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
Scientific
Department of Haematology
Stafford Hospital
Weston Road
Stafford
ST16 3SA
United Kingdom
Study information
| Study design | Single-centre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | A randomised controlled trial of a structured educational programme for patients starting warfarin therapy |
| Study objectives | The 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) studied | Education for patients starting warfarin therapy |
| Intervention | In-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 type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Warfarin |
| Primary outcome measure | Level of knowledge assessed by a questionnaire at discharge (0 months) and 3 months post-discharge |
| Secondary outcome measures | 1. 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 date | 01/09/2000 |
| Completion date | 01/06/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 45 |
| Key inclusion criteria | 1. 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 criteria | 1. 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 enrolment | 01/09/2000 |
| Date of final enrolment | 01/06/2001 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Stafford Hospital, Department of Haematology
Weston Road
Stafford
ST16 3SA
United Kingdom
Stafford
ST16 3SA
United Kingdom
Sponsor information
Mid Staffordshire NHS Foundation Trust
Hospital/treatment centre
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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.
