A novel approach to GP-patient interactions to improve outcomes in older people with high blood pressure

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2023
INTERVENTION: The MIAMI intervention is a structured set of supports for GPs and patients with hypertension to facilitate adequate information exchange about long‐term antihypertensive medication use and adherence skill development. Patient intervention: 1. Blood pressure measurement using an ambulatory blood pressure monitor 2. Providing a urine sample for a chemical urine test of adherence 3. A brief ‘pre‐consultation plan’ to be filled in before a GP consultation. This asks the patient ‘Is there anything you want to discuss with your GP in relation to your blood pressure?’ and prompts the patient and GP to write down an ‘agreed plan’. 4. Blood pressure education through written and video material GP intervention components: 1. Training in how to structure a consultation around adherence issues. This will be provided through educational videos, using a mixture of information and case studies 2. Booklet containing up‐to‐date prescribing guidelines 3. A drop‐down menu on GP software which will provide a reminder of the ‘pre‐consultation plan’ and a list of resources that can be recommended to the patient (e.g. medication reminders ‐ dontforget.ie and blood pressure education materials As this is a pilot study, the researchers will be open to further refinement of intervention throughout the study. Randomization: Three GP practices will be randomized to the MIAMI intervention arm and three will be randomized to the usual care control arm. The code to generate the randomization plan will be written in R (using a reproducible random generation seed) and implemented by an independent statistician. Intervention arm: Participants in the intervention arm will receive the MIAMI intervention at a minimum of one clinic appointment during a 3‐6 month period. Control arm: Participa CONDITION: Hypertension ; Circulatory System ; Hypertensive diseases PRIMARY OUTCOME: Acceptability and feasibility of the intervention and a future definitive RCT. This will be measured through:; 1. Recruitment of GP practices will be assessed by documenting the number of invitations sent, the number of refusals and the number of acceptances throughout the study; 2. Recruitment of patients will be assessed by documenting the number of invitations sent, the number of initial responses, the number of follow‐up phone calls required, the number of refusals and the number of acceptances throughout the study; 3. Attrition of participants will be documented at every timepoint throughout the study; 4. Levels of missing data in returned questionnaires will be reported at baseline and follow up; 5. The comprehensibility and acceptability of all questionnaires will be measured by asking participants how the questionnaires might be improved and how long they took to complete at baseline and follow up; ; 6, The perceptions and experiences of people with hypertension and GPs of participating in the MIAMI intervention and their views as to the feasibility and acceptability of the intervention, explored using qualitative interviews at the mid‐point of the intervention INCLUSION CRITERIA: Inclusion criteria for patient participants: 1. Have a confirmed diagnosis of hypertension 2. Participants must be on two or more anti‐hypertensive medications 3. Participants must not be achieving recommended blood pressure levels i.e. clinic readings are higher than 140/90 mmHg or day ABPM 135/85 mmHg 4. In the judgement of the GP regarding a change in medication, the balance of risk/benefit lies in favour of benefit Inclusion criteria for GP practices: 1. Within the catchment area of the biochemistry lab at University Hospital Galway 2. Using Socrates software system Inclusion criteria for GP participants: Doctors who are providing patient care in the practice SECONDARY OUTCOME: 1. Systolic blood pressure (ambulatory blood pressure monitoring [ABPM], average reading) measured at baseline and follow up; 2. Diastolic blood pressure (ABPM, average reading) measured at baseline and follow up; 3. Blood pressure control (ABPM, reading above or below 140/90mmHg) measured at baseline and follow up; 4. Medication adherence (urine screen, prescription refill records, Medication Adherence Report Scale (MARS) measured at baseline and follow up; 5. Beliefs about medication (Beliefs about Medication Questionnaire (BMQ), Illness Perceptions Questionnaire ‐ Revised (IPQ‐R) 'treatment control' and 'consequences' items) measured at baseline and follow up; 6. Habit strength measured using the Self‐Report Behavioural Automaticity Inde X(SRBAI) at baseline and follow up; 7. Pill burden (type and dosage) measured at baseline and follow‐up; 8. Health related quality of life measured using EuroQol‐5D‐5L at baseline and follow‐up; 9. Wellbeing measured using ICEpop CAPability measure for Older people (ICECAP‐O) at baseline and follow up
Epistemonikos ID: b3b01f26188c31dfd3b494364c71d3eb148c4bdb
First added on: Feb 20, 2024