Dataset Information

Enhancing field GP engagement in hospital-based studies. Rationale, design, main results and participation in the Diagest 3-GP motivation study.

ABSTRACT:

Background

Diagest 3 was a study aimed at lowering the risk of developing type 2 diabetes within 3?years after childbirth. Women with gestational diabetes were enrolled in the study. After childbirth, the subjects showed little interest in the structured education programme and did not attend workshops. Their general practitioners (GPs) were approached to help motivate the subjects to participate in Diagest 3, but the GPs were reluctant. The present study aimed to understand field GPs' attitudes towards hospital-based studies, and to develop strategies to enhance their involvement and reduce subject drop-out rates.

Methods

We used a three-step process: step one used a phenomenological approach exploring the beliefs, attitudes, motivations and environmental factors contributing to the GPs' level of interest in the study. Data were collected in face-to-face interviews and coded by hand and with hermeneutic software to develop distinct GP profiles. Step two was a cross-sectional survey by questionnaire to determine the distribution of the profiles in the GP study population and whether completion of an attached case report form (CRF) was associated with a particular GP profile. In step three, we assessed the impact of the motivation study on participation rates in the main study.

Results

Fifteen interviews were conducted to achieve data saturation. Theorisation led to the definition of 4 distinct GP profiles. The response rate to the questionnaire was 73%, but dropped to 52% when a CRF was attached. The link between GP profiles and the rate of CRF completion remains to be verified. The GPs provided data on the CRF that was of comparable quality to those collected in the main trial. Our analysis showed that the motivation study increased overall participation in the main study by 23%, accounting for 16% (24/152) of all final visits for 536 patients who were initially enrolled in the Diagest 3 study.

Conclusions

When a hospital-led study explores issues in primary care, its design must anticipate GP participation early in the trial. Based on our questionnaire response rates, we found that one in two GPs were willing to participate in our hospital-led study, regardless of their initial attitudes.

SUBMITTER: Berkhout C

PROVIDER: S-EPMC3441219 | biostudies-literature | 2012 Jun

REPOSITORIES: biostudies-literature

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Publications

Enhancing field GP engagement in hospital-based studies. Rationale, design, main results and participation in the Diagest 3-GP motivation study.

Berkhout Christophe C Vandaele-Bétancourt Marie M Robert Stéphane S Lespinasse Solène S Mitha Gamil G Bradier Quentin Q Vambergue Anne A Fontaine Pierre P

BMC family practice 20120621

<h4>Background</h4>Diagest 3 was a study aimed at lowering the risk of developing type 2 diabetes within 3 years after childbirth. Women with gestational diabetes were enrolled in the study. After childbirth, the subjects showed little interest in the structured education programme and did not attend workshops. Their general practitioners (GPs) were approached to help motivate the subjects to participate in Diagest 3, but the GPs were reluctant. The present study aimed to understand field GPs' a ...[more]

PMID: 22721372

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Project description:OBJECTIVE:The 340B program allows safety-net hospitals to acquire discounted outpatient drugs and charge payers full price. We examined whether 340B participation increases safety-net engagement. DATA SOURCES:340B participation data, Medicare hospital cost reports, American Hospital Association Survey, and Schedule 990 nonprofit hospital tax returns. STUDY DESIGN:Quasi-experimental difference-in-differences design comparing 340B hospitals (the "treatment" group) before and after participating to changes over time to three alternative "control" groups: all other nonprofit and public hospitals, hospitals that are not participating during our study, and hospitals that were not-yet-participating but started after 2015. Outcome measures include a range of safety-net care measures that are alternatives to the standard uncompensated care: charity care, community benefit spending, charity care policies, and low-profit service-line provision. DATA EXTRACTION:We extracted data on all nonprofit and public hospitals from 2011 to 2015. We linked 340B participation data to Medicare hospital cost reports and American Hospital Association data using Medicare hospital identifiers. 990 Data was linked on name and address. PRINCIPAL FINDINGS:New 340B participation was not associated with a change in uncompensated care, but was associated with a 28.9 percent increase in charity care spending (SE = 8.8), or about $880,000 per hospital. However, total community benefit spending (including charity care) did not change. 340B was associated with an increase in the probability of offering discounted care (4.3 percentage points, SE = 1.6) from 84 to 88 percent and an increase in the income eligibility limit for discounted care (18.9 percentage points, SE = 5.6) from 294 to 313 percent. Participation was not associated with the probability of offering low-profit medical care services. CONCLUSIONS:Alternative measures show that newly participating hospitals may increase charity care, potentially through offering more patients discounted care. However, increases appear to be fully offset by reductions in other community benefit programs.

Project description:BackgroundAcute kidney injury is common in hospitalized patients, increases morbidity and mortality, and is under-recognized. To improve provider recognition, we previously developed an electronic alert system for acute kidney injury. To test the hypothesis that this electronic acute kidney injury alert could improve patient outcome, we designed a randomized controlled trial to test the effectiveness of this alert in hospitalized patients. The study design presented several methodologic, ethical, and statistical challenges.PurposeTo highlight the challenges faced and the solutions employed in the design and implementation of a clinical trial to determine whether the provision of an early electronic alert for acute kidney injury would improve outcomes in hospitalized patients. Challenges included how to randomize the delivery of the alert system and the ethical framework for waiving informed consent. Other methodologic challenges included the selection and statistical evaluation of our study outcome, a ranked-composite of a continuous covariate (creatinine) and two dichotomous outcomes (dialysis and death), and the use of the medical record as a source of trial data.MethodsWe have designed a randomized trial to assess the effectiveness of an electronic alert system for acute kidney injury. With broad inclusion criteria, and a waiver of informed consent, we enroll and randomize virtually every patient with acute kidney injury in our hospital.ResultsAs of 31 March 2014, we have enrolled 2373 patients of 2400 targeted. Pre-alert data demonstrated a strong association between severity of acute kidney injury and inpatient mortality with a range of 6.4% in those with mild, stage 1 acute kidney injury, to 29% among those with stage 3 acute kidney injury (p < 0.001). We judged that informed consent would undermine the scientific validity of the study and present harms that are out of proportion to the very low risk intervention.ConclusionOur study demonstrates the feasibility of designing an ethical randomized controlled trial of an early electronic alert for acute kidney injury without obtaining informed consent from individual participants. Our study outcome may serve as a model for other studies of acute kidney injury, insofar as our paradigm accounts for the effect that early death and dialysis have on assessment of acute kidney injury severity as defined by maximum achieved serum creatinine.

Dataset Information

Enhancing field GP engagement in hospital-based studies. Rationale, design, main results and participation in the Diagest 3-GP motivation study.

Background

Methods

Results

Conclusions

Publications

Enhancing field GP engagement in hospital-based studies. Rationale, design, main results and participation in the Diagest 3-GP motivation study.

Similar Datasets

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