Complex lifestyle intervention among inactive older adults with elevated cardiovascular disease risk and obesity: a mixed-method, single-arm feasibility study for RESTART-a randomized controlled trial.

BACKGROUND: Physical inactivity and obesity are global public health challenges. Older adults are important to target for prevention and management of disease and chronic conditions. However, many individuals struggle with maintaining increased physical activity (PA) and improved diet. This feasibility study provides the foundation for the RESTART trial, a randomized controlled trial (RCT) to test a complex intervention to facilitate favourable lifestyle changes older adults can sustain. The primary objective of this study was to investigate study feasibility (recruitment, adherence, side-effects, and logistics) using an interdisciplinary approach. METHODS: This 1-year prospective mixed-method single-arm feasibility study was conducted in Tromsø, Norway, from September 2017. We invited by mail randomly selected participants from the seventh survey of the Tromsø Study (2015-2016) aged 55-75 years with sedentary lifestyle, obesity, and elevated cardiovascular risk. Participants attended a 6-month complex lifestyle intervention program, comprising instructor-led high-intensive exercise and nutritionist- and psychologist-led counselling, followed by a 6-month follow-up. All participants used a Polar activity tracker for daily activity monitoring during the intervention. Participants were interviewed three times throughout the study. Primary outcome was study feasibility measures. RESULTS: We invited potential participants (n=75) by mail of which 27 % (n=20) agreed to participate. Telephone screening excluded four participants, and altogether 16 participants completed baseline screening. The intervention and test procedures of primary and secondary outcomes were feasible and acceptable for the participants. There were no exercise-induced injuries, indicating that the intervention program is safe. Participants experienced that the dietary and psychological counselling were delivered too early in the intervention and in too close proximity to the start of the exercise program. Minor logistic improvements were implemented throughout the intervention period. CONCLUSION: This study indicates that it is feasible to conduct a full-scale RCT of a multi-component randomized intervention trial, based on the model of the present study. No dropouts due to exercise-induced injury indicates that the exercises were safe. While minor improvements in logistics were implemented during the intervention, we will improve recruitment and adherence strategies, rearrange schedule of intervention contents (exercise, diet, and psychology), as well as improve the content of the dietary and behavioural counselling to maximize outcome effects in the RESTART protocol. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03807323 Registered 16 January 2019 - retrospectively registered.

Changes in adiposity, physical activity, cardiometabolic risk factors, diet, physical capacity and well-being in inactive women and men aged 57-74 years with obesity and cardiovascular risk - A 6-month complex lifestyle intervention with 6-month follow-up.

A key challenge in lifestyle interventions is long-term maintenance of favorable lifestyle changes. Middle-aged and older adults are important target groups. The purpose of this analysis was to investigate changes in adiposity, physical activity, cardiometabolic risk factors, diet, physical capacity, and well-being, in inactive middle-aged and older women and men with obesity and elevated cardiovascular disease risk, participating in an interdisciplinary single-arm complex lifestyle intervention pilot study. Participants were recruited from the population-based Tromsø Study 2015-2016 with inclusion criteria age 55-74 years, body mass index (BMI) ≥30kg/m2, sedentary lifestyle, no prior myocardial infarction and elevated cardiovascular risk. Participants (11 men and 5 women aged 57-74 years) underwent a 6-month intervention of two 1-hour group-sessions per week with instructor-led gradually intensified exercise (endurance and strength), one individual and three 2-hour group counselling sessions with nutritionist (Nordic Nutrition Recommendations) and psychologist (Implementation intention strategies). We investigated changes in adiposity (weight, BMI, body composition, waist circumference), physical activity (self-reported and via physical activity trackers), cardiometabolic risk factors (blood pressure, HbA1c, blood lipids), diet (intake of energy, nutrients, foods), physical capacity (aerobic capacity, muscle strength), and psychological well-being, measured at baseline and end-of-intervention, using mean-comparison paired t-tests. Further, we investigated self-reported healthy lifestyle maintenance six months after end-of-intervention, and monthly changes in daily step count, moderate-to-vigorous physical activity (MVPA) and total energy expenditure. From baseline to end-of-intervention, there was a mean decrease in weight, BMI, fat mass, waist circumference, intake of total- and saturated fat, and increase in lean mass, lateral pulldown and leg press. We detected no changes in mean levels of physical activity, cardiometabolic risk factors or well-being. Six months after end-of-intervention, 25% responded healthy lifestyle achievement and maintenance, while objectively measured physical activity remained unchanged. The results are useful for development of a protocol for a full-scale trial. Trial registration: The study was registered at www.ClinicalTrials.gov registry (NCT03807323).

Succeeding with prolonged usage of consumer-based activity trackers in clinical studies: a mixed methods approach.

BACKGROUND: Lack of physical activity (PA) is a risk factor for death and non-communicable disease. Despite this, more than one fourth of adults worldwide do not follow PA guidelines. As part of a feasibility study to test a complex intervention for increasing PA, we included a consumer-based activity tracker (AT) as a tool to measure PA outcomes and to track heart rate during exercise sessions. The aim of the present study was to identify factors that increase wear time when using a consumer-based AT for monitoring of participants in clinical research. METHODS: Sixteen participants aged 55-74 years, with obesity, sedentary lifestyle, and elevated cardiovascular risk were recruited to a 12-month feasibility study. Participants wore a Polar M430 AT to collect continuous PA data during a six-month intervention followed by 6 months of follow-up. We performed quantitative wear time analysis, tested the validity of the AT, and completed two rounds of qualitative interviews to investigate how individual wear-time was linked to participant responses. RESULTS: From 1 year of tracking, mean number of valid wear days were 292 (SD = 86), i.e. 80%. The Polar M430 provides acceptable measurements for total energy expenditure. Motivations for increased wear time were that participants were asked to wear it and the ability to track PA progress. Perceived usefulness included time keeping, heart rate- and sleep tracking, becoming more conscious about day-to-day activity, and improved understanding of which activity types were more effective for energy expenditure. Sources of AT annoyance were measurement inaccuracies and limited instruction for use. Suggestions for improvement were that the AT was big, unattractive, and complicated to use. CONCLUSIONS: Adherence to wearing a consumer-based AT was high. Results indicate that it is feasible to use a consumer-based AT to measure PA over a longer period. Potential success factors for increased wear time includes adequate instruction for AT use, allowing participants to choose different AT designs, and using trackers with accurate measurements. To identify accurate trackers, AT validation studies in the target cohort may be needed. TRIAL REGISTRATION: U.S. National Library of Medicine, Clinical Trial registry: NCT03807323 ; Registered 16 September 2019 - Retrospectively registered.

Practice variation in surgical procedures and IUD-insertions among general practitioners in Norway - a longitudinal study.

BACKGROUND: Studies of Primary Health Care (PHC) reveal considerable practice variations in terms of the range of services provided. In Norway, general practitioners (GPs) are traditionally expected to perform IUD-insertions and several surgical procedures as a part of comprehensive PHC. We aimed to investigate variation in the provision of surgical procedures and IUD-insertions across GPs and over time and explore determinants of such variation. METHODS: Retrospective registry study of Norwegian GPs. From a comprehensive database of GPs' reimbursement claims, we obtained procedure codes and GP characteristics such as age, gender, list size and municipality characteristics from 2006 through 2013. Multivariable logistic regression models were fitted to explore determinants of practice variation. RESULTS: We extracted data from 4,828 GPs. In 2013, 91.0, 76.1 and 74.8% were reimbursed at least once for minor and major surgical procedures and IUD-insertion, respectively. Female GPs had lower odds for performing major surgical procedures (OR 0.38, 95% CI 0.32-0.45) and higher odds for performing IUD-insertions (OR 6.28, 95% CI 4.47-8.82) than male GPs. Older GPs and GPs with shorter patient lists were less likely to perform surgical procedures. GPs with longer patient lists had higher odds for performing IUD-insertions. The proportion of GPs performing surgical procedures increased over time, while the proportion decreased for IUD-insertions. The number of IUD-insertions in specialist care increased from 12,575 in 2011 to 15 216 (+21.0%) in 2014. CONCLUSION: We observed a large variation in the provision of surgical procedures and IUD-insertions amongst GPs in Norway. The GPs' age, gender, list size and size of municipality were associated with performing the procedures. Our findings suggest a shift of IUD-insertions from primary to specialist care.

