from hospital records and/or the appropriate facility. Community service use was also recorded at each assessment, based on self or proxy reports and will be used in the economic analyses.
Deaths were recorded and verified with reference to hospital, general practitioner or residential aged care records.
is a well validated and widely used generic preference based measure of health-related quality of life for application in economic evaluation. The instrument comprises two main components: a visual analogue scale (VAS) (0-100, representing worst imaginable to best imaginable health state) and five dimensions with three levels (of increasing severity) attached to each dimension: mobility; self-care; usual activities; pain/discomfort; and anxiety/depression. Respondents were asked to rate their own health on the VAS and indicate which of the three levels for each dimension best corresponded to their health on the day of assessment. Individual responses to the five dimension questions are converted to utilities through application of a scoring algorithm based upon general population values for all possible health states defined by the instrument.
Modified Barthel Index (MBI)
is a simple and rapid measure of functional independence with high reliability (0.9). The MBI has 10 items, each scored from unable to perform task to fully independent with a total score of 100 indicating complete independence. The MBI is a mandatory assessment tool for TC in Australia.
Short Physical Performance Battery (SPPB)
assesses gait, balance and lower extremity strength and endurance. The SPPB incorporates tests of standing balance (tandem, semi-tandem and side-by-side), a timed 2.4m walk at a normal pace and a timed test of five repetitions of rising from a chair and sitting down and is highly predictive subsequent disability.
Geriatric Depression Scale (GDS-15)
is a 15-item short-form self-report assessment designed specifically to identify depression in the elderly. Each item requires a yes/no response and total scores range from 0-15, with higher scores indicating greater illness severity. The GDS-15 can reliably detect the presence of a major depressive episode among older adults as defined by current diagnostic criteria-the International Classification of Diseases, 10th revision (ICD-10) and Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV).
Multidimensional Health Locus of Control Scale (MHLC)– Form A
is a widely used scale to characterise a person’s beliefs about control over health status. The instrument consists of three six-item scales: Internality (IHLC); Powerful Others externality (PHLC); and Chance externality (CHLC). The score on each subscale is the sum of the values circled for each item on the subscale where 1 = strongly disagree and 6 = strongly agree. Evidence for the validity of the MHLC is described as modest.
Client Satisfaction Questionnaire
, 8-item version (CSQ-8)
is a self-report measure of satisfaction with treatment, originally developed to evaluate mental health services. Each item is scored from 1-4 with higher scores indicating higher satisfaction with the treatment received. The CSQ-8 assesses global patient satisfaction and also provides a general score ranging from to 32.
The CSQ-8 is a widely used instrument with published data on reliability and validity
and is available in several languages.
was assessed against the key requirements of the Transition Care Program (TCP) in Australia,
using an instrument that was developed as part of the National Evaluation of the TCP.
TC recipients (or their proxies) were asked to rate the extent to which their experience matched TCP requirements for care to be goal oriented, patient-centred, seamless and to optimise independence. Initial testing of the 9-item instrument demonstrated test-retest reliability and construct validity.
Secondary outcomes for carers included carer burden and self-efficacy. In addition to the CTM-15, carers completed:
Bakas Caregiving Outcomes Scale (BCOS)
. This scale is a 10-item uni-dimensional scale of carer burden with good psychometric properties.
The BCOS provides an overall score of how the carer’s life has changed while providing care to the participant. The BCOS uses a 7-point Likert scale that ranges in response from ‘changed for the worst’ to ‘changed for the best’ to measure change in relationships, physical health, and subjective wellbeing.
New General Self-Efficacy Scale (NGSE)
. This 8-item scale assesses perceived self-efficacy regarding coping and adaptation abilities in both daily activities and isolated stressful events. Tests using item response theory (IRT) confirm that the NGSE has acceptable psychometric properties.