Investigating the usefulness of Automated Check-in Data Collection in general practice (AC DC Study): a multicentre, cross-sectional study in England.

Objectives: To investigate the usefulness of using automated appointment check-in screens to collect brief research data from patients, prior to their general practice consultation.Design: A descriptive, cross-sectional study.Setting: Nine general practices in the West Midlands, UK. Recruitment commenced in Autumn 2018 and was concluded by 31 March 2019.Participants: All patients aged 18 years and above, self-completing an automated check-in screen prior to their general practice consultation, were invited to participate during a 3-week recruitment period.Primary and secondary outcome measures:The response rate to the use of the automated check-in screen as a research data collection tool was the primary outcome measure. Secondary outcomes included responses to the two research questions and an assessment of impact of check-in completion on general practice operationalisationResults: Over 85% (n=9274) of patients self-completing an automated check-in screen participated in the Automated Check-in Data Collection Study (61.0% (n=5653) women, mean age 55.1 years (range 18–98 years, SD=18.5)). 96.2% (n=8922) of participants answered a ‘clinical’ research question, reporting the degree of bodily pain experienced during the past 4 weeks: 32.9% (n=2937) experienced no pain, 28.1% (n=2507) very mild or mild pain and 39.0% (n=3478) moderate, severe or very severe pain. 89.3% (n=8285) of participants answered a ‘non-clinical’ research question on contact regarding future research studies: 46.9% (n=3889) of participants responded ‘Yes, I’d be happy for you to contact me about research of relevance to me’.Conclusions: Using automated check-in facilities to integrate research into routine general practice is a potentially useful way to collect brief research data from patients. With the COVID-19 pandemic initiating an extensive digital transformation in society, now is an ideal time to build on these opportunities and investigate alternative, innovative ways to collect research data.Trial registration number ISRCTN82531292

Development and validation of a pain monitoring app for patients with musculoskeletal conditions (The Keele pain recorder feasibility study)

Background: Assessing daily change in pain and related symptoms help in diagnosis, prognosis, and monitoring response to treatment. However, such changes are infrequently assessed, and usually reviewed weeks or months after the start of treatment. We therefore developed a smartphone application (Keele Pain Recorder) to record information on the severity and impact of pain on daily life. Specifically, the study goal was to assess face, content and construct validity of data collection using the Pain Recorder in primary care patients receiving new analgesic prescriptions for musculoskeletal pain, as well as to assess its acceptability and clinical utility. Methods: The app was developed with Keele’s Research User Group (RUG), a clinical advisory group (CAG) and software developer for use on Android devices. The app recorded pain levels, interference, sleep disturbance, analgesic use, mood and side effects. In a feasibility study, patients aged > 18 attending their general practitioner (GP) with a painful musculoskeletal condition were recruited to use the app twice per day for 28 days. Face and construct validity were assessed through baseline and post-study questionnaires (Spearman’s rank correlation coefficient). Usability and acceptability were determined through post-study questionnaires, and patient, GP, RUG and CAG interviews. Results: An app was developed which was liked by both patients and GPs. It was felt that it offered the opportunity for GPs to discuss pain control with their patients in a new way. All participants found the app easy to use (it did not interfere with their activities) and results easy to interpret. Strong associations existed between the first 3 days (Spearman r = 0.79) and last 3 days (r = 0.60) of pain levels and intensity scores on the app with the validated questionnaires. Conclusions: Collaborating with patient representatives and clinical stakeholders, we developed an app which can be used to help clinicians and patients monitor painful musculoskeletal conditions in response to analgesic prescribing. Recordings were accurate and valid, especially, for pain intensity ratings, and it was easy to use. Future work needs to examine how pain trajectories can help manage changes in a patient’s condition, ultimately assisting in self-management

Integrating case-finding and initial management for osteoarthritis, anxiety, and depression into primary care long-term condition reviews: results from the ENHANCE pilot trial.

