A study of impact and outcome of a structured educational package on patients starting warfarin therapy

ISRCTN ISRCTN08016736
DOI https://doi.org/10.1186/ISRCTN08016736
Secondary identifying numbers N/A
Submission date
05/09/2009
Registration date
01/10/2009
Last edited
27/04/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Carol Ann Frampton
Scientific

Department of Haematology
Stafford Hospital
Weston Road
Stafford
ST16 3SA
United Kingdom

Study information

Study designSingle-centre randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleA randomised controlled trial of a structured educational programme for patients starting warfarin therapy
Study objectivesThe purpose of this study was to examine the relationship between knowledge, satisfaction and compliance to the administration of a structured educational package for patients starting warfarin therapy and its effects on safety. No prediction on outcome was made prior to conducting the research.
Ethics approval(s)Mid Staffordshire Local Research Ethics Committee, 20/04/2000
Health condition(s) or problem(s) studiedEducation for patients starting warfarin therapy
InterventionIn-patients started on warfarin during admission were randomised into a Control Group or an Experimental Group.

Control Group received the 'usual care'.

Experimental Group received a structured educational package which included structured counselling regarding their treatment by the study co-ordinator; and the opportunity to view a video "Living with Warfarin. A Guide for Patients" (St George's Hospital Medical School) as many times as they felt necessary, a copy of which was also available for the patient to take home if required.

General information handouts available were the same for both study groups. All patients then completed an anticoagulant questionnaire prior to discharge to reflect the knowledge considered essential for safe therapy.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Warfarin
Primary outcome measureLevel of knowledge assessed by a questionnaire at discharge (0 months) and 3 months post-discharge
Secondary outcome measures1. Satisfaction with the complete package of care assessed by a questionnaire at 3 months post-discharge
2. Percentage of INR readings within target range at 6 months (measured over 6 months)
Overall study start date01/09/2000
Completion date01/06/2001

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants45
Key inclusion criteria1. Both males and females, adult (over 16 years)
2. The patient was taking warfarin for the first time or as a new episode
3. The patient or individual supervising the treatment had appropriate capacity and was able to read, speak and write English
4. The patient would be maintained on warfarin therapy for at least 3 months
Key exclusion criteria1. They resided in a nursing or residential home where warfarin therapy would be supervised by a health professional
2. They were themselves a health professional
3. They had been commenced on warfarin at another hospital prior to follow-on admission to the Stafford Hospital (where they would have already received a different education package)
4. They were started on warfarin in Accident and Emergency and discharged home without formal hospital admission
Date of first enrolment01/09/2000
Date of final enrolment01/06/2001

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Stafford Hospital, Department of Haematology
Weston Road
Stafford
ST16 3SA
United Kingdom

Sponsor information

Mid Staffordshire NHS Foundation Trust
Hospital/treatment centre

Stafford Hospital
Weston Road
Stafford
ST16 3SA
England
United Kingdom

Website http://www.midstaffs.nhs.uk/

Funders

Funder type

Government

Local departmental budget at Mid Staffordshire Hospitals NHS Trust (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?
Results article results 01/08/2014 Yes No

Editorial Notes

27/04/2018: Publication reference added.
18/03/2016: No publications found, verifying study status with principal investigator.