Process evaluation of the Bridging the Age Gap in Breast Cancer decision support intervention cluster randomised trial.

Abstract BackgroundThe Bridging the Age Gap in Breast Cancer research programme sought to improve treatment decision-making for older women with breast cancer by developing and testing, in a cluster randomised trial, two decision support interventions (DESIs). One DESI supported the decision to have either primary endocrine therapy (PET) or surgery with adjuvant therapies and the second supported the decision to have adjuvant chemotherapy after surgery or not.MethodsSixteen sites were randomly selected to take part in the process evaluation. Multiple methods of data collection were used. Medical Research Council (MRC) guidelines for the evaluation of complex interventions were used.ResultsEighty-two patients, mean age 75.5, (range 70–93) provided data for the process evaluation. Seventy-three interviews were completed with patients. Ten clinicians from six intervention sites took part in telephone interviews. Dose: Ninety-one members of staff in the intervention arm received intervention training. Reach: The online tool was accessed on 324 occasions by 27 clinicians. Reasons for non-use of the online tool were commonly that the patient had already made a decision or that there was no online access in the clinic. Of the 32 women for whom there were data available, fifteen from the intervention arm and six from the usual care arm were offered a choice of treatment. Fidelity: Clinicians used the online tool in different ways, with some using it during the consultation and others checking the online survival estimates before the consultation. Adaptation: There was evidence of adaptation when using the DESIs. A lack of infrastructure, e.g. internet access, was a barrier to the use of the online tool. The brief decision aid was rarely used. Mediators: Shared decision-making: Most patients felt able to contribute to decision-making and expressed high level of satisfaction with the process. Participants’ responses to intervention: Six patients reported the DESIs to be very useful, one somewhat useful and two moderately useful.ConclusionsClinicians were mainly supportive of the interventions and had attempted some adaptations to make the interventions applicable, but there were practical and engagement barriers that led to sub-optimal adoption in routine practice.Trial Registered11th August 2016 - Retrospectively registered, http://www.isrctn.com/(ISRCTN: 46099296)

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Process evaluation of the Bridging the Age Gap in Breast Cancer decision support intervention cluster randomised trial

Trials ◽

10.1186/s13063-021-05360-z ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Maria Burton ◽

Kate J. Lifford ◽

Lynda Wyld ◽

Fiona Armitage ◽

Alistair Ring ◽

...

Keyword(s):

Breast Cancer ◽

Decision Making ◽

Decision Support ◽

Process Evaluation ◽

Decision Aid ◽

Randomised Trial ◽

Cluster Randomised Trial ◽

Online Tool ◽

Cluster Randomised ◽

Age Gap

Abstract Background The Bridging the Age Gap in Breast Cancer research programme sought to improve treatment decision-making for older women with breast cancer by developing and testing, in a cluster randomised trial (n = 1339 patients), two decision support interventions (DESIs). Both DESIs were used in the intervention arm and each comprised an online risk prediction model, brief decision aid and information booklet. One DESI supported the decision to have either primary endocrine therapy (PET) or surgery with adjuvant therapies and the second supported the decision to have adjuvant chemotherapy after surgery or not. Methods Sixteen sites were randomly selected to take part in the process evaluation. Multiple methods of data collection were used. Medical Research Council (MRC) guidelines for the evaluation of complex interventions were used. Results Eighty-two patients, mean age 75.5 (range 70–93), provided data for the process evaluation. Seventy-three interviews were completed with patients. Ten clinicians from six intervention sites took part in telephone interviews. Dose: Ninety-one members of staff in the intervention arm received intervention training. Reach: The online tool was accessed on 324 occasions by 27 clinicians. Reasons for non-use of the online tool were commonly that the patient had already made a decision or that there was no online access in the clinic. Of the 32 women for whom there were data available, fifteen from the intervention arm and six from the usual care arm were offered a choice of treatment. Fidelity: Clinicians used the online tool in different ways, with some using it during the consultation and others checking the online survival estimates before the consultation. Adaptation: There was evidence of adaptation when using the DESIs. A lack of infrastructure, e.g. internet access, was a barrier to the use of the online tool. The brief decision aid was rarely used. Mediators: Shared decision-making: Most patients felt able to contribute to decision-making and expressed high levels of satisfaction with the process. Participants’ responses to intervention: Six patients reported the DESIs to be very useful, one somewhat useful and two moderately useful. Conclusions Clinicians who participated were mainly supportive of the interventions and had attempted some adaptations to make the interventions applicable, but there were practical and engagement barriers that led to sub-optimal adoption in routine practice. Trial registration ISRCTN46099296. Registered on 11 August 2016—retrospectively registered

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Cluster randomised trial to evaluate the clinical benefits of decision support interventions for older women with operable breast cancer

European Journal of Cancer ◽

10.1016/s0959-8049(20)30545-1 ◽

2020 ◽

Vol 138 ◽

pp. S7

Author(s):

L. Wyld ◽

M. Reed ◽

K. Collins ◽

M. Burton ◽

K. Lifford ◽

...

