Dataset Information

Developing a complex intervention whilst considering implementation: the TANDEM (Tailored intervention for ANxiety and DEpression Management) intervention for patients with chronic obstructive pulmonary disease (COPD).

ABSTRACT:

Background

Guidelines now call for a thorough and comprehensive description of the development of healthcare interventions to aid evaluation and understanding of the processes of change. This was the primary aim of this study but we also recognised that effective interventions are commonly not implemented in clinical practice. It is suggested that insufficient attention is given to the implementation process at the development phase of interventions. This study outlines the 5 step iterative process we adopted for considering both implementation and effectiveness issues from the outset of intervention development. We use the development of a complex intervention Tailored intervention for ANxiety and DEpression Management (TANDEM) in patients with chronic obstructive pulmonary disease to illustrate this process.

Methods

Intervention development built upon the Medical Research Council framework for developing complex interventions and the person-based approach for development of behavioural interventions. Building an expert team, specifying theory, qualitative data collection and pre-piloting were all critical steps in our intervention development and are described here.

Results

Contact with experts in the field, and explicitly building on previous work, ensured efficiency of design. Qualitative work suggested guiding principles for the intervention such as introducing mood in relation to breathlessness, and providing flexible tailoring to patients' needs, whilst implementation principles focused on training selected respiratory professionals and requiring supervision to ensure standards of care. Subsequent steps of intervention development, pre-piloting and intervention refinement led to an intervention that was deemed acceptable and if successful will be ready for implementation.

Conclusions

The TANDEM study was developed efficiently by building on previous work and considering implementation issues from the outset, with the aim that if shown to be effective it will have more rapid translation in to the health care system with accelerated patient benefits.

Trial registration

ISRCTN ISRCTN59537391 . Registered on 20 March 2017. Protocol version 6.0, 22 April 2018.

SUBMITTER: Steed L

PROVIDER: S-EPMC8025339 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:BACKGROUND:People with chronic obstructive pulmonary disease (COPD) are at increased risk of depression and anxiety, which greatly reduces their quality of life and is associated with worse outcomes; but these psychological co-morbidities are under-recognised and undertreated in COPD patients. Pulmonary rehabilitation (PR) improves mood for up to 6 months but health practitioners under-refer, and patients commonly fail to attend/complete PR. Research suggests that complex non-pharmacological interventions, including both psychological and exercise components, may reduce anxiety and depression in COPD. We have developed a tailored, cognitive behavioural approach (CBA) intervention for patients with COPD and co-morbid anxiety and/or depression ('TANDEM'), which precedes and optimises the benefits of currently offered PR. We hypothesise that such a psychological intervention, delivered by supervised, trained respiratory healthcare professionals, will improve mood in patients with mild to moderate anxiety and/or depression and encourage uptake and completion of PR. METHODS:We will conduct a multi-centre, pragmatic, randomised controlled trial of the TANDEM intervention compared to usual care across the Midlands, London, the South East and Bristol, UK. We will train healthcare professionals familiar with COPD to deliver the manualised, tailored, face-to-face, one-to-one intervention weekly for 6-8?weeks. We will recruit 430 participants from primary, community and secondary care with confirmed COPD and moderate to very severe airflow limitation, who are eligible for assessment for PR, and who screen positive for symptoms of mild/moderate depression and/or anxiety using the Hospital Anxiety and Depression scale (HADS). Participants will be randomised 1.25:1 (intervention: usual care). The co-primary outcomes are the HADS anxiety and depression subscale scores at 6?months; participants will be followed up to 12?months. Secondary outcomes include uptake and completion of PR and healthcare resource use. There will be a parallel process evaluation and a health economic evaluation. DISCUSSION:The TANDEM intervention has the potential to optimise the unrealised synergy between a psychological intervention and PR. The CBA sessions will precede PR and target individuals' cognitions, behaviours and symptoms associated with anxiety and depression to decrease psychological morbidity and increase effective self-management amongst patients with COPD. TRIAL REGISTRATION:ISRCTN, ID: ISRCTN59537391. Registered on 20 March 2017. Protocol version 6.0, 22 April 2018.

