title: Educational Outreach with an Integrated Clinical Tool for Nurse-Led Non-communicable Chronic Disease Management in Primary Care in South Africa: A Pragmatic Cluster Randomised Controlled Trial.
abstract: BACKGROUND
  In many low-income countries, care for patients with non-communicable diseases (NCDs) and mental health conditions is provided by nurses. The benefits of nurse substitution and supplementation in NCD care in high-income settings are well recognised, but evidence from low- and middle-income countries is limited. Primary Care 101 (PC101) is a programme designed to support and expand nurses' role in NCD care, comprising educational outreach to nurses and a clinical management tool with enhanced prescribing provisions. We evaluated the effect of the programme on primary care nurses' capacity to manage NCDs.
  
  
  RESULTS
  In a cluster randomised controlled trial design, 38 public sector primary care clinics in the Western Cape Province, South Africa, were randomised. Nurses in the intervention clinics were trained to use the PC101 management tool during educational outreach sessions delivered by health department trainers and were authorised to prescribe an expanded range of drugs for several NCDs. Control clinics continued use of the Practical Approach to Lung Health and HIV/AIDS in South Africa (PALSA PLUS) management tool and usual training. Patients attending these clinics with one or more of hypertension (3,227), diabetes (1,842), chronic respiratory disease (1,157) or who screened positive for depression (2,466), totalling 4,393 patients, were enrolled between 28 March 2011 and 10 November 2011. Primary outcomes were treatment intensification in the hypertension, diabetes, and chronic respiratory disease cohorts, defined as the proportion of patients in whom treatment was escalated during follow-up over 14 mo, and case detection in the depression cohort. Primary outcome data were analysed for 2,110 (97%) intervention and 2,170 (97%) control group patients. Treatment intensification rates in intervention clinics were not superior to those in the control clinics (hypertension: 44% in the intervention group versus 40% in the control group, risk ratio [RR] 1.08 [95% CI 0.94 to 1.24; p = 0.252]; diabetes: 57% versus 50%, RR 1.10 [0.97 to 1.24; p = 0.126]; chronic respiratory disease: 14% versus 12%, RR 1.08 [0.75 to 1.55; p = 0.674]), nor was case detection of depression (18% versus 24%, RR 0.76 [0.53 to 1.10; p = 0.142]). No adverse effects of the nurses' expanded scope of practice were observed. Limitations of the study include dependence on self-reported diagnoses for inclusion in the patient cohorts, limited data on uptake of PC101 by users, reliance on process outcomes, and insufficient resources to measure important health outcomes, such as HbA1c, at follow-up.
  
  
  CONCLUSIONS
  Educational outreach to primary care nurses to train them in the use of a management tool involving an expanded role in managing NCDs was feasible and safe but was not associated with treatment intensification or improved case detection for index diseases. This notwithstanding, the intervention, with adjustments to improve its effectiveness, has been adopted for implementation in primary care clinics throughout South Africa.
  
  
  BACKGROUND
  The trial is registered with Current Controlled Trials (ISRCTN20283604).
authors.affiliation: Knowledge Translation Unit, University of Cape Town Lung Institute, Cape Town, South Africa.|Department of Medicine, University of Cape Town, Cape Town, South Africa.|Chronic Disease Initiative for Africa, Department of Medicine, University of Cape Town, Cape Town, South Africa.
authors.forename: Lara R
authors.initials: LR
authors.lastname: Fairall
authors.affiliation: Knowledge Translation Unit, University of Cape Town Lung Institute, Cape Town, South Africa.|Department of Medicine, University of Cape Town, Cape Town, South Africa.|Chronic Disease Initiative for Africa, Department of Medicine, University of Cape Town, Cape Town, South Africa.
authors.forename: Naomi
authors.identifier: http://orcid.org/0000-0002-2667-0956
authors.initials: N
authors.lastname: Folb
authors.affiliation: Knowledge Translation Unit, University of Cape Town Lung Institute, Cape Town, South Africa.
authors.forename: Venessa
authors.identifier: http://orcid.org/0000-0002-6172-9386
authors.initials: V
authors.lastname: Timmerman
authors.affiliation: Biostatistics Unit, Medical Research Council, Cape Town, South Africa.
authors.forename: Carl
authors.initials: C
authors.lastname: Lombard
authors.affiliation: Department of Medicine, University of Cape Town, Cape Town, South Africa.|Chronic Disease Initiative for Africa, Department of Medicine, University of Cape Town, Cape Town, South Africa.
authors.forename: Krisela
authors.initials: K
authors.lastname: Steyn
authors.affiliation: Norwich Medical School, University of East Anglia, Norwich, United Kingdom.
authors.forename: Max O
authors.initials: MO
authors.lastname: Bachmann
authors.affiliation: Knowledge Translation Unit, University of Cape Town Lung Institute, Cape Town, South Africa.|Department of Medicine, University of Cape Town, Cape Town, South Africa.
authors.forename: Eric D
authors.initials: ED
authors.lastname: Bateman
authors.affiliation: Alan J Flisher Centre for Public Mental Health, Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa.
authors.forename: Crick
authors.initials: C
authors.lastname: Lund
authors.affiliation: Knowledge Translation Unit, University of Cape Town Lung Institute, Cape Town, South Africa.
authors.forename: Ruth
authors.identifier: http://orcid.org/0000-0002-7391-3383
authors.initials: R
authors.lastname: Cornick
authors.affiliation: Knowledge Translation Unit, University of Cape Town Lung Institute, Cape Town, South Africa.
authors.forename: Gill
authors.initials: G
authors.lastname: Faris
authors.affiliation: Chronic Disease Initiative for Africa, Department of Medicine, University of Cape Town, Cape Town, South Africa.|Division of Cardiovascular Medicine, Brigham & Women's Hospital, Boston, Massachusetts, United States.
authors.forename: Thomas
authors.initials: T
authors.lastname: Gaziano
authors.affiliation: Knowledge Translation Unit, University of Cape Town Lung Institute, Cape Town, South Africa.
authors.forename: Daniella
authors.initials: D
authors.lastname: Georgeu-Pepper
authors.affiliation: Centre for Studies in Family Medicine, Department of Family Medicine, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada.
authors.forename: Merrick
authors.initials: M
authors.lastname: Zwarenstein
authors.affiliation: Department of Medicine, University of Cape Town, Cape Town, South Africa.|Chronic Disease Initiative for Africa, Department of Medicine, University of Cape Town, Cape Town, South Africa.
authors.forename: Naomi S
authors.initials: NS
authors.lastname: Levitt
mesh_terms: D000328:Adult; D002908:Chronic Disease / Q000628:therapy*; D015331:Cohort Studies; D003863:Depression / Q000628:therapy; D003920:Diabetes Mellitus / Q000628:therapy; D019468:Disease Management; D005260:Female; D006801:Humans; D006973:Hypertension / Q000628:therapy; D008297:Male; D008875:Middle Aged; D059017:Primary Care Nursing; D011320:Primary Health Care / Q000379:methods*; D012140:Respiratory Tract Diseases / Q000628:therapy; D013019:South Africa