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. 2019 Oct 28;2019(10):CD013124. doi: 10.1002/14651858.CD013124.pub2

Reed 2018.

Methods Study design: randomised controlled trial; parallel‐group design; 2 arms: 'chronic disease self‐management support' (CDSMS) intervention; 'positive attention' control
 Definition of multi‐morbidity: 2 or more of 8 types of chronic conditions identified as Australian National Health priority areas but with the addition of several chronic conditions that are frequently managed in Australian general practice
 Study duration: September 2009 to June 2010; 6‐month follow‐up period
Participants Description: patients at least 60 years old with multi‐morbidity (127 + 127)
Geographical location: Adelaide, Australia
Setting: general practice, patient's home. Research set up with no direct contact between providers and participants' usual GPs or other healthcare providers
Age: CDSMS group: 48% aged 60 to 75, 36% aged 76 to 85, 16% aged > 85; control group: 46% aged 60 to 75, 40% aged 76 to 85, 14% aged > 85
Number of long‐term conditions (S): CDSMS group 4.4 (0.11); control group 4.5 (0.12)
Gender: CDSMS group 59% women; control group 61% women
Country of birth: CDSMS group: Australia 76%, Ireland or United Kingdom 14%, Europe 9%, Other 1%; control group: Australia 76%, Ireland or United Kingdom 13%, Europe 8%, Other 2%
Language: not reported; however, all eligible participants spoke English
Socioeconomic status: household income CDSMS group: $0 to 20,000 29%, $20,001 to 40,000 44%, > $40,000 22%; missing data: 6%; household income control group: $0 to 20,000 31%, $20,001 to 40,000 47%, > $40,000 17%; missing data: 6%
Work status: CDSMS group: 85% retired from employment, 9% home duties, 6% other; control group: 85% retired from employment, 10% home duties, 5% other
IMD for practices: not reported
Place of residence: not explicitly reported but those residing in a long‐term care facility were excluded
Education: CDSMS group: 39% left school age 15 or earlier, 61% left school after age 15; control group: 49% left school age 15 or earlier, 51% left school after age 15
Frailty: not reported
Mobility/functional ability: not reported
Receipt of carer support: not reported
Communication vulnerability: not reported
Interventions Intervention name: Chronic Disease Self‐Management Support (CDSMS) programme
Intervention type: patient‐focused; an individual patient coaching intervention, utilising cognitive‐behavioural therapy (CBT) and motivational interviewing (MI)
Aims and rationale: based on the Flinders Chronic Condition Management Programme (Battersby 2007), the CDSMS programme is designed to be a structured intervention based on cognitive‐behavioural therapy and motivational interviewing, with the aim of achieving sustained behaviour change for patients by increasing patients’ skills and confidence in managing their chronic diseases. Theoretical reasons for utilising CDSMS for older people with multi‐morbidity are reported: (1) complexity of information and treatment regimens, and (2) need for priority setting
Materials: 3 standardised assessment and planning tools, designed to actively assist participants to achieve actions and goals and to develop and review a care plan: ‘Partners in Health Scale’; ‘Cue and Response Interview’; ‘Problems and Goals Assessment’
Procedures: a structured process to enable clinicians and patients to collaboratively assess self‐management behaviour, identify problems, set goals, and develop individual care plans that address self‐care, medical, psychosocial, and carer problems. The health professional's role is to facilitate goal‐setting and to act as coach and advisor. The participant's role is in active decision‐making in collaboration with the health professional. The ‘Partners in Health Scale’ is used first, the ‘Cue and Response Interview’ is then used to collaboratively identify problems and motivate behaviour change, and the ‘Problems and Goals Assessment’ is then used to identify goals; finally, a care plan is written
Elements related specifically to patient involvement in decision‐making: facilitated goal‐setting; active decision‐making in collaboration and care plan development and review between patient and health professional
Mode of delivery: a combination of paper‐based, face‐to‐face, and over‐the‐phone delivery
Who delivered the intervention?
