Impact of Clinical Pharmacist Intervention as a Part of the Multidisciplinary Team on Clinical Outcomes in Cancer Patients With Pain in Nepal: A Feasibility Pilot Randomized Controlled Trial (PharmCaP Trial)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cancer
- Sponsor
- Monash University Malaysia
- Enrollment
- 92
- Locations
- 2
- Primary Endpoint
- Pain Intensity
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The study aims to evaluate the impact of clinical pharmacist intervention as a part of a multidisciplinary team to improve clinical outcomes of cancer patients with pain in comparison to standard care.
Detailed Description
For the intervention group, medication review, patient education, counseling, and recommendation will be performed by clinical pharmacists for all randomized patients. Patient education and counseling include giving education regarding drugs used in pain management, their adverse drug reactions. Medication review includes assessing the appropriateness of each of the regular medications based on laboratory findings, medication lists, consultation and discharge notes, procedures, and test results. Face-to-face interviews will be conducted with patients prior to the follow-up. Clinical pharmacists will assess drug use history used for pain management, identify drug-related problems, identify ADRs and provide drug therapy interventions through written pharmacist notes to physicians during the follow-up, based on the medication chart review and the above pharmaceutical assessments. After the follow-up, the clinical pharmacist will educate on drug-related problems identified before the visit, reinforce physician's instruction, and encourage drug compliance using written patient educational leaflets. Telephone follow follow-up will be conducted 4 weeks after the visit. Patients randomized to the control group will attend the medical follow-up as usual and receive usual care. All patients will be followed up for 4 weeks post-intervention visits. Data collection will be conducted at baseline and 4 weeks after the pharmacist visit. The primary outcome of the study is pain intensity which will be measured at baseline (prior to physician visit), and at 4 weeks post-intervention follow-up. Patients will be encouraged to keep in touch with the clinical pharmacist through various communication tools (including short messages, mobile phone contact, or Viber or WhatsApp). They will be also encouraged to request a consultation for any pain control issue at any time. This prospective randomized controlled trial will be conducted in the cancer hospitals of Nepal.
Investigators
Sunil Shrestha
Principal Investigator
Monash University Malaysia
Eligibility Criteria
Inclusion Criteria
- •Patients above 18 years old, diagnosed with cancer, and had self-reported cancer pain within a month prior to the study.
- •Patients be able to read and understand the Nepalese language or English language.
- •the patient is under standard analgesia treatments.
- •the patient was estimated to have over 2 months of survival time.
- •Access to a telephone or mobile phone or internet
- •The patients must understand the study process and evaluation, agree to participate in this trial, and sign the informed.
Exclusion Criteria
- •Patients who self-reported to have severe cognitive impairments.
- •Patients who are unable to complete pain assessment.
- •Participating in any other investigational therapies or other study protocols that may impact pain intensity are the primary outcomes of this study.
- •History of drug abuse, history of drug addiction, or severe alcoholism.
- •Opioid allergy.
- •Critically ill patients
Outcomes
Primary Outcomes
Pain Intensity
Time Frame: 4 weeks
NRS was used to assess pain intensity. The responses were given using an eleven-point numeric rating scale (NRS) scored 0-10, where 0 = best outcome/does not interfere/no pain/complete pain relief and 10 = worst outcome/completely interferes/most pain/no pain relief.
Secondary Outcomes
- Edmonton Symptom Assessment System (revised version)(4 weeks)
- Adverse Drug Reaction(4 weeks)
- Hospital Anxiety and Depression(4 weeks)
- Change in Quality of life(4 weeks)
- Medication Adherence(4 weeks)