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Outcomes Mandate National Integration With Cannabis as Medicine

ABSTRACT: This will be a multistate, multicenter clinical study to determine the efficacy and safety of medical cannabis for a wide variety of chronic medical conditions.

DISEASE(S): Glaucoma,Anemia, Sickle Cell,Chronic Traumatic Encephalopathy,Sars-cov Infection,Tourette Syndrome,Epilepsy,Motor Neuron Disease,Wounds And Injuries,Chronic Pain Due To Injury,Fibromyalgia,Crohn Disease,Infections,Communicable Diseases,Stress Disorders, Traumatic,Chronic Pain Due To Trauma,Multiple Sclerosis,Traumatic Brain Injury,Amyotrophic Lateral Sclerosis,Stress Disorders, Post-traumatic,Brain Injuries,Opioid-related Disorders,Chronic Pain Syndrome,Ulcerative Colitis,Sickle Cell Disease,Brain Diseases,Anxiety,Seizures,Chronic Pain,Coronavirus Infections,Covid-19,Inflammatory Bowel Diseases,Depression,Brain Injuries, Traumatic,Parkinson Disease,Autism,Coronavirus,Bipolar Disorder,Hiv/aids,Insomnia,Covid19,Opioid-use Disorder,Corona Virus Infection,Hepatitis C,Post Traumatic Stress Disorder,Cancer

PROVIDER: 2305132 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Interventions: Participants of this study will be receiving prescribed medicinal cannabis product/s via their treating clinician, as per standard of care. Enrolment into the study requires their clinician to consent participants and provide relevant medical history information, prescription information and updates and regular adverse event reporting throughout the study duration (12 months observation per participant). Participants will be asked to complete a total of 14 questionnaires at set time points throughout the study. The study progress questionnaire including additional validated measures of health-related quality of life, medication adherence and patient reported change will be completed at enrolment, and months 1, 3, 6, 9 and 12 post-enrolment or until the participant ceases medicinal cannabis treatment (if prior to 12 months post-enrolment). A short-form questionnaire focused on side effect reporting, current dose and changes to other concomitant medications will be completed at months 2, 4, 5, 7, 8, 10 and 11 post-enrolment or until the participant ceases medicinal cannabis treatment (if prior to 12 months post-enrolment). It is anticipated that each questionnaire will take between 5-30 minutes to complete, requiring a total of 30 minutes maximum participation each month for the 12 months of the study. Clinicians will be asked to complete the baseline enrolment form (10 minutes to complete) for each patient at study enrolment as well as adverse event monitoring questionnaires, each taking 5-10 minutes to complete every 3 months for the period that they have patients enrolled in the study. Primary outcome(s): The type of medicinal cannabis product/s prescribed (including the formulation, prescribed dosage and underlying medical condition) as collected by study-specific questionnaires. [Collected at baseline, and then monthly for a 12 month period post-enrolment. ];Number of adverse and serious adverse events experienced that are related to medicinal cannabis treatment, including but not limited to, dry mouth, somnolence and gastrointestinal upset, as measured by study-specific questionnaires. These will be captured by clinicians at clinical examinations and also reported by patients on a monthly basis using the safety reporting questionnaire. The safety reporting questionnaires being used are study specific. The clinician AE reporting questionnaire is based on the TGA recommended guidelines for AE reporting which conform to WHO grading and causality definitions. [Patient reported data collected at baseline, and then monthly for a 12 month period post-enrolment. Clinician reported data collected at 3, 6, 9 and 12 months post-enrolment. ];Change to patient-reported concomitant medications (including opioid use) over the observational period using study-specific questionnaires. [Completed at baseline, and then monthly for 12 months post-enrolment. ] Study Design: Purpose: Natural history;Duration: Longitudinal;Selection: Defined population;Timing: Prospective

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Outcomes Mandate National Integration With Cannabis as Medicine

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