Primary care

Randomised controlled trial of an interactive multimedia decision aid on hormone replacement therapy in primary care

Elizabeth Murray, senior lecturer ^a, Hilary Davis, research fellow ^a, Sharon See Tai, senior research fellow ^a, Angela Coulter, director ^b, Alastair Gray, director ^c, Andy Haines, professor ^a. 

^a See Editorial by Deyo Department of Primary Care and Population Sciences, Royal Free and University College Medical School, University College London, London N19 3UA, ^b Picker Institute Europe, Oxford OX1 1RX, ^c Health Economics Research Centre, University of Oxford, Oxford OX3 7LF

Correspondence to: E Murray elizabeth.murray{at}pcps.ucl.ac.uk

	Abstract

Top Abstract Introduction Participants and methods Results Discussion References

Objective: To determine whether a decision aid on hormone replacement therapy influences decision making and health outcomes.
Design: Randomised controlled trial.
Setting: 26 general practices in the United Kingdom.
Participants: 205 women considering hormone replacement therapy.
Intervention: Patients' decision aid consisting of an interactive multimedia programme with booklet and printed summary.
Outcome measures: Patients' and general practitioners' perceptions of who made the decision, decisional conflict, treatment choice, menopausal symptoms, costs, anxiety, and general health status.
Results: Both patients and general practitioners found the decision aid acceptable. At three months, mean scores for decisional conflict were significantly lower in the intervention group than in the control group (2.5 v 2.8; mean difference 0.3, 95% confidence interval 0.5 to 0.2); this difference was maintained during follow up. A higher proportion of general practitioners perceived that treatment decisions had been made "mainly or only" by the patient in the intervention group than in the control group (55% v 31%; 24%, 8% to 40%). At three months a lower proportion of women in the intervention group than in the control group were undecided about treatment (14% v 26%; 12%, 23% to 0.4%), and a higher proportion had decided against hormone replacement therapy (46% v 32%; 14%, 1% to 28%); these differences were no longer apparent by nine months. No differences were found between the groups for anxiety, use of health service resources, general health status, or utility. The higher costs of the intervention were largely due to the video disc technology used.
Conclusions: An interactive multimedia decision aid in the NHS would be popular with patients, reduce decisional conflict, and enable patients to play a more active part in decision making without increasing anxiety. The use of web based technology would reduce the cost of the intervention.

	Introduction

Top Abstract Introduction Participants and methods Results Discussion References

Decision aids to assist patients in deciding about health care have been welcomed as one solution for improving doctor-patient communication, providing information for patients, and addressing the shortcomings in much of the information available.^1-5 Both patient outcomes and the rational use of health service resources may be improved by better provision of information.^6-9

Decision aids for patients differ from simple information packages. They often contain exercises to help patients clarify their own health needs, and they emphasise that different patients reach different decisions.¹⁰ Decision aids aim to promote shared decision making,¹¹ where the clinician and patient jointly negotiate and agree on a treatment decision, taking into account both the probability of a range of clinical outcomes and the relative weight the patient places on these outcomes.

A recent systematic review of decision aids determined that they improve patients' knowledge of their condition and treatment options.¹² They seem to help with decision making in that "decisional conflict scores" (a measure of patients' internal perceptions of ability to make a decision and satisfaction with the decision made) tend to be lower in groups that have used a decision aid than in control groups.¹³ There are, however, several unanswered questions,¹⁴ in particular the impact of decision aids on choice of treatment, satisfaction, health status, and persistence with treatment. Additionally, there is little evidence on the use of decision aids in primary care. Few data are available on clinicians' perceptions of decision aids or their cost effectiveness. We address these questions here and in the accompanying paper on patients with benign prostatic hypertrophy.¹⁵ The two trials were designed to complement each other by examining qualitatively different decisions in different populations. In this paper we aimed to determine whether an interactive multimedia decision aid promoted greater patient involvement in decision making and what influence this had on the uptake of hormone replacement therapy, health status, and anxiety. We also aimed to determine the acceptability of such a system and to undertake an economic analysis.

	Participants and methods

Top Abstract Introduction Participants and methods Results Discussion References

We invited general practitioners in two urban (Oxford and London) areas and one suburban (Harrow) and one semirural (Thame and the Chilterns) area to participate in our study. We asked participating general practitioners to recruit perimenopausal or menopausal women who were facing a decision about whether to start, stop, or continue with hormone replacement therapy.

Intervention
The intervention, developed by the Foundation for Informed Medical Decision Making, comprised an interactive multimedia programme, with booklet and printed summary.¹⁶ Information comprised quantified probabilities of the risks and benefits of hormone replacement therapy taken from systematic reviews and other published data available in 1996 and updated in 1998. Topics discussed were menopausal symptoms, mood changes, skin changes, changes in energy, vaginal dryness, changes in libido, heart disease, osteoporosis, breast cancer, and endometrial cancer. After viewing the programme the patients were given a summary of the information; a copy was also sent to their general practitioners.

