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Type-2 diabetes primary prevention program implemented in routine primary care: a process evaluation study.

ABSTRACT: Process evaluation studies are recommended to improve our understanding of underlying mechanisms related to clinicians, patients, context and intervention delivery that may impact on trial or program results and on their potential transferability to practice. This paper aims to document the translation of a type-2 diabetes (T2D) prevention program into the routine context of several primary care centers, assessing process indicators related to clinician adoption, patient recruitment, exposure to the intervention components and baseline characteristics.An observational descriptive process evaluation study was conducted of the 2.5-year implementation of the Prevention of Diabetes in Euskadi cluster randomized trial in 14 primary care centers of the Basque Health Service (Osakidetza). The clinical intervention consisted of three components: (1) risk screening, (2) an educational intervention promoting healthy lifestyles, and (3) remote support (follow-up). A passive dissemination strategy of providing training and materials was used to translate the intervention into practice. All non-diabetic patients aged 45 to 70 years who were identified as being at high risk of developing T2D were eligible for study inclusion. The RE-AIM framework guided the process evaluation.Overall, 31.4 % of family physicians and 57.6 % of nurses participated in the study, while 4170 out of 67,293 (6.2 %) targeted patients who attended the centers during the implementation period were reached through the screening. Around half of the screened patients were identified as being at high risk of developing T2D (FINDRISC score ?14). The rate of refusal to participate and the proportion of women were higher in the intervention group. Finally, 634 and 454 non-diabetic 45- to 70-year-old patients who were at high risk of T2D were included in the control and intervention group centers (intervention reach?=?48 %). Significant variability in most process indicators was observed at center level.The passive dissemination strategy has produced modest process indicators related to the adoption, reach and implementation of the intervention program, and reduced the possibility of its standardized application in heterogeneous contexts. The resulting different procedures and strategies used by the centers were associated with process outcomes. Context-specific variability and possible confounding will require rigorous procedures for analysis of the intervention effects.The trial was registered in ClinicalTrials.gov (identifier: NCT01365013 ). Registered on June 2011.

SUBMITTER: Sanchez A

PROVIDER: S-EPMC4875717 | biostudies-literature | 2016 May

REPOSITORIES: biostudies-literature

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Type-2 diabetes primary prevention program implemented in routine primary care: a process evaluation study.

Sánchez Alvaro A Sánchez Alvaro A Silvestre Carmen C Campo Natalia N Grandes Gonzalo G

Trials 20160520 1

<h4>Background</h4>Process evaluation studies are recommended to improve our understanding of underlying mechanisms related to clinicians, patients, context and intervention delivery that may impact on trial or program results and on their potential transferability to practice. This paper aims to document the translation of a type-2 diabetes (T2D) prevention program into the routine context of several primary care centers, assessing process indicators related to clinician adoption, patient recru ...[more]

PMID: 27206733

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Project description:ImportanceAlthough pain is among the most common symptoms reported by patients, primary care practitioners (PCPs) face substantial challenges identifying and assessing pain.ObjectiveTo evaluate a 2-step process for chronic pain screening and follow-up in primary care.Design, setting, and participantsA cross-sectional study of patients with a primary care visit between July 2, 2018, and June 1, 2019, was conducted at a statewide, multisite federally qualified health center. Participants included 68 PCPs and 58 medical assistants from 13 sites who implemented the screening process in primary care, and 38 866 patients aged 18 years or older with a primary care visit during that time.ExposuresSingle-question assessment of pain frequency, followed by a 3-question PEG (pain, enjoyment of life, general activity) functional assessment for patients with chronic pain.Main outcomes and measuresAdherence to a 2-step chronic pain screening and PEG process, proportion of patients with positive screening results, mean PEG pain severity greater than or equal to 7, and documented chronic painful condition diagnosis in patient's electronic health record between 1 year before and 90 days after screening.ResultsOf 38 866 patients with a primary care visit, 31 600 patients (81.3%) underwent screening. Mean (SD) age was 46.2 (15.4) years, and most were aged 35 to 54 years (12 987 [41.1%]), female (18 436 [58.3%]), Hispanic (14 809 [46.9%]), and English-speaking (22 519 [71.3%]), and had Medicaid insurance (18 442 [58.4%]). A total of 10 262 participants (32.5%) screened positive and, of these, 9701 (94.5%) completed the PEG questionnaire. PEG responses indicated severe pain interference with activities of daily living (PEG ≥7) in 5735 (59.1%) participants. A chronic painful condition had not been diagnosed in 4257 (43.9%) patients in the year before screening. A new chronic painful condition was diagnosed at screening or within 90 days in 2250 (52.9%) patients. Care teams found the workflow acceptable, but cited lengthy administration time, challenges with comprehension of the PEG questions, and limited comprehensiveness as implementation barriers.Conclusions and relevanceA systematic, 2-step process for chronic pain screening and functional assessment in primary care appeared to identify patients with previously undocumented chronic pain and was feasible to implement. Patient-provided information on the frequency of pain, pain level, and pain interference can help improve the assessment and monitoring of pain in primary care.

