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Can implementation failure or intervention failure explain the result of the 3D multimorbidity trial in general practice: mixed-methods process evaluation.

ABSTRACT: OBJECTIVES:During a cluster randomised trial, (the 3D study) of an intervention enacting recommended care for people with multimorbidity, including continuity of care and comprehensive biennial reviews, we examined implementation fidelity to interpret the trial outcome and inform future implementation decisions. DESIGN:Mixed-methods process evaluation using cross-trial data and a sample of practices, clinicians, administrators and patients. Interviews, focus groups and review observations were analysed thematically and integrated with quantitative data about implementation. Analysis was blind to trial outcomes and examined context, intervention adoption, reach and maintenance, and delivery of reviews to patients. SETTING:Thirty-three UK general practices in three areas. PARTICIPANTS:The trial included 1546 people with multimorbidity. 11 general practitioners, 14 nurses, 7 administrators and 38 patients from 9 of 16 intervention practices were sampled for an interview. RESULTS:Staff loss, practice size and different administrative strategies influenced implementation fidelity. Practices with whole administrative team involvement and good alignment between the intervention and usual care generally implemented better. Fewer reviews than intended were delivered (49% of patients receiving both intended reviews, 30% partially reviewed). In completed reviews >90% of intended components were delivered, but review observations and interviews with patients and clinicians found variation in style of component delivery, from 'tick-box' to patient-centred approaches. Implementation barriers included inadequate skills training to implement patient-centred care planning, but patients reported increased patient-centredness due to comprehensive reviews, extra time and being asked about their health concerns. CONCLUSIONS:Implementation failure contributed to lack of impact of the 3D intervention on the trial primary outcome (quality of life), but so did intervention failure since modifiable elements of intervention design were partially responsible. When a decisive distinction between implementation failure and intervention failure cannot be made, identifying potentially modifiable reasons for suboptimal implementation is important to enhance potential for impact and effectiveness of a redesigned intervention. TRIAL REGISTRATION NUMBER:ISRCTN06180958.

SUBMITTER: Mann C

PROVIDER: S-EPMC6858134 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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Can implementation failure or intervention failure explain the result of the 3D multimorbidity trial in general practice: mixed-methods process evaluation.

Mann Cindy C Shaw Ali R G ARG Guthrie Bruce B Wye Lesley L Man Mei-See MS Chaplin Katherine K Salisbury Chris C

BMJ open 20191106 11

<h4>Objectives</h4>During a cluster randomised trial, (the 3D study) of an intervention enacting recommended care for people with multimorbidity, including continuity of care and comprehensive biennial reviews, we examined implementation fidelity to interpret the trial outcome and inform future implementation decisions.<h4>Design</h4>Mixed-methods process evaluation using cross-trial data and a sample of practices, clinicians, administrators and patients. Interviews, focus groups and review obse ...[more]

PMID: 31699734

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Project description:An increasing number of people are living with multimorbidity. The evidence base for how best to manage these patients is weak. Current clinical guidelines generally focus on single conditions, which may not reflect the needs of patients with multimorbidity. The aim of the 3D study is to develop, implement and evaluate an intervention to improve the management of patients with multimorbidity in general practice.This is a pragmatic two-arm cluster randomised controlled trial. 32 general practices around Bristol, Greater Manchester and Glasgow will be randomised to receive either the '3D intervention' or usual care. 3D is a complex intervention including components affecting practice organisation, the conduct of patient reviews, integration with secondary care and measures to promote change in practice organisation. Changes include improving continuity of care and replacing reviews of each disease with patient-centred reviews with a focus on patients' quality of life, mental health and polypharmacy. We aim to recruit 1383 patients who have 3 or more chronic conditions. This provides 90% power at 5% significance level to detect an effect size of 0.27 SDs in the primary outcome, which is health-related quality of life at 15 months using the EQ-5D-5L. Secondary outcome measures assess patient centredness, illness burden and treatment burden. The primary analysis will be a multilevel regression model adjusted for baseline, stratification/minimisation, clustering and important co-variables. Nested process evaluation will assess implementation, mechanisms of effectiveness and interaction of the intervention with local context. Economic analysis of cost-consequences and cost-effectiveness will be based on quality-adjusted life years.This study has approval from South-West (Frenchay) National Health Service (NHS) Research Ethics Committee (14/SW/0011). Findings will be disseminated via final report, peer-reviewed publications and guidance to healthcare professionals, commissioners and policymakers.ISRCTN06180958; Pre-results.

Project description:BACKGROUND: Multimorbidity is common among ageing populations and it affects the demand for health services. The objective of this study was to examine the relationship between multimorbidity (i.e. the number of diseases and specific combinations of diseases) and the use of general practice services in the Dutch population of 55 years and older. METHODS: Data on diagnosed chronic diseases, contacts (including face-to-face consultations, phone contacts, and home visits), drug prescription rates, and referral rates to specialised care were derived from the Netherlands Information Network of General Practice (LINH), limited to patients whose data were available from 2006 to 2008 (N=32,583). Multimorbidity was defined as having two or more out of 28 chronic diseases. Multilevel analyses adjusted for age, gender, and clustering of patients in general practices were used to assess the association between multimorbidity and service utilization in 2008. RESULTS: Patients diagnosed with multiple chronic diseases had on average 18.3 contacts (95% CI 16.8 19.9) per year. This was significantly higher than patients with one chronic disease (11.7 contacts (10.8 12.6)) or without any (6.1 contacts (5.6 6.6)). A higher number of chronic diseases was associated with more contacts, more prescriptions, and more referrals to specialized care. However, the number of contacts per disease decreased with an increasing number of diseases; patients with a single disease had between 9 to 17 contacts a year and patients with five or more diseases had 5 or 6 contacts per disease per year. Contact rates for specific combinations of diseases were lower than what would be expected on the basis of contact rates of the separate diseases. CONCLUSION: Multimorbidity is associated with increased health care utilization in general practice, yet the increase declines per additional disease. Still, with the expected rise in multimorbidity in the coming decades more extensive health resources are required.

Project description:AimsHeart failure (HF) is an important health problem for which multidisciplinary care is recommended, yet few studies involve primary care practitioners in the multidisciplinary management of HF. We set up a multifaceted prospective observational trial, OSCAR-HF, piloting audit and feedback, natriuretic peptide testing at the point of care, and the assistance of a specialist HF nurse in primary care. The aim was to optimize HF care in general practice.Methods and resultsThis is an analysis at 6 month follow-up of the study interventions of the OSCAR-HF pilot study, a nonrandomized, noncontrolled prospective observational trial conducted in eight Belgian general practices [51 general practitioners (GPs)]. Patients who were assessed by their GP to have HF constituted the OSCAR-HF study population. We used descriptive statistics and mixed-effects modelling for the quantitative analysis and thematic analysis of the focus group interviews. There was a 10.2% increase in the registered HF population after 6 months of follow-up (n = 593) compared with baseline (n = 538) and a 27% increase in objectified HF diagnoses (baseline n = 359 to 456 at T6 M). Natriuretic peptide testing (with or without referral) accounted for 54% (n = 60/111) of the newly registered HF diagnoses. There was no difference in the proportion of patients with HF with reduced ejection fraction who received their target dosage of renin-angiotensin-aldosterone system inhibitors or beta-blockers at 6 months compared with baseline (P = 0.9). Patients who received an HF nurse intervention (n = 53) had significantly worse quality of life at baseline [difference in Minnesota Living with Heart Failure Questionnaire (MLHFQ) score 9.2 points; 95% confidence interval (CI) 4.0, 14] and had a significantly greater improvement in quality-of-life scores at the 6 month follow-up [change in MLHFQ score -9.8 points; 95% CI -15, -4.5] than patients without an HF nurse intervention. GPs found audit and feedback valuable but time intensive. Natriuretic peptides were useful, but the point-of-care test was impractical, and the assistance of an HF nurse was a useful addition to routine HF care.ConclusionsThe use of audit and feedback combined with natriuretic peptide testing was a successful strategy to increase the number of registered and objectified HF diagnoses at 6 months. GPs and HF nurses selected patients with worse quality-of-life scores at baseline for the HF nurse intervention, which led to a significantly greater improvement in quality-of-life scores at the 6 month follow-up compared with patients without an HF nurse intervention. The interventions were deemed feasible and useful by the participating GPs with some specific remarks that can be used for optimization.Trial registrationClinicalTrials.gov (NCT02905786), registered on 14 September 2016 at https://clinicaltrials.gov/.

Project description:BackgroundTreatment complexity rises in line with the number of drugs, single doses, and administration methods, thereby threatening patient adherence. Patients with multimorbidity often need flexible, individualised treatment regimens, but alterations during the course of treatment may further increase complexity. The objective of our study was to explore medication changes in older patients with multimorbidity and polypharmacy in general practice.MethodsWe retrospectively analysed data from the cluster-randomised PRIMUM trial (PRIoritisation of MUltimedication in Multimorbidity) conducted in 72 general practices. We developed an algorithm for active pharmaceutical ingredients (API), strength, dosage, and administration method to assess changes in physician-reported medication data during two intervals (baseline to six-months: ∆1; six- to nine-months: ∆2), analysed them descriptively at prescription and patient levels, and checked for intervention effects.ResultsOf 502 patients (median age 72 years, 52% female), 464 completed the study. Changes occurred in 98.6% of patients (changes were 19% more likely in the intervention group): API changes during ∆1 and ∆2 occurred in 414 (82.5%) and 338 (67.3%) of patients, dosage alterations in 372 (74.1%) and 296 (59.2%), and changes in API strength in 158 (31.5%) and 138 (27.5%) respectively. Administration method changed in 79 (16%) of patients in both ∆1 and ∆2. Simvastatin, metformin and aspirin were most frequently subject to alterations.ConclusionMedication regimens in older patients with multimorbidity and polypharmacy changed frequently. These are mostly due to discontinuations and dosage alterations, followed by additions and restarts. These findings cast doubt on the effectiveness of cross-sectional assessments of medication and support longitudinal assessments where possible.Trial registration1. Prospective registration: Trial registration number: NCT01171339 ; Name of registry: ClinicalTrials.gov; Date of registration: July 27, 2010; Date of enrolment of the first participant to the trial: August 12, 2010. 2. Peer reviewed trial registration: Trial registration number: ISRCTN99526053 ; Name of registry: Controlled Trials; Date of registration: August 31, 2010; Date of enrolment of the first participant to the trial: August 12, 2010.

Project description:Objective: China and many developing countries has placed high expectations on the general practice healthcare system in terms of lowering medical costs and improving the health status of the multimorbid population in recent years. However, the prevalence of multimorbidity among inpatients attending the general practice department of hospitals and its policy implications are largely unknown. The current study aimed to analyze the prevalence of comorbidities among inpatients attending the general practice department of the tertiary Grade-A Hospitals in China, and put forward evidence-based policy recommendations. Methods: Between December 2016 and November 2020, 351 registered general practitioners from 27 tertiary hospitals were selected, and their direct admissions were evaluated. The rate and composition ratio were used for descriptive analysis of the clinical and epidemiological characteristics of multimorbidity. A backward stepwise algorithm was used to explore independent variables. The absence of multicollinearity and plausible interactions among variables were tested to ensure the robustness of the logistic regression model. The pyramid diagram was used to show the link between gender and the involved human body system in multimorbidity. Results: Multimorbidity was present in 93.1% of the 64, 395 patients who were admitted directly. Multimorbidity was significantly more prevalent in patients aged 45-59 years (OR=3.018, 95% CI=1.945-4.683), 60-74 years (OR = 4.349, 95% CI = 2.574-7.349), ≥75 years (OR = 7.804, 95% CI = 3.665-16.616), and those with body mass index (BMI) ≥ 28 kg/m2 (OR = 3.770, 95% CI = 1.453-9.785). The circulatory system was found to be the most commonly involved human body system in multimorbidity, accounting for 79.2% (95% CI = 78.8-79.5%) of all cases. Significant gender inequity was further observed in the involved human body system in multimorbidity. Conclusion: Multimorbidity is likely common among the inpatients attending the general practice department of hospitals in China and many developing countries, with significant gender inequity in the involved human body systems. Effective countermeasures include establishing a GP-PCIC multimorbidity prevention and control model and enhancing the multimorbidity of elderly and obese patients at both the clinical and healthy lifestyle levels. The diagnosis and treatment capabilities of GPs on the circulatory, endocrine, metabolic, digestive, and respiratory systems should be prioritized.

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Can implementation failure or intervention failure explain the result of the 3D multimorbidity trial in general practice: mixed-methods process evaluation.

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Can implementation failure or intervention failure explain the result of the 3D multimorbidity trial in general practice: mixed-methods process evaluation.

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