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The feasibility of the PAM intervention to support treatment-adherence in people with hypertension in primary care: a randomised clinical controlled trial.

ABSTRACT: The PAM intervention is a behavioural intervention to support adherence to anti-hypertensive medications and therefore to lower blood pressure. This feasibility trial recruited 101 nonadherent patients (54% male, mean age 65.8 years) with hypertension and high blood pressure from nine general practices in the UK. The trial had 15.5% uptake and 7.9% attrition rate. Patients were randomly allocated to two groups: the intervention group (n = 61) received the PAM intervention as an adjunct to usual care; the control group (n = 40) received usual care only. At 3 months, biochemically validated medication adherence was improved by 20% (95% CI 3-36%) in the intervention than control, and systolic blood pressure was reduced by 9.16 mmHg (95% CI 5.69-12.64) in intervention than control. Improvements in medication adherence and reductions in blood pressure suggested potential intervention effectiveness. For a subsample of patients, improvements in medication adherence and reductions in full lipid profile (cholesterol 1.39 mmol/mol 95% CI 0.64-1.40) and in glycated haemoglobin (3.08 mmol/mol, 95% CI 0.42-5.73) favoured the intervention. A larger trial will obtain rigorous evidence about the potential clinical effectiveness and cost-effectiveness of the intervention.Trial registration Trial date of first registration 28/01/2019. ISRCTN74504989. https://doi.org/10.1186/ISRCTN74504989 .

SUBMITTER: Kassavou A

PROVIDER: S-EPMC8076273 | biostudies-literature | 2021 Apr

REPOSITORIES: biostudies-literature

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The feasibility of the PAM intervention to support treatment-adherence in people with hypertension in primary care: a randomised clinical controlled trial.

Kassavou Aikaterini A Mirzaei Venus V Shpendi Sonia S Brimicombe James J Chauhan Jagmohan J Bhattacharya Debi D Naughton Felix F Hardeman Wendy W Eborall Helen H Van Emmenis Miranda M De Simoni Anna A Takhar Amrit A Gupta Pankaj P Patel Prashanth P Mascolo Cecilia C Prevost Andrew Toby AT Morris Stephen S Griffin Simon S McManus Richard J RJ Mant Jonathan J Sutton Stephen S

Scientific reports 20210426 1

The PAM intervention is a behavioural intervention to support adherence to anti-hypertensive medications and therefore to lower blood pressure. This feasibility trial recruited 101 nonadherent patients (54% male, mean age 65.8 years) with hypertension and high blood pressure from nine general practices in the UK. The trial had 15.5% uptake and 7.9% attrition rate. Patients were randomly allocated to two groups: the intervention group (n = 61) received the PAM intervention as an adjunct to usual ...[more]

PMID: 33903656

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Project description:BACKGROUND:Most patients with antihypertensive medication do not achieve their blood pressure (BP) target. The most important factor behind this failure is poor medication adherence. However, non-adherence to therapy does not concern only patients. Clinicians also tend to lack adherence to hypertension guidelines, overestimate BP control and be satisfied with inadequate BP control. The aim of this non-blinded, cluster-randomised, controlled study was to investigate if using a checklist would improve the quality of care in the initiation of new antihypertensive medication and help reduce non-adherence. METHODS:The study was conducted in eight primary care study centres in Central Finland, randomised to function as either intervention (n = 4) or control sites (n = 4). We included patients aged 30-75 years who were prescribed antihypertensive medication for the first time. Initiation of medication in the intervention group was carried out with a 9-item checklist, filled in together by the treating physician and the patient. Hypertension treatment in the control group was managed by the treating physician without a study-specific protocol. RESULTS:In total, 119 patients were included in the study, of which 118 were included in the analysis (n = 59 in the control group, n = 59 in the intervention group). When initiating antihypertensive medication, an adequate BP target was set for 19% of the patients in the control group and for 68% in the intervention group. Shortly after the appointment, only 14% of the patients in the control group were able to remember the adequate BP target, compared with 32% in the intervention group. The use of the checklist was also related to more regular agreement on the next follow-up appointment (64% in the control group versus 95% in the intervention group). No adverse events or side effects were related to the intervention. CONCLUSIONS:Even highly motivated new hypertensive patients in Finnish primary care have significant gaps in their informational and behavioural skills. The use of a checklist for initiation of antihypertensive medication was related to significant improvement in these skills. Based on our findings, the use of a checklist might be a practical tool for addressing this problem. TRIAL REGISTRATION:NCT02377960 . Date of registration: February 26th, 2015.

