Pharmacist Provided Intervention (Education and Medication Review) in Osteoarthritis

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

Detailed Description
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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.

Official Title
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Pharmacist Provided Intervention in Osteoarthritis: Community Pharmacies Based Trial

Conditions
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Osteoarthritis, Pain

Intervention / Treatment
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* Other: Education intervention and medication review


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be assigned to either intervention or the control group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment group<br>Patients from the pharmacies assigned as treatment group will receive intervention. Intervention are education (aid with leaflet and video) and medication review with counselling. | Other: Education intervention and medication review<br>* 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.<br>|
| No Intervention: control group<br>Patients from the pharmacies assigned as control group will receive as usual care they have been provided regularly. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 |