View larger version (37K): [in this window] [in a new window]   Progress of patients through trial

As the programme used interactive video disc technology, we imported specialised hardware from the United States. This limited the number of machines available for patients to use. Patients travelled to one of five sites, chosen for ease of access from referring practices, to view the programme in a private room. All the patients saw the core programme, lasting about one hour; viewing optional sections for further information took up to 30 minutes more.

Randomisation and data collection
Patients randomised to the control group received normal clinical care. The randomisation schedule was generated by computer. Allocations were sealed in opaque numbered envelopes, opened by the study nurse after collection of the baseline data.

We collected data from the patients at baseline and at three and nine months after randomisation. Data included personal details, decisional conflict scores, patients' and general practitioners' perceptions of who made the decision, treatment preference, persistence with treatment, anxiety,¹⁷ health status and limitations in physical functioning (SF-36),¹⁸ health states and valuation of health states (EQ-5D),¹⁹ and menopausal symptoms (MenQol).²⁰ Patients in the intervention group completed a questionnaire immediately after viewing the programme.

Economic evaluation
We recorded the resources used by each patient over the trial period. The unit costs were attached to resource volumes to obtain a total cost per patient. As the technology we used was superseded by CD Rom, personal computer, and internet technology by the time our trial was completed, we also present some estimates of the costs of an alternative delivery system. Utility was measured with the EQ-5D at baseline and at three and nine months. Valuations of health states were taken from the UK population tariff.²¹ We conducted our economic evaluation from the perspective of the healthcare system. All costs are in pounds sterling at 1999 prices.

Sample size
Allowing for a 30% dropout rate, 120 women in each arm (84 women completing the trial) would give our study an 80% power of detecting a 15% point difference in use of hormone replacement therapy (between 8% and 23%)²² in the two arms at the 5% significance level.

View this table: [in this window] [in a new window]   Table 1. Baseline characteristics of participants. Values are numbers (percentages) of women unless stated otherwise

Analysis
We present the results for the patients who completed the nine months' assessment, as the intention to treat analysis did not alter the results.

	Results

Top Abstract Introduction Participants and methods Results Discussion References

Overall, 26 general practices agreed to participate, and between October 1996 and August 1998, 205 women were recruited (figure).

Baseline characteristics
The intervention and control groups were comparable at baseline (table 1), except for educational achievement, which was higher in the control group.

Reactions to decision aid
Patients reacted positively to the decision aid. Women in the intervention group seemed to make a more definite choice about treatment than those in the control group, with fewer women being "undecided" and more women deciding not to take hormone replacement therapy at three months; by nine months, however, this difference was no longer significant (table 2). Decisional conflict scores were lower in the intervention group than in the control group at three months (table 3); the significant differences persisted at nine months. General practitioners perceived the decision to have been made "mainly or only [by the] patient" in a significantly higher proportion of patients in the intervention group than in the control group, although there were no differences in patients' perceptions of who should make the decision.

View this table: [in this window] [in a new window]   Table 2. Treatment preferences for hormone replacement therapy at three and nine months' follow up. Values are numbers (percentages) of patients unless stated otherwise

View this table: [in this window] [in a new window]   Table 3. Decisional conflict scores at three months. Values are means (SDs) unless stated otherwise

Economic analysis
No significant differences were detected when the cost of the trial technology was excluded (table 4). When the cost of the video intervention was included, the cost per patient was £306 in the intervention group and £91 in the control group over nine months (P<0.001).

View this table: [in this window] [in a new window]   Table 4. Resource use and costs in pounds sterling (at 1999 prices) per patient, by allocation. Values are means (SDs) unless stated otherwise

	Discussion

Top Abstract Introduction Participants and methods Results Discussion References

The decision aid for hormone replacement therapy was acceptable to both the patients and their general practitioners. It enhanced the women's understanding of the effects of hormone replacement therapy and seemed to reduce decisional conflict for the duration of follow up. These findings are compatible with the recent systematic review of decision aids⁵ and provide new information on the acceptability of such decision aids to clinicians and patients in primary care and the impact on costs to the NHS.

Implications for the NHS
Public demand for improved access to quality sources of information is high and likely to increase. Decision aids have the potential to alter the use of healthcare resources in line with patients' preferences and, through the influence of patient choice on clinicians, may help to promote evidence based practice.²³

Delivering programmes to standard personal computers through the internet would reduce the cost per session from about £177 to £5 (excluding the cost of software). This assumes equipment costs of £1500 over three years, with a fairly low utilisation rate (two users per weekday) and lower space and staff costs commensurate with a less dedicated technology. Thus this type of interactive decision aid, which provides a realistic and practical solution to the problem of achieving informed patient choice at low cost, could easily be incorporated into multiple access points for information such as those envisaged for NHS Direct Online.

	Acknowledgments

We thank Jo Burns for administrative support, the research staff Liz Redfern, Sue Davis, Jean Catterson, and Marjorie Talbot, and the general practitioners. AH is currently based at the London School of Hygiene and Tropical Medicine, London WC1E 7HT.

	Footnotes

Funding: BUPA Foundation and the King's Fund.

Competing interests: None declared.

The full version of this paper is available on the BMJ's website

	References

Top Abstract Introduction Participants and methods Results Discussion References

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(Accepted 6 April 2001)