Dataset Information

Development of an intervention to increase adherence to nebuliser treatment in adults with cystic fibrosis: CFHealthHub.

ABSTRACT:

Background

Cystic fibrosis (CF) is a life-limiting genetic condition in which daily therapies to maintain lung health are critical, yet treatment adherence is low. Previous interventions to increase adherence have been largely unsuccessful and this is likely due to a lack of focus on behavioural evidence and theory alongside input from people with CF. This intervention is based on a digital platform that collects and displays objective nebuliser adherence data. The purpose of this paper is to identify the specific components of an intervention to increase and maintain adherence to nebuliser treatments in adults with CF with a focus on reducing effort and treatment burden.

Methods

Intervention development was informed by the Behaviour Change Wheel (BCW) and person-based approach (PBA). A multidisciplinary team conducted qualitative research to inform a needs analysis, selected, and refined intervention components and methods of delivery, mapped adherence-related barriers and facilitators, associated intervention functions and behaviour change techniques, and utilised iterative feedback to develop and refine content and processes.

Results

Results indicated that people with CF need to understand their treatment, be able to monitor adherence, have treatment goals and feedback and confidence in their ability to adhere, have a treatment plan to develop habits for treatment, and be able to solve problems around treatment adherence. Behaviour change techniques were selected to address each of these needs and were incorporated into the digital intervention developed iteratively, alongside a manual and training for health professionals. Feedback from people with CF and clinicians helped to refine the intervention which could be tailored to individual patient needs.

Conclusions

The intervention development process is underpinned by a strong theoretical framework and evidence base and was developed by a multidisciplinary team with a range of skills and expertise integrated with substantial input from patients and clinicians. This multifaceted development strategy has ensured that the intervention is usable and acceptable to people with CF and clinicians, providing the best chance of success in supporting people with CF with different needs to increase and maintain their adherence. The intervention is being tested in a randomised controlled trial across 19 UK sites.

SUBMITTER: Arden MA

PROVIDER: S-EPMC7780635 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

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Publications

Development of an intervention to increase adherence to nebuliser treatment in adults with cystic fibrosis: CFHealthHub.

Arden M A MA Hutchings M M Whelan P P Drabble S J SJ Beever D D Bradley J M JM Hind D D Ainsworth J J Maguire C C Cantrill H H O'Cathain A A Wildman M M

Pilot and feasibility studies 20210104 1

<h4>Background</h4>Cystic fibrosis (CF) is a life-limiting genetic condition in which daily therapies to maintain lung health are critical, yet treatment adherence is low. Previous interventions to increase adherence have been largely unsuccessful and this is likely due to a lack of focus on behavioural evidence and theory alongside input from people with CF. This intervention is based on a digital platform that collects and displays objective nebuliser adherence data. The purpose of this paper ...[more]

PMID: 33390191

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Project description:BackgroundPreventative medication reduces hospitalisations in people with cystic fibrosis (PWCF) but adherence is poor. We assessed the feasibility of a randomised controlled trial of a complex intervention, which combines display of real time adherence data and behaviour change techniques.MethodsDesign: Pilot, open-label, parallel-group RCT with concurrent semi-structured interviews.ParticipantsPWCF at two Cystic Fibrosis (CF) units. Eligible: aged 16 or older; on the CF registry. Ineligible: post-lung transplant or on the active list; unable to consent; using dry powder inhalers.InterventionsCentral randomisation on a 1:1 allocation to: (1) intervention, linking nebuliser use with data recording and transfer capability to a software platform, and behavioural strategies to support self-management delivered by trained interventionists (n?=?32); or, (2) control, typically face-to-face meetings every 3?months with CF team (n?=?32).OutcomesRCT feasibility defined as: recruitment of ??48 participants (75% of target) in four months (pilot primary outcome); valid exacerbation data available for ??85% of those randomised (future RCT primary outcome); change in % medication adherence; FEV1 percent predicted (key secondaries in future RCT); and perceptions of trial procedures, in semi-structured interviews with intervention (n?=?14) and control (n?=?5) participants, interventionists (n?=?3) and CF team members (n?=?5).ResultsThe pilot trial recruited to target, randomising 33 to intervention and 31 to control in the four-month period, June-September 2016. At study completion (30th April 2017), 60 (94%; Intervention?=?32, Control =28) participants contributed good quality exacerbation data (intervention: 35 exacerbations; control: 25 exacerbation). The mean change in adherence and baseline-adjusted FEV1 percent predicted were higher in the intervention arm by 10% (95% CI: -5.2 to 25.2) and 5% (95% CI -2 to 12%) respectively. Five serious adverse events occurred, none related to the intervention. The mean change in adherence was 10% (95% CI: -5.2 to 25.2), greater in the intervention arm. Interventionists delivered insufficient numbers of review sessions due to concentration on participant recruitment. This left interventionists insufficient time for key intervention procedures. A total of 10 key changes that were made to RCT procedures are summarised.ConclusionsWith improved research processes and lower monthly participant recruitment targets, a full-scale trial is feasible.Trial registrationISRCTN13076797 . Prospectively registered on 07/06/2016.