Background: Multimorbidity is increasingly the norm; however, primary care remains focused on single diseases. Osteoarthritis, anxiety, and depression are frequently comorbid with other long-term conditions (LTCs), but rarely prioritized by clinicians.Objectives: To test the feasibility of a randomized controlled trial (RCT) of an intervention integrating case-finding and management for osteoarthritis, anxiety, and depression within LTC reviews.Methods: A pilot stepped-wedge RCT across 4 general practices recruited patients aged >= A5 years attending routine LTC reviews. General practice nurses provided usual LTC reviews (control period), then, following training, delivered the ENHANCE LTC review (intervention period). Questionnaires, an ENHANCE EMIS-embedded template and consultation audio-recordings, were used in the evaluation.Results: General practice recruitment and training attendance reached prespecified success criteria. Three hundred and eighteen of 466 (68%) of patients invited responded; however, more patients were recruited during the control period (206 control, 112 intervention). Eighty-two percent and 78% returned their 6-week and 6-month questionnaires, respectively. Integration of the ENHANCE LTC review into routine LTC reviews varied. Case-finding questions were generally used as intended for joint pain, but to a lesser extent for anxiety and depression. Initial management through referrals and signposting were lacking, and advice was more frequently provided for joint pain. The stepped-wedge design meant timing of the training was challenging and yielded differential recruitment.Conclusion: This pilot trial suggests that it is feasible to deliver a fully powered trial in primary care. Areas to optimize include improving the training and reconsidering the stepped-wedge design and the approach to recruitment by targeting those with greatest need

Improving the care of people with long-term conditions in primary care: protocol for the ENHANCE pilot trial

Background:Long-term conditions (LTCs) are important determinants of quality of life and healthcare expenditure worldwide. Whilst multimorbidity is increasingly the norm in primary care, clinical guidelines and the delivery of care remain focused on single diseases, resulting in poorer clinical outcomes. Osteoarthritis, and anxiety and/or depression frequently co-occur with other LTCs, yet are seldom prioritized by the patient or clinician, resulting in higher levels of disability, poorer prognosis, and increased healthcare costs.Objective: To examine the feasibility and acceptability of an integrated approach to LTC management, tackling the underdiagnosis and under-management of osteoarthritis-related pain and anxiety and/or depression in older adults with other LTCs in primary care.Design: The ENHANCE study is a pilot stepped-wedge cluster randomized controlled trial to test the feasibility and acceptability of a nurse-led ENHANCE LTC review consultation for identifying, assessing, and managing joint pain, and anxiety and/or depression in patients attending LTCreviews. Specific objectives (process evaluation and research outcomes) will be achieved through a theoretically informed mixed-methods approach using participant self-reported questionnaires, a medical record review, an ENHANCE EMIS template, qualitative interviews, and audio recordings of the ENHANCE LTC review.Discussion: Success of the pilot trial will be measured against the level of the primary care team engagement, assessment of training delivery, and degree of patient recruitment and retention. Patient satisfaction and treatment fidelity will also be explored

A pilot study of a nurse-led integrated care review (the INCLUDE review) for people with inflammatory rheumatological conditions in primary care: feasibility study findings.

