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Two-year longitudinal analysis of a cluster randomized trial of physical activity promotion by general practitioners.

ABSTRACT: We evaluate the effectiveness of a physical activity promotion programme carried out by general practitioners with inactive patients in routine care.Pragmatic, cluster randomised clinical trial conducted in eleven public primary care centres in Spain. Fifty-six general practitioners (GPs) were randomly assigned to intervention (29) or standard care (27) groups. They assessed the physical activity level of a systematic sample of patients in routine practice and recruited 4317 individuals (2248 intervention and 2069 control) who did not meet minimum physical activity recommendations. Intervention GPs provided advice to all patients and a physical activity prescription to the subgroup attending an additional appointment (30%). A third of these prescriptions were opportunistically repeated. Control GPs provided standard care. Primary outcome measure was the change in self-reported physical activity from baseline to six, 12 and 24 months. Secondary outcomes included cardiorespiratory fitness and health-related quality of life. A total of 3691 patients (85%) were included in the longitudinal analysis and overall trends over the whole 24 month follow-up were significantly better in the intervention group (p<0.01). The greatest differences with the control group were observed at six months (adjusted difference 1.7 MET*hr/wk [95% CI, 0.8 to 2.6], 25 min/wk [95% CI, 11.3 to 38.4], and a 5.3% higher percentage of patients meeting minimum recommendations [95% CI: 2.1% to 8.8%] NNT = 19). These differences were not statistically significant at 12 and 24 months. No differences were found in secondary outcomes. A significant difference was maintained until 24 months in the proportion of patients achieving minimum recommendation in the subgroup that received a repeat prescription (adjusted difference 10.2%, 95% CI 1.5% to 19.4%).General practitioners are effective at increasing the level of physical activity among their inactive patients during the initial six-months of an intervention but this effect wears off at 12 and 24 months. Only in the subgroup of patients receiving repeat prescriptions of physical activity is the effect maintained in long-term.clinicaltrials.gov NCT00131079.

SUBMITTER: Grandes G

PROVIDER: S-EPMC3066231 | biostudies-literature | 2011 Mar

REPOSITORIES: biostudies-literature

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Two-year longitudinal analysis of a cluster randomized trial of physical activity promotion by general practitioners.

Grandes Gonzalo G Sanchez Alvaro A Montoya Imanol I Ortega Sanchez-Pinilla Ricardo R Torcal Jesús J

PloS one 20110329 3

<h4>Background</h4>We evaluate the effectiveness of a physical activity promotion programme carried out by general practitioners with inactive patients in routine care.<h4>Methods and findings</h4>Pragmatic, cluster randomised clinical trial conducted in eleven public primary care centres in Spain. Fifty-six general practitioners (GPs) were randomly assigned to intervention (29) or standard care (27) groups. They assessed the physical activity level of a systematic sample of patients in routine ...[more]

PMID: 21479243

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Project description:BackgroundMuch research worldwide is focussed on cost containment and better adherence to guidelines in healthcare. The research focussing on professional behaviour is often performed in a well-controlled research setting. In this study a large-scale implementation of a peer review strategy was tested on both test ordering and prescribing behaviour in primary care in the normal quality improvement setting.MethodsWe planned a cluster-RCT in existing local quality improvement collaboratives (LQICs) in primary care. The study ran from January 2008 to January 2011. LQICs were randomly assigned to one of two trial arms, with each arm receiving the same intervention of audit and feedback combined with peer review. Both arms were offered five different clinical topics and acted as blind controls for the other arm. The differences in test ordering rates and prescribing rates between both arms were analysed in an intention-to-treat pre-post analysis and a per-protocol analysis.ResultsTwenty-one LQIC groups, including 197 GPs working in 88 practices, entered the trial. The intention-to-treat analysis did not show a difference in the changes in test ordering or prescribing performance between intervention and control groups. The per-protocol analysis showed positive results for half of the clinical topics. The increase in total tests ordered was 3% in the intervention arm and 15% in the control arm. For prescribing the increase in prescriptions was 20% in the intervention arm and 66% in the control group. It was observed that the groups with the highest baseline test ordering and prescription volumes showed the largest improvements.ConclusionsOur study shows that the results from earlier work could not be confirmed by our attempt to implement the strategy in the field. We did not see a decrease in the volumes of tests ordered or of the drugs prescribed but were able to show a lesser increase instead. Implementing the peer review with audit and feedback proved to be not feasible in primary care in the Netherlands.Trial registrationThis trial was registered at the Dutch trial register under number ISRCTN40008171 on August 7th 2007.

