Clinical trial NCT04888897: The Experiences of People Prescribed Opioid Pain Medicines
Official title: A Mixed Methods Study Investigating the Experiences, and Information and Support Needs, of People Prescribed Opioids, and the Role of Community Pharmacy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Opioid Use
Lead sponsor: University of Nottingham
Sponsor class: OTHER
Collaborators: name: Boots UK
name: National Institute for Health Research, United Kingdom
First posted: 2021-05-17
Enrollment: 619
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients registered with a GP practice in England who have been prescribed an opioid medicine for non-cancer pain by their GP over a period of at least 3 months. Purposive sampling of GP practices within the NIHR CRN East Midlands is planned. We aim to utilise a sample of practices with a range of characteristics which are representative of GP practices across the East Midlands.

Brief summary: Opioids are morphine-type medicines which come from the opium poppy or are similar-to morphine. They are very effective for short-term pain, cancer pain, and pain at the end of life. Opioids are thought to be less useful for treating long-term non-cancer pain. Side effects are common and can be serious. People who take opioids for longer periods are at risk of tolerance (needing a higher dose to get the same effect), dependence (unable to cut down or stop without withdrawal effects), and addiction (uncontrollable use despite harmful consequences).

In the UK, opioid prescribing has increased substantially over the last two decades. Doses are higher and opioids are taken for longer, suggesting many people are at risk of harmful effects without useful pain relief. Research into opioid dependence and addiction has found people do not always fully understand the risks of these medicines at the start of treatment. Local Community Pharmacists could be used to improve information and support for those prescribed opioids.

This study aims to get a better understanding of the experiences of people prescribed opioids and their information and support needs, and to investigate whether information and support could be improved using Community Pharmacists. Findings may improve care for people prescribed opioids in the future.

The study will involve questionnaires and interviews with adults prescribed an opioid medicine for pain, not caused by cancer, over a period of at least 3 months. Participants will be recruited from GP practices in England.


Eligibility criteria: Inclusion Criteria:

* Ability to give informed consent
* Adults aged 18 years and above, with no upper age limit
* Prescribed any opioid analgesic (defined as any opioid or opioid/paracetamol combination analgesic from sections 4.7.2 and 4.7.1 British National Formulary) for non-cancer pain for a period of ≥3 months (defined as ≥ 2 opioid prescriptions issued in the previous 3 months with a minimum interval of 60 days between the first and last prescription)

Exclusion Criteria:

* Cancer pain
* Terminal illness
* Vulnerable patients (e.g. severe mental illness, learning difficulties, dementia, care home residents)
* Unable to understand English
* Deemed by their GP to be inappropriate to contact

Primary outcomes:
measure: To identify whether people prescribed opioids for non-cancer pain need more information and support at the start of treatment.
timeFrame: 6 -12 months
Secondary outcomes:
measure: To assess and explore the difficulties experienced by people prescribed opioids for non-cancer pain.
timeFrame: 6 - 12 months
measure: To explore the perceptions of people prescribed opioids for non-cancer pain on the information they received and the need for improved information and support at the start of treatment
timeFrame: 6 -12 months
measure: To investigate the use of pharmacy by people prescribed opioids for non-cancer pain and their views on using community pharmacists to provide additional information and support for opioid pain medicines
timeFrame: 6 -12 months
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: University of Nottingham
Study officials:
affiliation: Associate Professor, University of Nottingham
name: Matthew J Boyd, PhD
role: PRINCIPAL_INVESTIGATOR
References: