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An important and challenging part of living with cancer relates to the repeated visits to the hospital. Since how patients cope between these post-diagnostic visits depends partly on the information and support received from their physician during the visits, it is important to make the most of them. Recent findings reinforce the importance of training not only the health care professionals in communication skills, but providing patients with support in communication as well. Delivering such supportive interventions online can have potential benefits in terms of accessibility, cost-effectiveness, and ability to tailor information to personal needs. However, problems with attrition (dropout, non-usage) during the test phase and poor uptake after implementation are frequently reported. The marginal level of engagement of the patient as end user seems to play a role in this. Therefore, recent research suggests integrating theory-based development methods with methods that promote involvement of the patient at an early stage. This paper describes a participatory protocol, used to let patients guide a theory-informed development process.
The objective of this project was to apply a bottom-up inspired procedure to develop a patient-centered intervention with corresponding evaluation and implementation plan.
The applied development protocol was based on the intervention mapping framework, combined with patient participatory methods that were inspired by the participation ladder and user-centred design methods.
The applied protocol led to a self-directed online communication intervention aimed at helping patients gain control during their communications with health care professionals. It also led to an evaluation plan and an implementation plan. The protocol enabled the continuous involvement of patient research partners and the partial involvement of patient service users, which led to valuable insights and improvements.
The applied protocol realized patient participation on different levels throughout the entire project. Early involvement, involvement on different levels, and flexibility in terms of planning and setup seem to be preconditions to creating a bottom-up inspired development procedure with (seriously ill) patients. Further research is necessary to find out if a more patient-centered approach improves the implementation and uptake of eHealth interventions.
Netherlands National Trial Register ID number: NTR3779; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3779 (Archived by WebCite at http://www.webcitation.org/6TdfALKxV).
An important and challenging part of living with cancer concerns the repeated visits to the hospital. These visits are important as they monitor the development of the disease and set the stage for how to cope with life until the next consultation. Since how patients cope between these post-diagnostic visits depends partly on the information and support received from the health care professionals (HCPs) (eg, specialists, nurses) during the visits, it is important to get the most out of them. Many training programs are designed to improve HCPs’ communication skills, which may facilitate patient engagement in the medical dialogue. However, cancer patients ascribe many barriers in medical communication to their own attributes, such as a lack of communication skills, and interfering emotions and beliefs [
Such interventions can be especially efficient when delivered online. The content and type of online interventions can be computer tailored to patients’ preferences and needs and they can be accessible any time and any place in a cost-effective way [
The technology- and expert-driven development methods (top-down) are indicated as possible causes for attrition and adoption problems [
Considering the fact that the contribution of patients in oncology consultations is often limited [
This paper outlines the patient participatory approach used to develop an online intervention with corresponding evaluation and implementation plan. The goal of this paper is to share the applied protocol, the use of the protocol in the PatientTIME project, and our lessons learned in the attempt to create a bottom-up inspired intervention.
A stepwise protocol (
Stepwise protocol.
The IM framework systematically guides the planning and decision-making process in health promoting programs [
Intervention Mapping framework.
The way patients were involved in the applied protocol was inspired by the concept of participation ladders. Different participation ladders describe the idea of involving participants in varying degrees [
User-centered design (UCD) was used as a guide to realize patient participation in the different protocol steps. UCD is defined by Preece et al (2002) as “an approach, which views knowledge about users and their involvement in the design process as a central concern”. The challenge of UCD is to map the needs, behavior, actions, and abilities of the end user and let this information influence how the intervention takes shape. The context mapping method (Step 1) and the usability tests (Step 4) were inspired by UCD thinking.
All participating patients were adults diagnosed with malignant lymphoma and they all voluntarily signed up to contribute to the project. They were recruited via social media, online newsletters, advertisements on Hematon’s website, regional and national patient conferences, and leaflets in hospital waiting rooms. To recruit patient research partners, Hematon informed several of their active volunteers (patients) who had experience in information and communication technology (ICT) development and with supporting fellow patients.
A multidisciplinary working group consisting of researchers, HCPs, and a patient research partner was responsible for the daily coordination of the project. The working group collaborated with physicians, nurse practitioners, patients, user-interaction designers, software developers, and representatives of Hematon. Final decisions regarding the protocol were reached through discussions in the working group. Decisions related to the implementation plan were made in consultation with Hematon.
