Condition category
Signs and Symptoms
Date applied
26/08/2016
Date assigned
20/10/2016
Last edited
03/08/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Older people often take a number of medications and have multiple long-term medical conditions (multimorbidity). One in twenty Irish people aged over 65 years are prescribed 15 or more medications. Prescribing for older people with multiple medical conditions can be a challenging task for doctors as there is an increased chance of patients suffering from side effects, drug interactions (when one medication affects another) and potentially inappropriate prescribing (PIP). PIP is a term used to describe a number of substandard prescribing practices including overprescribing, misprescribing (prescribing the wrong drugs) and underprescribing of drugs. The study group has previously developed an program to target PIP in adults over 70 years called OPTI-SCRIPT. This involved providing education for GPs and a GP led medication review that was supported by a website which provided alternative treatment options for PIPs. The study showed that the program led to a lower chance PIP. There are now plans to build on this to incorporate the recommendations of the NICE Multimorbidity Guideline. This guideline recommends targeting people on 15 or more regular medicines and offering them a medication review. The guideline also focuses on reducing treatment burden for patients as well as stopping ineffective or inappropriate medication. Therefore, the aim of this current study is to determine the effectiveness and acceptability of an program designed to support GPs to improve medicines management and reduce treatment burden in patients with complex multimorbidity patients with multiple conditions involving three or more body systems) who are taking 15 or more regular medications.

Who can participate?
GP practices with 300 or more patients older than 65 years on their patient panel. Patients can participate if they are 65 years or older and are prescribed 15 or more regular medications.

What does the study involve?
Participating GP practices are given a patient finder tool to allow them to develop a list of patients aged 65 years or older and who are also being prescribed 15 or more regular medications. These patients are then invited to join the study. Questionnaires are sent out to all participating patients. Participating practices are then randomly allocated to one of two groups. The GPs in the first group conduct a medication review with their patients using a website to support them. They are also able to log in online to an educational presentation. GPs in the second group continue to provide usual care for their patients. Six months later, the medical records of patients in both groups are reviewed to see if there are any changes in their medication use. Those in the second group are then given the opportunity to take part in the program.

What are the possible benefits and risks of participating?
Participants who are treated by GPs taking part in the program may benefit from the medication review by being able to reduce PIP and are able to discuss any concerns they have about their medications. There are very few risks for the patients participating in this study. Any decision on whether to change prescribed medication will be at the discretion of the prescribing GP in consultation with the patient.

Where is the study run from?
The study is run by the Royal College of Surgeons in Ireland and takes place in 30 GP practices throughout Ireland (Ireland)

When is study starting and how long is it expected to run for?
August 2016 to August 2019

Who is funding the study?
The Heath Research Board Primary Care Clinical Trials Network (Ireland)

Who is the main contact?
Professor Susan Smith
susansmith@rcsi.ie

Trial website

Contact information

Type

Scientific

Primary contact

Prof Susan Smith

ORCID ID

Contact details

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
Dublin
Dublin 2
Ireland
+353 (0)1 402 2473
susansmith@rcsi.ie

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

SuPporting medicines management in multimorbidity in Primary caRE: a cluster randomised controlled trial

Acronym

SPPiRE

Study hypothesis

A multi-faceted intervention that combines computer generated patient identification, with academic detailing for GPs and a structured medication review for patients, has an effect in reducing polypharmacy and PIP in older people in Irish primary care.

Ethics approval

Irish College of General Practitioners, 22/07/2016

Study design

Pragmatic two-arm cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

See additional files

Condition

Polypharmacy and multimorbidity

Intervention

Practices will be recruited throughout Ireland, and will then be supported in recruiting eligible patients. Once all patients are recruited baseline data will be collected through medical record review. Practices will then be randomised using minimisation to either intervention or control groups. This will be done by an independent third party using egminimpy software.

Intervention arm: GPs will receive log in details to access online academic detailing and will be asked to arrange a medication review with their recruited patients. This will be supported by a website which will provide a basic structure for the review and a patient outcome form which will collect information about any changes made to the medication regime and reasons for process evaluation. Follow up data will be collected 6 months after the medication review is completed.

Control arm: Usual care will be delivered for the duration of the study. Once follow up is complete for both groups the control arm will be invited to take part in the intervention.

