Chronic Pain
Conditions
Keywords
Medication Review, Chronic Pain, Quality of Life, Pharmaceutical Care, Primary Care
Brief summary
The goal of this parallel-group, single-blinded, randomized study is to conduct Medication Review (MR) Type III in chronic non-cancer pain patients to optimize drug therapy and measure it's influence on Pain Intensity and Quality of Life in the primary care setting. The study took place in Porto, Portugal with the collaboration of two Primary Care Units (USF Arca D'Água and USF Campanhã - Polo S. Roque da Lameira) under ACeS Porto Oriental, from where patients were recruited. The main question it aims to answer is: * Does the implementation of pharmacist-led medication review benefit patients with chronic pain in the primary care setting? * Researchers will compare with Usual Care (UC) patients which receives general advice on how to manage their pain and/or recommendations to take over the counter drugs, similar to community pharmacy visits, to see if there is a clinically significant difference in pain intensity and quality of life between the two groups of patients. * Participants will be asked to attend face-to-face interviews once a month for 4 months with an expert in medication review, that evaluates their current medication and suggests an individualized care plan. These plans include measures aimed at physicians (e.g., medication adding; dose reduction) and participants (e.g., non-pharmacological measures; adherence to medication).
Interventions
OTHERMedication Review Type III
The MR arm will receive four MR interviews. In the first MR, information about the patient's personal and medical history, along with current health problems, relevant lab exams and medication will be gathered. This will be used to proceed with medication review process and assessment of Drug Related Problems (DRP) that may lead to negative medication results. A personalized care plan will be developed to correct any detected DRP, delivered in writing/e-mail to the patient and carefully explained. Some DRP's may need the physician's intervention to correct. In these cases, a detailed recommendation will be sent to the patient's physician via email. All physicians' recommendations acted upon or not, will be recorded. Subsequent interviews will assess patient compliance with the care plan and if necessary, adjustments will be made accordingly.
OTHERUsual Care
The UC arm will receive an intervention by the investigator at the same time frame defined for the MR arm. The intervention will also consist of interviews, although MR will not be conducted. The investigator will ask questions to the patient about is drug therapy in a similar fashion to what would happen in the community pharmacy. Simple advice and information will be carried out (i.e., reinforcement of adherence, explanation about indication of drugs etc.)
Sponsors
University of Salamanca
Polytechnic Institute of Porto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
This trial is blinded to subjects. Each subject will be informed they will be allocated to one of the two arms without knowing which one. Subjects will know they will receive pharmaceutical care, despite not knowing what type of pharmaceutical care they will receive.
Intervention model description
single-blinded, randomized study
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Non-cancer chronic pain (\>3 months, any cause) * Follow-up at one of the selected Primary Care Units * Average weekly pain score ≥4 at the screening phase * Ability to attend monthly in-person or video interviews
Exclusion criteria
* Pregnancy * Breastfeeding * Dementia * Other mental illness impairing self-reporting
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity | From enrollment to the end of the interventions at 16 weeks | Following IMMPACT recommendations, subjects will record weekly pain (defined as the average of three measurements in a week) scores in the following manner: In a 11-point NRS with three descriptors where 0 is no pain, 5 is moderate pain and 10 maximum pain, subjects will select which best describes the pain they felt in the last 24h and record their score in the morning. Also, subjects will be instructed to record their pain scores on the week previous to the interventions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life (QoL) | From enrollment to the end of the interventions at 16 weeks | In this study and according to the IMMPACT recommendations, the Brief Pain Inventory-short form (BPI) will be used to measure the pain interference using the interference scale of this QoL measurement instrument. Data regarding this outcome will be collected and registered in a similar fashion to PI. Patients will be instructed to fill out the BPI short form in paper in the same day they measure their third PI score. |
| Satisfaction with treatment | From enrollment to the end of the interventions at 16 weeks | In accordance with IMMPACT recommendations, the Patient Global Impression of Change (PGIC) scale will be used to determine participants global satisfaction with interventions. The PGIC scale was adapted from the Clinical Global Impression scale, proposed for patients with schizophrenia. It is a unidimensional scale which consists of a 7-rating scale where 1 = no change up to 7 = very much improved. Data regarding this outcome will be collected and registered in a similar fashion to primary outcomes. Patients will be instructed to fill out the PGIC on paper in the same day they measure their third PI score and BPI. |
Countries
Portugal
Outcome results
None listed