Project description:ObjectivesTo explore patients' and healthcare practitioners' (HCPs) views about non-adherence to hypertension medication and potential content of a combined very brief face-to-face discussion (VBI) and digital intervention (DI).MethodsA qualitative study (N=31): interviews with patients with hypertension (n=6) and HCPs (n=11) and four focus groups with patients with hypertension (n=14). Participants were recruited through general practices in Eastern England and London. Topic guides explored reasons for medication non-adherence and attitudes towards a potential intervention to support adherence. Stimuli to facilitate discussion included example SMS messages and smartphone app features, including mobile sensing. Analysis was informed methodologically by the constant comparative approach and theoretically by perceptions and practicalities approach.ResultsParticipants' overarching explanations for non-adherence were non-intentional (forgetting) and intentional (concerns about side effects, reluctance to medicate). These underpinned their views on intervention components: messages that targeted forgetting medication or obtaining prescriptions were considered more useful than messages providing information on consequences of non-adherence. Tailoring the DI to the individuals' needs, regarding timing and number of messages, was considered important for user engagement. Patients wanted control over the DI and information about data use associated with any location sensing. While the DI was considered limited in its potential to address intentional non-adherence, HCPs saw the potential for a VBI in addressing this gap, if conducted in a non-judgemental manner. Incorporating a VBI into routine primary care was considered feasible, provided it complemented existing GP practice software and HCPs received sufficient training.ConclusionsA combined VBI-DI can potentially address intentional and non-intentional reasons for non-adherence to hypertension medication. For optimal engagement, recommendations from this work include a VBI conducted in a non-judgmental manner and focusing on non-intentional factors, followed by a DI that is easy-to-use, highly tailored and with provision of data privacy details about any sensing technology used.

Project description:BackgroundIdentification in UK general practice of women affected by domestic violence and abuse (DVA) is increasing, but men and children/young people (CYP) are rarely identified and referred for specialist support. To address this gap, we collaborated with IRISi (UK social enterprise) to strengthen elements of the IRIS + intervention which included the identification of men, direct engagement with CYP, and improved guidance on responding to information received from other agencies. IRIS + was an adaptation of the national IRIS (Identification and Referral to Improve Safety) model focused on the needs of women victim-survivors of DVA. Without diminishing the responses to women, IRIS + also responded to the needs of men experiencing or perpetrating DVA, and CYP living with DVA and/or experiencing it in their own relationships. Our study tested the feasibility of the adapted IRIS + intervention in England and Wales between 2019-21.MethodsWe used mixed method analysis to triangulate data from various sources (pre/post intervention questionnaires with primary care clinicians; data extracted from medical records and DVA agencies; semi-structured interviews with clinicians, service providers and referred adults and children) to assess the feasibility and acceptability of the IRIS + intervention.ResultsThe rate of referral for women doubled (21.6/year/practice) from the rate (9.29/year/practice) in the original IRIS trial. The intervention also enabled identification and direct referral of CYP (15% of total referrals) and men (mostly survivors, 10% of total referrals). Despite an increase in self-reported clinician preparedness to respond to all patient groups, the intervention generated a low number of men perpetrator referrals (2% of all referrals). GPs were the principal patient referrers. Over two-thirds of referred women and CYP and almost half of all referred men were directly supported by the service. Many CYP also received IRIS + support indirectly, via the referred parents. Men and CYP supported by IRIS + reported improved physical and mental health, wellbeing, and confidence.ConclusionsAlthough the study showed acceptability and feasibility, there remains uncertainty about the effectiveness, cost-effectiveness, and scalability of IRIS + . Building on the success of this feasibility study, the next step should be trialling the effectiveness of IRIS + implementation to inform service implementation decisions.