Project description:ObjectivesTo explore service-user and provider experience of the acceptability and value of the Let's Prevent Diabetes programme, a pragmatic 6-hour behavioural intervention using structured group education, introduced into primary care practice.DesignQualitative interview-based study with thematic analysis.SettingPrimary care and community.ParticipantsPurposeful sample of 32 participants, including 22 people at high risk of diabetes who either attended, defaulted from or declined the intervention; and 10 stakeholder professionals involved in implementation.ResultsParticipants had low prior awareness of their elevated risk and were often surprised to be offered intervention. Attenders were commonly older, white, retired and motivated to promote their health; who found their session helpful, particularly for social interaction, raising dietary awareness, and convenience of community location. However attenders highlighted lack of depth, repetition within and length of session, difficulty meeting culturally diverse needs and no follow-up as negative features. Those who defaulted from, or who declined the intervention were notably apprehensive, uncertain or unconvinced about whether they were at risk of diabetes; sought more specific information about the intervention, and were deterred by its group nature and day-long duration, with competing work or family commitments. Local providers recognised inadequate communication of diabetes risk to patients. They highlighted significant challenges for implementation, including resource constraints, and facilitation at individual general practice or locality level.ConclusionsThis pragmatic diabetes prevention intervention was acceptable in practice, particularly for older, white, retired and health-motivated people. However, pre-intervention information and communication of diabetes risk should be improved to increase engagement and reduce potential fear or uncertainty, with closer integration of services, and more appropriate care pathways, to facilitate uptake and follow-up. Further development of this, or other interventions, is needed to enable wider, and more socially diverse, engagement of people at risk. Balancing a locality and individual practice approach, and how this is resourced are considerations for long-term sustainability.

Project description:IntroductionThe Diabetes Prevention Program, an intensive lifestyle change program, effectively reduces the risk of progression from prediabetes to type 2 diabetes but is underutilized. An implementation study using formative research was undertaken to increase Diabetes Prevention Program referrals at a primary care clinic.Study designA pragmatic, cluster randomized, mixed-methods study.Setting/particpantsClusters were teams of primary care clinicians from 2 primary care clinics. The 3 intervention clusters had 8-11 clinicians, and the 3 control clusters had 7-20 clinicians.InterventionImplementation activities occurred from December 2017 to February 2019. The activities included targeted clinician education, a prediabetes clinician champion, and a custom electronic health record report identifying patients with prediabetes.Main outcome measuresThe primary outcome was referral of patients with prediabetes to the institutional Diabetes Prevention Program. Study data, including patient demographic and clinical variables, came from electronic health record. Interviews with clinicians evaluated the implementation strategies. Generalized estimating equation analyses that accounted for multiple levels of correlation and interview content analysis occurred in 2019.ResultsStudy clinicians cared for 2,992 patients with a prediabetes diagnosis or HbA1c indicative of prediabetes (5.7%-6.4%). Clinicians in the intervention clusters referred 6.9% (87 of 1,262) of patients with prediabetes to the Diabetes Prevention Program and those in the control clusters referred 1.5% (26 of 1,730). When adjusted for patient age, sex, race, HbA1c value, HbA1c test location, and insurance type, intervention clinicians had 3.85 (95% CI=0.40, 36.78) greater odds of referring a patient with prediabetes to the Diabetes Prevention Program. The 11 interviewed intervention clinicians had mixed opinions about the utility of the interventions, reporting the prediabetes clinic champion (n=7, 64%) and educational presentations (n=6, 55%) as most helpful.ConclusionsIntervention clinicians were more likely to make Diabetes Prevention Program referrals; however, the study lacked power to achieve statistical significance. Clinician interviews suggested that intervention components that triggered Diabetes Prevention Program referrals varied among clinicians.

Project description:Objectives In 2014, a hospital-based smoking prevention programme ‘Nichtrauchen ist clever!’ (NIC!) for adolescents aged 12–14 was initiated. The aim of the study was to evaluate participants’ smoking behaviour and to explore the acceptance of the programme, and participants’ awareness on smoking-related diseases and factors that promote smoking initiation. Design We performed a cross-sectional survey to evaluate participant’s acceptance of the NIC! program and their smoking habits. A total of 1658 participants completed the survey between January 2016 and December 2019. A qualitative approach, including analysing feedback from students gathered at 77 prevention events between June 2014 and December 2019, was used to assess their view on reasons for smoking initiation and their knowledge about smoking-related diseases. Results Twenty-six per cent (429/1658) have already tried tobacco products (so called triers), specifically cigarettes, electronic (e)-cigarettes and shisha. The use of e-cigarettes was most popular among triers 58% (252/429). Eighty-eight per cent of participants (1408/1604) reported they had acquired good or excellent knowledge about smoking, and 89% (1439/1617) of participants stated that they intend not to smoke in the future. Particularly lung cancer and cancer in general, heart—and vascular diseases were frequently mentioned to be smoking related; where, on the other hand, a large number of relevant smoking-associated diseases were mentioned irregularly. Peer pressure, stress and coolness were identified as reasons for smoking initiation, whereas the influence of marketing and multimedia, as well as socioeconomic—and lifestyle-related factors on smoking behaviour was barely noticed. Conclusion NIC! had a high acceptance among the participants and a large number of students reported relevant gain of knowledge. We identified important knowledge-gaps relating to smoking initiation and smoking-related diseases, helping to improve further smoking prevention approaches.

