Roberts 2001.

Methods	Cluster‐RCT (randomised by care home) Total study duration: Two years
Participants	3230 residents (905 intervention, 13 homes); 2325 control, 39 homes) Setting: Nursing homes Age: Intervention < 60 2.0%, 60‐69 6.6%, 70‐79 21.9%, 80‐89 47.4%, 90‐99 20.7%, ≥ 100 1.7% Control < 60 2.6%, 60‐69 5.4%, 70‐79 22.3%, 80‐89 46.7%, 90‐99 21.1%, ≥ 100 1.6% Gender: Not reported Country: Australia Date of Study: Not reported
Interventions	Three‐phase intervention: introducing a new professional role to stakeholders with relationship‐building; nurse education; and medication review by pharmacists The clinical pharmacy service model introduced to each nursing home was supported with activities such as focus groups facilitated by a research nurse, written and telephone communication, and face‐to‐face professional contact between nursing home staff and clinical pharmacists on issues such as drug policy and specific resident problems, together with education and medication review by pharmacists holding a postgraduate diploma in clinical pharmacy. This was a multifaceted intervention directly targeting nursing homes. Most of the contact with GPs was indirect, using the existing relationships between nursing homes and visiting GPs. A number of focus groups and personal interviews about the project were conducted with GPs. In intervention homes, problem‐based education sessions (6 ± 9 seminars totaling approximately 11 h per home) were provided to nurses. Sessions addressed basic geriatric pharmacology and some common problems in long‐term care (depression, delirium and dementia, incontinence, falls, sleep disorders, constipation and pain). Sessions were supported by wall charts, bulletins, telephone calls and clinical pharmacy visits, averaging 26 h contact per home over the study. Written, referenced drug regimen reviews were prepared by the clinical pharmacists for 500 individual residents selected by the nursing home staff. The reviews highlighted the potential for: (1) adverse drug effects, (2) ceasing one or more drugs, (3) adding drugs, (4) better use of specific drug therapy, particularly psychoactive drugs, (5) non drug interventions, and (6) adverse effect and drug response monitoring. Initial reports (61% of total) were audited by a geriatrician before dissemination. Reports were placed in each resident's nursing home records, made available to the resident's GP and discussed with nursing staff. Drugs commonly targeted in reviews and education sessions included laxatives, histamine H2‐receptor antagonists, allopurinol, quinine, antibacterials, paracetamol, nonsteroidal anti‐inflammatory drugs (NSAIDs) and psychoactive drugs
Outcomes	Measured at baseline and 12 months post‐intervention: Hospital admissions (not defined) Mortality (survival also assessed at 22 months) Medication‐related problems Medication costs (per resident per year based on prescription claims data) Not used for this review: Adverse events (from incident reports) Resident Classification Instrument (RCI) Drug use
Notes	Supported by the Commonwealth Government of Australia under the Pharmaceutical Education Program
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Homes were assigned to intervention or control by being “drawn from a hat”
Allocation concealment (selection bias)	Low risk	Cluster design
Blinding of participants and personnel (performance bias) All outcomes	High risk	No blinding conducted
Blinding of outcome assessment (detection bias) Subjective outcomes	High risk	No blinding reported
Blinding of outcome assessment (detection bias) Objective outcomes	Low risk	No blinding reported, however outcomes not likely to be influenced by lack of blinding
Incomplete outcome data (attrition bias) Primary outcomes	Unclear risk	Insufficient reporting of attrition/exclusions to permit judgement
Incomplete outcome data (attrition bias) Secondary outcomes	Unclear risk	Insufficient reporting of attrition/exclusions to permit judgement
Selective reporting (reporting bias)	Unclear risk	Insufficient information to permit judgement
Similar baseline outcome measurements	Low risk	Slight imbalance in mortality and hospitalisations at baseline; however this was accounted for in the analysis
Similar baseline characteristics	Low risk	Similar baseline characteristics reported
Reliable primary outcome measure	Low risk	Mortality and Resident Classification Instrument (RCI)
Adequate protection against contamination	Unclear risk	Cluster design. [Attempted to contact author for further information but no response]
Other bias	High risk	Medication reviews were undertaken for a non‐random subsample of 500 residents (total intervention residents 905) selected by nursing staff