Methods for evaluating the extent to which different ways of presenting evidence of the effects of health care help people make decisions that are consistent with their own values: a randomised trial

ISRCTN ISRCTN14949974
DOI https://doi.org/10.1186/ISRCTN14949974
Secondary identifying numbers HIPPO 1
Submission date
04/01/2007
Registration date
28/02/2007
Last edited
03/10/2007
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Andrew Oxman
Scientific

Norwegian Knowledge Centre for the Health Services
P.O. Box 7004
St Olavs Plass
Oslo
0130
Norway

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymHIPPO pilot
Study objectivesPilot study - development of methodology to:
1. Analyse which of several presentations of evidence of treatment effects best help people to make treatment decisions congruent with their own values
2. Compare visual analogue scales and category rating scales as value elicitation instruments
Ethics approval(s)This study was approved by the ethics review board at the University at Buffalo on the 15 May 2002 with several renewals.
Health condition(s) or problem(s) studiedN/A
InterventionSix different summary statistics presenting ten year risk reduction effect of statins on coronary heart disease in the treatment of hypercholesteremia.

The methodological aspects reported in this study include comparison of two value elicitation instruments (visual analogue scales and category rating scales), four theory-grounded approaches to weighting elicited values, and six summary statistics to evaluate the extent to which they promote decisions consistent with elicited values. In addition, we report hypothesis generation and sample size calculation for a randomised controlled trial comparing the same six summary statistics for communicating evidence of reduced risk of coronary heart disease, as well as on the feasibility of conducting this type of Internet-based randomised trial.
Intervention typeOther
Primary outcome measure1. Acceptance or rejection of statin treatment
2. Estimated probability to accept or reject statin treatment in relation to value score
Secondary outcome measures1. To investigate the feasibility of conducting Internet-based randomised trials comparing different risk reduction presentations
2. To compare two methods of eliciting values
3. Four ways of weighting the elicited values to calculate a total value
4. To generate hypotheses and calculate sample size for a confirmatory study comparing six summary statistics for communicating evidence of reduced risk of Coronary Heart Disease (CHD) with statin therapy for treatment of high cholesterol
Overall study start date31/10/2002
Completion date04/12/2002

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants770
Key inclusion criteria1. 18 years old
2. Fluent in English or Norwegian
3. Must give informed consent
Key exclusion criteriaNot meeting inclusion requirements
Date of first enrolment31/10/2002
Date of final enrolment04/12/2002

Locations

Countries of recruitment

  • Norway
  • United States of America

Study participating centre

Norwegian Knowledge Centre for the Health Services
Oslo
0130
Norway

Sponsor information

Norwegian Research Council (Norway)
Government

P.O. Box 2700
St. Hanshaugen
Oslo
0131
Norway

Website http://www.forskningsradet.no
ROR logo "ROR" https://ror.org/00epmv149

Funders

Funder type

Government

Norwegian Research Council (Norway) (project 135210 - A series of randomised trials comparing different ways of presenting health evidence on the Internet)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan