Clinical trial NCT05337709: Pharmacist Provided Intervention (Education and Medication Review) in Osteoarthritis
Official title: Pharmacist Provided Intervention in Osteoarthritis: Community Pharmacies Based Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis
Pain
Lead sponsor: Monash University Malaysia
Sponsor class: OTHER
First posted: 2022-04-20
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be assigned to either intervention or the control group
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to initiate pharmacist intervention (educational and medication review) among osteoarthritis patients visiting community pharmacies.

Detailed description: Community pharmacists are one of the most accessible health care professionals for patient care in chronic diseases including osteoarthritis and can provide patient education, conduct medication review, and collaborate with the multidisciplinary pain management team, to improve treatment outcomes and quality of life. Studies have reported that pharmacist-provided intervention was beneficial as it increased patients' knowledge of osteoarthritis, reduced the rates of adverse events associated with analgesics, and improved self-perceived health and function. So this study aims to provide intervention through community pharmacists.

Potential patients will be identified from community pharmacies and consent will be obtained from patients before enrolling them in the study. The study will be a cluster-randomized trial. Thus pharmacies will be randomized, either to control or treatment group. Patients in the treatment group will receive the pharmacist-initiated intervention while in the control group will receive usual care.

The intervention will be an education on osteoarthritis, its management, and self-care activities followed by a medication review. Pharmacists assess patients' knowledge of medication indication, identify adverse effects or drug-related problems, and counsel patients on proper medication use.

Education intervention will be provided through face-to-face communication at the time of enrollment and a leaflet will be provided. The patient will receive a phone call and will be able to view the video in the succeeding weeks to enforce the intervention.

Outcome measures will be assessed at baseline, three months, and six months from enrolment in both treatment and control groups.

Eligibility criteria: Inclusion Criteria:

* Patient aged 18 years and above with the complaint of osteoarthritis
* Patient willing to participate in the study
* Patient with chronic pain (persisting for more than three months)

Exclusion Criteria:

* Patient unable to provide the consent due to severe mental health, cognitive impairment or learning difficulties
* Patient with a terminal illness
* Patient having sufficient knowledge on osteoarthritis, its management and self-care activities as assessed from the questionnaire (respond correctly to 80% of the question or above)

Primary outcomes:
measure: Change from baseline pain intensity at 3 and 6 months
timeFrame: baseline, 3 months and 6 months
measure: Change from baseline patient's knowledge at 3 and 6 months
timeFrame: baseline, 3 months and 6 months (change in patients knowledge from baseline
measure: Change from baseline physical function at 3 and 6 months
timeFrame: baseline, 3 months and 6 months
Secondary outcomes:
measure: Change from baseline depression score at 6 months
timeFrame: baseline and 6 months
measure: Change from baseline patients quality of life at 6 months
timeFrame: baseline and 6 months
measure: Patient satisfaction
timeFrame: At 6 months of enrollment
Other outcomes:
Locations:
city: Pokhara
country: Nepal
facility: Community Pharmacies
state: Gandaki
Study officials:
References:
citation: McLachlan AJ, Carroll PR, Hunter DJ, Wakefield TAN, Stosic R. Osteoarthritis management: Does the pharmacist play a role in bridging the gap between what patients actually know and what they ought to know? Insights from a national online survey. Health Expect. 2022 Jun;25(3):936-946. doi: 10.1111/hex.13429. Epub 2022 Jan 8.
citation: Kielly J, Davis EM, Marra C. Practice guidelines for pharmacists: The management of osteoarthritis. Can Pharm J (Ott). 2017 May 1;150(3):156-168. doi: 10.1177/1715163517702168. eCollection 2017 May-Jun. No abstract available.
citation: Thapa P, Lee SWH, Kc B, Dujaili JA, Mohamed Ibrahim MI, Gyawali S. Pharmacist-led intervention on chronic pain management: A systematic review and meta-analysis. Br J Clin Pharmacol. 2021 Aug;87(8):3028-3042. doi: 10.1111/bcp.14745. Epub 2021 Feb 24.
citation: Marra CA, Cibere J, Grubisic M, Grindrod KA, Gastonguay L, Thomas JM, Embley P, Colley L, Tsuyuki RT, Khan KM, Esdaile JM. Pharmacist-initiated intervention trial in osteoarthritis: a multidisciplinary intervention for knee osteoarthritis. Arthritis Care Res (Hoboken). 2012 Dec;64(12):1837-45. doi: 10.1002/acr.21763.
citation: Hansson EE, Jonsson-Lundgren M, Ronnheden AM, Sorensson E, Bjarnung A, Dahlberg LE. Effect of an education programme for patients with osteoarthritis in primary care--a randomized controlled trial. BMC Musculoskelet Disord. 2010 Oct 25;11:244. doi: 10.1186/1471-2474-11-244.