Randomised controlled trial of patient centred care of diabetes in general practice: impact on current wellbeing and future disease risk
Open accessAbstract
OBJECTIVE: To assess the effect of additional training of practice nurses and general practitioners in patient centred care on the lifestyle and psychological and physiological status of patients with newly diagnosed type 2 diabetes. DESIGN: Pragmatic parallel group design, with randomisation between practice teams to routine care (comparison group) or routine care plus additional training (intervention group); analysis at one year, allowing for practice effects and stratifiers; self reporting by patients on communication with practitioners, satisfaction with treatment, style of care, and lifestyle. SETTING: 41 practices (21 in intervention group, 20 in comparison group) in a health region in southern England. SUBJECTS: 250/360 patients (aged 30-70 years) diagnosed with type 2 diabetes and completing follow up at one year (142 in intervention group, 108 in comparison group). INTERVENTION: 1.5 days' group training for the doctors and nurses-introducing evidence for and skills of patient centred care and a patient held booklet encouraging questions. MAIN OUTCOME MEASURES: Quality of life, wellbeing, haemoglobin A1c and lipid concentrations, blood pressure, body mass index (kg/m2). RESULTS: Compared with patients in the C group, those in the intervention group reported better communication with the doctors (odds ratio 2.8; 95% confidence interval 1.8 to 4.3) and greater treatment satisfaction (1.6; 1.1 to 2.5) and wellbeing (difference in means (d) 2.8; 0.4 to 5.2). However, their body mass index was significantly higher (d=2.0; 0.3 to 3.8), as were triglyceride concentrations (d=0.4 mmol/l; 0.07 to 0.73 mmol/l), whereas knowledge scores were lower (d=-2.74; -0.23 to -5.25). Differences in lifestyle and glycaemic control were not significant. CONCLUSIONS: The findings suggest greater attention to the consultation process than to preventive care among trained practitioners; those committed to achieving the benefits of patient centred consulting should not lose the focus on disease management.
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The study was designed to have 90% power to detect a difference of 0.5% in A1C levels, using a two-sample t test (two-sided, α = 0.05), assuming a common SD of 1.5%; 408 patients were required.
“The study was designed to have a 90% power to detect a difference of 0.5% in A1C levels. This was determined using a two-sample t test (two-sided, α = 0.05), assuming a common SD of 1.5%. The estimate of SD in A1C values was inflated from 1.15 to 1.50 because of the clustering effect (18,19). We required a total of 408 patients (204 per study arm) to achieve the specified statistical power.”
From Structured Self-Monitoring of Blood Glucose Significantly Reduces A1C Levels in Poorly Controlled, Noninsulin-Treated Type 2 Diabetes (2011) · cites this paper as [19]
The Statistical analysis and sample size section gives different design figures: 80% power, 100 patients per group, and detection of a 1% haemoglobin A1c difference with an SD of 2.22%. These contradict the attributed 90% power, 0.5% difference, 1.5% SD, and 408-patient requirement. The cited passage does not specify a two-sample t test. (LLM, conf=0.93)
Checked by a reasoning model — may be wrong.
Experimental — accuracy not yet measuredOnly five out of the 22 cluster-randomized studies had the ICC reported.
“Notably, only five (Chenoweth 2009; Kennedy 2004; Kinmonth 1998; Krones 2008; Loh 2007) out of the 22 studies had the ICC reported.”
From Interventions for providers to promote a patient-centred approach in clinical consultations (2012) · cites this paper as Kinmonth 1998
In Kinmonth 1998, patients in the intervention group were more likely to report maximum communication with GPs.
“In Kinmonth 1998, patients in the intervention group were more likely to report maximum communication with GPs; but there was no significant difference between the two groups for agreement between patient and provider on main concerns discussed over the year.”
From Interventions for providers to promote a patient-centred approach in clinical consultations (2012) · cites this paper as Kinmonth 1998
All five studies that measured consultation process outcomes reported at least one consultation process outcome in favour of the intervention.
