Development and pre-testing a tailored interactive voice response (IVR) intervention to support adherence to anti-hypertensive medications
293
14 December 2017
01 September 2016
31 August 2017
12 months
Medication adherence, hypertension, Behaviour Change Techniques, digital intervention
Dr.Katerina Kassavou, Research Associate in Behavioural Science, University of Cambridge
N/A
Professor Stephen Sutton, Professor of Behavioural Science, University of Cambridge (advised on the development of the intervention content & process of intervention tailoring)
Vikki Houghton, Research Assistant University of Cambridge, (Research assistant involved in recruitment process)
James Brimicombe, Data Manager, University of Cambridge is a collaborator, who developed the application to facilitate the delivery of the tailored intervention content.
Simon Edwards is a collaborator, who developed the IVR application to deliver the intervention.
To develop and pre-test an IVR intervention to support adherence to anti-hypertensive medications. Funding would enable us to solve the technical aspects of setting up a tailored IVR intervention, develop some intervention content and pre-test it in a small sample of patients from the target population.
There were no changes to the project originally outlined in the proposal
This project had two main objectives: to (a) develop the content and the delivery mode of the intervention, and (b) test the intervention in a pre-post pilot study.
To develop the intervention content, a systematic literature review with meta-analysis and meta-regression was conducted to assess whether IVR interventions are effective at increasing medication adherence, and what is the active intervention content that associates with the intervention effectiveness, and a review of empirical evidence about the theoretical determinants of medication adherence behaviour change. The evidence synthesis resulted in the (a) development of theoretical framework of the intervention, (b) the tailoring questionnaire, and (c) the message file with Behaviour Change Techniques (BCTs).
To develop the intervention delivery mode, consultations with experts in the industry and academia were conducted, and an application to facilitate the delivery of the intervention was developed
A prototype intervention was developed by multiple and iterative syntheses of the data obtained during the intervention development process. The intervention is highly tailored to deliver very brief (³³1 minute), theory-based messages at participants’ preferred time, telephone to receive the calls (i.e., primary and/or secondary number), and at frequency of calls (e.g., repeat options). Patients use the voice recognition to provide feedback during inbound or outbound calls. The intervention consisted of 29 messages, delivered daily for a duration of one prescription-based month and at participants’ preferred time. Two messages were delivered at the first day of the intervention, with feedback tailored to participants’ responses at the tailoring questionnaire, and one message per day during the following 27 days of the intervention.
The pilot study had three main objectives: to (a) assess uptake, retention, fidelity, and engagement with the intervention, (b) obtain participants’ views, understanding, and actions upon the intervention content, and (c) obtain their feedback and recommendations about the intervention content, delivery mode, and implementation procedures.
Patients with hypertension were recruited by three primary care practices located at different areas of deprivation within the Cambridgeshire and Peterborough CCG. One nurse/health care assistant (HCA) per practice was recruited. Nurses/HCA were eligible if they consulted patients about taking medications.
Patients were eligible if they: (a) had a primary diagnosis of hypertension;; (b) had been prescribed at least one anti-hypertensive medication as confirmed by practice records for at least three months before recruitment;; (c) had gaps in collecting repeat prescriptions or had poorly controlled blood pressure as indicated by practice records;; and (d) were aged 40 years or older. Patients were excluded when they: (a) had hearing or speaking impairment, (b) had a diagnosis of dementia, aphasia or other cognitive difficulties that could affect the study participation, (c) had a recent severe life-threatening event, (d) had difficulty in speaking or understanding English, or (e) participated in another study. A practice GP double screened the list of selected patients against the inclusion and exclusion criteria to confirm eligibility. Eligible patients were invited (a) by post or telephone calls following up the postage invitation,
(b) face-to-face by practice nurses or health care assistants, or (c) by leaflets and posters in the practice waiting room. Practice nurses received training by a research assistant on the face-to-face recruitment procedures. Participants completed measures at baseline (T1) and at the end of the intervention (T2).
Participants completed the tailoring questionnaire (T1, T2), their preferred primary and secondary telephone number to receive the calls, and the time intervals of repeated calls per telephone number (T1), two items measuring medication adherence (T1, T2), 16 items measuring their experience and satisfaction with elements of the intervention (T2), and face- to-face interviews with a member of the research team (T2). Medication refill data for the duration of three months before T1, and at T2, were collected from the practice dispensary records. Telephone log files assessed uptake, retention, fidelity, and engagement with the intervention. Participants’ inbound calls to the IVR assessed intervention engagement and intervention impact. Face-to-face interviews (T2) assessed users’ feedback about the intervention content and delivery mode, and obtained recommendations for improvement. Face-to-face interviews with practice nurses assessed recruitment and data collection procedures, and obtained recommendations for improvement.
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Uptake and retention.
