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 |
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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 |
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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) |
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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 |
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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 |
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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 |