Clinical staff, with qualifications in nursing or psychology and associated with the research team, delivered the intervention. There was no direct contact between these staff and participants’ GPs or other healthcare providers. Ongoing mentoring from accredited trainers was available to clinicians delivering the CDSMS and control programmes. Participants continued taking routine medications and visiting their usual primary care physician throughout the study
Where was the intervention provided?
Patients’ homes, metropolitan Adelaide, South Australia
When and how often or how much of the intervention was provided?
Participants in each programme received 3 home visits and 4 follow‐up phone calls over a 6‐month period
Was the intervention tailored?
Care plans were individualised
Was the intervention modified or adapted?
No modifications or adaptations were reported
Outcomes Self‐rated health
 Tool: 5‐point scale initially developed for the US National Health and Nutrition Examination Survey; higher scores = higher self‐rated health
Review category: health status
 Timing of measurement: baseline and at 6 months
Self‐efficacy
 Tool: Patient self‐report using the self‐efficacy for managing chronic disease scale (Stanford 2018); higher scores = higher self‐efficacy
Review category: patient enablement and engagement
 Timing of measurement: baseline and at 6 months
(Review authors have calculated the SD from the SE for this outcome)
Patient reports of whether the programme changed management of their health conditions
 Tool: patient self‐report via questionnaire using a 3‐point scale; higher score = higher perception of changed management
Review category: patient evaluation of care/the intervention
 Timing of measurement: baseline and at 6 months
 Numbers of general practice visits during the preceding 6 months
Tool: patient self‐report via questionnaire
 Review category: resource use and cost
 Timing of measurement: baseline and at 6 months
(Review authors have calculated the SD from the SE for this outcome)
Control or usual care Control: attention‐control condition: patient‐focused.
The comparator group was chosen to control for the positive benefits of receiving attention from a health professional. The semi‐structured approach, delivered by clinical staff associated with the research team, provided health information, non‐directive counselling, and supportive listening. The approach used no assessment or self‐management tools; however, personalised health information was provided to facilitate health‐related conversations. The clinician’s role was to provide positive attention. The participant's role was to passively receive health information and to participate in informal conversations
Provided in patients' homes, metropolitan Adelaide, South Australia
Participants in each programme received 3 home visits and 4 follow‐up phone calls over a 6‐month period
Funding source and potential conflicts of interest Funding: Australian Department of Health and Ageing (DoHA) under the Sharing Health Care Initiative ‐ Innovations in Chronic Disease Self‐Management Research Grants programme
 Potential conflicts of interest:
 Richard Osborne was supported in part by a National Health and Medical Research Council Population Health Research Fellowship (Career Development Award)
 Malcolm Battersby is the developer of the Flinders Program but declares no financial interest
Notes Other outcomes, considered of less relevance to the review:
Health status: fatigue
Health status: pain
Health status: health distress
Health status: energy
Health status: depression
Health status: illness intrusiveness
Health behaviours: exercise
Health behaviours: medication adherence
Numbers of emergency department visits
Numbers of hospital admissions
Rating of usefulness of the programme
Whether the program improved patients' relationship with their GP
Whether patients would recommend the programme to other patients
Perceived usefulness of the programme in improving patients' health
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated randomisation sequence
Allocation concealment (selection bias) Low risk Central allocation after baseline
"A printed record of the allocation sequence was retained by an independent, centrally located hospital pharmacy … carried out after the baseline interview"
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Incomplete blinding (participants but not research personnel), but the review authors judge that the outcome is not likely to be influenced by lack of blinding
"Participants provided written, informed consent for participation; they were blinded to their allocation, but the investigators were not"
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to permit judgement of ‘low risk’ or ‘high risk’
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Attrition was balanced. ITT analysis; method of imputation reported
"The analyses were intention‐to‐treat analyses; missing data were imputed according to the baseline‐value‐carried‐forward method"
Selective reporting (reporting bias) Low risk The study protocol is available, and all of the study’s pre‐specified (primary and secondary) outcomes that are of interest in the review have been reported in the pre‐specified way
Other bias Low risk No other obvious sources of bias