Eighteen participants provided written informed consent and registered into the study, of whom 17 completed the one-month intervention: one participant was excluded by the research team before registration because he/she was meeting one of the exclusion criteria, one participant withdrew before registration to the IVR, and the other participant dropped out during the intervention. All seventeen participants completed the measures at baseline and at the end of the intervention. All primary care practices provided completed baseline (e.g., refill prescription data three months before the start of the intervention) and follow up data for all participants.
Fidelity of, and engagement with the intervention delivery and intervention content.
During the one-month intervention on average 29 calls were scheduled, of which 22.52 calls received by participants. On average 37 calls were made, of which 2.8 failed to be made due to technical issues and 13 calls made but failed to go through because they were not picked up by the participants. On average three calls were repeated and received by participants. However, 10 out of the 17 participants had chosen the calls to be repeated, if not answered, and five out of the 17 participants had provided a secondary number for the calls to be repeated, if there was no answered at the primary number. Overall, participants were highly engaged with the intervention and made inbound calls to change the schedule of the messages or report about intervention content. There was a very good fidelity of the intervention BCTs, with the majority of the BCTs having high fidelity scores (Table 1).
Table 1. Fidelity and engagement, intervention content (n=17)
Behaviour Change Techniques | IVR calls scheduled | IVR calls received |
Tailored to baseline questionnaire | 1 | 0.6 |
Personalised | 29 | 22.52 |
Information about health consequences | 5 | 4.41 |
Information about emotional consequences | 1 | 0.65 |
Action planning, implementation intentions | 4 | 4 |
Report whether or not the behaviour was performed | 2 | 1.74 |
Social reward | 2 | 1.4 |
Habit formation | 24 | 19.58 |
Social support (unspecified) | 3 | 2.29 |
Note data from log files reported as average number
Participants’ feedback about the intervention content and delivery mode.
Participants reported that the intervention content increased their awareness about medication adherence and the risk and benefits of maintaining adherent to medication taking, reminded them to take medications as prescribed, and reinforced habit formation and the sense of social support (Table 2).
Table 2. Participants’ experiential feedback about the intervention content (n=17).
Messages content and tailoring: Understanding and acceptability of the theoretical determinants |
Increase awareness of the importance to take medications as prescribed “So, that message came over quite clear, you know, that you must – you mustn’t miss them. You must take them, you know. So, I thought it was quite good.” patient 01001X Increase awareness of the benefits to keep taking medications as prescribed, and potential risks when not taking medications
Remind to take medication “For me, the short message was ideal, you know? Who am I? and yes, and, “Have you taken your medication?”” patients 01006W “I liked the idea of just a phone call to say, “Is that (name)?” “Yeah.” “Take your tablet.” Straightforward, you know” patient 01001X “Oh, well, just the, you know, jogging the memory… Yeah, it’s, you know, the telephone rings, somebody comes out with a message, are you so and so? Don’t forget to take your tablets and so, you take them” patient 01025G “I will say I liked it because it reminded me, like helped me to remember to take my tablet” patient 01051L “I thought it was a good system to – it just reminded me to take my tablets” patient 02028K Habit formation "Well, the telephone call comes through at the same time every morning and so, you know you’re going to take the pills.” Patient 01025G, follow up interview “Well, I mean, yes, I mean, the phone call alone, without any message at all, would remind you” patient 01031Q “it helped the routine, I mean, that was just that reminder of doing things ... by the end I’d developed a bit of a routine that I’m sitting there with the kind of phone ready for 8 o’clock, right, and then I would go and take my tablets” patient 01057V
Social support (unsp) “it was interesting to do it and to think someone’s taking some notice of what I’m doing, trying to get rid of my high blood pressure” patient 01024X |
Note: data from patients' face-to-face follow up interviews
Participants suggested that the intervention was acceptable and easy to use (Table 3), and they provided their views about specific features of the intervention delivery mode and content. Specifically, the tailored schedule of the messages, the personalisation, and the variation of the content was found to be particularly appealing, and were perceived to promote engagement with the intervention.
Table 3. Participants’ experiential feedback on the intervention delivery mode (N=17)
| Table 3 |
“It was certainly easy to use. There’s nothing complex about it really. I mean, if you’ve got any questions, you can just ring the numbers. I didn’t have any questions, personally, but if you’ve got any, you can ring the number and it’s quite easy and straightforward” patient 01006W “it was always dead on time too, and if I – so, it didn’t recognise it, they phoned back, sort of, about five minutes later and then it was alright” patient 01024X “Well, it was very easy, just – yeah, very easy. I had clear numbers to call if there was a problem, which I did, on a couple of occasions. No, it was very easy … I think having the choice of time is best… Yes, yeah, no, I think that is important, the choice of time, definitely” patient 02028K “they were easy and as long as they were at a set time, which they were, and there’s – and if there’s a second mobile phone, so if the first one misses, at least you can get hold of the person on the mobile if they’re out and about” patient 01025G |
Participants reported being satisfied with the overall experience with the intervention, the availability of the intervention 24/7, and their ability to call in and leave a message. They also reported that they would recommend the intervention to other people who take prescribed medications (Table 4 and 5).Note:data from face -to-face follow up interviews
Satisfaction with … | Mean (sd) |
the experience with the intervention | 4 (0.7) |
the voice delivering the intervention messages | 3.7 (1.1) |
the content of the intervention messages | 3.8 (0.8) |
being able to call the intervention | 4 (0.7) |
the availability of the intervention 24/7 | 4.2 (0.8) |
the response you receive from the intervention | 3.4 (0.7) |
the response you received to your particular queries/questions | 3.4 (0.7) |
Note: data from follow up questionnaires. Likert scale, 1 strongly agree to 5 strongly disagree.
