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Developing evidence based blood tests to monitor long term conditions in GP practices

The clinical and cost-effectiveness of an evidence-based testing package to monitor long term conditions (LTC) in primary care: the “Test Smart” cluster randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN31106231
Enrollment
20
Registered
2024-11-13
Start date
2025-09-01
Completion date
Unknown
Last updated
2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Optimising blood tests for monitoring hypertension, chronic kidney disease and type 2 diabetes Other

Interventions

GP practices will be randomised to the Test Smart intervention or to the control on a 1:1 basis. Randomisation will be at the practice level and will be stratified by ICB. The Test Smart intervention

Sponsors

University of Bristol
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 110 Years

Inclusion criteria

Inclusion criteria: Current key inclusion criteria as of 20/02/2026: GP practices in England will be eligible if they meet all the following criteria: 1. Located in the specified recruitment area. 2. Use Accurx text messaging software (98% of English practices use this system). 3. Practice staff willing to take part in qualitative interviews. 4. Phlebotomy is conducted either at the practice level or at an external hub, provided that all monitoring test decisions are made by a healthcare professional at the study site. 5. Practices that have existing LTC monitoring panels that include at least one additional test group beyond those in the Test Smart panels. Patients will be eligible for recruitment to provide patient-reported outcomes if they are: 1. Aged 18 or over. 2. Registered at a participating practice and diagnosed with hypertension, and/or chronic kidney disease and/or type 2 diabetes at the start of the study period. 3. Attend for routine monitoring during the study period. Previous inclusion criteria as of 31/07/2025: GP practices in England will be eligible if they meet all the following criteria: 1. Located in the specified recruitment area. 2. Use Accurx text messaging software (98% of English practices use this system). 3. Practice staff willing to take part in qualitative interviews. 4. Phlebotomy is conducted at the practice level rather than via referral to a central location. 5. Practices that have existing LTC monitoring panels that include at least one additional test group beyond those in the Test Smart panels. Patients will be eligible for recruitment to provide patient-reported outcomes if they are: 1. Aged 18 or over. 2. Registered at a participating practice and diagnosed with hypertension, and/or chronic kidney disease and/or type 2 diabetes at the start of the study period. 3. Attend for routine monitoring during the study period. Previous inclusion criteria: GP practices in England will be eligible if they meet all the following criteria: 1. Located in the specified recruitment area. 2. Use Accurx text messaging software (98% of English practices use this system). 3. Practice staff willing to take part in qualitative interviews. 4. Phlebotomy is conducted at the practice level rather than via referral to a central location. Patients will be eligible for recruitment to provide patient-reported outcomes if they are: 1. Aged 18 or over. 2. Registered at a participating practice and diagnosed with hypertension, and/or chronic kidney disease and/or type 2 diabetes at the start of the study period. 3. Attend for routine monitoring during the study period.

Exclusion criteria

Exclusion criteria: Current exclusion criteria as of 31/07/2025: We will exclude practices meeting any of the following criteria: 1. Practices that currently use standardised testing protocols for LTC, and have equivalent testing panels as those in the Test Smart study. 2. Practices that currently use standardised communication protocols for LTC. 3. Practices that regularly use point of care (PoC) testing for LTC monitoring (eg PoC HbA1c testing). PoC tests would not be captured in our testing data and may replace laboratory testing and therefore data from these practices would not be comparable. 4. Practices that decline to provide a practice champion. Patients will be excluded if they are: 1. Unable to understand written English or one of the two other study languages sufficiently to complete a questionnaire. The other study languages will be selected based on those most commonly spoken in the GP practices recruited to the study. 2. Decline consent or are unable to consent. 3. Have previously declined to be contacted for research purposes. Previous exclusion criteria: GP practices will be excluded if they meet any of the following criteria: 1. Practices that currently use standardised testing protocols for LTC. 2. Practices that currently use standardised communication protocols for LTC. 3. Practices that regularly use point of care (PoC) testing for LTC monitoring (eg PoC HbA1c testing). PoC tests would not be captured in our testing data and may replace laboratory testing and therefore data from these practices would not be comparable. 4. Practices that decline to provide a practice champion. Patients will be excluded if they are: 1. Unable to understand written English or one of the two other study languages sufficiently to complete a questionnaire. The other study languages will be selected based on those most commonly spoken in the GP practices recruited to the study. 2. Decline consent or are unable to consent. 3. Have previously declined to be contacted for research purposes.

Design outcomes

Primary

MeasureTime frame
1. Monthly practice-level blood testing rates are measured via automated searches of the primary care electronic health records in the 12 months prior to implementation and 12 months post implementation. 2. Patient activation is measured using the Patient Activation Measure (PAM) 1 week prior to the first long-term condition monitoring appointment, 2 weeks post-appointment, and 6 months post-appointment.

Secondary

MeasureTime frame
1. Serious Adverse Events (hospital admissions and significant harm events attributed to lack of testing) measured using GP records and laboratory records 6 months post-appointment. 2. Patient satisfaction measured using the NHS Friends and Family test at 1 week prior to the first long-term condition monitoring appointment, 2 weeks post-appointment, and 6 months post-appointment. 3. Patient understanding of test results measured using Questionnaire 3: Your blood test results (adapted from Ballets study) at 1 week prior to the first long-term condition monitoring appointment, 2 weeks post-appointment, and 6 months post-appointment. 4. Acceptability measured through qualitative interviews with health-care professionals (HCPs) and patients. Fidelity measured using GP records 12 months post implementation. 5. Cost-effectiveness measured using GP records at the end of the study. 6. Barriers and facilitators to the widespread adoption, integration and sustainability of the Test Smart intervention measured through qualitative interviews with health-care professionals (HCPs) at the end of the study.

Countries

England, United Kingdom

Contacts

Public ContactIsobel Lindsay-Wiles
info-test-smart-study@bristol.ac.uk+44 1174558748

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 17, 2026