Project description:Background: Medication adherence can prevent health risks, but many patients do not adhere to their prescribed treatment. Our recent trial found that a digital intervention was effective at improving medication adherence in non-adherent patients with Hypertension or Type 2 Diabetes; but we do not know how it brought about behavioural changes. This research is a post-trial process evaluation of the mechanism by which the intervention achieved its intended effects. Methods: A mixed methods design with quantitative and qualitative evidence synthesis was employed. Data was generated by two studies. Study 1 used questionnaires to measure the underlying mechanisms of and the medication adherence behaviour, and digital logfiles to objectively capture intervention effects on the process of behaviour change. Multilevel regression analysis on 57 complete intervention group cases tested the effects of the intervention at modifying the mechanism of behaviour change and in turn at improving medication adherence. Study 2 used in depth interviews with a subsample of 20 intervention patients, and eight practise nurses. Thematic analysis provided evidence about the overarching intervention functions and recommendations to improve intervention reach and impact in primary care. Results: Study 1 found that intervention effectiveness was significantly associated with positive changes in the underlying mechanisms of behaviour change (R 2 = 0.26, SE = 0.98, P = 0.00); and this effect was heightened twofold when the tailored intervention content and reporting on medication taking (R 2 = 0.59, SE = 0.74, P = 0.00) was interested into the regression model. Study 2 suggested that the intervention supported motivation and ability to adherence, although clinically meaningful effects would require very brief medication adherence risk appraisal and signposting to ongoing digitally delivered behavioural support during clinical consultations. Conclusion: This post trial process evaluation used objective methods to capture the intervention effect on the mechanisms of behaviour change to explain intervention effectiveness, and subjective accounts to explore the circumstances under which these effects were achieved. The results of this process evaluation will inform a large scale randomised controlled trial in primary care.

Project description:BackgroundPrimary care needs to respond effectively to patients experiencing or perpetrating domestic violence and abuse (DVA) and their children, but there is uncertainty about the value of integrated programmes. The aim of the study was to develop and test the feasibility of an integrated primary care system-level training and support intervention, called IRIS+ (Enhanced Identification and Referral to Improve Safety), for all patients affected by DVA. IRIS+ was an adaptation of the original IRIS (Identification and Referral to Improve Safety) model designed to reach female survivors of DVA.MethodsObservation of training; pre/post intervention questionnaires with clinicians and patients; data extracted from medical records and DVA agency; semi-structured interviews with clinicians, service providers and referred adults and children. Data collection took place between May 2017 and April 2018. Mixed method analysis was undertaken to triangulate data from various sources to assess the feasibility and acceptability of the intervention.ResultsClinicians and service providers believed that the IRIS+ intervention had filled a service gap and was a valuable resource in identifying and referring women, men and children affected by DVA. Despite increased levels of preparedness reported by clinicians after training in managing the complexity of DVA in their practice, the intervention proved to be insufficient to catalyse identification and specialist referral of men and direct identification and referral (without their non-abusive parents) of children and young people. The study also revealed that reports provided to general practice by other agencies are important sources of information about adult and children patients affected by DVA. However, in the absence of guidance about how to use this information in patient care, there are uncertainties and variation in practice.ConclusionsThe study demonstrates that the IRIS+ intervention is not feasible in the form and timeframe we evaluated. Further adaptation is required to achieve identification and referral of men and children in primary care: an enhanced focus on engagement with men, direct engagement with children, and improved guidance and training on responding to reports of DVA received from other agencies.