The intervention development protocol resulted in three products: a self-directed online communication tool, a corresponding evaluation plan, and an implementation plan. The goal of the intervention is to help patients gain more control in the communications with their HCPs. Patients can access the intervention before each hospital visit. The information is provided via an algorithm computer-tailored to the patient’s self-assessed, momentary efficacy for communication with their HCP, to whether he or she attends the HCP alone or with a companion, and to the stage of treatment. The central information consists of short video clips of simulated consultations that model adequate communication behavior. Additionally, the intervention includes an open question prompt sheet (QPS), a reminder system linked to a list of planned hospital visit dates, and an option to store and play back audio recordings of the consultation (see
The goal of this preparatory step was to integrate and plan the patient involvement throughout the entire protocol. This resulted in the recruitment of two patients as research partners. They both had been active in supporting fellow patients and therefore they had built a rich body of knowledge about the different aspects of having malignant lymphoma. Additionally they both had a relevant professional background in ICT (Web-development, system design, research and development). One research partner (HG) became part of the working group. The second research partner was consulted on a more irregular basis. The research partners were directly involved in the planning of the PatientTIME project and in the decision-making processes in each protocol step. This involvement approach aligns with the upper steps of the participation ladder as they had an initiating and agenda-setting role and they worked directly with the other stakeholders. Additionally, patient service users were invited to participate in the needs assessment (Step 1), intervention design (Step 4), and the evaluation (Step 5). Moreover, their input was used to inspire the other protocol steps. Last, representatives of Hematon were consulted to explore the possibilities for implementing the intervention after the research project has ended (Step 6) and how we could use their network to keep in close contact with patients.
The goal of the needs assessment step was to map the patient-perceived barriers and facilitators in communication with HCPs and to learn from patients’ experiences. A qualitative two-step method was applied, inspired by user-centered design thinking. The applied method is derived from the context mapping framework, used by product developers and user interaction researchers to gain insight into the needs of prospective users of new products [
The expressed barriers were analyzed, clustered, and translated into a list of intervention objectives (Step 2) and used as a basis for the central information of the intervention (Step 4). For example, patients did not want to be bothersome and therefore they found it hard to ask (all of) their questions and to express details about their physical and/or mental health status. This information was used to develop information about how to request attention for your prepared questions (
Intervention objectives, theory-based methods, and practical strategies.
The goal of the second and third step was to establish the objectives of the intervention by specifying what would change as a result of the intervention. The overall aim of the intervention is to support patients in effective communication by creating awareness about the role they can play and the benefits they can gain from participating, as well as providing matching communication skills. Patient input gathered during the needs assessment was used to operationalize the overarching objective in 11 intervention objectives that relate to the awareness, attitude, and skills of the patient (
The main method chosen was modelling. Modelling has proven to be effective in patient-targeted skill building interventions [
The intervention objectives were based on the experiences expressed by the patient service users. However, because this was a more theoretical phase comprising the literature search and the analysis of data, further patient involvement in this step was limited to a discussion with the patient research partners. The outcomes were presented and the feasibility of the operationalization was discussed, which was important for the final implementation. Their feedback did not change the initial outcomes.
The goal of the fourth step was to design the content, structure, and layout of the intervention, inspired by the information gathered in the previous steps. An iterative design method was applied, that is, intermediate results (eg, video scripts, website navigation) were presented to patients and experts. Subsequently, the intermediate results were adapted to their feedback, which is discussed in the following paragraphs.
The targeted intervention objectives (Step 2) were translated into five video diaries, in which five simulated patients demonstrate different communication skills. Each video diary (see
Given the changing preferences and needs of the patient, the working group chose not to present all 58 video clips to the patient at once. The patient-perceived, pre-visit communication needs determine the selection of three most relevant objectives, leading to the matching video clips. These needs are measured with an adapted version of the 10-item, 5-point Likert scaled Perceived Efficacy in Patient-Physician Interaction instrument (PEPPI). In this scale, patients indicate pre-visit their expected efficacy and post-visit their perceived momentary efficacy in communication [
Special attention was paid to two aspects that can influence the uptake of eHealth interventions: usability and credibility. According to Nielsen, usability is a quality attribute that assesses how easy user interfaces are to use and it is a necessary condition to bind users to a website. Credibility is an important element for the persuasive character of the intervention [
The main credibility and usability issues that were identified are summarized in
Summary of identified credibility and usability issues.
