Improved Treatment for Patients With Long-term Opioid Therapy for Non-cancer Pain in Primary Care
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Person-centred team-based approach.
- Кому может быть актуально
- Состояния в реестре: Chronic Pain, Chronic Pain Management, Primary Care. Базовые параметры: 18 лет — 70 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Швеция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Improved Treatment for Patients With Long-term Opioid Therapy for Non-cancer Pain in Primary Care (Opi-Prim)
Обзор
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.
Подробное описание
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.
Вмешательства
- Поведенческое Person-centred team-based approach
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
Первичные конечные точки
- Pain interference [Срок оценки: The primary outcome measure will be the difference in mean pain interference after 6 months.]
Вторичные конечные точки (8)
- Pain intensity [Срок оценки: After 3, 6 and 12 months]
- Symptoms of depression [Срок оценки: After 3, 6 and 12 months]
- Symptoms of anxiety [Срок оценки: After 3, 6 and 12 months]
- Patient satisfaction [Срок оценки: After 3, 6 and 12 months]
- Quality of life according to the 5-level EuroQol 5D [Срок оценки: After 3, 6 and 12 months]
- Opioid use [Срок оценки: After 3, 6 and 12 months]
- Symptoms of withdrawal [Срок оценки: After 3, 6 and 12 months]
- Pain interference [Срок оценки: After 3 and 12 months]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Нерандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Швеция · 3 центра
- Region Sörmland — Strängnäs
- Region Uppsala — Uppsala
- Region Örebro Län — Örebro
Публикации
- 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. PMID 42083502
Идентификаторы
NCT: NCT06856733 · Opi-Prim