Cardiovascular, medication non-adherence, hypertension Circulatory System
Conditions
Interventions
All eligible patients in the IMAB-Qi practices will be offered the Identification of Medication Adherence Barriers Questionnaire intervention (IMAB-Qi). The IMAB-Qi comprises a validated 10-item quest
Sponsors
University of East Anglia
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: GP Practices: 1. Have a named clinician who is willing and appropriate to undertake principal investigator responsibility. 2. Suitably trained staff available and willing to set up the study at the site, identify and recruit patient participants and collect and enter data as per protocol. 3. A named person based at the site to support IMAB-Qi implementation of the intervention and staff to support this (intervention sites only). 4. HCPs (pharmacists, doctors, nurses and other team members) with prescribing rights who conduct non-disease-specific MR consultations, available during the recruitment period and willing to deliver IMAB-Qi within their MRs, participate in the study, and undertake the required research-related tasks. 5. Use either SystmOne or EMIS electronic health record system GP practice staff: Staff fulfilling the following criteria will be eligible: 1. The Principal Investigator 2. Staff involved with supporting IMAB-Qi adoption and implementation 3. Staff involved with setting-up and delivering research processes Healthcare professionals (HCPs) involved with IMAB-Qi delivery: HCPs fulfilling the following criteria will be eligible: 1. Have Prescribing rights 2. Conduct MR consultations 3. Willing to deliver IMAB-Qi within their MRs, participate in the study and undertake required research-related training and tasks GP practice patients: 1. Adults aged >=18 years 2. On the hypertension register 3. Current prescription for >=1 antihypertensive medicine(s) prescribed for hypertension for at least the past 4 weeks 4. Blood pressure exceeding their NICE guidelines target for hypertension** 4.1. Aged 18-79 years >=140/90 mm Hg in clinic or >= 135/85 using home blood pressure monitor 4.2. Aged >=80 years >=150/90 mm Hg in clinic or >= 145/85 using home blood pressure monitor 5. Due a MR during the planned study recruitment period **Confirmed after consent
Exclusion criteria
Exclusion criteria: GP practices: General practices with <5% of their patient population prescribed an antihypertensive medicines Healthcare professionals (HCPs) involved with IMAB-Qi delivery: Healthcare professionals who conduct only disease-specific medication reviews, e.g., annual diabetes reviews Patient participants: 1. Not self-administering their medications 2. Excepted from NICE guideline age-related blood pressure target because it is inappropriate, e.g., receiving end-of-life care, on maximal tolerated doses of medication, declined treatment 3. On the severe mental illness register (IMAB-Q is not validated in this population) 4. Deemed by the practice staff to lack capacity to understand the study and unable to make a decision regarding participating 5. Under the care of a secondary care HCP for treatment of hypertension 6. Pregnant, lactating or known to be planning pregnancy during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Ability to identify and recruit a representative sample of patients with hypertension willing to consent to take part in the study and study activities across sites, measured using the number of eligible patients identified and invited, the number (and percentage) who agree to enter the study, remain in the study, and complete study activities, including how representative they are of the practice population, measured over the course of the study 2. Ability to collect outcome data, including systolic blood pressure, from patient participants at relevant time points throughout the study, measured using the number (and percentage) who provide valid outcome measure data and health economic data at baseline and 12-week follow-up; completeness of blood pressure data; completeness of routine data collected from medical records; and the proportion who agree to take part in process evaluation activities (having their MR recorded and taking part in an interview with a researcher), measured over the course of the study. 3. Ability to, and acceptability of, embedding IMAB-Qi into primary care patient records and retrieving the data, measured using confirmation that the IMAB-Q questionnaire template has been embedded into the GP clinical records system; that invitations to complete IMAB-Q have been sent from the GP clinical system; the number (and percentage) of patients who complete the IMAB-Q; and through interviews and/or focus groups with patients who receive IMAB-Qi and staff who implement and deliver IMAB-Qi, measured over the course of the study. 4. Fidelity of the delivery of the IMAB-Qi intervention by healthcare professionals (HCPs) measured using a fidelity framework, and its acceptability measured through interviews with patients and HCPs, measured over the course of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Health-related quality of life is measured using the EQ-5D-5L questionnaire at baseline and 12-week follow-up 2. Blood pressure is patient-reported at baseline, 4- and 12-week follow-ups and from GP medical records 3. Health and social care resource use is measured using the modified Client Service Receipt Inventory (CSRI) questionnaire and from GP clinical records at baseline and 12-week follow-up 4. Adherence to antihypertensive medication and all other medications measured using a visual analogue scale (VAS) and from GP clinical records at baseline and 12-week follow-up 5. Adverse medicine reactions measured using a bespoke 17-item adverse medicine reaction questionnaire at baseline and 12-week follow-up 6. Intervention appropriateness is measured using the four-item Intervention Appropriateness Measure (IAM) 1 week after the medication review 7. Demographic information is measured using demographic questions at baseline and from GP medical records at baseline 8. Health and health and service care use are measured using data from GP medical records at 12-week follow-up For the intervention group only: 9. Barriers to medication adherence measured using the 10-item IMAB-Q at baseline, 4-week follow-up, and 12-week follow-up 10. Self-enactment of behaviour change techniques (SE BCTs) measured using the SE BCTs questionnaire after the medication review and at 12-week follow-up | — |
Countries
England, United Kingdom
Contacts
Public ContactDebi;Sion Bhattacharya;Scott
;
Outcome results
None listed