Identified issues | Processed changes | |
Credibility | Information about collaborating parties, help function, and privacy issues is missing / unclear. | An extra information page was added with separate tabs containing information about collaborating stakeholders, introducing members of the working group, explaining privacy issues, and explaining the scientific context. A separate ‘help’ function was highlighted with contact details, frequently asked questions, and a project summary. |
Functionality | Print function QPS unclear and use of the agenda not clear. | The agenda was made accessible on the home page, corresponding text was changed, and buttons were highlighted. The print function of the QPSawas highlighted. |
Navigation | Location and additional text related to ‘log-in’ button is confusing. It is not always clear which elements are ‘buttons’. Not always clear where you are in the website. | The consistency in color use and type of buttons improved, more contrasting colors were used when mouse-over, headings of active pages remain highlighted and stand out more comparing to the headings of inactive pages, the home pages present instructing messages to the user about the project status. |
Information | Some texts are too formal. Some inconsistency in use of terms / jargon. | Textual changes were made. |
Layout | Illustrative pictures too positive / happy. Unclear presentation of the selection of video clips. It is not clear what the content of the ‘video archive’ is or will be. | Another way to present the video diaries was developed, the video archive was removed and its function was incorporated in the video page. |
aQPS: question prompt sheet
The goal of the fifth step was to develop an evaluation plan to examine the effects of the intervention. Decisions regarding the evaluation were partly stipulated in the research protocol, which proposed a randomized controlled trial (RCT) in which participants are randomized into the intervention group (with access to PatientTIME) and control group patients (without access to PatientTIME).
While working out the RCT protocol, practical issues like recruitment and patient information were discussed with the research partners and questionnaires were developed in collaboration with them. One patient research partner and one patient service user were asked to pre-test the developed questionnaires with a think-aloud procedure. Their feedback focused mainly on questions initially formulated as too formal or medical jargon that was unclear.
The involvement of prospective participants (ie, patient service users) in the RCT was planned on different levels. Both intervention and control group participants were asked to participate for a maximum of three consultations and they were both asked to fill in questionnaires delivered via their personal account. On the lowest participation level, participants are provided with information and asked to complete questionnaires. On a second level, they are encouraged to verbalize their ideas and input with regard to the study design to inform decisions taken by the working group. Last, a random subset of patients in the intervention group is encouraged to audio record and upload their consultation(s) on their secured PatientTIME account. This pilot was designed for the purpose of evaluating the playback option as well as to be analyzed by the researchers on their actual participation during their consultation.
The developed RCT protocol was audited with external experts to evaluate privacy issues and the exchange of online information and to assess and reduce possible risks. Because of the juridical, technical nature of the audit, we did not include patients in this audit. The Medical Ethical Committee of the Radboud University Nijmegen Medical Centre evaluated the RCT protocol and concluded that following the Dutch Medical Research Involving Human Subjects Act, the study did not require ethics approval. The RCT (registered in the Netherlands Trial Register, 3779) started in 2013 and the first results are expected to be available in 2015.
The goal of the last step was to design an implementation plan that would guide the transfer of the intervention to a publicly available online tool. Contrary to the detailed evaluation plan, the implementation plan was a rough setup of actions that were guided by and adapted to decisions made in previous steps. To increase the chance of a successful implementation and adoption, the involvement of patients and Hematon in the planning and execution of the actual implementation started as early as the project planning. In the preparatory step, the board of Hematon was asked to help thinking about the valorization of the research results. In this way, we aimed to divide responsibilities at an early stage and awareness was created about the upcoming intervention.
Hematon wanted to make developed materials available for all their members and other patients. As a result, an agreement was established noting that after research is finalized, Hematon would become responsible for hosting the tool. Subsequently, during the development of the intervention and evaluation plan, several meetings were planned with our software developer and the webmasters of Hematon. In consultation with them, we aimed to develop materials that were not only usable for the secured trial setting, but could easily be transferred to a publicly available tool. Both patient research partners will be actively involved in the actual transfer of the intervention.
This transfer is not within the scope of this paper and will be done when the RCT proves to be acceptable, usable, and efficient. Lessons learned from the evaluation will be used to optimize the intervention before implementation.
In the PatientTIME project, patients were given the opportunity to actively participate in the development of an online communication intervention with corresponding evaluation and implementation plan. In conformity with previously publications, the cooperation with patients brought valuable insights and appeared to influence many decisions made [
The combination of evidence-based and patient participatory methods did assist us in involving patients. The structure of the IM framework helped us choose when to involve patients, while the idea of participation ladders and user-centered design thinking inspired us in how to involve patients.
The involvement of patients on different levels appeared to be useful and practical. The patient research partners ensured a continuous patient-centered view, while the patient service users were able to give fresh new insights on different protocol steps.
Both Hematon as well as the research partners were involved from the very beginning of the project as a result of the preparatory planning step. We experienced this as a precondition to creating a continuous patient-centered view. Their early involvement supported the participation of patient service users and it gave the opportunity to discuss possible valorization of results at an early stage.
Another facilitating aspect was the attitude of the participating patients. They all seemed to recognize why the intervention was developed. This appeared to be a driving force behind their motivation to participate. Attracting engaged patients may be a precondition to creating a successful patient-centered approach.
The recruitment and involvement of patients was a time-consuming part of the project. In some steps, we could have benefited from more involved patient service users (especially the intervention development step), but time constraints prevented us from doing so. The extent of patient involvement relates to the amount of time available to execute the project. However, we think time constraints should not be a reason for limited participation.
Flexibility in terms of planning and setup seemed a precondition to including the perspectives of the (seriously ill) patients. For example, during the needs assessment, some patients were too ill to attend a focus group session. An interview at their home gave us the opportunity to incorporate their experiences as well. Considering the illness of the targeted patients, we think the extent of involvement of service users should be evaluated per protocol step.
Flexibility also appeared to be a key concept in incorporating patients’ viewpoints and experiences in the defined research proposal. In the current study, a research proposal defined certain decisions, for example, the intervention would be delivered online and the evaluation of the effects would be tested in an RCT. Although the proposal was built on previous research and experiences, these decisions were made before the targeted patients could be consulted (see Future Research).
While there is a desire for more patient participation in research, it seems to clash with strict research proposals and protocols that need to be approved before the start of a project. Perhaps researchers should involve (ex-) patients in the design of such documents. However, this still does not give the required flexibility to adapt a project to the input of patients, gathered along the way. Patient participation in research projects that include design activities requires methodologies that allow the dynamics of design (eg, by patient input) to influence the process. Intervention mapping can be a guiding method, unless it is bounded to a strict predefined proposal. Participatory Learning and Action Research or Design Inclusive Research might be interesting alternative methodologies [
Considering the evaluation of online interventions and the necessary flexibility to incorporate patients’ input, it might be interesting to study other perhaps more flexible evaluation methods than an RCT. A longitudinal study where intermediate results can be used to optimize the intervention during the test phase might be an interesting alternative. Furthermore, some patients might have a strong preference for using or not using technology. In the case of strong preferences, results may be biased when using a regular randomized controlled trial. Within preference trial designs, this bias is dealt with by the fact that patients with strong preferences for either intervention will get the intervention they prefer. Only those without explicit preference are randomly assigned to either the intervention or the control group [
A limitation of the applied method is that the participating patients represent a self-selected convenience sample as involved patients voluntary signed up to contribute to the study. This could have led to a biased view of a more empowered group of patients. In general, the possibility of having a biased group of participants in a participatory development approach is evident, as one needs to find patients that are interested in cooperating. On the other hand, one wants to develop an intervention that reaches out to the whole targeted population. This advocates the use of different participation levels and creative solutions to attract and/or select patient service users to capture a broad view of experiences.
Similar to other studies [
Involvement of patient research partners in combination with patient service users can inspire and guide the evidence-based intervention mapping protocol. Early involvement, involvement on different levels, and flexibility in terms of planning and setup seem to be preconditions to create a bottom-up inspired development procedure with (seriously ill) patients. Further research is necessary to find out if a more patient-centered approach improves the implementation and uptake of eHealth interventions.
Intervention.
Video diaries.
health care professional
information and communication technology
intervention mapping framework
Patients Talk in Medical Encounters
Perceived Efficacy in Patient-Physician Interaction
question prompt sheet
randomized controlled trial
user-centered design
We are grateful to all patients for their involvement, Hematon representatives for their advice and help with patient recruitment, and the Alpe d’HuZes program of the Dutch Cancer Society for its financial support.
None declared.