Table 5. Participants’ perception of the intervention utility and future use
| Mean (sd) |
the IVR messages helped me to take my tablets as prescribed | 3.2 (1.3) |
the IVR reminded me to take my medications as prescribed | 3.5 (1.3) |
the IVR system was easy to use | 4.3 (0.7) |
the IVR addressed my personal needs | 3.3 (1.1) |
it would have been useful, if the IVR was part of the regular care | 3.7 (0.9) |
I would recommend the IVR to other people who take medications for long-term conditions | 4.2 (0.8) |
Note: data from follow up questionnaires. Likert scale, 1 strongly agree to 5 strongly disagree.
A highly tailored intervention has been developed to support adherence to medications prescribed for high blood pressure and co-morbidities (e.g., glucose lowering medications). The intervention is based on rigorous theory and evidence. It aims to increase adherence to daily prescribed medications and includes a combination of Behavioural Change Techniques (BCTs) tailored to patients’ beliefs (e.g., beliefs about medications, self-efficacy, social norms, perceived regimens complexity) and prescription plan. The intervention has been found to be acceptable and feasible, with high retention, engagement and fidelity. To our knowledge, this is the first medication adherence intervention delivered using IVR that has been developed and piloted within the UK primary care setting. Future studies could usefully test the efficacy of such intervention to support medication adherence, and other health behaviours.
Interactive voice response (IVR) interventions are effective ways to increase adherence to medications, and can potentially be cost-effective if applied into a larger scale. This report briefly describes the systematic development and piloting of a tailored IVR intervention to increase adherence to anti-hypertensive medications. To our knowledge this is the first IVR medication adherence intervention that has been developed and pre-tested within the primary care setting.
The intervention content was based on rigorous evidence and theory, and the development process was informed by a review of the literature andPPI input. Twenty people with hypertension, presumed to be non-adherent, were recruited by three primary care practices, of whom 17 tested the one-month intervention. The intervention consisted of 29 very brief messages (³³1 minute), delivered daily to participants phones (landline and/or mobiles). Two messages were delivered at the first day of the intervention, with feedback tailored to participant’s responses at the tailoring questionnaire, and one tailored message per day during the following 27 days of the intervention. Patients used the voice recognition to provide feedback during inbound or outbound calls. A mixed methods study generated data from baseline and follow-up questionnaires, call log files, inbound voice messages, and face- to-face follow up interviews.
On average, 29 calls were scheduled and 23 messages were received. Log file data suggested that intervention fidelity and engagement was high. Participants’ experiential feedback suggested that the tailored schedule of the calls and the variation of the content were found to be particularly appealing, and were perceived to promote engagement with the intervention. Data suggested that the intervention messages increased awareness of the importance to take medications as prescribed, and facilitated habit formation and social support.
Participants agreed on the need for, and the potential benefits of, an IVR intervention to support adherence to anti-hypertensive medication, as an adjunct to primary care consultations. Future research could usefully test the feasibility of a tailored IVR intervention to support medication adherence in the primary care.
Two PPI members, recruited by the NIHR CBR PPI, pre-tested the IVR intervention for one month, and provided their experiential feedback about the intervention content and delivery mode during four, weekly telephone-based interviews with a researcher, and completed the baseline and follow up questionnaire. PPI members also provided their input, using think aloud protocols, on the development of the tailoring questionnaire.
PPI input, with approximately 100 people during public events (e.g., Science Festival) or using emails, informed the content of the message file and the recruitment material.
The data generated from PPI refined the intervention, before testing it with patients recruited in primary care.
The PPI involvement also increased PPI awareness about the use of digital interventions to healthcare.
The data generated from this study has impacted in the development of a highly tailored intervention to support adherence to anti-hypertensive medications. The intervention will be tested in a feasibility trial. If it is effective, it could increase the number of patients who take their medications as prescribed in the long term and achieve associated health benefits, and it could also reduce costs to the NHS from health complications and premature deaths associated with these conditions and waste in prescribing.
Project website: https://www.phpc.cam.ac.uk/pcu/research/research-projects-list/other-projects/ivrpilot/
This project was funded by the National Institute for Health Research School for Primary Care Research (project number 293)
The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the NIHR School for Primary Care Research, NIHR, NHS or the Department of Health.
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