Implementation study on population based carrier screening via the general practitioner in the northern part of the Netherlands. Research on the implementation of a clinically validated population based carrier screening test for couples with a child wish.

Implementation study on population based carrier screening via the general practitioner in the northern part of the Netherlands. Research on the implementation of a clinically validated population based carrier screening test for couples with a child wish. - PCS implementation study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON42389

Enrollment

2000

Registered

2015-11-02

Start date

2016-01-14

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

population based preconceptional carrier screening preconceptionscreening

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1 be a female patient from one of the participating GPs 2 aged 18-40 3 have a partner 4 have a wish to have children with that partner 5 and: male partners of these females

Exclusion criteria

Exclusion criteria: women who are already pregnant

Design outcomes

Primary

Measure	Time frame
1. psychological impact and informed choice 2. uptake 3. practical feasibility (GP) Ad 1. Psychological impact and informed choice Receiving information about the PCS test may, raise a couple*s awareness of the risk of having a child with a severe disorder. This awareness, in addition to having to make a decision whether to take the test or not may evoke adverse psychological reactions with both an emotional (anxiety, distress) and/or cognitive (rumination, decisional conflict) nature. Both couples who take the test as well as those who decide not to, immediately, or after consultation of the GP, may experience adverse psychological reactions. The broader literature on receiving genetic risk information and genetic counselling and testing shows that in general the psychological impact is moderate or at best short lived (Haga et al, 2014). To date, however, no studies have been conducted examining the psychological reactions of prospective parents without a positive family history to expanded PCS. In general, implementation a test, such as the PCS test, is acceptable from a psychological point of view, if psychological effects on population level are limited and if the level of knowledge of the population that gets the information is such that the decision on whether or not to take the test is based on an informed one. This implementation study is meant to investigate the impact on those couples who are offered the test, might take the test, but who are not a carrier couple. This concerns the large majority of our study population, since only 1-3 couples are expected to be a carrier couple. The impact on this group is relevant to measure, since the positive consequences of the PCS offer and taking the test, (increasing reproductive autonomy), for a small group (1 in 150 couples who take the test) need to be balanced against the burden of offering the test to the whole population that gets the offer. Informed Choice: Similar as in studie	—

Measure

Time frame

1. psychological impact and informed choice 2. uptake 3. practical feasibility (GP) Ad 1. Psychological impact and informed choice Receiving information about the PCS test may, raise a couple*s awareness of the risk of having a child with a severe disorder. This awareness, in addition to having to make a decision whether to take the test or not may evoke adverse psychological reactions with both an emotional (anxiety, distress) and/or cognitive (rumination, decisional conflict) nature. Both couples who take the test as well as those who decide not to, immediately, or after consultation of the GP, may experience adverse psychological reactions. The broader literature on receiving genetic risk information and genetic counselling and testing shows that in general the psychological impact is moderate or at best short lived (Haga et al, 2014). To date, however, no studies have been conducted examining the psychological reactions of prospective parents without a positive family history to expanded PCS. In general, implementation a test, such as the PCS test, is acceptable from a psychological point of view, if psychological effects on population level are limited and if the level of knowledge of the population that gets the information is such that the decision on whether or not to take the test is based on an informed one. This implementation study is meant to investigate the impact on those couples who are offered the test, might take the test, but who are not a carrier couple. This concerns the large majority of our study population, since only 1-3 couples are expected to be a carrier couple. The impact on this group is relevant to measure, since the positive consequences of the PCS offer and taking the test, (increasing reproductive autonomy), for a small group (1 in 150 couples who take the test) need to be balanced against the burden of offering the test to the whole population that gets the offer. Informed Choice: Similar as in studie

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Countries

Netherlands

Outcome results