Patient medical records are reviewed in both groups at baseline and 6 months to find out if prescribing practices have changed.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

1. Number of repeat medications are measured through medical record review at baseline and 6 months post-intervention
2. Proportion of patients with any potentially inappropriate prescription (PIP) (defined by explicit criteria, used for OPTI-SCRIPT which were based on more prevalent STOPP-START PIP indicators) are measured through medical record review at baseline and 6 months post-intervention

Secondary outcome measures

Current secondary outcome measures as of 17/07/2017:
Measured through medical record review at baseline and 6 months post-intervention:
1. Reduction in proportion of patients with 15 or more medicines (100% at baseline)
2. Medication changes
2.1 Number of medications stopped
2.2 Numbers of medications started
2.3 Reduction in the number of PIP (per patient and absolute numbers in the intervention versus control
2.4 Proportion of patients with any reduction in PIP
3. Multimorbidity treatment burden questionnaire
4. Health related Quality of life (EQ5D)
5. Revised patient’s attitudes to deprescribing
6. Patient-reported adverse drug withdrawal events (defined as either recurrence of the condition for which the drug was prescribed or a physiologic reaction to drug withdrawal)
7. Health service utilisation (based on chart data and provided by practice admin staff)
7.1 Number of GP/nurse visits
7.2 Number of out of hours visits
7.3 Number of Accident & Emergency (A&E) visits
7.4 Number of hospital admissions
7.5 Number of in-patient days
7.6 Number of out-patient visits

Previous secondary outcome measures:
Measured through medical record review at baseline and 6 months post-intervention:
1. Reduction in proportion of patients with 15 or more medicines (100% at baseline)
2. Medication changes
2.1 Number of medications stopped
2.2 Numbers of medications started
2.3 Numbers of high risk medications
2.4 Adverse drug withdrawal events (Naranjo adverse drug reaction probability scale)
3. Treatment burden (Translated Treatment Burden Questionnaire)
4. Health related Quality of life (EQ5D)
5. Shared decision making (DCS)
6. Moriskey Medicacation Adherence Measure
7. Patients' attitudes towards deprescribing (PATD)
8. Health service utilisation (based on chart data and provided by practice admin staff)
8.1 Number of GP/nurse visits
8.2 Number of out of hours visits
8.3 Number of Accident & Emergency (A&E) visits
8.4 Number of hospital admissions
8.5 Number of in-patient days
8.6 Number of out-patient visits

Overall trial start date

04/04/2016

Overall trial end date

28/08/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Practice inclusion criteria:
1. Have 300 or more older patients (aged ≥65 years) on their patient panel (based on the need to identify at least 15 patients per practice who are receiving 15 or more medicines and allowing for refusals)
2. Use Socrates or Health One as a practice management system

Patient inclusion crtieria:
1. Aged 65 years and over
2. Being prescribed at least 15 regular medications

Participant type

Mixed

Age group

Senior

Gender

Both

Target number of participants

450 patients from 30 GP practices (15 patients per practice).

Participant exclusion criteria

Practice exclusion criteria:
Involved in the development and piloting of the intervention or other concurrent medication quality related studies

Patient exclusion criteria:
1. Significant mental or physical illness that would impair their ability to consent and take part in the study
2. Unable to attend the surgery for medication review (e.g. nursing home residents)
3. Those involved in another medication study

Recruitment start date

19/04/2017

Recruitment end date

19/08/2017

Locations

Countries of recruitment

Ireland

Trial participating centre

Department of General Practice Royal College of Surgeons in Ireland
Department of General Practice Royal College of Surgeons in Ireland Beaux Lane House Lower Mercer Street
Dublin
Dublin 2
Ireland

Sponsor information

Organisation

The Health Research Board - Centre for Primary Care Research (Ireland)

Sponsor details

c/o Ms Linda O'Connor
Royal College of Surgeons in Ireland (RCSI)
Lower Ground Floor
Beaux Lane House
Mercer Street Lower
Dublin
Dublin 2
Ireland
+353 (0)1 402 2473
lindapoconnor@rcsi.ie

Sponsor type

University/education

Website

Funders

Funder type

Research organisation

Funder name

The Health Research Board Primary Care Clinical Trials Network

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

1. Planned publication of the trial protocol (2016/2017)
2. Planned publication of RCT and process evaluation in a high impact journal (2018/2019)

Intention to publish date

31/12/2019

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

2017 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/28764753

Publication citations

Additional files

Editorial Notes

03/08/2017: Publication reference added. 17/07/2017: Recruitment dates changed from 07/11/2016 - 28/08/2019 to 19/04/2017- 19/08/2019. Outcome measures have been updated.