Project description:BackgroundA general practitioner (GP)-targeted intervention aimed at improving the prescribing of appropriate polypharmacy for older people was previously developed using a systematic, theory-based approach based on the UK Medical Research Council's complex intervention framework. The primary intervention component comprised a video demonstration of a GP prescribing appropriate polypharmacy during a consultation with an older patient. The video was delivered to GPs online and included feedback emphasising the positive outcomes of performing the behaviour. As a complementary intervention component, patients were invited to scheduled medication review consultations with GPs. This study aimed to test the feasibility of the intervention and study procedures (recruitment, data collection).MethodsGPs from two general practices were given access to the video, and reception staff scheduled consultations with older patients receiving polypharmacy (≥4 medicines). Primary feasibility study outcomes were the usability and acceptability of the intervention to GPs. Feedback was collected from GP and patient participants using structured questionnaires. Clinical data were also extracted from recruited patients' medical records (baseline and 1 month post-consultation). The feasibility of applying validated assessment of prescribing appropriateness (STOPP/START criteria, Medication Appropriateness Index) and medication regimen complexity (Medication Regimen Complexity Index) to these data was investigated. Data analysis was descriptive, providing an overview of participants' feedback and clinical assessment findings.ResultsFour GPs and ten patients were recruited across two practices. The intervention was considered usable and acceptable by GPs. Some reservations were expressed by GPs as to whether the video truly reflected resource and time pressures encountered in the general practice working environment. Patient feedback on the scheduled consultations was positive. Patients welcomed the opportunity to have their medications reviewed. Due to the short time to follow-up and a lack of detailed clinical information in patient records, it was not feasible to detect any prescribing changes or to apply the assessment tools to patients' clinical data.ConclusionThe findings will help to further refine the intervention and study procedures (including time to follow-up) which will be tested in a randomised pilot study that will inform the design of a definitive trial to evaluate the intervention's effectiveness.Trial registrationISRCTN18176245.

Project description:BackgroundCare transitions from hospital to home are a critical period for patients and their families, especially after a stroke. The aim of this study was to assess the feasibility, fidelity and acceptability of a co-designed care transition support for stroke survivors.MethodsA non-randomised controlled feasibility study recruiting patients who had had stroke and who were to be discharged home and referred to a neurorehabilitation team in primary healthcare was conducted. Data on the feasibility of recruitment and fidelity of the intervention were collected continuously during the study with screening lists and checklists. Data on the perceived quality of care transition were collected at 1-week post-discharge with the Care Transition Measure. Data on participant characteristics, disease-related data and outcomes were collected at baseline (hospitalisation), 1 week and 3 months post-discharge. Data on the acceptability of the intervention from the perspective of healthcare professionals were collected at 3 months using the Normalisation Measure Development Questionnaire.ResultsAltogether, 49 stroke survivors were included in the study: 28 in the intervention group and 21 in the control group. The recruitment and data collection of patient characteristics, disease-related data, functioning and outcomes were feasible. The fidelity of the intervention differed in relation to the different components of the co-designed care transition support. The intervention was acceptable from the perspective of healthcare professionals. Concerns were raised about the fidelity of the intervention. A positive direction of effects of the intervention on the perceived quality of the care transition was found.ConclusionThe study design, data collection, procedures and intervention were deemed feasible and acceptable. Modifications are needed to improve intervention fidelity by supporting healthcare professionals to apply the intervention. The feasibility study showed a positive direction of effect on perceived quality with the care transition, but a large-scale trial is needed to determine its effectiveness.Patient or public contributionStroke survivors, significant others and healthcare professionals were involved in a co-design process, including the joint development of the intervention's components, contextual factors to consider, participant needs and important outcomes to target.Trial registrationClinicalTrials.gov ID: NCT0292587.

Dataset Information

The feasibility of the PAM intervention to support treatment-adherence in people with hypertension in primary care: a randomised clinical controlled trial.

Publications

The feasibility of the PAM intervention to support treatment-adherence in people with hypertension in primary care: a randomised clinical controlled trial.

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