Project description:Background & aimsChild growth impairments are rampant in sub-Saharan Africa. To combat this important health problem, long-term follow-up studies are needed to examine possible benefits and sustainability of various interventions designed to correct inadequate child growth. Our aim was to perform a follow-up study of children aged 60-72 months whose mothers participated in a two-armed cluster-randomized education intervention trial lasting 6 months in rural Uganda when their children were 6-8 months old with data collection at 20-24 and at 36 months. The education focused on nutrition, hygiene, and child stimulation.MethodsWe measured growth using anthropometry converted to z-scores according to WHO guidelines. We also included assessments of body composition using bioimpedance. We used multilevel mixed effect linear regression models with maximum likelihood method, unstructured variance-covariance structure, and the cluster as a random effect component to compare data from the intervention (receiving the education and routine health care) with the control group (receiving only routine health care).ResultsOf the 511 children included in the original trial, data from 166/263 (63%) and 141/248 (57%) of the children in the intervention and control group, respectively, were available for the current follow-up study. We found no significant differences in any anthropometrical z-score between the two study groups at child age of 60-72 months, except that children in the intervention group had lower (P = 0.006) weight-for-height z-score than the controls. There were no significant differences in the trajectories of z-scores or height growth velocity (cm/year) from baseline (start of original trial) to child age of 60-72 months. Neither did we detect any significant difference between the intervention and control group regarding body composition (fat mass, fat free mass, and total body water) at child age 60-72 months. Separate gender analyses had no significant impact on any of the growth or body composition findings.ConclusionIn this long-term study of children participating in a randomized maternal education trial, we found no significant impact of the intervention on anthropometrical z-scores, height growth velocity or body composition.Trial registrationClinical Trials (clinical trials.gov) ClinicalTrials.gov ID NCT02098031.

Project description:BACKGROUND:For a decade, experts have suggested integrating mental health care into primary care to help bridge mental health Treatment Gap. General Practitioners (GPs) are the first port-of-call for many patients with mental ill-health. In Indonesia, the WHO mhGAP is being systematically introduced to its network of 10,000 primary care clinics as an add-on mental health training for pairs of GPs and Nurses, since the end of 2015. In one of 34 provinces, there exists an integrated care model: the co-location of clinical psychologists in primary care clinics. This trial evaluates patient outcomes among those provided mental health care by GPs with those treated by clinical psychologists in primary care. METHODS:In this partially-randomised, pragmatic, two-arm cluster non-inferiority trial, 14 primary care clinics were assigned to receive the WHO mhGAP training and 14 clinics with the co-location framework were assigned to the Specialist arm. Participants (patients) were blinded to the existence of the other pathway, and outcome assessors were blinded to group assignment. All adult primary care patients who screened positive for psychiatric morbidity were eligible. GPs offered psychosocial and/or pharmacological interventions and Clinical Psychologists offered psychosocial interventions. The primary outcome was health and social functioning as measured by the HoNOS and secondary outcomes include disability measured by WHODAS 2.0, health-related quality of life measured by EQ-5D-3L, and resource use and costs evaluated from a health services perspective, at six months. RESULTS:153 patients completed the outcome assessment following GP care alongside 141 patients following Clinical Psychologists care. Outcomes of GP care were proven to be statistically not inferior to Clinical Psychologists in reducing symptoms of social and physical impairment, reducing disability, and improving health-related quality of life at six months. Economic analyses indicate lower costs and better outcomes in the Specialist arm and suggest a 50% probability of WHO mhGAP framework being cost-effective at the Indonesian willingness to pay threshold per QALY. CONCLUSION:General Practitioners supported by nurses in primary care clinics could effectively manage mild to moderate mental health issues commonly found among primary care patients. They provide non-stigmatising mental health care within community context, helping to reduce the mental health Treatment Gap. TRIAL REGISTRATION:ClinicalTrials.gov NCT02700490.

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Two-year longitudinal analysis of a cluster randomized trial of physical activity promotion by general practitioners.

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Two-year longitudinal analysis of a cluster randomized trial of physical activity promotion by general practitioners.

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