Nurse-led medication monitoring and adverse events
| ISRCTN | ISRCTN10386209 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10386209 |
| Protocol serial number | NA |
| Sponsor | Swansea University (UK) |
| Funder | Research Capacity Building Collaboration (RCBC) Wales (UK) |
- Submission date
- 30/11/2010
- Registration date
- 05/04/2011
- Last edited
- 30/01/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Sue Jordan
Scientific
Scientific
School of Human and Health Sciences
Swansea University
Singleton Park
Swansea
SA2 8PP
United Kingdom
Study information
| Primary study design | Observational |
|---|---|
| Study design | Single centre pragmatic randomised controlled parallel group trial with stratified random allocation to groups |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Nurse-led medication monitoring and adverse events in a respiratory medicine outpatient department. A single site parallel group pragmatic randomised controlled trial (RCT) of the West Wales Adverse Drug Reaction (WWADR) Profile for Respiratory Medicine |
| Study acronym | WWADR 2 |
| Study objectives | Concurrent and formal monitoring of respiratory medication Adverse Drug Reactions (ADRs) using the WWADR Profile for Respiratory Medicine in addition to 'usual' care will increase the number of problems detected and actioned by nurses compared to 'usual' nursing care alone. |
| Ethics approval(s) | The South West Wales Research Ethics Committee approved on the 10th of February 2010 (ref: 09/WMW02/60) |
| Health condition(s) or problem(s) studied | Chronic respiratory disease |
| Intervention | Patients with chronic respiratory disease attending the nurse-led respiratory clinics will be allocated to one of two groups. Allocation by concealment, stratified randomisation by West Wales Organisation for Rigorous Trials in Health and Social Care (WWORTH). 1. WWADR Profile for Respiratory Medicine in addition to usual nursing care: A five sectioned profile that records medication used by patient, vital signs, and asks a series of questions about their medication and several observations along with checking when laboratory tests were last done. 2. Usual nursing care alone |
| Intervention type | Other |
| Primary outcome measure(s) |
Number of problems detected in rounds one and two identified using the WWADR profile |
| Key secondary outcome measure(s) |
1. Number of problems actioned by the nurse in rounds one and two |
| Completion date | 01/06/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 50 |
| Key inclusion criteria | 1. Patients attending the outpatient respiratory clinics in Singleton Hospital, Swansea, Wales 2. Existing chronic respiratory condition 3. Currently prescribed and receiving at least one of: 3.1. Bronchodilators 3.2. Corticosteroids 3.3. Theophylline 3.4. Leukotriene receptor antagonists |
| Key exclusion criteria | 1. Aged 16 or under 2. Lack of fluency in English or Welsh 3. Patients will be screened by trained physicians and/or nurses to ensure they are well enough to participate in this project, and will be excluded as necessary by their clinicians: 3.1. Patients considered lacking the capacity to consent 3.2. Patients experiencing undue stress or vulnerability |
| Date of first enrolment | 05/01/2011 |
| Date of final enrolment | 01/06/2012 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centre
School of Human and Health Sciences
Swansea
SA2 8PP
United Kingdom
SA2 8PP
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | 05/05/2014 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
