Item | Description or tool used to measure the outcome | Data source | Data collection time points | |
Baseline | 4 months post study entry | |||
Demographics | Age, sex, living arrangements |
| ✓ | |
Aged care package | The commencement date, the service type and package level will be identified. |
| ✓ | ✓ |
No of home visits in the preceding week | Number of community-based home care provider visits over the last 7 days will be extracted. |
| ✓ | ✓ |
Medical conditions | Diagnoses of medical conditions, syndromes and diseases will be determined from multiple sources. |
| ✓ | ✓ |
Medications taken | Data relating to prescribed medications, medication use and previous adverse drug events will be reconciled from multiple sources. Details of all prescription and non-prescription medications, including complementary and alternative medications, administered regularly and as required will be recorded. The medication name, strength, number of dosing times and administration details will be recorded. |
| ✓ | ✓ |
Home Medicines Review (HMR) | An HMR is an Australian Government remunerated service undertaken collaboratively by pharmacists accredited to conduct HMRs and GPs, to identify and resolve medication-related problems for people living in the community.40 Dates that any HMRs were provided will be determined using multiple sources. People who have previously received an HMR remain eligible for inclusion in this study. |
| ✓* | ✓ |
Adherence to medication regimen | Adherence to the medication regimen will be assessed using the 13-item Self-Efficacy for Appropriate Medication use Scale (SEAMS).33 The SEAMS has been demonstrated to be valid and reliable among people with a variety of chronic health conditions and among people with low literacy.33 There is a strong correlation between measurement of self-efficacy with the SEAMS and medication adherence as assessed by the Morisky Scale.33 |
| ✓ | ✓ |
Frailty | Frailty status will be assessed using the 5-item FRAIL screening test scale that assesses fatigue, resistance, ambulation, illnesses and recent weight loss.41 The FRAIL is relatively short and can be easily administered in clinical and research settings to screen for frailty. Possible scores range from 0 to 5, with a score of 0 indicating robust health status, scores of 1–2 indicating the person is prefrail and a score of 3 or more indicating the person is frail.41 A recent meta-analysis of three studies showed prefrailty and frailty, as defined by the FRAIL Scale, are associated with increased mortality.42 |
| ✓ | ✓ |
Dementia severity | Assessed using the 12-item Dementia Severity Rating Scale (DSRS),43 which provides a validated measure of impairment across the major functional and cognitive domains. The DSRS is recommended by the Australian Government Dementia Outcomes Measurement Suite for assessing the severity and progression of dementia.44 The DSRS has excellent ability to distinguish between people without cognitive impairment and people with mild cognitive impairment or Alzheimer’s disease.44 The DSRS is written in a multiple choice format and it can be administered in 4–5 min.44 |
| ✓ | ✓ |
Activities of daily living | Activities of daily living will be assessed using the 6-item Katz Activities of Daily Living Scale.45 The Katz Scale is widely used to assess basic activities of daily living in research studies and in clinical practice, can be administered in 5–10 min, has a good quality rating and is recommended in the Australian Government Dementia Outcomes Measurement Suite.44 |
| ✓ | ✓ |
Quality of life | Quality of life will be assessed using the Quality of Life in Alzheimer’s Disease (QoL-AD) Scale,34 which is recommended in the Australian Government Dementia Outcomes Measurement Suite.44 Each of the 13 measures is rated on a scale of one to four, with lower scores indicating reduced quality of life. The QoL-AD Scale was found to be reliable and valid when administered to people living with dementia who have MMSE scores greater than 10 in a previous study in which 155 people completed the QoL-AD Scale.46 |
| ✓ | ✓ |
Participant satisfaction | Participant satisfaction will be measured using the revised version of the 7-item Short Assessment of Patient Satisfaction Scale,35 which is recommended in the Australian Government Dementia Outcomes Measurement Suite.44 |
| ✓ | ✓ |
Incidents | Incidents that are routinely collected by the community-based home care provider will be captured. Falls will be defined as ‘events that results in a person coming to rest inadvertently on the ground or floor or other lower level’.47 Details of all falls, including the date of the fall, severity and related health outcomes (eg, fracture, hospitalisation) will be recorded. Medication incidents will be recorded, noting: the date of the medication incident, the type of incident (eg, prescribing error, pharmacy dispensing error identified by staff, participant error, administration error or adverse drug reaction) and severity. |
| ✓* | ✓ |
Ambulance call-outs | Ambulance call-outs with and without transportation will be determined. The date and the reason(s) will be recorded. |
| ✓* | ✓ |
Hospital visits | Emergency department visits that do not result in admission and hospital admissions will be determined. The date and the reason(s) will be recorded. |
| ✓* | ✓ |
Residential aged care facility admission | Admission to a residential aged care facility will be defined as either respite or permanent accommodation. |
| ✓† | ✓ |
All-cause mortality | Any deaths in the 4 months after study entry will be determined, and the date of death recorded. |
| ✓ |
*Data relating to these variables will be extracted for events in the 4 months prior to study entry.
†Data relating to admissions for respite care in the 4 months prior to study entry will be extracted.
FRAIL, Fatigue, Resistance, Ambulation, Illnesses, & Loss of Weight; MMSE, Mini-Mental State Exam.