Associations between primary healthcare and unplanned medical admissions in Norway: a multilevel analysis of the entire elderly population.

OBJECTIVE: To examine if individual risk of unplanned medical admissions (UMAs) was associated with municipality general practitioner (GP) or long-term care (LTC) volume among the entire Norwegian elderly population. DESIGN: Cross-sectional population-based study. SETTING: 428 of 430 Norwegian municipalities in 2009. PARTICIPANTS: All Norwegians aged ≥65 years (n=721 915; 56% women-15% of the total population). MAIN OUTCOME MEASURE: Individual risk of UMA. RESULTS: Using a multilevel analytical framework, consisting of individuals (N=722 464) nested within municipalities (N=428), nested within local hospital areas (N=52) we found no association between municipality GP or LTC volume and UMAs. However, we found that higher LTC levels of provision were associated with fewer hospitalisations among the older age groups. A modest geographical variability was observed for UMA in adjusted analysis. CONCLUSIONS: A higher primary healthcare volume was only associated with fewer UMAs among the oldest old in a universally accessible healthcare system.

High referral rates to secondary care by general practitioners in Norway are associated with GPs' gender and specialist qualifications in family medicine, a study of 4350 consultations.

BACKGROUND: Referral rates of general practitioners (GPs) are an important determinant of secondary care utilization. The variation in these rates across GPs is considerable, and cannot be explained by patient morbidity alone. The main objective of this study was to assess the GPs' referral rate to secondary care in Norway, any associations between the referral decision and patient, GP, health care characteristics and who initiated the referring issue in the consultation. METHODS: The probabilities of referral to secondary care and/or radiological examination were examined in 100 consecutive consultations of 44 randomly chosen Norwegian GPs. The GPs recorded whether the issue of referral was introduced, who introduced it and if the patient was referred. Multilevel and naive multivariable logistic regression analyses were performed to explore associations between the probability of referral and patient, GP and health care characteristics. RESULTS: Of the 4350 consultations included, 13.7% (GP range 4.0%-28.0%) of patients were referred to secondary somatic and psychiatric care. Female GPs referred significantly more frequently than male GPs (16.0% versus 12.6%, adjusted odds ratio, AOR, 1.25), specialists in family medicine less frequently than their counterparts (12.5% versus 14.9%, AOR 0.76) and salaried GPs more frequently than private practitioners (16.2% versus 12.1%, AOR 1.36).In 4.2% (GP range 0%-12.9%) of the consultations, patients were referred to radiological examination. Specialists in family medicine, salaried GPs and GPs with a Norwegian medical degree referred significantly more frequently to radiological examination than their counterparts (AOR 1.93, 2.00 and 1.73, respectively).The issue of referral was introduced in 23% of the consultations, and in 70.6% of these cases by the GP. The high referrers introduced the referral issue significantly more frequently and also referred a significantly larger proportion when the issue was introduced. CONCLUSIONS: The main finding of the present study was a high overall referral rate, and a striking range among the GPs. Male GPs and specialists in family medicine referred significantly less frequently to secondary care, but the latter referred more frequently to radiological examination. Our findings indicate that intervention on high referrers is a potential area for quality improvement, and there is a need to explore the referral decision process itself.

Is a high level of general practitioner consultations associated with low outpatients specialist clinic use? A cross-sectional study.

OBJECTIVE: To examine if increased general practice activity is associated with lower outpatient specialist clinic use. DESIGN: Cross-sectional population based study. SETTING: All 430 Norwegian municipalities in 2009. PARTICIPANTS: All Norwegians aged ≥65 years (n=721 915; 56% women-15% of the total population). MAIN OUTCOME MEASURE: Specialised care outpatient clinic consultations per 1000 inhabitants (OPC rate). Main explanatory: general practitioner (GP) consultations per 1000 inhabitants (GP rate). RESULTS: In total, there were 3 339 031 GP consultations (57% women) and 1 757 864 OPC consultations (53% women). The national mean GP rate was 4625.2 GP consultations per 1000 inhabitants (SD 1234.3) and the national mean OPC rate was 2434.3 per 1000 inhabitants (SD 695.3). Crude analysis showed a statistically significant positive association between GP rates and OPC rates. In regression analyses, we identified three effect modifiers; age, mortality and the municipal composite variable of 'hospital status' (present/not present) and 'population size' (small, medium and large). We stratified manually by these effect modifiers into five strata. Crude stratified analyses showed a statistically significant positive association for three out of five strata. For the same three strata, those in the highest GP consultation rate quintile had higher mean OPC rates compared with those in the lowest quintile after adjustment for confounders (p<0.001). People aged ≥85 in small municipalities had approximately 30% lower specialist care use compared with their peers in larger municipalities, although the association between GP-rates and OPC-rates was still positive. CONCLUSIONS: In a universal health insurance system with high GP-accessibility, a health policy focusing solely on a higher activity in terms of GP consultations will not likely decrease OPC use among elderly.

Does long-term care use within primary health care reduce hospital use among older people in Norway? A national five-year population-based observational study.

BACKGROUND: Population ageing may threaten the sustainability of future health care systems. Strengthening primary health care, including long-term care, is one of several measures being taken to handle future health care needs and budgets. There is limited and inconsistent evidence on the effect of long-term care on hospital use. We explored the relationship between the total use of long-term care within public primary health care in Norway and the use of hospital beds when adjusting for various effect modifiers and confounders. METHODS: This national population-based observational study consists of all Norwegians (59% women) older than 66 years (N = 605676) (13.2% of total population) in 2002-2006. The unit of analysis was defined by municipality, age and sex. The association between total number of recipients of long-term care per 1000 inhabitants (LTC-rate) and hospital days per 1000 inhabitants (HD-rate) was analysed in a linear regression model. Modifying and confounding effects of socioeconomic, demographic and geographic variables were included in the final model. We defined a difference in hospitalization rates of more than 1000 days per 1000 inhabitants as clinically important. RESULTS: Thirty-one percent of women and eighteen percent of men were long-term care users. Men had higher HD-rates than women. The crude association between LTC-rate and HD-rate was weakly negative. We identified two effect modifiers (age and sex) and two strong confounders (travel time to hospital and mortality). Age and sex stratification and adjustments for confounders revealed a positive statistically significant but not clinically important relationship between LTC-rates and hospitalization for women aged 67-79 years and all men. For women 80 years and over there was a weak but negative relationship which was neither statistically significant nor clinically important. CONCLUSIONS: We found a weak positive adjusted association between LTC-rates and HD-rates. Opposite to common belief, we found that increased volume of LTC by itself did not reduce pressure on hospitals. There still is a need to study integrated care models for the elderly in the Norwegian setting and to explore further why municipalities far away from hospital achieve lower use of hospital beds.

Use of health care in the main area of Sami habitation in Norway - catching up with national expenditure rates.

INTRODUCTION: For many years political and professional concerns have centred on the health service access of Norway's modern Indigenous Sami people. Thirty years ago, a study determined that a low rate of health expenditure on Sami patients had lead to inferior health services for the Sami people, with their average consultation rate 6 times lower than the Norwegian national average. Since 1980, there have been few studies of differences in the utilization of medical services between the Sami people and the rest of the Norwegian population. There are few official statistics relating to the ethnic category Sami. This study explored the present utilization of healthcare services among the Sami people by investigating Sami municipalities' current expenditure on somatic hospital and specialist service. METHODS: To assess the use of health care in Sami municipalities, data on expenditure of somatic hospitals and specialist services were retrieved from the Norwegian Patient Registry, and age- and sex-adjusted expenditure rates were calculated. Predominantly Sami and non-Sami municipalities were compared, as well as a comparison with the national average. Factors considered to be explanatory variables for expenditure rates were distance to care, the supply and characteristics of the healthcare system, and the stability of GPs. RESULTS: The overall public hospital expenditure in Sami municipalities was above the national average and equivalent to corresponding municipalities in the same geographical area. However, there was considerable variation among the Sami municipalities. The age groups 35-49 and 50-64 years in all Sami municipalities had higher expenditure rates than the national average regarding out-patient contacts and hospitalizations, while the expenditure on the elderly (&#8805;80 years) was below the national average in most Sami municipalities. In addition to the public sector, there was a considerable volume of private practice specialist health care, mostly public funded and in urban parts of Norway. If the use of specialists in private practice is included, there is less variation in total out-patient expenditure rates in the Sami municipalities, with one exception. The municipalities with the lowest rate of public expenditure have the highest rate of private expenditure. CONCLUSION: No marked differences in healthcare expenditure was observed between the Sami and other municipalities. Overall healthcare use in Sami municipalities is above the national average and similar to corresponding municipalities in the same geographic area. However, a considerable variation in expenditure was observed among the Sami municipalities. These results do not indicate that ethnic barriers prevent Sami inhabitants from utilization of somatic hospital and specialist services. Disregarding the magnitude of expenditure, however, it is not possible to exclude that Sami patients experience a patient-physician relationship of lower quality.

Acute psychiatric admissions from an out-of-hours Casualty Clinic; how do referring doctors and admitting specialists agree?

BACKGROUND: Over the last decades there has been an increasing pressure on the acute psychiatric wards in Norway. The major contributor to psychiatric acute admissions at the University Hospital of North Norway in the city of Tromsø in 2001 was the GP-based Tromsø Casualty Clinic, only open out-of-hours. We explored all acute psychiatric referrals from Tromsø Casualty Clinic in 2001. The purpose of the study was to characterize the admissions and assess the agreement between the referring doctors and the hospital specialists according to the need for hospitalization, agreement on application of the law and the diagnostic evaluation to assess whether the admissions were appropriate. METHODS: Retrospective, record based, descriptive study comprising 101 psychiatric acute referrals from the Tromsø Casualty Clinic to the psychiatric acute wards at the University Hospital of North Norway. RESULTS: The specialists accepted all referrals except one, they mostly agreed upon the diagnoses suggested by the referring doctors and they mostly confirmed the application of the law.Seventy-five percent of the admissions took place during weekends, public holidays or nighttimes. Diagnoses of psychoses or suicidal attempts accounted for 76 % of the total referrals. Substance abuse was noted for 43 %, and in 22 % of all admissions the patients had stopped taking their psychopharmacological medication. The police assisted the referring doctors in one third of all admissions, and was the legal representative in 52 out of 59 involuntary admissions. Thirty percent of the admissions were first- time admissions. Thirty-two percent of the hospital stays lasted for three days or less. Median length of stay was 6.5 days. CONCLUSION: The casualty clinic physicians and the hospital specialists mostly agreed in their evaluation of patients indicating that most of the admissions were appropriate. The police was more often involved in the involuntary admissions than intended in the law. The proportion of patients with substance abuse was significant. Alternative treatment strategies should be developed for non-psychotic patients in need of short-term stays.

Difficulties in moving routine medical checks from the specialist level to the general practitioner level.

We began a project to move routine medical checks for appropriate patients from the specialist level to the patient's normal general practitioner (GP). The GP's analysis and conclusions would be checked by the specialist, using electronic messaging. The idea for the project came from the top level of the regional health authority. Despite that, the project was closed down before pilot testing began. We used stakeholder theory as a post-project evaluation to analyse what happened and where it went wrong. A common mistake in project planning is to focus the planning effort on system tasks and not to pay attention to a well-thought-out handling of the project's stakeholders. This was what happened in our project. Ideal objectives and good political intentions are not enough to implement a new e-health service.