Medication Review Improves Pain Management and Quality of Life in Chronic Pain
NCT ID: NCT06997861
Last Updated: 2025-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2023-11-03
2024-06-26
Brief Summary
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* 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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Medication Review (MR)
Medication 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.
Usual-Care (UC)
Usual 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.)
Interventions
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Medication 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.
Usual 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.)
Eligibility Criteria
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Inclusion Criteria
* 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
* Breastfeeding
* Dementia
* Other mental illness impairing self-reporting
18 Years
70 Years
ALL
No
Sponsors
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University of Salamanca
OTHER
Polytechnic Institute of Porto
OTHER
Responsible Party
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Nuno Miguel da Silva Duarte
Principal Investigator
Locations
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Centro de Investigação em Saúde e Ambiente (CISA) - School of Health of the Polytechnic Institute of Porto
Porto, , Portugal
Countries
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References
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McDermott ME, Smith BH, Elliott AM, Bond CM, Hannaford PC, Chambers WA. The use of medication for chronic pain in primary care, and the potential for intervention by a practice-based pharmacist. Fam Pract. 2006 Feb;23(1):46-52. doi: 10.1093/fampra/cmi068. Epub 2005 Aug 17.
Kadam P, Bhalerao S. Sample size calculation. Int J Ayurveda Res. 2010 Jan;1(1):55-7. doi: 10.4103/0974-7788.59946. No abstract available.
Domingues L, Cruz E. Adaptação Cultural e Contributo para a Validação da Escala Patient Global Impression of Change. Ifisionline. 2011;2(1):31-7
Cleeland CS. The Brief Pain Inventory User Guide. University of Texas ; 2009
Ferreira-Valente MA, Pais-Ribeiro JL, Jensen M. Further Validation of a Portuguese Version of the Brief Pain Inventory Interference Scale. Clin Salud. 2012;23(1):89-96
Sabater Hernández D, Milena Castro Silva M, María Faus Dáder J. Método Dáder: manual de seguimento farmacoterapêutico. 3a. Lisboa: Edições Universitárias Lusófonas; 2009
Wan X, Wang W, Liu J, Tong T. Estimating the sample mean and standard deviation from the sample size, median, range and/or interquartile range. BMC Med Res Methodol. 2014 Dec 19;14:135. doi: 10.1186/1471-2288-14-135.
Dworkin RH, Turk DC, Farrar JT, Haythornthwaite JA, Jensen MP, Katz NP, Kerns RD, Stucki G, Allen RR, Bellamy N, Carr DB, Chandler J, Cowan P, Dionne R, Galer BS, Hertz S, Jadad AR, Kramer LD, Manning DC, Martin S, McCormick CG, McDermott MP, McGrath P, Quessy S, Rappaport BA, Robbins W, Robinson JP, Rothman M, Royal MA, Simon L, Stauffer JW, Stein W, Tollett J, Wernicke J, Witter J; IMMPACT. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005 Jan;113(1-2):9-19. doi: 10.1016/j.pain.2004.09.012. No abstract available.
International Pharmaceutical Federation (FIP). International Pharmaceutical Federation (FIP). Medication review and medicines use review: A toolkit for pharmacists. The Hague: International Pharmaceutical Federation; 2022.
Griese-Mammen N, Hersberger KE, Messerli M, Leikola S, Horvat N, van Mil JWF, Kos M. PCNE definition of medication review: reaching agreement. Int J Clin Pharm. 2018 Oct;40(5):1199-1208. doi: 10.1007/s11096-018-0696-7. Epub 2018 Aug 2.
Hepler CD, Strand LM. Opportunities and responsibilities in pharmaceutical care. Am J Hosp Pharm. 1990 Mar;47(3):533-43.
Other Identifiers
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CE/2023/87
Identifier Type: -
Identifier Source: org_study_id
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