Project description:Chronic obstructive pulmonary disease (COPD) is commonly associated with anxiety/depression which can affect self-management and quality of life. The TANDEM trial evaluated a cognitive behavioural approach intervention targeting COPD-related symptoms of anxiety and/or depression, comprising up to eight one-to-one sessions delivered by respiratory healthcare professionals prior to pulmonary rehabilitation (PR). The intervention showed no improvement in anxiety/depression or uptake/completion of PR. We present patient perspectives of the intervention to help understand these results. Semi-structured individual interviews, using a semi-structured topic guide informed by Sekhon's Theoretical Framework of Acceptability, were conducted with 19 patients between September 2019 and April 2020. The interviews were audio-recorded, transcribed verbatim and analysed thematically. The following could have limited the impact of the intervention: (1) The lives of patients were complex and commonly affected by competing comorbidities or other external stressors which they managed through previously adopted long-standing coping strategies. (2) Some patients were reluctant to talk about their mood despite the Facilitators' training and person centred-skills which aimed to enable patients to talk freely about mood. (3) The intervention handouts and 'home-practice' were perceived as helpful for some, but not suitable for all. (4) Many patients perceived improvements in their physical and mental health, but this was not sustained due to a mix of personal and external factors, and some did not perceive any benefits. (5) PR non-attendance/non-completion was a result of personal and PR service-related reasons. (6) Discussing COPD and mental health with the Facilitator was a novel experience. Many patients felt that TANDEM could be of benefit if it was offered earlier on/at different time points in the COPD illness journey. We found the delivery of TANDEM prior to PR was not helpful for patients with advanced COPD often experiencing other comorbidities, and/or difficult personal/external events. These patients already utilised long-standing coping strategies to manage their COPD. Holistic interventions, that address the impact of COPD in relation to wider aspects of a patients' life, may be more beneficial. ISRCTN Registry 59,537,391. Registration date 20 March 2017.

Project description:BackgroundDevelopment of complex interventions for management of chronic conditions has become increasingly common, with guidance now provided. Fidelity (whether the intervention is designed, delivered and received as intended) is critical to understanding if, and how an intervention works (or not). However, methods for achieving this are still evolving. This study describes the methods used in the TANDEM trial - a large multicentre study evaluating the impact of a cognitive behavioural intervention preceding routine pulmonary rehabilitation for people with chronic obstructive pulmonary disease and anxiety and or depression. Results for enhancement and training aspects of fidelity, are presented.MethodsUsing the National Institute for Health Behaviour Change Consortium (NIH BCC) framework of fidelity, a set of enhancement strategies and a fidelity measurement strategy were developed with input from a multidisciplinary team. The Cognitive First Aid Rating Scale (CFARS) was used to assess Facilitator (the respiratory professional delivering TANDEM) therapeutic competence at the end of the initial training and throughout treatment delivery (on a randomly selected set of cases). A TANDEM specific treatment adherence measure was developed following previously recommended procedures. Together these (the CFARS and adherence measure) comprised the TANDEM treatment delivery fidelity tool.ResultsHiring of respiratory professionals to the initial training programme was successful, with 44% of those expressing initial interest in being a Facilitator successfully completing the process. Video recordings of potential Facilitators conducting standardized patient role plays at the end of the initial training demonstrated fidelity of training.ConclusionsAddressing fidelity in complex intervention trials is a time and resource intensive process but has significant potential to increase understanding of results and strengthen the evidence base for effective interventions. By defining a full fidelity assessment method prior to analysis we aimed to minimise bias when interpreting results.Trial registrationISRCTN59537391 . Registered on 20 March 2017. Trial protocol version 6.0, 22 April 2018. Process evaluation protocol version 4.0, 1 November 2020.

Project description:BackgroundStratified care approach involving use of the STarT-Back tool to optimise care for patients with low back pain is gaining widespread attention in western countries. However, adoption and implementation of this approach in low-and-middle-income countries will be restricted by context-specific factors that need to be addressed. This study aimed to develop with physiotherapists, tailored intervention strategies for the implementation of stratified care for patients with low back pain.MethodsA two-round web-based Delphi survey was conducted among purposively sampled physiotherapists with a minimum of three years of clinical experience, with post-graduation certification or specialists. Thirty statements on barriers and enablers for implementation were extracted from the qualitative phase. Statements were rated by a Delphi panel with additional open-ended feedback. After each Delphi round, participants received feedback which informed their subsequent responses. Additional qualitative feedback were analysed using qualitative content analysis. The criteria for consensus and stability were pre-determined using percentage agreement (≥ 75%), median value (≥ 4), Inter-quartile range (≤ 1), and Wilcoxon matched-pairs test respectively.ResultsParticipants in the first round were 139 and 125 of them completed the study, yielding a response rate of 90%. Participants were aged 35.2 (SD6.6) years, and 55 (39.6%) were female. Consensus was achieved in 25/30 statements. Wilcoxon's test showed stability in responses after the 5 statements failed to reach consensus: 'translate the STarT-Back Tool to pidgin language' 71% (p = 0.76), 'begin implementation with government hospitals' 63% (p = 0.11), 'share knowledge with traditional bone setters' 35% (p = 0.67), 'get second opinion on clinician's advice' 63% (p = 0.24) and 'carry out online consultations' 65% (p = 0.41). Four statements strengthened by additional qualitative data achieved the highest consensus: 'patient education' (96%), 'quality improvement appraisals' (96%), 'undergraduate training on psychosocial care' (96%) and 'patient-clinician communication' (95%).ConclusionThere was concordance of opinion that patients should be educated to correct misplaced expectations and proper time for communication is vital to implementation. This communication should be learned at undergraduate level, and for already qualified clinicians, quality improvement appraisals are key to sustained and effective care. These recommendations provide a framework for future research on monitored implementation of stratified care in middle-income countries.

