RELEASE: Redressing long-term antidepressant use in general practice

RELEASE and RELEASE+ are user-informed multi-modal interventions based in general practice that target both GPs and patients on long-term antidepressants. The interventions have the following guiding principles: - All prescribing decisions are made as usual by the GP and patient together. - Empowering patients. - Acceptable and translatable in routine general practice. - Resources developed to raise awareness, prompt medication review, support decision-making, and guide safe cessation of long-term antidepressants when these medications are no longer clinically indicated. RELEASE for GPs includes: 1) Interactive e-Learning module for GPs (30-60 minutes). Content includes information about antidepressant use in Australia, clinical guideline recommendations, adverse effects and risks associated with long-term antidepressant use, withdrawal symptoms, hyperbolic tapering of drug dose to minimise withdrawal symptoms and safely stop long-term antidepressants, and other strategies to mitigate withdrawal symptoms. 2) Outreach visit to Practice and GPs by research Practice Liaison Officer to: a. Update practice management software to include printable antidepressant drug-specific tapering protocols b. Update practice management software to include bespoke prescriptions for antidepressant drug mini-doses for hyperbolic tapering c. Provide the practice with a list of practice patients enrolled in the study d. Provide to each GP: i. The RELEASE study Pack that includes copies of printable resources including drug-specific tapering protocols, Decision Aid, Medicines Information Brochure and a reporting adverse events proforma. ii. One-on-one training (15-30 minutes) in the 3-As informed ‘RELEASE conversation’ medication review process, and prescribing for hyperbolic tapering of antidepressant drug dose. The mode of training includes case-based discussion, evidence-based medicine discussion, and demonstration of prescribing for hyperbolic tapering protocols. RELEASE for GPs will be scheduled soon after practice randomisation, with delivery completed by 4-weeks when patients are informed of allocation and receive the RELEASE pack for patients. 3) Local community pharmacists near intervention practices will be provided with a letter outlining the study and informing pharmacists that patients may inquire about compounding of min-doses of antidepressants. 4) GP prompts to initiate RELEASE AAA conversations with patients on long-term antidepressants, every 28 days x 6 from week 0. RELEASE for patients includes: 1) RELEASE Study pack - Letter informing patients of allocation to RELEASE intervention group and inviting patients to schedule a medication review appointment with their GP. Researchers will prompt patient participants via email to schedule the medication review with their GP 4-weekly for 6 months. - RELEASE pen and fridge magnet. - A tri-fold evidence-based Medicines Information Brochure to raise awareness of antidepressant adverse effects and physiological withdrawal effects. - A Decision Aid (1 double-sided A4 sheet) to support shared decision making and to help patients weigh up the risks and potential benefits of stopping or continuing antidepressants. - A drug-specific tapering protocol (1 double-sided A4 sheet), providing step by step guidance for slow tapering of antidepressant drug dose, including advice on flexibility of tapering speed and availability of drug mini-doses via compounding chemists. Tapering protocols advise patients that if withdrawal symptoms occur and are unbearable to return to previous drug dose for symptom relief and, when ready to try again, use a more gradual taper with smaller dose reductions and/or longer steps. - A family and friends brochure to help patients communicate with family and friends by raising awareness of antidepressant adverse effects and physiological withdrawal effects, to address the common misconception that depression is a long-term condition caused by a chemical (serotonin) deficiency in the brain that requires long-term medication, and to provide ways in which to support someone stopping antidepressants as a friend or family member. 2) RELEASE conversation medication review with GP: Participants are invited to schedule and attend a medication review appointment with their GP. The duration is not specified, although the standard appointment is 15 minutes. Usual fee applies to ensure scalability. The medication review includes the RELEASE conversation and shared decision-making based around the RELEASE Decision Aid. If the patient decides to discontinue antidepressants, then the GP may provide the RELEASE drug-specific tapering protocol and prescriptions for requisite antidepressant drug mini-doses. Cost to the patient for the antidepressant drug mini-doses is 50c-$1 per capsule from compounding chemist depending on quantity. All prescribing decisions are made as usual by the GP and patient together. 3) Follow-up with GP: Follow-up with GP as determined by the GP and patient together. Strategies used to monitor adherence to the intervention include data collected from the patients’ GP electronic health record (number of GP visits, prescriptions etc), and interviews with both GPs and patients. The RELEASE+ intervention is a more intensive intervention and in addition to the above includes: For GPs - additional outreach visit from researcher Practice liaison officer supported by audit and feedback of practice prescribing data, and For patients - use of an App that includes links to evidence-based information and e-mental health support sites. The app is specifically designed for this study. Patients will be provided an opportunity to access the app for the duration of the intervention, during which they will be free to use the app as they wish. There is no minimum frequency of use.