Improved Treatment for Patients With Long-term Opioid Therapy for Non-cancer Pain in Primary Care
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUppsala County Council, Sweden
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Person-centred team-based approach
BehavioralPhase 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
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: ControlNo intervention 0 interventions
Group B: InterventionActive comparator 1 intervention
Trial outcomes
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.
Time frame
The primary outcome measure will be the difference in mean pain interference after 6 months.Secondary outcomes
1
Pain intensity
Measured with the Brief Pain Inventory - Short Form (BPI-SF), question number 3-8. Scale: 0-10. Higher score is worse
Time frame
After 3, 6 and 12 months2
Symptoms of depression
Measured with the Patient Health Questionnaire-9 (PHQ-9). Scale: 0-27. Higher score is worse
Time frame
After 3, 6 and 12 months3
Symptoms of anxiety
Measured with the General Anxiety disorder-7 (GAD-7). Scale: 0-27. Higher score is worse
Time frame
After 3, 6 and 12 months4
Patient satisfaction
Measured with the Patients´ Global impression of Change (PGIC). Scale: 0-6. Higher score is worse
Time frame
After 3, 6 and 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Uppsala County Council, Sweden
Lead sponsor
Uppsala University
Collaborator
Örebro University, Sweden
Collaborator
Sormland County Council, Sweden
Collaborator
Örebro County Council
Collaborator
Source ClinicalTrials.gov