Contact information
Type
Scientific
Contact name
Dr Heather Waterman
ORCID ID
Contact details
School of Nursing
Midwifery and Health Visiting
University of Manchester
Oxford Road
Manchester
M13 9PL
United Kingdom
+44 (0)161 275 5334
Heather.waterman@man.ac.uk
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
PSI14-20
Study information
Scientific title
Acronym
Study hypothesis
The 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
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Condition
Cataract
Intervention
Patients 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 type
Other
Primary outcome measure
For 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 measures
Not provided at time of registration
Overall study start date
01/07/1995
Overall study end date
10/07/1997
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients with cataracts
Participant type(s)
Patient
Age group
Adult
Sex
Both
Target number of participants
63
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
01/07/1995
Recruitment end date
10/07/1997
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
School of Nursing, Midwifery and Health Visiting
Manchester
M13 9PL
United Kingdom
Sponsor information
Organisation
Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Primary and Secondary Care Interface National Research and Development Programme (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
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 |