Project description:The Diabetes Prevention Program (DPP) lifestyle intervention reduced the incidence of type 2 diabetes mellitus (DM) among high-risk adults by 58%, with weight loss as the dominant predictor. However, it has not been adequately translated into primary care.We evaluated 2 adapted DPP lifestyle interventions among overweight or obese adults who were recruited from 1 primary care clinic and had pre-DM and/or metabolic syndrome. Participants were randomized to (1) a coach-led group intervention (n = 79), (2) a self-directed DVD intervention (n = 81), or (3) usual care (n = 81). During a 3-month intensive intervention phase, the DPP-based behavioral weight-loss curriculum was delivered by lifestyle coach-led small groups or home-based DVD. During the maintenance phase, participants in both interventions received lifestyle change coaching and support remotely-through secure email within an electronic health record system and the American Heart Association Heart360 website for weight and physical activity goal setting and self-monitoring. The primary outcome was change in body mass index (BMI) (calculated as weight in kilograms divided by height in meters squared) from baseline to 15 months.At baseline, participants had a mean (SD) age of 52.9 (10.6) years and a mean BMI of 32.0 (5.4); 47% were female; 78%, non-Hispanic white; and 17%, Asian/Pacific Islander. At month 15, the mean ± SE change in BMI from baseline was -2.2 ± 0.3 in the coach-led group vs -0.9 ± 0.3 in the usual care group (P < .001) and -1.6 ± 0.3 in the self-directed group vs usual care (P = .02). The percentages of participants who achieved the 7% DPP-based weight-loss goal were 37.0% (P = .003) and 35.9% (P = .004) in the coach-led and self-directed groups, respectively, vs 14.4% in the usual care group. Both interventions also achieved greater net improvements in waist circumference and fasting plasma glucose level.Proven effective in a primary care setting, the 2 DPP-based lifestyle interventions are readily scalable and exportable with potential for substantial clinical and public health impact.clinicaltrials.gov Identifier: NCT00842426.

Project description:The largest and longest clinical trial of metformin for the prevention of diabetes is the Diabetes Prevention Program/Diabetes Prevention Program Outcomes Study (DPP/DPPOS). In this review, we summarise data from the DPP/DPPOS, focusing on metformin for diabetes prevention, as well as its long-term glycaemic and cardiometabolic effects and safety in people at high-risk of developing diabetes. The DPP (1996-2001) was a RCT of 3234 adults who, at baseline, were at high-risk of developing diabetes. Participants were assigned to masked placebo (n = 1082) or metformin (n = 1073) 850 mg twice daily, or intensive lifestyle intervention (n = 1079). The masked metformin/placebo intervention phase ended approximately 1 year ahead of schedule because of demonstrated efficacy. Primary outcome was reported at 2.8 years. At the end of the DPP, all participants were offered lifestyle education and 88% (n = 2776) of the surviving DPP cohort continued follow-up in the DPPOS. Participants originally assigned to metformin continued to receive metformin, unmasked. The DPP/DPPOS cohort has now been followed for over 15 years with prospective assessment of glycaemic, cardiometabolic, health economic and safety outcomes. After an average follow-up of 2.8 years, metformin reduced the incidence of diabetes by 31% compared with placebo, with a greater effect in those who were more obese, had a higher fasting glucose or a history of gestational diabetes. The DPPOS addressed the longer-term effects of metformin, showing a risk reduction of 18% over 10 and 15 years post-randomisation. Metformin treatment for diabetes prevention was estimated to be cost-saving. At 15 years, lack of progression to diabetes was associated with a 28% lower risk of microvascular complications across treatment arms, a reduction that was no different among treatment groups. Recent findings suggest metformin may reduce atherosclerosis development in men. Originally used for the treatment of type 2 diabetes, metformin, now proven to prevent or delay diabetes, may serve as an important tool in battling the growing diabetes epidemic. Long-term follow-up, currently underway in the DPP/DPPOS, is now evaluating metformin's potential role, when started early in the spectrum of dysglycaemia, on later-stage comorbidities, including cardiovascular disease and cancer.ClinicalTrials.gov NCT00038727 and NCT00004992.

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Type-2 diabetes primary prevention program implemented in routine primary care: a process evaluation study.

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Type-2 diabetes primary prevention program implemented in routine primary care: a process evaluation study.

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