“and all of these (Brown 2001; Glasgow 2004; Kinmonth 1998; Krones 2008; Loh 2007) reported at least one consultation process outcome in favour of the intervention.”
From Interventions for providers to promote a patient-centred approach in clinical consultations (2012) · cites this paper as Kinmonth 1998
In Kinmonth 1998, there was no significant difference between groups for agreement between patient and provider on main concerns discussed over the year.
“In Kinmonth 1998, patients in the intervention group were more likely to report maximum communication with GPs; but there was no significant difference between the two groups for agreement between patient and provider on main concerns discussed over the year.”
From Interventions for providers to promote a patient-centred approach in clinical consultations (2012) · cites this paper as Kinmonth 1998
Five of the six studies in intervention category 4 assessed between one and three health behaviour outcomes.
“Five of the six studies assessed between one and three outcomes in this category (Brown 2001; Glasgow 2004; Kinmonth 1998; Krones 2008; Loh 2007)”
From Interventions for providers to promote a patient-centred approach in clinical consultations (2012) · cites this paper as Kinmonth 1998
In Kinmonth 1998, average body mass index was higher (worse) in the intervention group compared with the control group.
“However, average blood triglyceride concentrations and average body mass index were both also higher (i.e. worse) in the intervention group compared with the control group.”
From Interventions for providers to promote a patient-centred approach in clinical consultations (2012) · cites this paper as Kinmonth 1998
In Kinmonth 1998, average blood triglyceride concentrations were higher (worse) in the intervention group compared with the control group.
“However, average blood triglyceride concentrations and average body mass index were both also higher (i.e. worse) in the intervention group compared with the control group.”
From Interventions for providers to promote a patient-centred approach in clinical consultations (2012) · cites this paper as Kinmonth 1998
In Kinmonth 1998, there were no significant differences between groups for mean total cholesterol.
“Furthermore, one year after the intervention, there were no significant differences between the intervention and the control group for mean glycated haemoglobin concentrations; mean total cholesterol; and for mean systolic and diastolic blood pressure.”
From Interventions for providers to promote a patient-centred approach in clinical consultations (2012) · cites this paper as Kinmonth 1998
In Kinmonth 1998, there was no difference in satisfaction with style of care.
“Patients in the intervention group were more likely than control patients to report high satisfaction with treatment at one year, but there was no difference in satisfaction with style of care.”
From Interventions for providers to promote a patient-centred approach in clinical consultations (2012) · cites this paper as Kinmonth 1998
In Kinmonth 1998, there was no difference in the three health behaviours assessed.
“Alternatively, Kinmonth 1998 found no difference in the three behaviours they assessed, and Glasgow 2004 did not report statistical testing for the two outcomes they assessed.”
From Interventions for providers to promote a patient-centred approach in clinical consultations (2012) · cites this paper as Kinmonth 1998
In Kinmonth 1998, patients in the intervention group were more likely than control patients to report high satisfaction with treatment at one year.
“Patients in the intervention group were more likely than control patients to report high satisfaction with treatment at one year, but there was no difference in satisfaction with style of care.”
From Interventions for providers to promote a patient-centred approach in clinical consultations (2012) · cites this paper as Kinmonth 1998
In Kinmonth 1998, one year after the intervention, there were no significant differences between groups for mean glycated haemoglobin concentrations.
“Furthermore, one year after the intervention, there were no significant differences between the intervention and the control group for mean glycated haemoglobin concentrations; mean total cholesterol; and for mean systolic and diastolic blood pressure.”
From Interventions for providers to promote a patient-centred approach in clinical consultations (2012) · cites this paper as Kinmonth 1998
The intervention resulted in at least one positive outcome in three of the six studies (Brown 2001; Dijkstra 2006; Kinmonth 1998).
