Pharmacist Provided Intervention (Education and Medication Review) in Osteoarthritis

Pain Clinical Trial

Official title:

Pharmacist Provided Intervention in Osteoarthritis: Community Pharmacies Based Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05337709
• Other study ID #: 0
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: December 1, 2022

Study information

• Verified date: August 2022
• Source: Monash University Malaysia
• Contact: Parbati Thapa
• Phone: 0165471475
• Email: parbati.thapa[@]monash.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 154
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Osteoarthritis
• Pain

Intervention

Other:
• Education intervention and medication review
Education on osteoarthritis and pain management will be provided to the patients by face-to-face communication at the first meeting, aided with a leaflet, then patients will get the follow-up calls and a video will be shown to enforce the intervention. Medication review includes the assessment of patients' knowledge on the indication, identification of any drug-related problem, and counseling on the proper use of medication.

Locations

Country	Name	City	State
Nepal	Community Pharmacies	Pokhara	Gandaki

Sponsors (1)

Lead Sponsor	Collaborator
Monash University Malaysia

Country where clinical trial is conducted

Nepal, 

References & Publications (5)

Hansson EE, Jönsson-Lundgren M, Ronnheden AM, Sörensson E, Bjärnung 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. — View 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. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline pain intensity at 3 and 6 months	Numeric pain rating scale will be used to measure the pain intensity. The numeric pain rating scale (NPRS) is an 11-point scale. Respondents can choose a number between 0 to 10, where 0 = no pain and 10 = extreme or worst pain. It has shown a high correlation with the visual analogue scale and can be used in rheumatoid arthritis and other types of chronic pain. It can be administered verbally to be done over the telephone. It has been translated into the Nepalese language.	baseline, 3 months and 6 months
Primary	Change from baseline patient's knowledge at 3 and 6 months	Patient knowledge will be assessed using the questionnaire developed by the principal investigator in consultation with literature review and expert consultation. It consists of 12 questions on osteoarthritis and pain management. It has been translated into Nepalese languages and validated. Correct responses will be counted and presented as percentages. Higher percentages mean better knowledge.	baseline, 3 months and 6 months (change in patients knowledge from baseline
Primary	Change from baseline physical function at 3 and 6 months	Western Ontario and Mc Master Universities Arthritis Index (WOMAC) is the tool commonly used for evaluation in osteoarthritis.It consist of 24 items divided into 3 subscales; pain (5 items), stiffness (2 items), physical Function (17 items). Its response is based on a number between 0 to 4, where 0=none, 1=mild, 2=moderate, 3=severe, 4=extreme.	baseline, 3 months and 6 months
Secondary	Change from baseline depression score at 6 months	Patient-Reported Outcomes Measurement Information System (PROMIS) depression scale 8 items: is a set of person-centred measures that evaluates mental health in adults and children. It can be used with the general population and individuals living with chronic conditions. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of depression.	baseline and 6 months
Secondary	Change from baseline patients quality of life at 6 months	The quality of life assessment questionnaire EQ-5D-3L (EUROQOL) is one of the most common tools to measure health-related quality of life. It helps to assess the Quality of life-based on five dimensions mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems.	baseline and 6 months
Secondary	Patient satisfaction	Patient satisfaction will be assessed using the patient satisfaction questionnaire. Higher the score better is the satisfaction level.	At 6 months of enrollment