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OPTImizing preSCRIbing for older People in primary care: a cluster randomized controlled Trial
ISRCTN ISRCTN41694007
DOI 10.1186/ISRCTN41694007
ClinicalTrials.gov identifier
EudraCT number
Public title OPTImizing preSCRIbing for older People in primary care: a cluster randomized controlled Trial
Scientific title OPTImizing preSCRIbing for older People in primary care: a cluster randomized controlled Trial
Acronym OPTI-SCRIPT
Serial number at source N/A
Study hypothesis A multi-faceted intervention that combines a pharmaceutical treatment algorithm and quality improvement strategy delivered using decision support materials and academic detailing, with alternative recommendations for GPs, has an effect in reducing PIP in older people in Irish primary in intervention practices as compared to controls
Lay summary Lay summary under review 1
Ethics approval Irish College of General Practitioners (ICGP) 13 March 2012
Study design Pragmatic two arm cluster randomised controlled trial with qualitative analysis
Countries of recruitment Ireland
Disease/condition/study domain Instances of potentially inappropriate prescribing (PIP) in older people in primary care
Participants - inclusion criteria GP Practices
1. Have approximately 80 or more older patients (aged ≥ 70 years) on their patient panel

Patients
1. Aged 70 years or above
2. They are being prescribed one or more selected potentially inappropriate prescribing (PIP) drugs on a repeat basis (only patients with existing PIP will be included as the intervention is specifically targeting PIP management).
Participants - exclusion criteria GP Practices
1. Involved in the development and piloting of the intervention or other concurrent medication quality related studies

Patients:
1. Have significant mental or physical illness which is likely to impair their ability to participate in the study or their ability to give informed consent
2. They are unable to attend the GP surgery for consultation (e.g. nursing home resident)
3. They are participating in another medication quality related study
Anticipated start date 01/04/2012
Anticipated end date 01/10/2013
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants Recruitment of 22 GP practices and 220 patients (10 per practice)
Interventions Practices will be assigned to intervention or control using minimization to ensure balance between the groups in terms of practice size (number of whole-time-equivalent GPs) and practice location (urban/rural, an urban area is defined as a relatively small centre of population, with 5000 or more residents.

In the intervention arm of the trial, the intervention comprises of:
1. GP Training
General practitioners (GPs) will be trained about PIP and in how to use the intervention decision support material via academic detailing style visits to practices by a GP research team member

2. Medicines Review
GPs will be asked to conduct a medicines review with participant patients using the intervention material at the next appointment.

3. Decision Support
The decision support materials will be available in both paper and web based versions available for use during the medication review. The materials are divided into the following sections:
Section A: The individual PIP with reason for concern
Section B: Alternative pharmacological and non-pharmacological treatment options
Section C: Background information (where relevant)

4. Patient information leaflets about the recommended treatment options will also be provided in pdf format for printing.

In the control arm of the trial, practices will continue to provide usual care but will also be provided with simple feedback. Data for patients in the control group will be reviewed during recruitment and a personalised patient list, summarising the potentially inappropriate prescriptions, will be fed back to the GP. Participants will not be prompted to carry out a medicines review with the individual patients and will not receive decision support with alternative therapy options.
Primary outcome measure(s) 1. Proportion of patients with a PIP (composite measure i.e. any number of the study PIPs)
2. Mean number of PIPs per patient
Secondary outcome measure(s) 1. Drug specific outcomes:
1.1. The absolute number of PIPs per patient of the top five occurring PIP drugs:
1.1.1. Proton pump inhibitor (PPI) for peptic ulcer disease at full therapeutic dosage for>8 weeks
1.1.2. Long-term use of Non-steroidal anti-inflammatory drug (NSAID) (>3 months) for relief of mild joint pain in osteoarthritis
1.1.3. Long-term (i.e. >1 month), long-acting benzodiazepines e.g. chlordiazepoxide, fluazepam, nitrazepam, chlorazepate and benzodiazepines with long-acting metabolites e.g. diazepam
1.1.4. Any regular duplicate drug class prescription
1.1.5. Tricyclic antidepressants (TCAs) with an opiate or calcium channel blocker
1.2. Mean number of PIPs per patient of the top five PIP drugs (as above)

2. Process evaluation measures:
2.1. Number of times alternatives were prescribed
2.2. Decisions made per PIP
2.3. Reported primary reason for decision made e.g. risks outweigh benefits, patient preference, hospital/consultant initiated

3. Patient reported outcomes:
3.1. Quality of Life (as measured using EQ-5D)
3.2. Patientsí medication beliefs (as measured using the Beliefs About Medicines Questionnaire, BMQ)
3.3. Well-being (as measured by the Well-Being Questionnaire, WBQ-12)

4. Process of care measures:
4.1. Number of GP visits
4.2. Number of hospital admissions
Sources of funding 1. Health Research Board - PhD Scholars Programme in Health Services Research (Ireland) ref: PHD/2007/16
2. The Health Research Board Centre for Primary Care Research (Ireland) ref: 1139
Trial website
Publications 2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23497575
2013 development and pilot study in: http://www.ncbi.nlm.nih.gov/pubmed/23941110
Contact name Prof  Tom  Fahey
  Address The Health Research Board
Centre for Primary Care Research
Royal College of Surgeons in Ireland (RCSI)
Lower Ground Floor
Beaux Lane House
Mercer Street Lower
  City/town Dublin
  Zip/Postcode 2
  Country Ireland
  Tel +353 (0)1 402 2305
  Email tomfahey@rcsi.ie
Sponsor The Health Research Board - Centre for Primary Care Research (Ireland)
  Address c/o Mr Niall Doherty
Royal College of Surgeons in Ireland (RCSI)
Lower Ground Floor
Beaux Lane House
Mercer Street Lower
  City/town Dublin
  Zip/Postcode 2
  Country Ireland
  Tel +353 (0)1 402 2473
  Email nialldoherty@rcsi.ie
  Sponsor website: http://www.hrbcentreprimarycare.ie/
Date applied 21/03/2012
Last edited 28/10/2013
Date ISRCTN assigned 05/04/2012
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