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Proactive clinical review of patients taking opioid medicines long-term for persistent pain led by clinical pharmacists in primary care teams feasibility study

Proactive clinical Review of patients taking Opioid Medicines long-term for persistent Pain led by clinical Pharmacists in primary care Teams (PROMPPT). A non-randomised Feasibility Study with mixed methods process evaluation.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN87628403
Enrollment
80
Registered
2020-07-31
Start date
2020-10-26
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic pain Musculoskeletal Diseases Patients prescribed opioids for 6 months or longer for persistent non-cancer pain

Interventions

Patients with persistent pain who have been prescribed opioids regularly for 6 months will be offered an initial appointment for a face-to-face consultation with the clinical pharmacist in a private c

Sponsors

Keele University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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[ref ]) for chronic non-cancer pain continuously for =6 months, (= one 28-day opioid prescription issued at least every two months in previous 6 months)

Exclusion criteria

Exclusion criteria: 1. Acute pain 2. Cancer pain 3. Terminal illness (life expectancy < 6 months) 4. Vulnerable patients (e.g. severe mental illness, learning difficulties, dementia) 5. Current treatment for substance misuse 6. Unable to understand English

Design outcomes

Primary

MeasureTime frame
Feasibility outcome measures: 1. Availability and recruitment of eligible patients, the proportion scheduling and attending clinical pharmacist appointments and retention to 3-month follow-up: 1.1. Proportion of patients eligible (out of all GP registered patients) to be mailed a study invitation 1.2. Proportion of patients returning a baseline questionnaire (out of those mailed a study invitation) 1.3. Proportion of participants attending the initial PROMPPT consultation with the clinical pharmacist (out of those who returned the baseline questionnaire) 1.4. Proportion of participants who have at least one follow-up appointment scheduled (out of those who attend the initial consultation) 1.5. Proportion of participants who fail to attend one or more scheduled follow-up appointments (out of those who are scheduled a follow-up following the initial consultation) 1.6. Proportion of participants returning a 3-month follow-up questionnaire (out of those consenting to complete questionnaires at baseline) 2. Completeness of data collection: Missing data rates will be calculated for each outcome measure in the baseline and follow-up self-report questionnaires at each data collection time-point (baseline and 3-month) 3. Fidelity of intervention delivery per protocol: 3.1. Proportion of times that use of each intervention component is recorded in intervention case report forms (CRFs) 3.2. Proportion of patients being treated per-protocol (out of all patients who attended the initial clinical pharmacist appointment) 3.3. Findings from qualitative analysis of observed/audio-recorded consultations 4. Suitability of a self-reported pain medicines use questionnaire to calculate mean daily morphine equivalent dose: 4.1. Completeness of response to pain medicines use questionnaire 4.2. Comparison of average daily morphine equivalent dose (MED) calculated using data from self-report questionnaires with MED calculated using prescription data from electronic medical records at baseli

Secondary

MeasureTime frame
There are no secondary outcome measures

Countries

England, United Kingdom

Contacts

Public ContactChristian Mallen
c.d.mallen@keele.ac.uk+44 (0)1782734879

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 5, 2026