BACKGROUND: People with inflammatory rheumatological conditions such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, polymyalgia rheumatica and giant cell arteritis are at an increased risk of common comorbidities including cardiovascular disease, osteoporosis and mood problems, leading to increased morbidity and mortality. Identifying and treating these problems could lead to improved patient quality of life and outcomes. Despite these risks being well-established, patients currently are not systematically targeted for management interventions for these morbidities. This study aimed to assess the feasibility of conducting a randomised controlled trial (RCT) of a nurse-led integrated care review in primary care to identify and manage these morbidities. METHODS: A pilot cluster RCT was delivered across four UK general practices. Patients with a diagnostic Read code for one of the inflammatory rheumatological conditions of interest were recruited by post. In intervention practices (n = 2), eligible patients were invited to attend the INCLUDE review. Outcome measures included health-related quality of life (EQ-5D-5L), patient activation, self-efficacy and treatment burden. A sample (n = 24) of INCLUDE review consultations were audio-recorded and assessed against a fidelity checklist. RESULTS: 453/789 (57%) patients responded to the invitation, although 114/453 (25%) were excluded as they either did not fulfil eligibility criteria or failed to provide full written consent. In the intervention practices, uptake of the INCLUDE review was high at 72%. Retention at 3 and 6?months both reached pre-specified success criteria. Participants in intervention practices had more primary care contacts than controls (mean 29 vs 22) over the 12?months, with higher prescribing of all relevant medication classes in participants in intervention practices, particularly so for osteoporosis medication (baseline 29% vs 12?month 46%). The intervention was delivered with fidelity, although potential areas for improvement were identified. CONCLUSIONS: The findings of this pilot study suggest it is feasible to deliver an RCT of the nurse-led integrated care (INCLUDE) review in primary care. A significant morbidity burden was identified. Early results suggest the INCLUDE review was associated with changes in practice. Lessons have been learnt around Read codes for patient identification and refining the nurse training. TRIAL REGISTRATION: ISRCTN, ISRCTN12765345

The assessment of the prognosis of musculoskeletal conditions in older adults presenting to general practice: a research protocol

BACKGROUND: Musculoskeletal conditions represent a common reason for consulting general practice yet with the exception of low back pain, relatively little is known about the prognosis of these disorders. Recent evidence suggests that common 'generic' factors may be of value when assessing prognosis, irrespective of the location of the pain. This study will test a generic assessment tool used as part of the general practice consultation to determine prognosis of musculoskeletal complaints. METHODS/DESIGN: Older adults (aged 50 years and over) presenting to six general practices with musculoskeletal complaints will be assessed as part of the routine consultation using a generic assessment of prognosis. Participants will receive a self-completion questionnaire at baseline, three, six and 12 months post consultation to gather further data on pain, disability and psychological status. The primary outcome measure is participant's global rating of change. DISCUSSION: Prognosis is considered to be a fundamental component of scientific medicine yet prognostic research in primary care settings is currently neglected and prognostic enquiry is disappearing from general medical textbooks. This study aims to address this issue by examining the use of generic prognostic factors in a general practice setting

Predicting pain and function outcomes in people consulting with shoulder pain: the PANDA-S clinical cohort and qualitative study protocol

Introduction: People presenting with shoulder pain considered to be of musculoskeletal origin is common in primary care but diagnosing the cause of the pain is contentious, leading to uncertainty in management. To inform optimal primary care for patients with shoulder pain, the study aims to (1) to investigate the short-term and long-term outcomes (overall prognosis) of shoulder pain, (2) estimate costs of care, (3) develop a prognostic model for predicting individuals' level and risk of pain and disability at 6 months and (4) investigate experiences and opinions of patients and healthcare professionals regarding diagnosis, prognosis and management of shoulder pain. Methods and analysis: The Prognostic And Diagnostic Assessment of the Shoulder (PANDA-S) study is a longitudinal clinical cohort with linked qualitative study. At least 400 people presenting to general practice and physiotherapy services in the UK will be recruited. Participants will complete questionnaires at baseline, 3, 6, 12, 24 and 36 months. Short-term data will be collected weekly between baseline and 12 weeks via Short Message Serevice (SMS) text or software application. Participants will be offered clinical (physiotherapist) and ultrasound (sonographer) assessments at baseline. Qualitative interviews with ≈15 dyads of patients and their healthcare professional (general practitioner or physiotherapist).Short-term and long-term trajectories of Shoulder Pain and Disability Index (using SPADI) will be described, using latent class growth analysis. Health economic analysis will estimate direct costs of care and indirect costs related to work absence and productivity losses. Multivariable regression analysis will be used to develop a prognostic model predicting future levels of pain and disability at 6 months using penalisation methods to adjust for overfitting. The added predictive value of prespecified physical examination tests and ultrasound findings will be examined. For the qualitative interviews an inductive, exploratory framework will be adopted using thematic analysis to investigate decision making, perspectives of patients and clinicians on the importance of diagnostic and prognostic information when negotiating treatment and referral options. Ethics and dissemination: The PANDA-S study has ethical approval from Yorkshire and The Humber-Sheffield Research Ethics Committee, UK (18/YH/0346, IRAS Number: 242750). Results will be disseminated through peer-reviewed publications, social and mainstream media, professional conferences, and the patient and public involvement and engagement group supporting this study, and through newsletters, leaflets and posters in participating sites