Project description:Preventative inhaled treatments in cystic fibrosis will only be effective in maintaining lung health if used appropriately. An accurate adherence index should therefore reflect treatment effectiveness, but the standard method of reporting adherence, that is, as a percentage of the agreed regimen between clinicians and people with cystic fibrosis, does not account for the appropriateness of the treatment regimen. We describe two different indices of inhaled therapy adherence for adults with cystic fibrosis which take into account effectiveness, that is, "simple" and "sophisticated" normative adherence.Denominator adjustment involves fixing a minimum appropriate value based on the recommended therapy given a person's characteristics. For simple normative adherence, the denominator is determined by the person's Pseudomonas status. For sophisticated normative adherence, the denominator is determined by the person's Pseudomonas status and history of pulmonary exacerbations over the previous year. Numerator adjustment involves capping the daily maximum inhaled therapy use at 100% so that medication overuse does not artificially inflate the adherence level.Case A is an example of inhaled therapy under prescription based on Pseudomonas status resulting in lower simple normative adherence compared to unadjusted adherence. Case B is an example of inhaled therapy under-prescription based on previous exacerbation history resulting in lower sophisticated normative adherence compared to unadjusted adherence and simple normative adherence. Case C is an example of nebulizer overuse exaggerating the magnitude of unadjusted adherence.Different methods of reporting adherence can result in different magnitudes of adherence. We have proposed two methods of standardizing the calculation of adherence which should better reflect treatment effectiveness. The value of these indices can be tested empirically in clinical trials in which there is careful definition of treatment regimens related to key patient characteristics, alongside accurate measurement of health outcomes.

Project description:ObjectivesAdherence to nebulizer treatment in adults with Cystic Fibrosis (CF) is poor, and interventions are needed. This research aimed to identify the factors affecting nebulizer adherence using the Theoretical Domains Framework (TDF) and to compare these for participants with different levels of adherence.DesignData-prompted interviews using the TDF.MethodsEighteen semi-structured interviews were conducted with adults with CF during which objectively measured adherence data were discussed. Framework analysis was used to code the data into TDF domains, and inductive qualitative content analysis was used to code different beliefs and experiences. Aspects of the TDF that differed between participants with different adherence levels were explored.ResultsFactors influencing adherence to treatment included all 14 domains of the TDF, 10 of which appeared to vary by adherence level: Skills; Memory and decision-making; and Behavioural regulation; Environmental context and resources; Social influences; Beliefs about consequences; Beliefs about capability; Reinforcement; Social role and identify; Intentions; Optimism; and Emotions.ConclusionsThis study is the first to use objectively measured adherence data in a data-prompted interview using the TDF framework to systematically assess the full range of factors potentially influencing adherence. The results highlighted that interventions need to consider issues of capability, opportunity, and motivation. Interventions that challenge dysfunctional beliefs about adherence and which support the development of routines or habits and problem-solving may be particularly useful for adults with CF. Statement of contribution What is already known? Adherence to medication in adults with cystic fibrosis is poor. Previous research has identified a range of contributing factors in relation to subjective reports of adherence. There is a wide discrepancy between self-reported adherence and objectively measured adherence. What this study adds A data-prompted interview using objectively measured adherence data enabled the systematic assessment of potential factors that could be targeted in an intervention to increase adherence. There were some differences in the factors that were identified by high and low adherers. There is not one-size fits all intervention for adherence to medication in cystic fibrosis.

