Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Uppsala University | OTHER |
| Örebro University, Sweden | OTHER |
| Sormland County Council, Sweden | OTHER |
| Örebro County Council |
Not provided
Not provided
Not provided
Not provided
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:
The evidence for prescribing opioids to patients suffering from chronic non-cancer pain is weak, and using opioids in these circumstances is questionable. Swedish primary health care is responsible for about one-third of all first-time opioid prescriptions and has the highest rate of prescription renewals for opioids. The decision for long-term opioid therapy (LTOT) should rest on an accurate pain analysis and should result in an individualized assessment where the risks of LTOT are set against the impact on quality of life that living with long-term pain entails. Multi-professional interventions and a person-centered approach are recommended for chronic non-cancer pain. Although pharmacists in primary health care have been established internationally with successful examples related to LTOT, their role in Swedish primary care and the management of chronic non-cancer pain remains to be studied. Currently, it is unclear which interventions are effective in reducing inappropriate LTOT and which alternative interventions are suitable for patients who are currently receiving LTOT. The involvement of a care manager in the patient´s care has shown promising results regarding quality of care for other long-term conditions, for example depresssion. In Region Uppsala, clinical pharmacists havte recently been employed in primary health care, but it is unclear what their tasks and responsibilities are and how to best make use of their competence. It is therefore relevant and justified to investigate a new person-centered team-based approach including care manager and pharmacist to optimize the management of pain in patients with chronic non-cancer pain in Swedish primary care. This project aims to reduce inappropriate LTOT and optimize pain management in patients with LTOT for chronic non-cancer pain in primary care through a new person-centered and team-based approach.
Primary objective:
To investigate 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
Trial design and setting:
This study is a controlled before-and-after study that has been designed, and will be reported, according to the CONSORT guidelines. Participation will be during 52 weeks (12 months).
This study will be conducted at eight healthcare centres in Region Uppsala. At four of the healthcare centres, a new person-centred team-based treatment model including pharmacists (intervention) will be implemented. Prerequisites for these healthcare centres are the accessibility of at least one person of each healthcare profession: pharmacist, general practitioner (GP), psychologist (or social worker) and physiotherapist, where one of these (or a rehabilitation coordinator or a nurse) takes the role of care manager. Healthcare personnel will receive special training in managing patients with chronic pain before the study. In addition, four control healthcare centres without a pharmacist will be matched with the intervention healthcare centres according to geographic area (urban, suburban, rural), socioeconomical setting and the size of the centres (number of listed patients). No specific efforts of implementation will be made in these control centres.
Prior to the full trial, a feasibility study will be conducted at one intervention centre and one control centre with 12 weeks follow-up per participant.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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):
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):
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Person-centred team-based approach | Behavioral | Phase 1 (investigation and assessment, week 1-3):
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):
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity | Measured with the Brief Pain Inventory - Short Form (BPI-SF), question number 3-8. Scale: 0-10. Higher score is worse | After 3, 6 and 12 months |
| Symptoms of depression | Measured with the Patient Health Questionnaire-9 (PHQ-9). Scale: 0-27. Higher score is worse |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Magnus Peterson, PhD, MD | Contact | +46702882768 | magnus.peterson@regionuppsala.se | |
| Anna Svensson, MD | Contact | +46702206400 | anna.k.svensson@uu.se |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Region Sörmland | Not yet recruiting | Strängnäs | Sörmland | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42083502 | Result | Svensson A, Ljungvall H, Kempen T, Kalvemark-Sporrong S, Peterson M. The constant conflicts of opioid prescribing - GPs' views on treating chronic pain with opioids in primary care: a reflexive qualitative analysis. Scand J Prim Health Care. 2026 Dec;44(1):2665697. doi: 10.1080/02813432.2026.2665697. Epub 2026 May 5. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 1, 2024 | Feb 26, 2025 | Prot_000.pdf |
Not provided
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| After 3, 6 and 12 months |
| Symptoms of anxiety | Measured with the General Anxiety disorder-7 (GAD-7). Scale: 0-27. Higher score is worse | After 3, 6 and 12 months |
| Patient satisfaction | Measured with the Patients´ Global impression of Change (PGIC). Scale: 0-6. Higher score is worse | After 3, 6 and 12 months |
| Quality of life according to the 5-level EuroQol 5D | Measured with the 5-level EuroQol 5D (EQ-5D-5L). Scale: 1-5 per dimension. Higher score is worse. | After 3, 6 and 12 months |
| Opioid use | Measured with as morphine equivalents: in mg. | After 3, 6 and 12 months |
| Symptoms of withdrawal | Measured with the Short Opioid Withdrawal Scale (SOWS). Scale: 0-40. Higher score is worse | After 3, 6 and 12 months |
| Pain interference | Measured with the Brief Pain Inventory - Short Form (BPI-SF), question number 9 a-g. Scale: 0-10. Higher score is worse. | After 3 and 12 months |
| Region Uppsala | Recruiting | Uppsala | Uppsala County | Sweden |
|
| Region Örebro Län | Recruiting | Örebro | Örebro County | Sweden |
|