Linda Gask

Understanding the implementation of complex interventions in health care: The normalization process model

BackgroundThe Normalization Process Model is a theoretical model that assists in explaining the processes by which complex interventions become routinely embedded in health care practice. It offers a framework for process evaluation and also for comparative studies of complex interventions. It focuses on the factors that promote or inhibit the routine embedding of complex interventions in health care practice.MethodsA formal theory structure is used to define the model, and its internal causal relations and mechanisms. The model is broken down to show that it is consistent and adequate in generating accurate description, systematic explanation, and the production of rational knowledge claims about the workability and integration of complex interventions.ResultsThe model explains the normalization of complex interventions by reference to four factors demonstrated to promote or inhibit the operationalization and embedding of complex interventions (interactional workability, relational integration, skill-set workability, and contextual integration).ConclusionThe model is consistent and adequate. Repeated calls for theoretically sound process evaluations in randomized controlled trials of complex interventions, and policy-makers who call for a proper understanding of implementation processes, emphasize the value of conceptual tools like the Normalization Process Model.

The treatment of somatization: teaching techniques of reattribution.

Patients commonly present to general practitioners with somatic symptoms for which no adequate physical cause can be found, which are accompanied by the symptoms of an anxiety state or a depressive illness. These illnesses pose a major public health problem, but little is known about optimal management. A three stage model is proposed to encourage patients to reattribute these symptoms, and relate them to psychosocial problems. These stages are; feeling understood; changing the agenda; and making the link. A videotaped learning package is described suitable for use with vocational trainees in general practice, consisting of demonstrations of component parts of the model followed by micro-teaching, as a preliminary to video-feedback of actual interviews with such patients.

Collaborative care for depression in UK primary care: a randomized controlled trial

to the cluster-randomized control group. For the intervention compared to the cluster control the PHQ-9 effect size was 0.63 (95 % CI 0.18-1.07). There was evidence of substantial contamination between intervention and patient-randomized control participants with less difference between the intervention group and patient-randomized control group (x2.99, 95 % CI x7.56 to 1.58, p=0.186) than between the intervention and cluster-randomized control group (x4.64, 95 % CI x7.93 to x1.35, p=0.008). The intra-class correlation coefficient for our primary outcome was 0.06 (95 % CI 0.00-0.32). Conclusions. Collaborative care is a potentially powerful organizational intervention for improving depression treat- ment in UK primary care, the effect of which is probably partly mediated through the organizational aspects of the intervention. A large Phase III cluster-randomized trial is required to provide the most methodologically accurate test of these initial encouraging findings. Received 5 February 2007 ; Revised 5 June 2007 ; Accepted 22 June 2007 ; First published online 6 September 2007

Improving the psychiatric skills of established general practitioners: evaluation of group teaching

Summary. Ten established general practitioners, eight of whom were also trainers, took part in a course designed to improve their psychiatric interviewing skills. Participants were instructed in the problem‐based model with audiotape and videotape feedback of real consultations in a group setting. Although those attending were experienced practitioners with a particular interest in the management of psychological problems, evaluation demonstrated a significant improvement in their skills after training. It is suggested that trainers could be trained to provide a similar teaching experience for their own trainees.

What Do Patients Choose to Tell Their Doctors? Qualitative Analysis of Potential Barriers to Reattributing Medically Unexplained Symptoms

BACKGROUNDDespite both parties often expressing dissatisfaction with consultations, patients with medically unexplained symptoms (MUS) prefer to consult their general practitioners (GPs) rather than any other health professional. Training GPs to explain how symptoms can relate to psychosocial problems (reattribution) improves the quality of doctor–patient communication, though not necessarily patient health.OBJECTIVETo examine patient experiences of GPs’ attempts to reattribute MUS in order to identify potential barriers to primary care management of MUS and improvement in outcome.DESIGNQualitative study.PARTICIPANTSPatients consulting with MUS whose GPs had been trained in reattribution. A secondary sample of patients of control GPs was also interviewed to ascertain if barriers identified were specific to reattribution or common to consultations about MUS in general.APPROACHThematic analysis of in-depth interviews.RESULTSPotential barriers include the complexity of patients’ problems and patients’ judgements about how to manage their presentation of this complexity. Many did not trust doctors with discussion of emotional aspects of their problems and chose not to present them. The same barriers were seen amongst patients whose GPs were not trained, suggesting the barriers are not particular to reattribution.CONCLUSIONSImproving GP explanation of unexplained symptoms is insufficient to reduce patients’ concerns. GPs need to (1) help patients to make sense of the complex nature of their presenting problems, (2) communicate that attention to psychosocial factors will not preclude vigilance to physical disease and (3) ensure a quality of doctor–patient relationship in which patients can perceive psychosocial enquiry as appropriate.

Psychotherapy mediated by remote communication technologies: a meta-analytic review

BackgroundAccess to psychotherapy is limited by psychopathology (e.g. agoraphobia), physical disability, occupational or social constraints and/or residency in under-served areas. For these populations, interventions delivered via remote communication technologies (e.g. telephone, internet) may be more appropriate. However, there are concerns that such delivery may influence the therapeutic relationship and thus reduce therapy effectiveness. This review aimed to determine the clinical effectiveness of remotely communicated, therapist-delivered psychotherapy.MethodsSystematic review (including electronic database searching and correspondence with authors) of randomised trials of individual remote psychotherapy. Electronic databases searched included MEDLINE (1966–2006), PsycInfo (1967–2006), EMBASE (1980–2006) and CINAHL databases (1982–2006). The Cochrane Central Register of Controlled Trials (CENTRAL) and the Cochrane Collaboration Depression, Anxiety and Neurosis Controlled Trials Register (CCDAN-CTR). All searches were conducted to include studies with a publication date to July 2006.ResultsThirteen studies were identified, ten assessing psychotherapy by telephone, two by internet and one by videoconference. Pooled effect sizes for remote therapy versus control conditions were 0.44 for depression (95%CI 0.29 to 0.59, 7 comparisons, n = 726) and 1.15 for anxiety-related disorders (95%CI 0.81 to 1.49, 3 comparisons, n = 168). There were few comparisons of remote versus face-to-face psychotherapy.ConclusionRemote therapy has the potential to overcome some of the barriers to conventional psychological therapy services. Telephone-based interventions are a particularly popular research focus and as a means of therapeutic communication may confer specific advantages in terms of their widespread availability and ease of operation. However, the available evidence is limited in quantity and quality. More rigorous trials are required to confirm these preliminary estimates of effectiveness. Future research priorities should include overcoming the methodological shortcomings of published work by conducting large-scale trials that incorporate both clinical outcome and more process-orientated measures.

Clinical effectiveness of collaborative care for depression in UK primary care (CADET): cluster randomised controlled trial

Objective To compare the clinical effectiveness of collaborative care with usual care in the management of patients with moderate to severe depression. Design Cluster randomised controlled trial. Setting 51 primary care practices in three primary care districts in the United Kingdom. Participants 581 adults aged 18 years and older who met ICD-10 (international classification of diseases, 10th revision) criteria for a depressive episode on the revised Clinical Interview Schedule. We excluded acutely suicidal patients and those with psychosis, or with type I or type II bipolar disorder; patients whose low mood was associated with bereavement or whose primary presenting problem was alcohol or drug abuse; and patients receiving psychological treatment for their depression by specialist mental health services. We identified potentially eligible participants by searching computerised case records in general practices for patients with depression. Interventions Collaborative care, including depression education, drug management, behavioural activation, relapse prevention, and primary care liaison, was delivered by care managers. Collaborative care involved six to 12 contacts with participants over 14 weeks, supervised by mental health specialists. Usual care was family doctors’ standard clinical practice. Main outcome measures Depression symptoms (patient health questionnaire 9; PHQ-9), anxiety (generalised anxiety disorder 7; GAD-7), and quality of life (short form 36 questionnaire; SF-36) at four and 12 months; satisfaction with service quality (client satisfaction questionnaire; CSQ-8) at four months. Results 276 participants were allocated to collaborative care and 305 allocated to usual care. At four months, mean depression score was 11.1 (standard deviation 7.3) for the collaborative care group and 12.7 (6.8) for the usual care group. After adjustment for baseline depression, mean depression score was 1.33 PHQ-9 points lower (95% confidence interval 0.35 to 2.31, P=0.009) in participants receiving collaborative care than in those receiving usual care at four months, and 1.36 points lower (0.07 to 2.64, P=0.04) at 12 months. Quality of mental health but not physical health was significantly better for collaborative care than for usual care at four months, but not 12 months. Anxiety did not differ between groups. Participants receiving collaborative care were significantly more satisfied with treatment than those receiving usual care. The number needed to treat for one patient to drop below the accepted diagnostic threshold for depression on the PHQ-9 was 8.4 immediately after treatment, and 6.5 at 12 months. Conclusions Collaborative care has persistent positive effects up to 12 months after initiation of the intervention and is preferred by patients over usual care. Trial registration number ISRCTN32829227.

Effects of befriending on depressive symptoms and distress: Systematic review and meta-analysis

BACKGROUND High rates of emotional distress and depressive symptoms in the community can reflect difficult life events and social circumstances. There is a need for appropriate, low-cost, non-medical interventions for many individuals. Befriending is an emotional support intervention commonly offered by the voluntary sector. AIMS To examine the effectiveness of befriending in the treatment of emotional distress and depressive symptoms. METHOD Systematic review of randomised trials of interventions focused on providing emotional support to individuals in the community. RESULTS Compared with usual care or no treatment, befriending had a modest but significant effect on depressive symptoms in the short term (standardised mean difference SMD = -0.27, 95% CI -0.48 to -0.06, nine studies) and long term (SMD = -0.18, 95% CI -0.32 to -0.05, five studies). CONCLUSIONS Befriending has a modest effect on depressive symptoms and emotional distress in varied patient groups. Further exploration of active ingredients, appropriate target populations and optimal methods of delivery is required.

Integrated primary care for patients with mental and physical multimorbidity: cluster randomised controlled trial of collaborative care for patients with depression comorbid with diabetes or cardiovascular disease

Objective To test the effectiveness of an integrated collaborative care model for people with depression and long term physical conditions. Design Cluster randomised controlled trial. Setting 36 general practices in the north west of England. Participants 387 patients with a record of diabetes or heart disease, or both, who had depressive symptoms (≥10 on patient health questionaire-9 (PHQ-9)) for at least two weeks. Mean age was 58.5 (SD 11.7). Participants reported a mean of 6.2 (SD 3.0) long term conditions other than diabetes or heart disease; 240 (62%) were men; 360 (90%) completed the trial. Interventions Collaborative care included patient preference for behavioural activation, cognitive restructuring, graded exposure, and/or lifestyle advice, management of drug treatment, and prevention of relapse. Up to eight sessions of psychological treatment were delivered by specially trained psychological wellbeing practitioners employed by Improving Access to Psychological Therapy services in the English National Health Service; integration of care was enhanced by two treatment sessions delivered jointly with the practice nurse. Usual care was standard clinical practice provided by general practitioners and practice nurses. Main outcome measures The primary outcome was reduction in symptoms of depression on the self reported symptom checklist-13 depression scale (SCL-D13) at four months after baseline assessment. Secondary outcomes included anxiety symptoms (generalised anxiety disorder 7), self management (health education impact questionnaire), disability (Sheehan disability scale), and global quality of life (WHOQOL-BREF). Results 19 general practices were randomised to collaborative care and 20 to usual care; three practices withdrew from the trial before patients were recruited. 191 patients were recruited from practices allocated to collaborative care, and 196 from practices allocated to usual care. After adjustment for baseline depression score, mean depressive scores were 0.23 SCL-D13 points lower (95% confidence interval −0.41 to −0.05) in the collaborative care arm, equal to an adjusted standardised effect size of 0.30. Patients in the intervention arm also reported being better self managers, rated their care as more patient centred, and were more satisfied with their care. There were no significant differences between groups in quality of life, disease specific quality of life, self efficacy, disability, and social support. Conclusions Collaborative care that incorporates brief low intensity psychological therapy delivered in partnership with practice nurses in primary care can reduce depression and improve self management of chronic disease in people with mental and physical multimorbidity. The size of the treatment effects were modest and were less than the prespecified effect but were achieved in a trial run in routine settings with a deprived population with high levels of mental and physical multimorbidity. Trial registration ISRCTN80309252.

Integrating service development with evaluation in telehealthcare: an ethnographic study

Abstract Objectives To identify issues that facilitate the successful integration of evaluation and development of telehealthcare services. Design Ethnographic study using various qualitative research techniques to obtain data from several sources, including in-depth semistructured interviews, project steering group meetings, and public telehealthcare meetings. Setting Seven telehealthcare evaluation projects (four randomised controlled trials and three pragmatic service evaluations) in the United Kingdom, studied over two years. Projects spanned a range of specialties—dermatology, psychiatry, respiratory medicine, cardiology, and oncology. Participants Clinicians, managers, technical experts, and researchers involved in the projects. Results and discussion Key problems in successfully integrating evaluation and service development in telehealthcare are, firstly, defining existing clinical practices (and anticipating changes) in ways that permit measurement; secondly, managing additional workload and conflicting responsibilities brought about by combining clinical and research responsibilities (including managing risk); and, thirdly, understanding various perspectives on effectiveness and the limitations of evaluation results beyond the context of the research study. Conclusions Combined implementation and evaluation of telehealthcare systems is complex, and is often underestimated. The distinction between quantitative outcomes and the workability of the system is important for producing evaluative knowledge that is of practical value. More pragmatic approaches to evaluation, that permit both quantitative and qualitative methods, are required to improve the quality of such research and its relevance for service provision in the NHS.