Project description:The course of cystic fibrosis (CF) progression in children is affected by parent adherence to treatment plans. The Theory of Reasoned Action (TRA) posits that intentions are the best behavioral predictors and that intentions reasonably follow from beliefs ("determinants"). Determinants are affected by multiple "background factors," including spirituality. This study's purpose was to understand whether two parental adherence determinants (attitude towards treatment and self-efficacy) were associated with spirituality (religious coping and sanctification of the body). We hypothesized that parents' attitudes toward treatment adherence are associated with these spiritual constructs. A convenience sample of parents of children with CF aged 3-12 years (n = 28) participated by completing surveys of adherence and spirituality during a regular outpatient clinic visit. Type and degree of religious coping was examined using principal component analysis. Adherence measures were compared based on religious coping styles and sanctification of the body using unpaired t-tests. Collaborative religious coping was associated with higher self-efficacy for completing airway clearance (M = 1070.8; SD = 35.8; P = 0.012), for completing aerosolized medication administration (M = 1077.1; SD = 37.4; P = 0.018), and for attitude towards treatment utility (M = 38.8; SD = 2.36; P = 0.038). Parents who attributed sacred qualities to their child's body (e.g., "blessed" or "miraculous") had higher mean scores for self-efficacy (airway clearance, M = 1058.6; SD = 37.7; P = 0.023; aerosols M = 1070.8; SD = 41.6; P = 0.020). Parents for whom God was manifested in their child's body (e.g., "My child's body is created in God's image") had higher mean scores for self-efficacy for airway clearance (M = 1056.4; SD = 59.0; P = 0.039), aerosolized medications (M = 1068.8; SD = 42.6; P = 0.033) and treatment utility (M = 38.8; SD = 2.4; P = 0.025). Spiritual constructs show promising significance and are currently undervalued in chronic disease management.

Project description:People with a psychiatric diagnosis smoke at high rates, yet are rarely treated for tobacco use. Health care systems often use a 'no treatment' default for tobacco, such that providers must actively choose (opt-in) to treat their patients who express interest in quitting. Default bias theory suggests that opt-in systems may reinforce the status quo to not treat tobacco use in psychiatry. We aim to conduct a pilot study testing an opt-out system for implementing a 3A's (ask, advise, assist) tobacco treatment model in outpatient psychiatry. We will use a mixed-methods, cluster-randomized study design. We will implement a tobacco use clinical reminder for outpatient psychiatrists at the VA New York Harbor Healthcare System. Psychiatrists (N = 20) will be randomized 1:1 to one of two groups: (1) Opt-In Treatment Approach: Psychiatrists will receive a reminder that encourages them to offer cessation medications and referral to cessation counseling; or (2) Opt-Out Treatment Approach: Psychiatrists will receive a clinical reminder that includes a standing cessation medication order and a referral to cessation counseling that will automatically generate unless the provider cancels. Prior to implementation of the reminders, we will hold a 1-hour training on tobacco treatment for psychiatrists in both arms. We will use VA administrative data to calculate the study's primary outcomes: 1) the percent of smokers prescribed a cessation medication and 2) the percent of smokers referred to counseling. During the intervention period, we will also conduct post-visit surveys with a cluster sample of 400 patients (20 per psychiatrist) to assess psychiatrist fidelity to the 3 A's approach and patient perceptions of the opt-out system. At six months, we will survey the clustered patient sample again to evaluate the study's secondary outcomes: 1) patient use of cessation treatment in the prior 6 months and 2) self-reported 7-day abstinence at 6 months. At the end of the intervention period, we will conduct semi-structured interviews with 12-14 psychiatrists asking about their perceptions of the opt-out approach. This study will produce important data on the potential of opt-out systems to overcome barriers in implementing tobacco use treatment in outpatient psychiatry. Clinicaltrials.gov Identifier NCT04071795 (registered August 28, 2019). https://www.clinicaltrials.gov/ct2/show/NCT04071795.

Dataset Information

Development of an intervention to increase adherence to nebuliser treatment in adults with cystic fibrosis: CFHealthHub.

Background

Methods

Results

Conclusions

Publications

Development of an intervention to increase adherence to nebuliser treatment in adults with cystic fibrosis: CFHealthHub.

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