Project description:Background: Tailoring implementation strategies to local contexts is a promising approach to supporting implementation and sustainment of evidence-based practices in health settings. While there is increasing research on tailored implementation of mental health interventions, implementation research on suicide prevention interventions is limited. This study aimed to evaluate implementation and subsequently develop a tailored action plan to support sustainment of an evidence-based suicide prevention intervention; Collaborative Assessment and Management of Suicidality (CAMS) in an Australian public mental health service. Methods: Approximately 150 mental health staff working within a regional and remote Local Health District in Australia were trained in CAMS. Semi-structured interviews and focus groups with frontline staff and clinical leaders were conducted to examine barriers and facilitators to using CAMS. Data were analysed using a reflexive thematic analysis approach and mapped to the Exploration, Preparation, Implementation and Sustainment (EPIS) framework and followed by stakeholder engagement to design a tailored implementation action plan based on a 'tailored blueprint' methodology. Results: A total of 22 barriers to implementing CAMS were identified. Based on the perceived impact on implementation fidelity and the feasibility of addressing identified barriers, six barriers were prioritised for addressing through an implementation action plan. These barriers were mapped to evidence-based implementation strategies and, in collaboration with local health district staff, goals and actionable steps for each strategy were generated. This information was combined into a tailored implementation plan to support the sustainable use of CAMS as part of routine care within this mental health service. Conclusions: This study provides an example of a collaborative approach to tailoring strategies for implementation on a large scale. Novel insights were obtained into the challenges of evaluating the implementation process and barriers to implementing an evidence-based suicide prevention treatment approach within a geographically large and varied mental health service in Australia. Plain language abstract: This study outlines the process of using a collaborative stakeholder engagement approach to develop tailored implementation plans. Using the Exploration Preparation Implementation Sustainment Framework, findings identify the barriers to and strategies for implementing a clinical suicide prevention intervention in an Australian community mental health setting. This is the first known study to use an implementation science framework to investigate the implementation of the clinical suicide prevention intervention (Collaborative Assessment and Management of Suicidality) within a community mental health setting. This work highlights the challenges of conducting implementation research in a dynamic public health service.

Project description:BackgroundAn important prerequisite for the Chronic Care Model is to be able to identify, in a valid, simple and inexpensive way, the population with a chronic condition that needs proactive and planned care. We investigated if a set of administrative data could be used to identify patients with Chronic Obstructive Pulmonary Disease in a Danish population.MethodsSeven general practices were asked to identify patients with known Chronic Obstructive Pulmonary Disease in their practices. For the 266 patients (population A), we used administrative data on hospital admissions for lung-related diagnoses, redeemed prescriptions for lung-diseases drugs and lung- function tests combined to develop an algorithm that identified the highest proportion of patients with Chronic Obstructive Pulmonary Disease with the fewest criteria involved. We tested nine different algorithms combining two to four criteria. The simplest algorithm with highest positive predictive value identified 532 patients (population B); with possible diagnosis of Chronic Obstructive Pulmonary Disease in five general practices. The doctors were asked to confirm the diagnosis. The same algorithm identified 2,895 patients whom were asked to confirm their diagnosis (population C).ResultsIn population A the chosen algorithm had a positive predictive value of 72.2 % and three criteria: a) discharged patients with a chronic lung-disease diagnosis at least once during the preceding 5 years; or b) redeemed prescription of lung-medication at least twice during the preceding 12 months; or c) at least two spirometries performed at different dates during the preceding 12 months. In population B the positive predictive value was 65.0 % [60.8;69.1 %] and the sensitivity 44.8 % [41.3;48.4 %)] when the "uncertain" were added to where doctors agreed with the diagnosis. For the 1,984 respondents in population C, the positive predictive value was 72.9 % [70.8;74.8 %] and the sensitivity 29.7 % [28.4;31.0 %].ConclusionsAn algorithm based on administrative data has been developed and validated with sufficient positive predictive value to be used as a tool for identifying patients with Chronic Obstructive Pulmonary Disease. Some of the identified patients had other chronic lung-diseases (asthma). The algorithm should mostly be regarded as a tool for identifying chronic lung-disease and further development of the algorithm is needed.Trial registrationwww.clinicaltrials.gov (NCT01228708).