Keyword(s):

Breast Cancer ◽

Decision Support ◽

Older Women ◽

Randomised Trial ◽

Operable Breast Cancer ◽

Cluster Randomised Trial ◽

Cluster Randomised ◽

Clinical Benefits

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Barriers to a software reminder system for risk assessment of stroke in atrial fibrillation: a process evaluation of a cluster randomised trial in general practice

British Journal of General Practice ◽

10.3399/bjgp18x699809 ◽

2018 ◽

Vol 68 (677) ◽

pp. e844-e851

Author(s):

Tim A Holt ◽

Andrew RH Dalton ◽

Susan Kirkpatrick ◽

Jenny Hislop ◽

Tom Marshall ◽

...

Keyword(s):

Atrial Fibrillation ◽

Risk Assessment ◽

General Practice ◽

Process Evaluation ◽

Oral Anticoagulants ◽

Qualitative Interviews ◽

Randomised Trial ◽

Software Tool ◽

Cluster Randomised Trial ◽

Cluster Randomised

BackgroundOral anticoagulants reduce the risk of stroke in patients with atrial fibrillation (AF), but are underused. AURAS-AF (AUtomated Risk Assessment for Stroke in AF) is a software tool designed to identify eligible patients and promote discussions within consultations about initiating anticoagulants.AimTo investigate the implementation of the software in UK general practice.Design and settingProcess evaluation involving 23 practices randomly allocated to use AURAS-AF during a cluster randomised trial.MethodAn initial invitation to discuss anticoagulation was followed by screen reminders appearing during consultations until a decision had been made. The reminders required responses, giving reasons for cases where an anticoagulant was not initiated. Qualitative interviews with clinicians and patients explored acceptability and usability.ResultsIn a sample of 476 patients eligible for the invitation letter, only 159 (33.4%) were considered suitable for invitation by their GPs. Reasons given were frequently based on frailty, and risk of falls or haemorrhage. Of those invited, 35 (22%) started an anticoagulant (7.4% of those originally identified). A total of 1695 main-screen reminders occurred in 940 patients. In 883 instances, the decision was taken not to initiate and a range of reasons offered. Interviews with 15 patients and seven clinicians indicated that the intervention was acceptable, though the issue of disruptive screen reminders was raised.ConclusionAutomated risk assessment for stroke in atrial fibrillation and prompting during consultations are feasible and generally acceptable, but did not overcome concerns about frailty and risk of haemorrhage as barriers to anticoagulant uptake.

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Process evaluation of a workplace-based health promotion and exercise cluster-randomised trial to increase productivity and reduce neck pain in office workers: a RE-AIM approach

BMC Public Health ◽

10.1186/s12889-020-8208-9 ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

Alyssa Welch ◽

Genevieve Healy ◽

Leon Straker ◽

Tracy Comans ◽

Shaun O’Leary ◽

...

Keyword(s):

Health Promotion ◽

Neck Pain ◽

Process Evaluation ◽

Randomised Trial ◽

Office Workers ◽

Cluster Randomised Trial ◽

Cluster Randomised ◽

Increase Productivity

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Process evaluation protocol for a cluster randomised trial of a complex, nurse-led intervention to improve hypertension management in India

BMJ Open ◽

10.1136/bmjopen-2018-027841 ◽

2019 ◽

Vol 9 (5) ◽

pp. e027841 ◽

Cited By ~ 1

Author(s):

Nikhil Srinivasapura Venkateshmurthy ◽

Kevin Mc Namara ◽

Harriet Koorts ◽

Sailesh Mohan ◽

Vamadevan S Ajay ◽

...

Keyword(s):

Mixed Methods ◽

Process Evaluation ◽

Randomised Trial ◽

Intervention Development ◽

Health Department ◽

Uncontrolled Hypertension ◽

Cluster Randomised Trial ◽

Care Coordinator ◽

Cluster Randomised ◽

Number Of Patients

IntroductionIndia has high prevalence of hypertension but low awareness, treatment and control rate. A cluster randomised trial entitled ‘m-Power Heart Project’ is being implemented to test the effectiveness of a nurse care coordinator (NCC) led complex intervention to address uncontrolled hypertension in the community health centres (CHCs). The trial’s process evaluation will assess the fidelity and quality of implementation, clarify the causal mechanisms and identify the contextual factors associated with variation in the outcomes. The trial will use a theory-based mixed-methods process evaluation, guided by the Consolidated Framework for Implementation Research.Methods and analysisThe process evaluation will be conducted in the CHCs of Visakhapatnam (southern India). The key stakeholders involved in the intervention development and implementation will be included as participants. In-depth interviews will be conducted with intervention developers, doctors, NCCs and health department officials and focus groups with patients and their caregivers. NCC training will be evaluated using Kirkpatrick’s model for training evaluation. Key process evaluation indicators (number of patients recruited and retained; concordance between the treatment plans generated by the electronic decision support system and treatment prescribed by the doctor and so on) will be assessed. Fidelity will be assessed using Borrelliet al’s framework. Qualitative data will be analysed using the template analysis technique. Quantitative data will be summarised as medians (IQR), means (SD) and proportions as appropriate. Mixed-methods analysis will be conducted to assess if the variation in the mean reduction of systolic blood pressure between the intervention CHCs is influenced by patient satisfaction, training outcome, attitude of doctors, patients and NCCs about the intervention, process indicators etc.Ethics and disseminationEthical approval for this study was obtained from the ethics committees at Public Health Foundation of India and Deakin University. Findings will be disseminated via peer-reviewed publications, national and international conference presentations.Trial registration numberNCT03164317; Pre-results.

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