Improved Treatment for Patients With Long-term Opioid Therapy for Non-cancer Pain in Primary Care

NCT06856733 | Recruiting

• 1 other identifier: Opi-Prim
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to reduce inappropriate long term opioid treatment (LTOT) and to optimize pain management in patients with LTOT for chronic non-cancer pain in primary care through a new person-centred and team-based approach. The main question it aims to answer is: What are the effects of a new person-centred and team-based approach on pain interference in patients with LTOT for chronic non-cancer pain in primary care? Researchers will compare a new person-centred and team-based approach to usual care to see if pain interference is lower. Participants will receive a person-centred team-based treatment consisting of:

• Phase 1 (investigation and assessment, week 1-3): A medication review, pain analysis and other assessments through separate visits to a pharmacist, general practitioner, physiotherapist, psychologist and care manager
• Phase 2 (treatment plan, week 3-4): A team consultations with all healthcare personnel involved in Phase 1 including the patient where an individualized rehabilitation plan is made based.
• Phase 3 (treatment and follow-up, week 4-24): Implementation of the individualized rehabilitation plan with frequent follow-up contacts (1 per 1-3 weeks) by phone with the care manager.

Conditions

Chronic Pain; Chronic Pain Management; Primary Care

Outcome Measures

Primary Outcomes (1)

• Pain interference

  Measured with the Brief Pain Inventory - Short Form (BPI-SF), question number 9 a-g. Scale: 0-10. Higher score is worse.

  The primary outcome measure will be the difference in mean pain interference after 6 months.

Secondary Outcomes (8)

• Pain intensity

  After 3, 6 and 12 months

• Symptoms of depression

  After 3, 6 and 12 months

• Symptoms of anxiety

  After 3, 6 and 12 months

• Patient satisfaction

  After 3, 6 and 12 months

• Quality of life according to the 5-level EuroQol 5D

  After 3, 6 and 12 months

Study Arms (2)

Control

NO INTERVENTION

Participants in the control healthcare centres will receive usual care. This may include appointments and treatment by a general practitioner, nurse, physiotherapist and/or psychologist. No pharmacist will be working at the healthcare centre. However, Uppsala County Council does provide centralized medication review services to all primary healthcare centres in Region Uppsala. Any healthcare professional may request a medication review by a pharmacist on a work-from-home basis as part of usual care.

Intervention

ACTIVE COMPARATOR

Phase 1 (investigation and assessment, week 1-3): * A medication review focusing on pain, sleep and depression/anxiety disorders by a pharmacist. * A thorough pain analysis by a GP according to existing guidelines including duration of pain, pain localization and pain mechanisms. * A visit to a physiotherapist for evaluation and assessment of possible treatment regarding physical exercise/physical activities. * A visit to a psychologist for diagnostics and treatments regarding psychological and social factors. * A visit to a care manager Phase 2 (treatment plan, week 3-4): \- A team consultation with all healthcare personnel involved in Phase 1 including the patient where an individualized rehabilitation plan is made. Phase 3 (treatment and follow-up, week 4-24): * Implementation of the individualized rehabilitation plan. * Frequent follow-up contacts (1 per 1-3 weeks) by phone with an established contact person, i.e. care manager. * A second team consultation half-way

Behavioral: Person-centred team-based approach

Interventions

Person-centred team-based approach BEHAVIORAL

Phase 1 (investigation and assessment, week 1-3): * A medication review focusing on pain, sleep and depression/anxiety disorders by a pharmacist. * A thorough pain analysis by a GP according to existing guidelines including duration of pain, pain localization and pain mechanisms. * A visit to a physiotherapist for evaluation and assessment of possible treatment regarding physical exercise/physical activities. * A visit to a psychologist for diagnostics and treatments regarding psychological and social factors. * A visit to a care manager Phase 2 (treatment plan, week 3-4): \- A team consultation with all healthcare personnel involved in Phase 1 including the patient where an individualized rehabilitation plan is made. Phase 3 (treatment and follow-up, week 4-24): * Implementation of the individualized rehabilitation plan. * Frequent follow-up contacts (1 per 1-3 weeks) by phone with an established contact person, i.e. care manager. * A second team consultation half-way

Intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having received the equivalent of 90 days or more prescription of opioids for chronic pain made by the general practitioner during the recent 12 months
• Able to speak Swedish or English

You may not qualify if:

• Having been referred to a pain clinic (either at hospital or multimodal rehabilitation in primary care) within the last 6 months
• No current opioid use, severe cognitive dysfunction, e.g., suicidal ideation, psychotic symptoms, or dementia, that prevents informed consent.
• Using their opioids for cancer pain

Sponsors & Collaborators

• Uppsala County Council, Sweden: lead
• Uppsala University: collaborator

Study Sites (1)

Region Uppsala

Uppsala, Sweden

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Magnus Peterson, PhD, MD

CONTACT

+46702882768; magnus.peterson@regionuppsala.se

Anna Svensson, MD

CONTACT

+46702206400; anna.k.svensson@uu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 4, 2025
• Study Start: March 10, 2025
• Primary Completion (Estimated): March 10, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 30, 2025

Record last verified: 2025-04

Locations

SE (1)