“the intervention resulted in at least one positive outcome in three of these studies (Brown 2001; Dijkstra 2006; Kinmonth 1998).”
From Interventions for providers to promote a patient-centred approach in clinical consultations (2012) · cites this paper as Kinmonth 1998
Four of the six studies in intervention category 4 assessed satisfaction.
“Four of the six studies assessed this outcome (Glasgow 2004; Kinmonth 1998; Krones 2008; Loh 2007)”
From Interventions for providers to promote a patient-centred approach in clinical consultations (2012) · cites this paper as Kinmonth 1998
In Kinmonth 1998, one year after the intervention, overall well being scores were significantly higher in the intervention group.
“One year after the intervention, overall well being scores were significantly higher in the intervention group.”
From Interventions for providers to promote a patient-centred approach in clinical consultations (2012) · cites this paper as Kinmonth 1998
Kinmonth 1998 was at high risk of attrition bias because of missing patient data, despite intention-to-treat analysis.
“Incomplete outcome data (attrition bias) All outcomes High risk Attrition rate was minimal for practices 1/22 (4.5%) intervention and 1/21 (4.8%) control; but 57/199 (28.6%) intervention patients and 53/161 (32.9%) control patients had some missing data after 1 year. Analysis was by intention to treat (but tables included only those with complete data)”
From Interventions for providers to promote a patient-centred approach in clinical consultations (2012) · cites this paper as Kinmonth 1998
Random sequence generation in Kinmonth 1998 was low risk because of initial stratified random allocation of practices by computer.
“Random sequence generation (selection bias) Low risk”
From Interventions for providers to promote a patient-centred approach in clinical consultations (2012) · cites this paper as Kinmonth 1998
Allocation concealment in Kinmonth 1998 was low risk (blind and secure).
“Allocation procedure: Blind and secure”
From Interventions for providers to promote a patient-centred approach in clinical consultations (2012) · cites this paper as Kinmonth 1998
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- Authors
- Kinmonth, A. L., Woodcock, A., Griffin, S., Spiegal, N., & Campbell, M. J.
- Affiliations
- University of Southampton (GB)
- University of Cambridge (GB)
- Corresponding author
- Kinmonth, A. L.
- ORCID
- Campbell, M. J
- Venue
- BMJ
- Publisher
- BMJ
- Published
- 1998-10-31
- Volume
- 317
- Issue
- 7167
- Pages
- 1202-1208
- ISSN
- 0007-1447 (ISSN-L)
- 0959-8138
- 1468-5833
- PMC
- PMC28704
- OpenAlex
- W2124794946
- Cited by
- 474
- References
- 32
- Citations by year
- 2026: 4 · 2025: 3 · 2024: 5 · 2023: 7 · 2022: 11 · 2021: 13 · 2020: 10 · 2019: 16 · 2018: 13 · 2017: 14 · 2016: 17 · 2015: 12 · 2014: 20 · 2013: 28 · 2012: 25
- FWCI
- 11.63
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- BMJ (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- HighWire Press Open Archive (submittedVersion)
- Funders
- Wellcome Trust
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
- Health Sciences › Health Professions › General Health Professions › Patient-Provider Communication in Healthcare
- Health Sciences › Health Professions › General Health Professions › Primary Care and Health Outcomes
- Keywords
- patient-centered care, type 2 diabetes, newly diagnosed diabetes, general practice, general practice training, patient communication, treatment satisfaction, quality of life, well-being, glycemic control, HbA1c, lipid concentration, blood pressure, body mass index, lifestyle, disease risk
- MeSH terms
- Adult, Aged, Communication, Diabetes Mellitus, Type 2, England, Family Practice, Health Status, Humans, Life Style, Mental Health, Middle Aged, Nurse Practitioners, Nurse-Patient Relations, Physician-Patient Relations, Treatment Outcome, Patient Satisfaction, Risk Assessment, Patient-Centered Care
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