Innovative methods for optimising clinical trial recruitment and retention within primary care

BackgroundRecruiting patients to research and collecting study data in a primary care setting, combined with maximising retention rates from a primary care population can be challenging and requires recruitment and retention methods which are innovative, efficient and transferrable.ObjectiveTo apply low resource intensive and rapidly implemented recruitment and retention innovations for use in primary care settings that ensure patient recruitment and follow-up targets are achieved.MethodsA range of innovative recruitment and retention strategies are utilised by Keele CTU including; electronic aide-memoires linked to Read codes; physical aide-memoire prompts in consulting rooms; automated referral methods; postcard, repeat, email, SMS and minimum data collection reminder mailings; death and departure auditing.ResultsMethods used; sustain routine care whilst simultaneously screening for research data and participants; provide flexible instruments compatible with all general practice infrastructures; increase clinical precision in identifying suitable participants; automates recording of study data collection; ensures minimal impact on consultation time; contribute towards the delivery of excellent retention rates.ConclusionsRecruitment aide-memoires, automated innovations and retention strategies can all be embedded easily into a primary care setting. These tools, without over burdening the busy primary care practitioner, result in simple and effective methods of prompting patient recruitment and retention. Excellent recruitment and retention rates are possible, despite encountering differences in primary care infrastructure. Such methods should be utilised more widely to facilitate primary care research, if this is where many conditions are diagnosed and managed

Development and validation of a pain monitoring app for patients with musculoskeletal conditions (The Keele pain recorder feasibility study)

Abstract Background Assessing daily change in pain and related symptoms help in diagnosis, prognosis, and monitoring response to treatment. However, such changes are infrequently assessed, and usually reviewed weeks or months after the start of treatment. We therefore developed a smartphone application (Keele Pain Recorder) to record information on the severity and impact of pain on daily life. Specifically, the study goal was to assess face, content and construct validity of data collection using the Pain Recorder in primary care patients receiving new analgesic prescriptions for musculoskeletal pain, as well as to assess its acceptability and clinical utility. Methods The app was developed with Keele’s Research User Group (RUG), a clinical advisory group (CAG) and software developer for use on Android devices. The app recorded pain levels, interference, sleep disturbance, analgesic use, mood and side effects. In a feasibility study, patients aged > 18 attending their general practitioner (GP) with a painful musculoskeletal condition were recruited to use the app twice per day for 28 days. Face and construct validity were assessed through baseline and post-study questionnaires (Spearman’s rank correlation coefficient). Usability and acceptability were determined through post-study questionnaires, and patient, GP, RUG and CAG interviews. Results An app was developed which was liked by both patients and GPs. It was felt that it offered the opportunity for GPs to discuss pain control with their patients in a new way. All participants found the app easy to use (it did not interfere with their activities) and results easy to interpret. Strong associations existed between the first 3 days (Spearman r = 0.79) and last 3 days (r = 0.60) of pain levels and intensity scores on the app with the validated questionnaires. Conclusions Collaborating with patient representatives and clinical stakeholders, we developed an app which can be used to help clinicians and patients monitor painful musculoskeletal conditions in response to analgesic prescribing. Recordings were accurate and valid, especially, for pain intensity ratings, and it was easy to use. Future work needs to examine how pain trajectories can help manage changes in a patient’s condition, ultimately assisting in self-management