ISRCTN ISRCTN13118302
DOI https://doi.org/10.1186/ISRCTN13118302
Secondary identifying numbers PSI14-20
Submission date
23/01/2004
Registration date
23/01/2004
Last edited
17/09/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Heather Waterman
Scientific

School of Nursing, Midwifery and Health Visiting
University of Manchester
Oxford Road
Manchester
M13 9PL
United Kingdom

Phone +44 (0)161 275 5334
Email Heather.waterman@man.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesThe aim of the study was to test the key hypothesis that: Co-management of care in a peripheral ophthalmic clinic will improve the efficiency and cost-effectiveness of, and patient satisfaction with, day-care management of cataract surgery. Three objectives were identified:
1.To assess the value of introducing a trained ophthalmic nurse into the care of patients with cataract attending the peripheral clinic
2. To ascertain the best site for pre-operative assessment (peripheral or main hospital)
3. To evaluate the post-operative management of patients including possible role changes in the multi-disciplinary team
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedCataract
InterventionPatients were randomly allocated to receive either the experimental (introduction of a trained ophthalmic nurse) or control (standard) model of care. N = 31 - intervention, N = 32 - control
Intervention typeOther
Primary outcome measureFor both groups, visual outcomes (acuity and function), anxiety and depression, costs to patients and the NHS, and patient satisfaction were the outcome measures selected. Observational data relating to development of staff roles were also collected. All data were collected by an independent researcher.
Secondary outcome measuresNot provided at time of registration
Overall study start date01/07/1995
Completion date10/07/1997

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants63
Key inclusion criteriaPatients with cataracts
Key exclusion criteriaDoes not match inclusion criteria
Date of first enrolment01/07/1995
Date of final enrolment10/07/1997

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

School of Nursing, Midwifery and Health Visiting
Manchester
M13 9PL
United Kingdom

Sponsor information

Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Government

NHS Primary and Secondary Care Interface National Research and Development Programme (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 01/06/1999 Yes No
Results article results 01/06/1999 Yes No